The Bright Hope for Allergic Rhinitis

As the name suggests, Allergic rhinitis (also known as hay fever) is an inflammatory disorder of the nasal mucosa, which occurs when the immune system overreacts to allergens in the air. This might sound small, but it affects 20% of the adult population and up to 40% of children.

Allergic rhinitis is biologically associated and equated with decreased learning, performance, productivity at work and school, and reduced life quality. It affects the quality of life, including fatigue, irritability, memory deficits, and depression. It is reflecting the social-economic costs and the negative impact on the quality of life.

Light Therapy for Rhinitis

If we talk about the current therapeutic options like allergen avoidance, medication, and immunotherapy, they are quite far from ideal. Light therapy has been treating immune-mediated dermatological conditions, e.g., psoriasis and atopic dermatitis.

Light Therapy has been There!

It is one of the oldest treatments that has been practiced in ancient times. Red light therapy has profound immunosuppressive effects on the human body.

As per ARIA guidelines, Red light therapy has been recommended for patients with allergic rhinitis who do not respond to standard medical treatment.

Now, the questions arise what the benefits of red light therapy are? Why should you opt for it?

Well, there are many benefits to using red light therapy:

  • Better and increased blood circulation in the nasal tissues
  • Enhanced local blood oxygen saturation
  • Reduced nasal obstruction (congestion) caused by nasal swelling
  • Improved nasal anti-virus ability
  • Repaired local blood capillaries
  • Strengthened detoxification ability of the nasal mucosa
The Mechanism

Light therapy treatment delivers light to pathological areas to promote tissue regeneration, reduce inflammation, and relieve pain. This treatment improves the nasal obstruction caused by Allergic rhinitis. The sessions involve illuminating the nasal cavity through specific wavelength log light ((660nm — 810nm) to the nose for a certain amount of time.

Most light therapy devices include one or two small LED light-emitting probes, which quickly stimulate the nasal cavity's blood capillaries.

Light therapy mechanisms reduce the number and function of dendritic cells and induce immunomodulatory cytokines like IL-10. Cytokines are a large group of proteins, peptides secreted by specific cells of our immune system. The Red Light therapy generates little heat, modulating mucosal blood supply and histamine release (organic nitrogenous compound involved in local immune responses). This heat alters mucosal blood supply.

The therapy shows improvement in the symptoms of nasal congestion and a decrease in nasal resistance. Studies showed that Phototherapy resulted in a significant improvement of clinical symptoms for nasal itching, rhinorrhea, sneezing, and total nasal score.

Red light therapy resulted in a remarkable improvement of clinical symptoms for nasal itching, rhinorrhea, sneezing, and total nasal score.

Adopt light therapy and give your life a better quality. Improve the shape of your life; let the negativity and obstructions be at bay!

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Green Light Continues to Show Positive Effects on Migraine Sufferers

Anyone who’s had a migraine knows how debilitating can be - even more so if that person is a chronic migraine sufferer. At its worst, migraines can be all-consuming: you can't open your eyes from the pain, perhaps even suffering from nausea and vomiting. 

Migraines are even more common than you think. They’re a more powerful headache, which usually affects one side of the head. Sometimes they come with warnings, but most times you’ll just get them suddenly, which is probably the most inconvenient part. Migraines can be difficult and painful. You could be having a regular day with no problems, and suddenly you'll get a jolt of pain to your head that feels inescapable.

Dealing with a migraine is often a serious challenge; you can’t just go lie down and take 30-minutes to rest up. It takes hours, even days for a migraine to end. And if you’re working, unable to take multiple days off, this is a serious problem. 

Migraines can happen with or without auras. When they occur with auras, this means you see flickering light, spots, or lines. It can feel like your mind is playing games with you when in reality, it's a migraine forming. 

Migraines without auras are the ones that come without warning; however, mood changes can be an indicator that a migraine is manifesting itself for you. Your eyes could start burning or watering, and your nose could be stuffy right before a migraine. They usually feel like a throbbing pain in your head, as mentioned, often on one side of the head. Neck pains and cramps are also something you could be feeling and experiencing during a migraine. 

They often feel like a tightening of the whole head and body, giving a rather inconvenient sensation. It's not uncommon to experience vertigo and double vision, as well. Migraines sometimes feel incurable, precisely because of the way the symptoms can vary. You can experience one type of migraine and, within a few days, a completely different one. Sometimes they last for minutes and others, hours or days. 

If you, someone you know, or a patient of yours is experiencing migraines frequently and severely, that person has probably seen a doctor for the condition. And though some people have shelves full of prescriptions, many are seeking something less invasive, without side effects, yet still effective. Well, luckily, there is a solution for non-invasive migraine treatment: light therapy lamp treatments.

Light therapy is a way of transforming your overall health. In a light therapy treatment, you not only receive relief for your migraine but also for your general health. LED light therapy health benefits multiply the more invested you are. Light therapy eases the symptoms of whatever may be getting in your way while increasing your energy and improving mood.

How light therapy can help migraines is via green light. While green light therapy has been studied for a while, recent studies are proving its effectiveness against migraines. A new study shows that green light exposure reduced the number of headache days per month by an average of about 60%. The light not only reduced the pain but reduced the time of the migraine, making it shorter and more bearable. Another study showed that immediately after light therapy treatment, patients reported reduced migraine discomfort by 20%. Green light also produces a relaxing effect and has shown a much better result at dealing with migraines long-term than any other form of light. 

So by penetrating into the body’s cells, it regenerates your cellular system, and thus, the whole body. It’s a process that should be done in the darkness, at any given time, for a period of 15-30 minutes. With daily treatments, you are more likely to reap the many benefits of light therapy. 

Kayian's light therapy devices are perfect for at-home treatments or for use in medical clinics, specifically designed for you or your clients’ wants and needs. They are MDA-certified and FDA-approved, ensuring that your light therapy device meets medical and safety standards.

College Students use Light Therapy to Improve Seasonal Affective Disorder (SAD)

The life of a college student is taxing, to say the least. It's likely the first time you're doing something on your own, and are responsible for yourself, your schedule and lifestyle. For some, this is the most liberating time; for others, it’s incredibly overwhelming. However, there's a general agreement that college students all go through difficult times. 

Whether still living with parents or sharing a dorm or space with roommates, college students are immersed in an entirely new life experience. Classes are challenging and students struggle with getting their work done while maintaining a social life, and perhaps a job. The level of pressure to succeed is very demanding, and this can cause negatively associated thoughts, leading to stress. Eating habits change and alter, usually for the worst, not to mention that the new sense of freedom can be chaotic for many young adults. 

Taking care of yourself is the number one priority, and when learning to deal with the new load of responsibility, college students often get sidetracked. Health and self-care get only an ounce of attention and not nearly as much as it should. While many students think it takes a lot of effort, just starting small shows results. 

Stress is the precursor of everything in our body, and leads to all sorts of illness and disorders. It's pretty common for college students to experience stress; more than 40% of students claimed to have experienced above-average stress levels, with it getting worse during exam periods and the winter season, when even more time is spent indoors. All of this, compounded by a pandemic and social distancing, makes for extremely challenging circumstances for college students today.

Now, colleges such as the University of Iowa are turning to light therapy to help get students the light they need to continue thriving. 

Seasonal affective disorder (SAD) is a mood disorder that occurs annually, generally in fall and early winter, and ends in sunnier and warmer months of spring and early summer. However, it’s worth noting that it’s not a perfect formula; there have been reported cases of the opposite, where a person starts experiencing the disorder spring or summer, and it only ends with the arrival of fall/winter. 

SAD can affect 11 million people in the U.S. each year, and 25 million more may have a milder form of the same disorder, also known as winter blues. Depression and anxiety affect 40 million adults in America, while only 36.9% receive the proper care for these mental health conditions

And, SAD’s symptoms can look and feel much like depression. It causes you to sleep more and gives you symptoms that look like other disorders such as chronic fatigue syndrome, under-active thyroid, low blood sugar, viral illnesses, or other mood disorders.

Seasonal affective disorder is linked to a lack of sunlight. The winter days are shorter, and that itself our circadian rhythm, or internal body clock. Everyone has a specific sensitivity to sunlight, and our bodies take a cue from the morning sunlight each day. In the winter time, the lack of sunlight creates perfect circumstances to experience SAD.

Light therapy, by definition, gives you a healthy supply of what you lack in winter months, often leading to SAD. But light therapy is much more than that. Light therapy’s uses and benefits are many, so while treating SAD, you could also be treating other problems you may not even know of – it’s like killing multiple birds with one stone, and that stone happens to be safe, non-invasive, and non-pharmaceutical.

Light therapy mimics the positive effects produced by exposure to the sun. It reproduces the effects the sun provides us with, and can solve numerous symptoms of SAD through the use of ultraviolet rays. You may be wondering if red light therapy is safe for skin: yes, it is entirely safe. Specifically, with Kayian's light therapy devices, which are FDA-approved and MDA-certified.

With light therapy, you're able to stimulate your cells into rejuvenation. The light works directly at the cellular level and triggers the reproduction of ATP, the fuel our system needs to function properly. 

Light therapy helps with SAD by causing our brain to believe it's getting more sunlight. Even though the light is fabricated, it's still light. We still reap all of the benefits as we do from sun exposure. Melatonin and serotonin are what affects the impact; they too, are triggered by our light therapy devices, which is what battles SAD. 

The scientific evidence on light therapy and SAD says that even within the first hour, you may experience positive results. With daily use of light therapy, thousands of people have overcome the debilitating symptoms of SAD and other disorders, and now even college students can turn to the holistic treatment to replenish the light they’re lacking.

Light Therapy Proves Effective in COVID-19 Treatment Once Again

Even though we’ve been in the pandemic for over a year now, we are still collecting knowledge on the disease. No one could’ve prepared us for the impact of this virus, and COVID-19 has changed our lives forever. 

It is a disease caused by the coronavirus, and the symptoms are similar, but people react differently. It isn’t a virus that gives the same outcome, which is why we have to be so cautious with it. Most common symptoms include fever and dry cough, and extreme fatigue. Apart from those, the other major symptoms are a loss of smell and taste, joint pain, diarrhea, conjunctivitis, and headaches.

Scientists and doctors have learned that respiratory problems are the biggest issue while having the disease. The downfall of our immune system during COVID-19 is what gives a chance for pneumonia to develop. Apart from those symptoms and the dangers of getting pneumonia, there’s also potential long-term effects. 

So far, only one peer-reviewed study has reported results on the long-term symptoms of COVID-19 infection: a single group of 143 survivors from Rome. Most of them did not need hospitalization and were assessed at least 60 days after infection. They reported a worsened quality of life in 44.1% of cases, including symptoms of persistent fatigue (53.1%), breathlessness (43.4%), joint pain (27.3%), and chest pain (21.7%).

Treatment has evolved within this short period, and now with the vaccine in power, it poses a question: is it the only solution? It's still necessary to nourish our immune system no matter what; intake of vitamins and supplements is still highly advised. But naturally, aside from the vaccine, you would want a non-invasive alternative as well, which is where light therapy comes into play.

Red light therapy is a non-invasive and non-pharmaceutical method of treatment. It works with light that emits at a close, safe distance, penetrating into the cells. Once it reaches cell level, it helps reproduce ATP, which gives a higher and better cell turnout. 

Our cells rejuvenate and reproduce themselves; light therapy only aids in this natural process. With light therapy, we get a better and higher count of cells that are genetically improved over time with treatment. 

The ways in which light therapy can help with COVID-19 have been studied for a while now, and we shared some information on early clinical trials with you previously. 

Light therapy can help with COVID-19 in reducing severity and prominence of symptoms; it works so that light therapy generates the activation of mitochondrial antiviral signaling protein (MAVS), thus resulting in the reduced expression of viral spike protein and restores the proliferation of infected cells.

Your cells are healing your body by using light therapy––similar to how UV light therapy aids wound healing––and it is there to provide you with more vital cells for your system. A significant reduction of viral infection in the trachea was noticed, the spots where we notice symptoms first, such as our nose and our throats. This means that light therapy helps regulate and decrease the possibility of getting a respiratory disease like pneumonia. 

A significantly smaller level of C-reactive protein was observed within seven days of UVA therapy regarding biochemical parameters. It proves that light therapy helps with the deconstruction of damaging proteins in our cells. 

Photo-disinfection is used to get rid of harmful bacteria from surgical patients; this is only another form of that. There's also a method where a non-toxic dye is inserted into the nose. It is one that is triggered by light, and then it is measured whether or not the light therapy device has successfully inactivated the virus. This method is used in the early stages of COVID-19.

The one used in the beforehand mentioned study included a light therapy device equipped with a multi-LED UVA light catheter connected to the nasal tube to deliver UVA light to the patients. Our devices are created with multi-LED, so the type of light therapy is your choice, depending on your needs.

The UVA therapy was administered for 20 minutes to all patients once daily for 5 consecutive days. Before the treatment, all patients received oxygen supplementation for 30 minutes. The regimen varies however light therapy should be done consecutively and 10 to 15 minutes.

The coronavirus is still here, but you’re not defenseless. Kaiyan Medical works to develop the best high-quality light therapy devices, with FDA-approved and MDA-certified light therapy devices perfect for at-home treatments. Whether you’re looking to bolster your immune system or wish to provide non-invasive treatment to patients with COVID-19, light therapy is an incredibly powerful and effective tool in fighting the serious symptoms of this virus.

Alzheimer's and Light Therapy Treatment

Losing our memory is something we all fear of. Alzheimer's disease is a very difficult, and the most common form of dementia. This general term refers to the loss of memory and other intellectual skills so severe that it interferes with daily life. Alzheimer's disease accounts for 50-80% of dementia cases.

Alzheimer's is a neurological disorder believed to have genetic components. It's thought to be caused by the abnormal build-up of proteins in and around brain cells; and Alzheimer's is not just a disease of old age, as it was once widely believed to be. Up to 5% of people suffering from this disease have an early onset of Alzheimer's disease (also known as "early-onset"), which often appears when a person is between forty and fifty years old. 

It is a life-altering disease and can be extremely challenging. It's not something that affects only the patient; it is a disease that alters the lives of those around you, as well.

The life expectancy after diagnosis is typically eight to ten years. Of course, this varies; a person can live up to 20 years post-diagnosis. Sometimes people don't get diagnosed for a few years, thus leading them to have less time. 

When Alzheimer's disease strikes, it initially presents symptoms that may be so mild that they go unnoticed by both the patient and his family; however, as the disease progresses, these symptoms become more evident and begin to interfere with daily activities and relationships.

The main symptoms are significant memory loss, difficulties in producing and understanding language, inability to recognize people, objects, or places, decoding external stimuli, and difficulty performing simple voluntary movements, such as using objects. As the disease progresses, psychiatric symptoms often occur, such as depression, anxiety, apathy, irritability, and even aggression.

A person with Alzheimer's needs a safe place and environment. Things must be kept simple, and their life significantly changes. You can't really expect a person suffering from this disorder to be the same. Their personality and behavioral changes are entirely normal.  

The list of light therapy uses and benefits goes on and on, as it is a form of treatment that can help with many health issues and disorders. However, for people with Alzheimer's, it can have a powerful effect on their experience.

Red light therapy is a form of therapy that works simply by producing light. There are many different devices, lightboxes, masks, and lamps that are used. The ultraviolet rays you receive in a light therapy session are the ones who directly target at the cellular level. Once the cells are penetrated by light, they accelerate at their reproductive level, increasing ATP production. ATP is the powerhouse of the mitochondria, essential for our system to function optimally.

A review of red light therapy is something we can all benefit from. There are no downsides to red light therapy, as it is a non-invasive and non-pharmaceutical procedure. 

Light therapy focuses on the cellular level. MRI imaging uncovered a 61% reduction in whole-brain atrophy and losses of volume in areas associated with Alzheimer's from red light therapy treatments. It works by rejuvenating the cells, creating new ones at a higher rate. Our organism benefits from cellular alteration because of the production of new cells. This means they're not only fresh cells, but they're stronger than before.

Light therapy masks help suppress Beta-amyloid (Aβ) build-up, the protein that forms senile plaques in the brains of people with Alzheimer's and dementia. So it's focusing on getting rid of the root of the problem. With a reduced build-up, our brain cells return to their natural state, the protein having been successfully eradicated.

Kaiyan specializes in light therapy devices that are MDA-certified and FDA-approved, making our product easy and accessible, perfect for at-home treatments – even for some of the most challenging diseases and health conditions.

Green Light for Migraines: Does This Therapy Work?


“Migraine is one of the most common neurological conditions in the world, and it’s debilitating,” said Dr. Ibrahim

Green Light

The noninvasive nature of green light exposure makes it an ideal therapeutic candidate for other neurological conditions, such as fibromyalgia or HIV-related pain. Dr. Ibrahim and his team recently completed another clinical study in which people with fibromyalgia tried green light therapy. Like the migraine study, those results are similarly encouraging.

Clinical Study

Pharmacological management of migraines can be ineffective for some patients. Studies previously demonstrated that exposure to green light resulted in antinociception and reversal of thermal and mechanical hypersensitivity in rodent pain models. Given green light-emitting diodes' safety, they evaluated green light as a potential therapy in patients with episodic or chronic migraines.

For the study, they recruited (29 total) patients, of whom seven had episodic migraines, and 22 had chronic migraines. They used a one-way cross-over design consisting of exposure for 1–2 hours daily to the white light-emitting diodes for 10 weeks, followed by a 2-week washout period followed by exposure for 1–2 hours daily green light-emitting diodes for 10 weeks. Patients were allowed to continue current therapies and to initiate new treatments as directed by their physicians. Outcomes consisted of patient-reported surveys. The primary outcome measure was the number of headache days per month. Secondary outcome measures included patient-reported changes in the headaches' intensity and frequency over a two-week period and other quality of life measures, including the ability to fall and stay asleep and ability to perform work. Changes in pain medications were obtained to assess potential reduction.

When seven episodic migraine and 22 chronic migraine patients were analyzed as separate cohorts, white light-emitting diodes produced no significant change in headache days in either episodic migraine or chronic migraine patients. Combining data from the episodic migraine and chronic migraine groups showed that white light-emitting diodes produced a small but statistically significant reduction in headache days (days ± SEM) 18.2 ± 1.8 to 16.5 ± 2.01 days. Green light-emitting diodes resulted in a significant decrease in headache days from 7.9 ± 1.6 to 2.4 ± 1.1 and 22.3 ± 1.2 to 9.4 ± 1.6 in episodic migraine and chronic migraine patients, respectively. While some improvement in secondary outcomes was observed with white light-emitting diodes, more secondary outcomes with significantly greater magnitude, including assessments of the quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version of the EuroQol five-dimensional survey without reported side effects, were observed with green light-emitting diodes. Conclusions regarding pain medications reduction with green light-emitting diode exposure were not possible. No side effects of light therapy were reported. None of the patients in the study reported initiation of new therapies.

Green light-emitting diodes significantly reduced the number of headache days in people with episodic migraines or chronic migraines. Additionally, the green light-emitting diodes significantly improved multiple secondary outcome measures, including quality of life, intensity, and headache attack duration. As no adverse events were reported, the green light-emitting diodes may provide a treatment option for those patients who prefer non-pharmacological therapies or may be considered in complementing other treatment strategies. The limitations of this study are the small number of patients evaluated. The positive data obtained support the implementation of larger clinical trials to determine the possible effects of green light-emitting diode therapy.


This study is registered with clinicaltrials.gov under NCT03677206.

https://journals.sagepub.com/doi/10.1177/0333102420956711

Red light Therapy and Hyperpigmentation

Skin conditions can majorly affect a person’s self-esteem. One of the most common issues: hyperpigmentation. We've all heard the term before, but what is it, exactly? 

Hyperpigmentation causes dark spots on the face, hands, and other visible parts of the body that have been exposed to the sun's rays. Not only can it cause insecurities, but it can be very difficult to hide as these spots form in different shapes and sizes, with colors ranging from light brown to black.

There are many types of hyperpigmentation, but the following are the most common:

Pigmentation spots are age spots that occur as a result of exposure to sunlight. This is why they mostly appear in parts of the body that are usually exposed, such as the face, hands and arms. These are usually small, darkened areas of skin.

Melasma or chloasma is often called a "pregnancy mask" because it affects 90% of pregnant women. It occurs as a consequence of hormonal influences during pregnancy and contraception. It causes dark spots of irregular shapes on the face or hands, which can be large in size.

Gradual hyperpigmentation occurs when a flat area of ​​discoloration remains after the skin injury has healed. It is a common occurrence among people who suffer from acne, and it can also be caused by cosmetic treatments such as dermabrasion, laser treatment, and chemical peels.

There are other factors that can darken parts of the skin - such as moles, scars, scars, sun or actinic keratosis, and skin cancer - but they’re not considered forms of hyperpigmentation. 

So, how does hyperpigmentation occur? It develops due to excessive production of melanin—a pigment that gives natural color to our skin, hair, and eyes—on certain parts of the skin. Many factors cause this overproduction, but the main ones can be related to sun exposure, genetic factors, age, hormonal influences, and injuries or inflammation of the skin. It can also be a symptom of certain diseases as well. 

Naturally, limiting the time you spend in the sun, wearing protective clothing, and using sunscreen with a high protection factor, both UVA and UVB, can help reduce the risk of hyperpigmentation and prevent worsening of existing dark spots.

Battling hyperpigmentation is possible in many ways, but red light therapy has proven to be the most effective form of treatment. It’s no secret that most of us lack vitamin D, at least in the Northern Hemisphere, yet light therapy has done wonders in vitamin D production. But red light therapy has shown to be helpful in even more ways than you could imagine. 

Red light therapy works by stimulating cells through red light. Mitochondria in the skin cells can absorb the light particles which emit through the red light, and this can help them produce more adenosine triphosphate (ATP), which is the energy source for all cells. By improving cellular energy, cells repair themselves quickly, returning the skin back to normal pigmentation levels. 

In turn, collagen levels increase, working to reduce other skin conditions, including rosacea. Elastin levels also increase, which helps fight against aging, giving the skin a lift and youthful glow. 

Though there are many ways to treat hyperpigmentation, ideally, you want a treatment that’s the least invasive and the most effective. Luna’s red light therapy devices are designed to treat a variety of skin conditions, including hyperpigmentation. Our devices are MDA-certified and FDA-approved, ensuring that your treatment will be safe for your skin while providing you the best results. 

The Perfect Pair: Light Therapy & PRP

Platelet-Rich Plasma (PRP) Injections

In recent years, doctors have learned that the body has the ability to heal itself. Platelet-rich plasma therapy is a form of regenerative medicine that can harness those abilities and amplify the natural growth factors your body uses to heal tissue.

What is Plasma, and what are Platelets?

Plasma is the liquid portion of whole blood. It is composed largely of water and proteins, and it provides a medium for red blood cells, white blood cells, and platelets to circulate through the body. Platelets, also called thrombocytes, are blood cells that cause blood clots and other necessary growth healing functions. Platelet activation plays a key role in the body’s natural healing process.

What is Platelet-Rich Plasma (PRP), and what are PRP injections?

Platelet-rich plasma (PRP) therapy uses injections of a concentration of a patient’s own platelets to accelerate the healing of injured tendons, ligaments, muscles, and joints. In this way, PRP injections use each patient’s own healing system to improve musculoskeletal problems.

PRP injections are prepared by taking anywhere from one to a few tubes of your own blood and running it through a centrifuge to concentrate the platelets. These activated platelets are then injected directly into your injured or diseased body tissue. This releases growth factors that stimulate and increase the number of reparative cells your body produces.

Ultrasound imaging is sometimes used to guide the injection. The photographs below illustrate a PRP injection into a patient’s torn tendon. The ultrasound guidance is shown at the left, and the injection is shown at the right.

PRP harnesses the body’s own rejuvenating powers to stimulate hair growth naturally. The treatment involves drawing a small amount of blood from the patient’s arm. This blood is then spun in a centrifuge until the plasma is separated and growth factors and stem cells are extracted. This plasma, complete with growth factors and stem cells, is then injected into the patient’s scalp, stimulating hair growth.

Light Therapy

Red Light/Blue Light therapy uses light energy to stimulate hair growth. Red light/Blue Light therapy works using light delivered at specific therapeutic wavelengths within infrared and red-light spectrums. The energy from these lights stimulates the hair follicles so that they are constantly in the growth, or anagen, stage. This results in thicker, longer, and healthier hair.

Red light (630 nm) therapy stimulates ATP (cellular energy) production to stimulate hair follicle cells. It also increases blood flow to the hair root, which delivers more nutrients to the hair follicle cells. The increased blood flow is also thought to help flush away the damaging waste products that may affect hair growth.

Near-Infrared light (880 nm) therapy, which is an invisible light energy, promotes collagen and elastin production. It penetrates deeper into the scalp to help reduce inflammation, which causes thinning of hair.

Blue light (420 nm) therapy is especially effective for acne, penetrating molecules within the skin that cause P. acnes bacteria to form. These molecules react

Ophthalmologists: Light Therapy May be the Solution to Eye Strain and Declining Eyesight

As much as we're advancing in technology, we're paying the price of sight. More and more people are spending their working days in front of a desk, staring at a computer screen. 

Whether we’re at home or on the bus, we're glued to our smartphones or tablets, staying connected to the world around us. What we don't realize is that the more time we spend looking at screens, the worse our vision becomes. 

Staring at your smartphone, laptop, or tablet for too long can lead to tired, itchy, and dry eyes, eventually leading to blurred vision and headaches. There's actually a name for this; it's called Computer vision syndrome

Computer vision syndrome is described as vision-related problems resulting from prolonged usage of digital devices, including computers, smartphones, and tablets. However, other vision-related problems  stem from cataracts, prescription glasses or contact lenses, migraines, age, glaucoma, trauma, and more. 

But with the help of light therapy, it looks like there's a solution to eye strain and declining eyesight. Researchers from the University College of London published their study in the Journals of Gerontology found that red light therapy may help improve eye function through mitochondria and adenosine triphosphate (ATP) interaction.

How do the mitochondria and ATP benefit from red light? The mitochondria produce most of the chemical energy needed for all biochemical reactions within the body. The energy produced is stored as ATP, which then converts into adenosine diphosphate (ADP) or to adenosine monophosphate (AMP). For the human body to stay healthy, ATP is essential for the cellular process. 

Concerning the eyes, the retina ages faster than any other in the body, according to Glen Jeffrey, lead study author and neuroscience professor at University College London's Institute of Ophthalmology. Glen adds that up to 70% of the ATP in the retinas will decline over a person's lifetime, which causes reduced eye function.  

This is where red light therapy plays an important role in improving eye function and vision. It's believed that red light therapy increases ATP production in the mitochondria, improving and restoring cellular energy, keeping your eyes healthy and functioning optimally. 

In the study, researchers tested the eye function and sensitivity of 21 participants between 28 and 72 without pre-existing eye diseases. The participants were given a small LED light, which they had to look directly into the light for three minutes a day over two weeks. The results were extremely interesting. For those under 40, they did not see any measurable differences. However, those over 40 experienced significant improvements in their ability to differentiate between colors and in sensitivity of up to 20%. 

Glen explains that red light therapy "uses simple brief exposures to light wavelengths that re-charge the energy system that has declined in the retina cells, rather like re-charging a battery." 

Though there are further studies that need to be done, this shines a light on the power of red light to restore eye function. Prior to the study above, other studies have been done in the past; however, this is the first on humans. Yet, previous studies also proved positive effects on retinal performance and damage reversal. 

The future's looking bright for those who have eye issues and want non-invasive treatments. As Glen said, “the technology is simple and very safe.” 

With Kayian Medical’s MDA-certified and FDA-approved red light therapy devices, you can provide clients with non-invasive and effective treatment to improve eye function. 

Private Label Your Dream Light Therapy Product with Kaiyan

Whether you’re a dermatologist, physical therapist, fitness enthusiast or just someone considering integrating light therapy into their practice, you’ve likely heard about the multitude of benefits that these non-invasive yet powerful devices offer. As light therapy continues to gain popularity, more professionals are looking for light therapy devices to level up. 

Naturally, you can purchase professional devices from light therapy companies, but you can also develop a light therapy device that can be customized to fit your individual client’s needs. This is where we, Kaiyan Medical, come in to help guide you through the process of producing your very own private label light therapy products at our state-of-the-art manufacturing facility. 

If you’re interested in creating your own light therapy products, it’s crucial you understand the development process.

The Steps of Private Label Product Development

We want our clients to comprehend the creative and manufacturing process of developing private label light therapy devices. As this is your idea we’re bringing to life, you need to be included every step of the way. Here’s our step-by-step process:

Step 1: Feasibility Study

It’s easy to lose money by investing in a product without understanding user needs. If you don’t know your target audience, you’ll struggle to create a viable product. During the feasibility step, we determine the practicality of your project and examine its strengths and weaknesses. This helps to ensure the idea you want to bring to life is viable and effective in achieving its goal. 

Step 2: Industrial Design

With our advanced conceptual design team, we determine how we can best engage with your target audience. While we focus on design, we also make sure your device fits under the required safety and health regulations. Our in-house design process creates visually appealing, high-quality, and functional concepts for manufacturing and product planning. 

Step 3: Electrical Engineering

Our in-house team has vast experience in lasers, sourcing, prototyping, and LEDs to incorporate these components and masterfully develop your product. Our electrical engineers, who are in charge of this step, take your idea and bring it to life while ensuring high-quality performance. 

Step 4: Rapid Prototyping

Rapid prototyping is essential for our projects and allows the client to see and feel their idea in the palm of their hands. In addition, it also helps clients test products with their users and receive constructive feedback. Our rapid prototyping is completed in-house as we have the capacity to create a range of samples varying from simple to complex, multi-piece models. 

Step 5: Mass Production

After your idea is turned into a tangible product and has been tested, we then plan production with in-house, pre-pilot quantities. By doing so, we’re able to identify production areas that need to be fine-tuned while ensuring high-quality and performance standards. Once these steps are completed, your product will be ready for shipment. Through our vast experience and stellar team, we can ensure a smooth manufacturing process and will guide you each step along the way, from start to finish. 

So, Who do we Work with?

We’ve been creating MDA-certified and FDA-approved light therapy devices for years. That said, we’ve successfully worked with various brands in different industries, taking their ideas and bringing them to life. Here are some of the brands and products we’ve developed.

DemarkQ

DenmarkQ offers skin care devices that use red and blue light LED to target acne and scarring. The LED light uses the body's natural healing process to improve its overall wellbeing. 

Aduro Mask
Established in 2006, Aduro Skincare specializes in LED beauty-related products under a medical license. The product is internationally renowned and clinically proven as an effective, non-invasive therapeutic skin care treatment.

Perfect Countour

Perfect Contour is our line of permanent make-up machines. Our permanent make-up machines were designed for clinical use; however, we feel permanent make-up is more of an art form than a medical procedure through our experience.

Golden Eagles

Teeth whitening has been around for ages, and we've mastered the art of developing effective teeth whitening devices. We currently have over 20 different OEM models for professional whitening and devices for at-home whitening. 

Akstra

Akstra's brand focuses on hair regrowth and hair rejuvenation and offers products ranging from home-use to professional-use models. Since Asktra's first line of hair lasers was made for clinical environments, we opted for a sleek and clean design. 

Lumiceuticals

Lumiceuticals is a brand focusing on using LED technology for pain relief. We combined LED technology with neoprene material for practical treatment pads. The pads are secured by Velcro straps, making them easy-to-use for customers. 

If you’re considering developing private label light therapy devices, at Kaiyan Medical, we create MDA-certified and FDA-approved light therapy devices, ensuring you medical-grade, high-quality devices for your business. We are eager to work with like-minded partners in developing truly effective, safe, and valuable products that tap into the power of light therapy. 

We look forward to working with you!


FDA Pre-Submission (Q-Sub) and Medical Device Companies

There is always uncertainty baked into any government submission process, and it’s helpful to companies if there is a way to tackle issues before submitting a 510(k).

The FDA Pre-Submission is a way for companies to request feedback from the agency on potential and planned medical device, biologics, and drug submissions. It’s a great service to take advantage of, only we’ve found that it tends to get underutilized.

What is the Pre-submission?

The Pre-Submission allows you to request formal feedback on your medical device before you make a move to submit your 510(k). This is known as a Q-Submission, which under the guidance published by FDA, allows you to request the following:

  • Pre-Submission (what we’re focusing on here)
  • An informal meeting
  • An agreement meeting
  • Other (such as submission issues or study risk determinations)

The Pre-Submission process was born out of a need to provide expanded access to the FDA and allow companies to get valuable feedback ahead of time. This can help keep your company on track for getting your device to market as soon as possible — it helps to be aware of possible issues ahead of time and deal with them before final submission.

The guidance for Pre-Submission is clearly laid out in the FDA document Requests for Feedback on Medical Device Submissions. If you happen to have a combination product (such as a stent that administers a drug or an inhaler), there may be other, similar processes you need to go through. The document to check out, in that case, is Guidance for Industry.

In any case, the basic definition of what a Pre-Submission is remains the same. It is a formal written request from an applicant/sponsor for feedback from the FDA to be provided in a formal written response, meeting, or teleconference. The feedback is documented in meeting minutes.

It’s a great way to meet with the FDA, ask them some questions, then document that information for future use. It boils down to identifying key issues that keep you up at night and making your overall submission process easier.

The FDA continues to expand its Pre-Submission program to include several different medical device submissions that a manufacturer may choose to bring a device to market. The comprehensive list of submission types is known collectively as Q-Submissions(Q-Subs), which include:

E, De Novo request, 510(k), Dual, BLA, IND), Accessory Classification Request, or CW.

  • Investigational device exemptions (IDE)
  • Premarket approvals (PMA)
  • Premarket notifications (510(k))
  • Dual
  • HDE — Humanitarian Device Exemption
  • De novo requests
  • Clinical Laboratory Improvement Amendments (CLIA)
  • Certain Investigational New Drug Applications (IND) and Biologic License Applications (BLAs)
Benefits of the Pre-submissions

Should I really use a Pre-Submission? This is a key question that companies often ask, so it’s important to understand the relative pros and cons. Here are some of the pros:

  • You develop a “human” relationship with the FDA. They are, after all, humans themselves and want to know who you are.
  • You can remove some of the risk elements from your submission. You get asked about things you don’t know and confirm things that you think you do know.
  • You can get “free advice” to help drive your development and regulatory strategy.
  • Sometimes the FDA will request a review of Pre-Submission materials, giving you a “bonus round” ahead of your 510(k) submission. This is a great opportunity to gain valuable feedback.

One thing to note is that you’re not getting a final acceptance at this stage; the FDA will never give you this until the actual submission. However, it’s well worth getting the early heads-up.

Cons of the Pre-submission

There’s always a money and time aspect. You’re looking at $5,000 to $25,000 to have a consultant help you with a Pre-Submission. If all timelines are met, the typical process takes 60–75 days.

A con that is frequently raised is, “What if they tell us no and say we have to do X, Y, and Z instead of what we’re already doing?”

Our answer to this will always be the same: Isn’t it better to know about this now rather than go ahead with your 510(k) submission and find out then? The FDA will pick out that same issue regardless, so it’s a much better use of your time to find out about it during a Pre-Submission.

Perhaps these cons are a big part of the reason that the Pre-Submission is underutilized, but I would strongly suggest that you don’t let them put you off using it. The FDA actively encourages medical device manufacturers to use the Pre-Submission because doing so helps the final submission's overall quality.

Conclusions

A Pre-Submission program is a valuable tool that tends to be underutilized. Perhaps companies are put off by the idea that the process will take too much time and money, or they’re worried that the FDA will tell them they need to do something they hadn’t already planned on doing. In Kaiyan Medical, we make sure our devices are FDA cleared and we constantly communicate with the FDA. Like many other medical device companies, you may find it’s well worth the time and money.

Removing the Double Chin with Light Therapy

Your face is the first thing people notice about you, and it stares back at you every time you see a mirror. If you aren’t friends with your image in the mirror because of a double chin, it can be an annoying reminder of the aging process at best and hurtful to your self-esteem at worst.

You don’t have to have plastic surgery to see results that rid you of a double chin. Advances in technology and some simple exercises can help you see the return of your younger jawline.

Youthful skin has an abundance of collagen and elastin to keep the skin smooth, firm, and plump. But, in your 20’s, collagen decreases, elastin breaks down, and cells don’t turn over. By age 30, your skin loses half its collagen. Once collagen breaks down, the skin loses firmness and elasticity, resulting in wrinkles, crow’s feet, loss of firmness, and dullness. At the same time, the layer of skin beneath the dermis begins to thin.

The body is always looking for new places to put fat cells, and one area it particularly likes is the top part of the front of your neck, right underneath your jaw. The technical name for this is ‘submental fat.’ If too much fat gets stored in this area and the skin isn’t taut enough to hold that canopy up in the battle with gravity, you can look in the mirror and find that it looks like you’ve grown a second chin. This can even continue developing into a triple or quadruple chin. The two factors you need to be aware of as you read on are fat levels and skin tautness.

What About the Creams?

In a word? No. Why don’t double-chin creams work? Because they’re not removing the bulk of the fat cells that are creating the double chin, nor are they tightening up the sagging skin, letting that double chin flop forward. Perhaps, if a double-chin cream is one that contains active ingredients such as high-strength vitamin C and retinol or another retinoid, it may be strengthening the skin. Still, this effect won’t be strong enough to rein in an existing double chin.

Then, What to Do?

Low levels of infrared light waves applied to the chin's skin can achieve excellent results and help you lose a double chin. Applying heat to the deeper layers of the skin while keeping the upper layers cool appears to trigger the skin’s ability to renew the collagen beneath the skin's surface layers.

Changes in skin thickness, elasticity, and tightness were visible changes that patients noticed when their double chin was treated with infrared light. These near-infrared devices are handheld systems that a dermatologist or physician can apply in an outpatient procedure with no pain.

The Jaw and Double Chin Kaiyan LED Therapy Slimming Device safely brighten, rejuvenates, shapes, and repairs your chin and jaw areas using red and blue LED light therapy, plus vibration. You just need 10min session, 2 times per day and you will see the results in weeks.

What Are the Different Types of Clinical Research?

Different types of clinical research are used depending on what the researchers are studying. Below are descriptions of some different kinds of clinical research.

Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.

Prevention Research looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.

Diagnostic Research refers to the practice of looking for better ways to identify a particular disorder or condition.

Screening Research aims to find the best ways to detect certain disorders or health conditions.

Quality of Life Research explores ways to improve comfort and the quality of life for individuals with a chronic illness.

Genetic studies aim to improve disorders' prediction by identifying and understanding how genes and illnesses may be related. Research in this area may explore how a person’s genes make him or her more or less likely to develop a disorder. This may lead to the development of tailor-made treatments based on a patient’s genetic make-up.

Epidemiological Studies seek to identify the patterns, causes, and control of disorders in groups of people.

An important note: some clinical research is “outpatient,” meaning that participants do not stay overnight at the hospital. Some are “impatient,” meaning that participants will need to stay for at least one night in the hospital or research center. Be sure to ask the researchers what their study requires.

Phases of Clinical Trials: When Clinical Research is Used to Evaluate Medications and Devices
Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.

  • Phase I trials
    Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.
  • Phase II trials
    The experimental drug or treatment is given to a larger group of people to see if it is effective and further evaluate its safety.
  • Phase III trials
    The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information to allow the experimental drug or treatment to be used safely.
  • Phase IV trials
    Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information, including the treatment or drug’s risks, benefits, and best use.

Examples of Other Kinds of Clinical Research
Many people believe that all clinical research involves testing new medications or devices. This is not true, however. Some studies do not involve testing medications, and a person’s regular medications may not need to be changed. Healthy volunteers are also needed so that researchers can compare their results to the results of people with the illness being studied. Some examples of other kinds of research include the following:

  • A long-term study that involves psychological tests or brain scans
  • A genetic study that involves blood tests but no changes in medication
  • A family history study involves talking to family members to learn about people’s medical needs and history.

Advantages of Medical Device Manufacturing in China Post Covid-19

China’s overall economic recovery in part has been attributed to the strong rebound in the manufacturing sector. The medical device manufacturing sector specifically recorded an astounding 46.4% growth.

High-Quality Human Resources

Despite living in the age of automation, labor remains one of the higher costs of manufacturing. Manufacturing companies in the west have to deal with worker’s unions, paying high wages, and inflexible staffing that cannot readily scale and resize as fluctuating production output needs may require. On the other hand, achieving this flexibility level is easier for Chinese manufacturers due to China’s readily available, efficient workforce. This used to be the primary reason for companies to outsource their manufacturing activities in China.

Manufacturing in China can significantly bring down overall production costs, and a large part of those savings is due to Chinese labor efficiency. Chinese facilities have been optimizing manufacturing costs for decades and have largely achieved very efficient workforce operations. Depending on the labor intensity of product manufacturing activities, a Chinese facility can offer an excellent number of parts produced per work hour spent.

Low Raw Materials Cost

Another most important manufacturing cost is raw materials cost, for which China also provides a cost-effective option, for two main reasons. Firstly, the same labor efficiency condition exists throughout the entire raw materials production value chain. So Chinese manufacturing companies can themselves access cost-efficient raw materials than most companies based in other countries. Secondly, the transfer of materials is cheap since it only happens from close sources and within China. This results in avoiding long shipping routes, additional customs tariffs, and long delivery waiting times. When manufacturers in all industries are trying to cut expenses and maximize profits to remain competitive, access to affordable raw materials can help bring down manufacturing costs to a considerable extent.

Most Chinese manufacturing facilities will typically have low cost local (or close) material suppliers. This way, they gain a significant cost advantage that further contributes to their cost-effectiveness.

Strategic Location

Companies worldwide are nowadays targeting the growing Asian markets, so much so that the phrase “expand to Asia” has become somewhat of a cliché business term. China is the largest of those markets, with its consumer market surpassing $6 trillion in value. Moreover, it also benefits from its proximity to several large and growing markets, such as India and South Korea. In terms of regulatory compliance, medical devices of Chinese manufacturing have no issues in being accepted in both the country’s domestic and other Asian markets. So outsourcing medical device production to China gives manufacturers access to its rapidly growing domestic market, as well as immediate access to its developing neighboring markets.

Evolving Supply Chain Network

In times of market, instability is when a supply chain is a huge determining factor for a manufacturer’s chance for survival. Chinese materials suppliers have been rapidly evolving, following the country's growing trend of becoming an international manufacturing hub. This has made it easier for medical device contract manufacturers to identify and establish a trustworthy network of reliable local suppliers.
This gives the more top tier Chinese manufacturers such as Kaiyan, the opportunity to create resilience in the face of the coronavirus outbreak. Additionally, a robust supply chain allows for a manufacturer’s flexibility to offer simple, efficient, and flexible options for increasing or scaling production as market needs change. What’s also important is that this supply chain evolution has also increased quality standards, which is a decisive factor in medical device manufacturing.

Access to Cutting-edge Technology

Realizing the potential of its market in the era of globalization, China has spent the last decades developing its technology. Heavy investments in research and development, importing talent and technology, and the emergence of specialized tech hubs have helped China gain an innovation edge over other emerging countries. The mentality of rapid research and development is of notable importance and surpasses the speed of many tech hubs in the west. Part of the reason this happens is that such a large portion of the world’s product manufacturing has been outsourced to China. And the low costs achieved by Chinese companies are not the result of just cheap labor, but also, to an extent, involve practical applications of innovative technologies.

Flexible Scale of Manufacturing

Another benefit of manufacturing in China is the ability to scale up or down as needs change. Top tier Chinese factories such as Kaiyan’s facilities are manufacturing products for many companies at the same facility, so they have the means to produce large quantities and adapt according to the market’s and customer’s needs. And being able to scale up easily is an obvious advantage. A critical characteristic of every trade is offering product availability. As you market your medical device to new markets, customers, importers, and distributors, you will be required to increase quantities and ensure timely delivery. Manufacturing your medical device in a Chinese facility that can support scaling up production becomes an obvious advantage.

Clinical Trials for Medical Devices: FDA and the IDE Process

What is a Medical Device?

Section 201(h) of the Food, Drugs, and Cosmetics Act defines a medical device as any healthcare product that does not achieve its principal intended purposes by chemical action or metabolized.

Medical Device Classes
  • Class I — General Controls — Most exempt from premarket submission.
  • Class II — Special Controls — Premarket Notification [510(k)].
  • Class III — Premarket Approval — Require Premarket Application [PMA].
510(k) Premarket Notification
  • Substantial equivalence.
  • 10–15% require clinical data.
  • Performance testing.
  • Usually confirmatory.
  • Type of study dictated by
  • The ability of bench and animal testing to answer questions.
  • Amount of difference between subject device and predicate.
PMA Premarket Approval Application
  • Establish reasonable assurance of safety and effectiveness.
  • Bench-Animal-Human.
  • Clinical Studies.
  • Feasibility and pivotal.
Stages of Review for PMA Device
  1. Pre-Sub: Discuss the device design, bench/animal testing, and the clinical trial
  2. IDE: Request approval for a clinical trial.
  3. PMA: Request market approval.
  4. PMA-S: Request approval for device change or upgrade.

What is an Investigational Device Exemption (IDE)?

The FDA approval of an IDE is required for US human study of a significant risk device that is not approved for the study's indication.

Device trials are unique.

  • Trials tend to be smaller than drug trials.
  • Some novel, many “me-too.”
  • Many difficult to blind, randomize, and control.
  • Many depend on physician technique.
  • Device modifications occur during the trial.
  • Endpoints are highly diverse.
  • Typically, a single pivotal trial follows the feasibility stage(s).
  • Designed to support a “reasonable assurance of safety and effectiveness” for the marketing application.

Types of IDEs

Feasibility Study
  • May provide support for a future pivotal study or may be used to answer basic research questions.
  • Not intended to be the primary support for a marketing application.
  • Endpoints and sample size are generally not statistically driven.
  • Often required by the FDA before the pivotal study to assess basic safety and potential for effectiveness.
  • Generally ~10–40 patients but may be larger.
  • The FDA review is primarily focused on safety and whether the data's potential benefit or value justifies the risk.
Pivotal Study
  • Designed to demonstrate a “reasonable assurance of safety and effectiveness. ness.”
  • Generally intended as the primary clinical support for a marketing application.
  • Endpoints and sample size are statistically driven.
  • Designed to assess both safety and effectiveness.
  • FDA review is much more complex.

Basic Submission Elements

Background of medical issue, the study goals, and why this study will further the science.

A Detailed Description of the Device Understudy
  • Previous studies (preclinical and clinical).
  • Summary of available data.
  • Why is a clinical study needed at this stage?
  • What evidence supports this study/device's safety and the study data's potential to be meaningful?
  • Are there outstanding safety questions that should be addressed with preclinical data?
Risk analysis

Should include:

  • What are the potential risks to the patient?
  • Does the study mitigate the risks where possible?
  • Are the risks outweighed by the potential for benefit and/or value of the study?
  • Patient monitoring and follow-up plan.
  • Inclusion and exclusion criteria.
  • Informed consent document.
  • Sample size and the number of investigational centers, with justification.

Submission Elements, Pivotal IDEs

Primary and Secondary Endpoints

Discussion of the appropriateness of endpoint parameters, hypotheses, and success criteria

Basic Trial Design
  • Controlled? If not, why not?
  •   Randomized? If not, why not?
  •   Blinded? If not, why not?
Trial Conduct and Study Monitoring
  • Sponsor blinding
  • Data handling and adjudication process
  • Independent committees
  • Case report forms
  • Is the right information being gathered to support the study endpoints, and are investigators adequately prompted to report adverse events?

Primary Endpoint Design

Should evaluate the safety and effectiveness of the device in the population expected to be indicated.

  • Generally divided into 1 or more “safety” endpoints and 1 or more “effectiveness” endpoints.
  • A study will be considered successful if both the safety and effectiveness endpoints are met.
  • The clinical protocol should clearly and prospectively detail: — Methods for obtaining endpoint data — Definitions for what will be counted as a primary event in the analysis — Situations in which patient data will be excluded — How missing data will be handled — How the impact of covariates will be assessed.

Sample Size & Follow-Up

Driven by either:

  • Primary safety endpoint
  • Primary effectiveness endpoint

The minimum number of patients and/or minimum duration of follow-up may be required depending on:

  • Understanding of the device's safety and effectiveness  
  • concerns regarding the durability of device safety or effectiveness.

Secondary Endpoints

Generally used to evaluate additional meaningful claims.

  • Generally only considered if primary endpoints are successful.
  • It should be used to provide further insight into the device's effects and mechanisms of action.
  • Definitions and analysis methods should be clearly detailed prospectively.
  • Not considered “statistically significant” unless a pre-specified alpha allocation plan is in the protocol, even if the p-value is < 0.05.

FDA’s IDE Review Decisions

  1. Approval — Approves the trial for a specified number of patients and investigational centers.
  2. Approval with Conditions — Allows sponsor to begin the trial if the sponsor agrees to address the conditions (deficiencies) from the conditional approval letter within 45 days.
  3. Disapproval — The trial may not start until the sponsor addresses the letter's deficiencies, submits this information to the FDA, and receives approval.

Conclusions

One size does not fit all for device trials. Pivotal studies should be designed to evaluate whether there is a “reasonable assurance of safety and effectiveness.” PMA approbation is based upon a Benefit-Risk assessment that strongly considers the outcome of primary safety and effectiveness endpoints. Secondary endpoints are generally used to support claims if the primary endpoints are successful. All endpoint analyses and definitions should be clearly pre-specified in the approved clinical protocol.

Clinical Trial Participation - Diversity

Medical products are safer and more effective for everyone when clinical research includes diverse populations.

Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to investigate how well demographic subgroups (sex, age, race, and ethnicity) in applications for medical products — drugs, biologics, and devices, submitted to the agency for marketing approval:

1) Are included in clinical trials; and
2) If subgroup-specific safety and effectiveness data are available.

It is important to test drugs and medical products in the people they are meant to help. The FDA works to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. The links below provide information on different populations and their involvement in clinical trials for medical products.

The Office of Minority Health is leading groups made up of many FDA centers to develop actions to reduce health disparities.

  • FDASIA Section 907 required the FDA to provide Congress with an action plan detailing “recommendations for improving the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and labeling; on the inclusion of such data, or the lack of availability of such data, in labeling; and on improving the public availability of such data to patients, health care professionals, and researchers” and to indicate the center(s) tasked with each recommendation. Congress directed the Agency to issue the action plan one year following the Sec. 907 reports publication.
  • More information on CERSI (Centers of Excellence in Regulatory Science and Innovation)
  • Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data
  • Questions and Answers about section 907
  • Drug Trials Snapshots: Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported new drugs' FDA approval. The Snapshots' information also highlights any differences in the benefits and side effects among sex, race, and age groups. Drug Trials Snapshots as part of an overall FDA effort to make demographic data more available and transparent.

More Information on Diversity in Clinical Trials

  • Men During Their Reproductive Years
    It gives men who were previously excluded because of potential reproductive harm access to clinical trials to treat life-threatening diseases.
  • Women
    See how the FDA and the Office of Women’s Health are working for diversity in clinical trials.
  • Minority Health Resources
    See how the FDA Office of Minority Health keeps you informed about; safe medication use, diabetes, food safety, product approvals, HIV/AIDS, and clinical trials.
  • Racial/Ethnic Groups
    Reviews the participation of racial or ethnic groups in clinical trials (data from 1995 to 1999).
  • NIH Office of Equity, Diversity, and Inclusion
    Sexual and Gender Minority
  • Older Adults
    Information on why older adults should participate in clinical trials.
  • Children
    A Consumer Update article from January 2010 on children and clinical trials.

Sinus Infections & Low-level Laser Therapy

Sinus infections are inflammation based. Sinusitis is when inflammation is chronic, and the body is unable to overcome it. Sinusitis or sinus infections may be acute (coming on suddenly) or chronic (long-lasting & nothing seems to fix it.

There are sinus cavities above the eyebrows, behind the nose, and under the cheekbones. When the mucus membranes within the sinuses become inflamed, mucus is generated. Sometimes even air is trapped, which puts pressure on the walls of the sinus cavities, making our face hurt, causing difficulty in breathing thru the nose — this is called sinusitis.

Studies have shown that 37 million people per year in the US are affected with sinusitis at one time or another involving all age brackets.

Is There a Natural, Safer Treatment Option?

Some people immediately run to a doctor wanting antibiotics, which may not help since not all sinusitis is due to bacteria. Low-level laser therapy (LLLT) has been proven effective in enabling the body to overcome inflammation. Many of our patients find that when they use low light Laser Therapy to treat their sinus infections, they experience two things: First — patients notice a significant difference after 1 treatment (breathing easier and sinus drainage); Second — they are less likely to get recurring infections, as is often the case when taking antibiotics.

Irradiation of red light penetrates several millimeters into tissue; in the infrared part of the spectrum, the penetration goes up to several centimeters, usually 4–6 cm. This is a very advantageous fact for treating sinusitis, for laser irradiation can be applied externally. However, when applying a red laser, it is necessary to introduce a light guide in the sinus.

Laser therapy is a safe, painless, non-invasive, and effective therapy to reduce pain and swelling, allowing the body to restore damaged tissue. Laser therapy uses red and infrared light to relieve pain and accelerate healing and decrease inflammation. When the light source is placed against the skin, the photons penetrate several centimeters and get absorbed by the mitochondria, the cell’s energy-producing cells part. This energy fuels many positive physiological responses resulting in the restoration of normal cell function. Laser therapy offers our bodies the opportunity to heal with no side effects and no long term damage.

Long Term/Cumulative Effects of Laser Therapy:

  • Improved resistance to infections
  • The immune response is stimulated
  • Reduction in swelling
  • Lymphatic drainage is improved
  • The body’s natural healing process is enhanced

LLLT irradiation is a benefit for the treatment of acute sinusitis. External irradiation with a laser with 830 nm wavelength, enabling the beam to penetrate 4–6 cm deep, is recommended. Irradiation with red light-emitting lasers is also effective. Still, due to the need for application through a light guide inserted into the cavity, this method has been discarded from clinical practice.

Laser irradiation works through its analgesic, anti-inflammatory, and biostimulation effects on ease of pain or elimination. It also causes a quicker withdrawal of inflammation and edema of the mucosa. It thus brings restoration of drainage of sines as well as normalization of mucociliary function. Immunomodulatory effect — improvement of both specific and non-specific immunities by stimulation of T and B lymphocytes, lysozyme, and phagocytosis — is also significant. Stimulation of Langerhans cells of the mucose of sines is presumed, too.

Laser irradiation in treating sinusitis has no contraindications (except for general contraindications, i.e., malignant tumors in the irradiation area or epilepsy). As physiotherapy, it can suitably complement therapy with antibiotics, mucolytics, and antihistaminics. The use of a laser with 830 nm wavelength appears to be the most beneficiary on diagnosis sinusitis acute with liquid levels in paranasal sinuses, the treatment of which was cut down by 59 percent in average, and on a group of patients with plain catarrhal obscure and decreased transparency (the most frequent) where the duration of therapy was shortened by 39 percent.

By using red light therapy devices from Kaiyan Medical, you’re able to reduce sinus inflammation and improve your immune system by investing a few minutes using a red light device.

How Light Therapy can Help you Manage Holiday Stress

If there's one thing that many of us experience during the holiday season, it’s stress. As much as it can be a time of joy, there’s a lot of pressures that come along with this time of the year. And now, the holidays come with yet another set of stressors that we're not so unaccustomed to: an ongoing global pandemic. None of us have gone through a holiday season during lockdowns and quarantines, making it stressful and difficult to navigate. 

With many of us unable to see our families, we are potentially having to spend the holidays alone, only seeing our loved ones over Zoom or Skype. It’s an unusual time we’re living in right now and it can bring up various emotions. The chronic stress we’re currently living in can lead to serious health problems, including inflammation, headaches, insomnia, digestion issues, and loss of sexual desire. 

On top of everything, the winter season brings SAD (seasonal affective disorder), resulting in many people suffering from low energy, depression, and appetite changes. So, as you can see, we’re dealing with a lot this holiday season, and it’s evermore important to take care of ourselves. 

Of course, the fact that we're separated from our families is difficult, and sadly, there's not much we can do about it. However, we can help ourselves find mental, emotional, and physical balance during these stressful times, and reduce inflammation stemming from stress in the body.

If you're suffering from inflammation and have experienced pain, heat, swelling, and discomfort, you've probably done some Googling to find the cause. As you know, endless search results point to diet, weight, and exercise, which are all valid causes, but they are not the only ones. But there's one main cause we tend to ignore: stress. 

What happens to us when we’re stressed? When we're stressed, our inflammatory response jumps into action and our body enters allostasis. Allostasis is the process of adapting to acute stress by producing stress-related hormones such as cortisol and adrenaline. In other words, our bodies go into "flight or fight" mode. 

This isn't necessarily unhealthy; this is part of the natural human response. However, the problem comes when we're experiencing chronic stress as our bodies cannot return to homeostasis. This causes the body to believe we're fighting for our lives continually, and ultimately causes inflammation. 

Naturally, in today’s world, you’re going to experience stressful situations. And yes, yoga and meditation help to reduce stress, but they don’t reduce inflammation entirely. So, what can you do? When it comes to bringing your body back to a state of balance, red light therapy works wonders.

If you've ever visited the doctor for inflammation issues, you've probably been prescribed nonsteroidal anti-inflammatory drugs or steroids. Though they're useful, they don't deal with the root cause of your inflammation.

Red light therapy does combat the root of inflammation by sending wavelengths of red and near-infrared (NIR) light to the skin and cells, cutting down the oxidative stress and enhancing cellular energy to boost your immune system, even preventing diseases that are caused by chronic inflammation. In addition, red light therapy also increases the cell's healing process, improving blood flow and reducing any existing inflammation. 

Aside from the inflammation, red light therapy also aids in treating seasonal affective disorder (SAD). Red light therapy’s benefits are particularly powerful during the winter season, as you can eliminate or reduce winter-related conditions such as inflammation and SAD. 

Inflammation is a natural part of the human body, but chronic inflammation can cause serious health risks that can significantly reduce the quality of your life. Therefore, we’re intent on helping people reduce inflammation at Lunas through our state-of-the-art red light therapy devices that are MDA and FDA approved and can be used from the comfort of your home during this holiday season. 

Winter can be a dreary and gloomy time of year, but that doesn’t mean you need to feel poorly, too. With red light therapy, you’ll be able to reduce inflammation, eliminate symptoms and get your life back. 

Laser and Light-based Treatment of Keloids

Keloids are an overgrowth of fibrotic tissue outside the original boundaries of an injury and occur secondary to defective wound healing. Keloid scars commonly grow beyond the wound boundaries, while hypertrophic scars are confined to the wound’s original area. Both types of scars arise as a result of impaired fibroblastic proliferation and collagen deposition after skin injury. Keloids often have a functional, aesthetic, or psychosocial impact on patients, as highlighted by quality-of-life studies. They can greatly affect the patient’s quality of life and emotional wellbeing by causing intense pain, itching, unappealing red appearance, and inexorable spread. Interestingly, keloids and hypertrophic scars are exclusively found in humans and do not occur in animals naturally. The lack of suitable animal models that recapitulate the key processes in keloidal/hypertrophic scarring has greatly hampered our understanding and treatment of these scars.

Treatments for keloids include surgical excision, intralesional or topical corticosteroids, other intralesional therapies: 5-fluorouracil (5-FU), bleomycin, and interferon, topical imiquimod, compression, cryotherapy, radiation, silicone sheeting, and laser or light-based therapies. Recurrence is common, even with combination therapy. Laser and other light-based technology have introduced new ways to manage keloids that may improve aesthetic and symptomatic outcomes and decrease keloid recurrence. Laser and light-based therapies for keloids can be grouped into three categories: ablative lasers, non-ablative lasers, and non-coherent light sources.

Non-ablative lasers target hemoglobin or melanin. 585 or 595-nm pulsed-dye lasers (PDL) are non-ablative, and the major chromophore is oxyhemoglobin. PDL also targets melanin; therefore, care must be taken to avoid pigmentary alterations. PDL is hypothesized to treat keloids by selective damage of blood vessels that supply the scar. The 980-nm diode laser targets hemoglobin and melanin. The 1064-nm neodymium-doped: yttrium, aluminum, and garnet laser and the 532-nm neodymium-doped: vanadate laser is hypothesized to primarily treat keloids by damaging deep dermal blood vessels.

Non-laser light sources are also used to treat keloids. These techniques include intense pulsed light therapy (IPL), light-emitting diode (LED) phototherapy, also known as low-level light therapy, and photodynamic therapy (PDT). These modalities utilize light energy that may cause keloid fibroblast functional modification. IPL emits non-coherent, broadband wavelength, pulsed light, and targets pigmentation and vasculature. LED phototherapy is hypothesized to photomodulate mitochondrial cytochrome C oxidase altering intracellular signaling. PDT requires the application of a photosensitizer, commonly 5-aminolevulinic acid or methyl aminolevulinic acid, that is preferentially absorbed by highly vascularized or metabolically active tissue and converted to protoporphyrin IX. Upon exposure to light, PpIX causes reactive oxygen species free radicals that have a cytotoxic effect. PDT may also cause alterations in extracellular matrix synthesis and degradation and modulate cytokine and growth factor expression.

The mechanisms by which topical PDT improves abnormal scars are largely unknown. However, they probably involve downstream responses to the ROS produced by the photodynamic reactions: the ROS induces membrane and mitochondrial damage, which activates signaling molecules such as TNF-α and interleukins 1 6 and cell death. The cell death may be via apoptosis, necrosis, and/or autophagy. These changes may alter growth factor and cytokine expression in the lesion, thereby modulating collagen production and extracellular matrix organization.

Notably, the shallowness of PDT suggests that it may be useful as an adjunct treatment of the wound area after keloid resection. In this setting, PDT may help to prevent postoperative keloid recurrence.

Melasma & Light Therapy

Light can be a powerful skincare tool, whether it’s an LED facial or light therapy for all skin. Light therapy can also seem a little mysterious if you’ve never done it before because light doesn’t interact with the skin in the same obvious way as, say, serum or moisturizer.

Here, we’re breaking down light therapy and melasma, explaining what they are, how they work, and experts’ advice for adding them to your skincare routine.

Melasma is sometimes referred to as the mask of pregnancy because it is sometimes triggered by an increase in pregnant women's hormones. But while the condition may be common among pregnant women, it isn’t limited to them.

“It’s not only associated with pregnancy but can affect women at all stages of life,”

Says Dr. Shadi Kourosh, director of the Pigmentary Disorder and Multi-Ethnic Skin Clinic at Harvard-affiliated Massachusetts General Hospital. And it may last for many years.

“Women who develop melasma in their teens or 20s or 30s may see it stay around for decades,”

Says Dr. Barbara Gilchrest, senior lecturer on dermatology at Harvard Medical School.

What is Melasma

Melasma is a common skin problem. The condition causes dark, discolored patches on your skin.

It’s also called chloasma, or the “mask of pregnancy,” when it occurs in pregnant women. The condition is much more common in women than men, though men can get it too. According to the American Academy of Dermatology, 90 percent of people who develop melasma are women.

Causes of Melasma

It isn’t obvious what causes melasma. Darker-skinned individuals are more at risk than those with fair skin. Estrogen and progesterone sensitivity are also associated with the condition. This means birth control pills, pregnancy, and hormone therapy can all trigger melasma. Stress and thyroid disease are also thought to be causes of melasma.

Additionally, sun exposure can cause melasma because ultraviolet rays affect the cells that control pigment (melanocytes).

How is Melasma Diagnosed?

A visual exam of the affected area is often enough to diagnose melasma. To rule out specific causes, your healthcare professional might also perform some tests.

One testing technique is a Wood’s lamp examination. This is a special kind of light that’s held up to your skin. It allows your healthcare professional to check for bacterial and fungal infections and determine how many skin layers the melasma affects. To check for any serious skin conditions, they might also perform a biopsy. This involves removing a small piece of the affected skin for testing.

Light Therapy Based Treatments

Light therapy for melasma treatment is best suited for patients with refractory melasma who failed with topical treatment or a series of chemical peels. Topical therapy takes at least three months or longer to see skin lightening, and those patients who are interested in a more rapid response could consider light therapy.

When a patient wishes for an accelerated pace of improvement, analogous to chemical peels, these modalities accelerate melanin pathways’ removal. Still, they do not target the melanin production itself.

One key point of patient counseling before laser- and light-based treatment is that these therapies can speed up removing melasma-related hyperpigmentation, but they are not cures for melasma.

References

Arora P, Sarkar R, Garg VK, Arya L. Lasers to treat melasma and post-inflammatory hyperpigmentation. J Cutan Aesthet Surg.

Barolet D. Light-emitting diodes (LEDs) in dermatology. Semin Cutan Med Surg. 2008;27(4):227–238.

Lee HM, Haw S, Kim JK, et al. Split-face study using a 1,927-nm thulium fiber fractional laser to treat photoaging and melasma in Asian skin. Dermatol Surg. 2013;39(6):879–888.

Kauvar AN. The evolution of melasma therapy: targeting melanosomes using low-fluence Q-switched neodymium-doped yttrium aluminum garnet lasers. Semin Cutan Med Surg.

Weiss RA, McDaniel DH, Geronemus RG, Weiss MA. A clinical trial of a novel non-thermal LED array for reversal of photoaging: clinical, histologic, and surface profilometric results. Lasers Surg Med. 2005;36(2):85–91.

Stretch Marks & Light Therapy

Why Do We Get Stretch Marks?

A stretch mark is a type of scar called striae, meaning “thin, narrow scar”. In people who develop stretch marks, the skin has stretched faster than it can grow, such as during pregnancy, growth spurts, or rapid fat or muscle gain. The abrupt stretching causes the collagen and elastin proteins responsible for the skin’s structure and elasticity to rupture. This, in turn, causes the dermis to tear.

As the dermis tears, the body’s healing mechanisms spring into action to close the wound as quickly as possible to prevent infection and further damage.

Normally, as the skin regenerates and grows, it’s an elegantly organized latticework of collagen and elastin proteins. But when the skin tears, the body doesn’t have time to build an elegant structure to fill in the gap. Time is of the essence in any wound repair, including torn skin.

The collagen clumps together hurriedly, aiming for efficient closure of the wound before infection can set in. “Scarring is the result of a system that has learned to respond extremely quickly to a wound,” says Dr. John Newman, a cosmetic surgeon and researcher at the Laser Center of Virginia in Virginia Beach.

This haphazard process results in tough and functional but unattractive tissue — what we know as a scar. “It is kind of like nailing down a crisscross of two-by-fours over a hole in a deck,” says Newman. “It seals the hole, but it doesn’t look very nice.”

Newly formed stretch marks are darker than the surrounding skin and can be slightly raised, itchy, or painful. If they’re left untreated, they become permanent scars. Their color will lighten, and their appearance will fade below the top layer of the surrounding skin.

The bigger mystery is why stretch marks don’t disappear over time as the skin regenerates. The key lies in the information that emerging cells receive from adult cells in the area. Skin cells, whether they’re normal cells or scar cells, regenerate about once every 30 days. Growth of new skin cells begins at the bottom-most layer of the scar, and older (dying) cells are pushed to the surface where they naturally slough off.

However, Neuman explains that that that that emerging cells “learn” from their immediate neighbors and predecessors and develop the same characteristics as ir replacement their replacement cells. As a result, any emerging cell in contact with scar cells will become new scar tissue rather than normal skin tissue.

Red Light Therapy For Stretch Marks

If you have tried to get rid of stretch marks, perhaps you’ve used specialized creams that contain retinoids. These work to some extent, but only if you catch your stretch marks early and treat them while they’re still forming. Retinoids work by stimulating collagen production. However, they can irritate sensitive individuals, and doctors often recommend that pregnant women avoid anything containing retinoids.

Another common treatment, known as microdermabrasion, essentially involves “sandblasting” the skin with tiny crystals. This sloughs off dead skin

cells and stimulates the production of collagen. Microdermabrasion is a fairly harsh treatment that can lead to irritation and damage, especially to sensitive skin.

The most extreme treatment for stretch marks is plastic surgery, such as a mini tummy tuck. This may be effective, but there are risks associated with any invasive procedure and the high cost.

Is there a better option for restoring the appearance of the skin? The answer is yes, absolutely. Also known as photobiomodulation and low-level light therapy (LLLT), red light therapy improves skin appearance, reduces signs of aging, treats chronic skin conditions, reduces scarring, and promotes skin wound healing.

When red light therapy is used, visible red light and invisible near-infrared (NIR) light are applied to the skin with LED bulbs' devices. Wavelengths of light are measured in nanometers (nm), with red light ranging from 630nm to 660nm and NIR light ranging from 810nm to 850nm. Human cells respond favorably to these wavelengths, similar to how natural sunlight affects plant cells by stimulating more energy and optimization of cell function.

When the red light is shone on bare skin, it soaks into the mitochondria, colloquially referred to as the powerhouses of cells' energy factories. The mitochondria are, in turn, stimulated to produce more adenosine triphosphate (ATP), which is the primary cellular fuel. This energizes cells to perform their normal functions, from fighting off pathogens to performing repair and regeneration.

Improved Blood Flow

Proper healing relies on good circulation to the skin. Red light promotes the proliferation of endothelial cells, which make up the inner layer of capillaries (the tiny blood vessels that deliver oxygen and nutrients throughout the body). This was the focus of a 2017 study by a team of researchers from Austria, who found that red light consistently increased migration and proliferation of endothelial cells.

Without proper blood circulation, there would be no healing since endothelial cells also deliver white blood cells to the sites they need. In skin wound healing, white blood cells are necessary to protect the vulnerable area from infection while the wound closes up.

Reduced Inflammation

Acute inflammation results in the redness that’s noticeable in fresh stretch marks. This is a normal and necessary part of the tissue regeneration scar's process. Acute inflammation, which is a function of the immune system, actually sets the stage for normal tissue repair and regeneration. Inflammation is quickly followed by the production of new skin structures — which, as previously described, are hastily assembled to ensure that the torn skin doesn’t become infected.

But sometimes, the inflammatory process continues after the wound has healed, leading to chronic inflammation. It can lead to a variety of widespread problems throughout the body, including disease. “Some inflammation is good,” says Dr. Robert H. Shmerling, an associate professor of medicine at Harvard Medical School. “Too much is often bad. The goal is to recognize when inflammation is simply doing its job, and when it can potentially cause problems.”

Hundreds of studies have shown how red light therapy can significantly reduce inflammation. Many of these were conducted by Dr. Michael A. Hamblin, an associate professor of dermatology at Harvard Medical School and a noted expert on red light therapy. In the final report of a 2017 study, Hamblin refers to red light therapy’s “pronounced anti-inflammatory effects.”

Mobilize Stem Cells

During the skin-rebuilding phase, stem cells, which are unspecialized “master” cells, mobilize to the site and develop into most any type of specialized cells that are needed by the body. Ideally, they develop into normal skin cells, rather than scar tissue, to replenish damaged or destroyed cells due to skin tearing.

Red light has been shown to activate stem cells. As Barbara Gefvert, editor-in-chief of BioOptics World, explains: “Recent research shows … that noninvasive application of light can boost the natural growth of an individual’s own stem cells to enable exciting new treatments.” Stem cells can assist with the tissue regeneration process and stimulate normal and healthy behavior in existing cells. This can prevent the formation of new stretch marks and gradually reduce the appearance of existing stretch marks.



Photodynamic Therapy for Cancer

Photodynamic therapy (PDT) is a treatment that uses a drug, called a photosensitizer or photosensitizing agent, and a particular type of light. When photosensitizers are exposed to a specific wavelength of light, they produce a form of oxygen that kills nearby cells

Each photosensitizer is activated by light of a specific wavelength. This wavelength determines how far the light can travel into the body. Thus, doctors use specific photosensitizers and wavelengths of light to treat different areas of the body with PDT.

How is PDT Used to Treat Cancer?

In the first step of PDT for cancer treatment, a photosensitizing agent is injected into the bloodstream. The agent is absorbed by cells worldwide but stays in cancer cells longer than it does in normal cells. Approximately 24 to 72 hours after injection, when most of the agent has left normal cells but remains in cancer cells, the tumor is exposed to light. The photosensitizer in the tumor absorbs the light and produces an active form of oxygen that destroys nearby cancer cells.

In addition to directly killing cancer cells, PDT appears to shrink or destroy tumors in two other ways. The photosensitizer can damage blood vessels in the tumor, thereby preventing cancer from receiving necessary nutrients. PDT also may activate the immune system to attack the tumor cells.

The light used for PDT can come from a laser or other sources. Laser light can be directed through fiber optic cables (thin fibers that transmit light) to deliver light to areas inside the body. For example, a fiber optic cable can be inserted through an endoscope (a thin, lighted tube used to look at tissues inside the body) into the lungs or esophagus to treat cancer in these organs. Other light sources include light-emitting diodes (LEDs), which may be used for surface tumors, such as skin cancer.

PDT is usually performed as an outpatient procedure. PDT may also be repeated and used with other therapies, such as surgery, radiation therapy, or chemotherapy.

Extracorporeal photopheresis (ECP) is a type of PDT in which a machine is used to collect the patient’s blood cells, treat them outside the body with a photosensitizing agent, expose them to light, and then return them to the patient. The U.S. Food and Drug Administration (FDA) has approved ECP to help lessen the severity of skin symptoms of cutaneous T-cell lymphoma that has not responded to other therapies. Studies are underway to determine if ECP may have some application for other blood cancers and help reduce rejection after transplants.

What Types of Cancer are Currently Treated with PDT?

To date, the FDA has approved the photosensitizing agent called porfimer sodium, or Photofrin®, for use in PDT to treat or relieve the symptoms of esophageal cancer and non-small cell lung cancer. Porfimer sodium is approved to relieve esophageal cancer symptoms when cancer obstructs the esophagus or when cancer cannot be satisfactorily treated with laser therapy alone. Porfimer sodium is used to treat non-small cell lung cancer in patients for whom the usual treatments are not appropriate and relieve symptoms in patients with non-small cell lung cancer that obstruct the airways. In 2003, the FDA approved porfimer sodium to treat precancerous lesions in patients with Barrett esophagus, a condition that can lead to esophageal cancer.

What are the Limitations of PDT?

The light needed to activate most photosensitizers cannot pass through more than about one-third of an inch of tissue. For this reason, PDT is usually used to treat tumors on or just under the skin or on the lining of internal organs or cavities. PDT is also less effective in treating large tumors because the light cannot pass far into these tumors. PDT is a local treatment and generally cannot treat cancer that has spread.

Does PDT have any Complications or Side Effects?

Porfimer sodium makes the skin and eyes sensitive to light for approximately 6 weeks after treatment. Thus, patients are advised to avoid direct sunlight and bright indoor light for at least 6 weeks.

Photosensitizers tend to build up in tumors, and the activating light is focused on the tumor. As a result, damage to healthy tissue is minimal. However, PDT can cause burns, swelling, pain, and scarring in nearby healthy tissue. Other side effects of PDT are related to the area that is treated. They can include coughing, trouble swallowing, stomach pain, painful breathing, or shortness of breath; these side effects are usually temporary.

What Does the Future Hold for PDT?

Researchers continue to study ways to improve the effectiveness of PDT and expand it to other cancers. Clinical trials (research studies) are underway to evaluate PDT's use for cancers of the brain, skin, prostate, cervix, and peritoneal cavity (the space in the abdomen that contains the intestines, stomach, and liver). Other research is focused on the development of more powerful photosensitizers, more specifically target cancer cells, and are activated by light that can penetrate tissue and treat deep or large tumors. Researchers are also investigating ways to improve equipment and the activating light's delivery.

Bipolar Disorder & Light Therapy

I have a friend who often shows extreme shifts in moods. Sometimes I see an extremely elevated mood, and sometimes, it's depression. On some days, I see episodes of uplifted feelings and depression at the same time.

Strange right!

Later I figured out that she was going through a mental illness called bipolar disorder. This isn’t a rare brain disorder. In fact, about 15 million U.S adults suffer from this disorder.

Bipolar disorder is a mental illness characterized by dramatic transfer in mood and behavior. Bipolar depression can last from several days to years, depending on the person's type and state.

Let’s put light on some of the unknown facts of Bipolar Disorder.

  • Firstly we need to understand that bipolar depression has several types. It is distinguished by profuse behaviors, moods, depression, and, yes, mixed emotions. The symptoms of this illness can present at different severities and in many combinations in different people. So, it may not be the same for every person who has Bipolar disorder.

We basically classify the states into two broad classes:

  • Manic — overly elevated emotions, increase in energy, higher self-confidence, and decreased need for sleep.
  • Depression — sad, worthless, suicidal, low feelings
  • It is possible that people can experience symptoms of mania and depression at the same time.
  • The length of mood episodes and varying behavior can vary from person to person.
  • There is no known single cause of this mental illness.
  • Not only adults but children and teenagers can have bipolar disorder too.
Light Therapy — the Bipolar Disorder Soother!

If we compare other types of depression, there are fewer treatments available for bipolar disorder.

Hence, it is important to find an effective treatment for your illness.

Antidepressant medications, on the other hand, are not clearly effective. They may aggravate the mood cycling in people with bipolar disorder. Also, many people with bipolar disorder are prescribed to take other medications like mood stabilizers.

That’s why it is important to go for a non-medication treatment, like light therapy!

But why is it recommended? Light therapy is more effective, non-invasive, and absolutely safe because it can be used without worrying about additional drug interactions.

But How Light Therapy Helps?

Humans have natural 24-hour clocks, which are disrupted in bipolar disorder. One way of treating bipolar disorder is to handle the circadian rhythm (24*7 natural cycle that regulates the physical, mental, and behavior changes). And this can be achieved with bright light therapy.

The light emitted during light therapy activates the retina in the eye, resulting in a stimulus being transmitted from the eye to the brain's hypothalamus. The hypothalamus is a part of the brain that has a vital role in regulating mood. It also helps control many bodily functions, such as the release of hormones from the pituitary gland and channelizing the mood.

The light acts through the eyes to regulate the biological clock located in a tiny brain region. There are disturbances in the biological clock that affect circadian rhythms in people with bipolar disorder, including hormonal rhythms, sleep, feelings, cognition, and other behaviors.

Light therapy triggers the hypothalamus and helps bipolar patients to calm their emotional flow and have normal behavior.

Studies have shown that light can affect the major neurotransmitters, or chemical messengers, involved in mood and behavior, e.g., serotonin and dopamine. So, light therapy may act similarly to antidepressants by directly working on these neurotransmitters.

We found trials of light therapy compared to a placebo in people with bipolar depression. The studies' results displayed a significant improvement in depressive symptoms with bright light compared to placebo conditions.

I recommended my friend to you light therapy, and that really helped her. The quality of personal life is great since then. If you are also like my friend who is dealing with bipolar disorder, you possibly got the remedy.

Remember, your Mental Health matters!!

References:

Blue Light Reduces Photosynthetic Efficiency of Cyanobacteria

Almost 140 years ago, professor Theodor Engelmann showed that light color plays an important role in photosynthesis (Engelmann 1882). In his classic experiment, Engelmann placed a filamentous green alga from the genus Cladophora on a microscopic slide. He illuminated through a prism glass, thus dividing sunlight into separate wavelengths across the filament. By introducing aerotactic bacteria and observing how regions of visible light these bacteria aggregated, he established that photosynthetic oxygen (O2) production occurred in red and blue light, thereby creating the first “living” action spectrum of chlorophyll.

In the following years, Engelmann continued his studies with cyanobacteria from the genus Oscillatoria, demonstrating that in these cyanobacteria, red and blue light and orange light resulted in high O2 production rates (Engelmann 1883, 1884). Engelmann’s findings were criticized for many years, but 60 years later, his results were confirmed by Emerson and Lewis, who showed that the phycobiliproteins of cyanobacteria and red algae play a key role in light-harvesting for photosynthesis (Emerson and Lewis 1942). We now know that these phycobiliproteins make up specialized light-harvesting antennae, called phycobilisomes (PBSs), consisting of an allophycocyanin core and stacked rods of phycocyanin often in combination with phycoerythrin. These phycobiliproteins consist of an apo-protein and one or more chromophores, also known as bilins, including phycocyanobilin absorbing orange light (620 nm), phycoerythrobilin absorbing green light (545 nm), and phycourobilin absorbing blue-green light (495 nm) (Grossman et al. 1993; Tandeau de Marsac 2003; Six et al. 2007). Recent reviews on the structure and function of PBSs are provided by Tamary et al. (2012), Watanabe and Ikeuchi (2013), and Stadnichuk and Tropin (2017).

Light energy absorbed by PBSs is effectively transferred via allophycocyanin to the chlorophyll a (Chl a) pigments in the photosystems (Arnold and Oppenheimer 1950; Duysens 1951; Lemasson et al. 1973). It has long been assumed that most PBSs transfer their energy to photosystem II (PSII). However, it is now well established that cyanobacteria can re-balance excitation energy by moving PBSs between photosystem I (PSI) and PSII in a process called state transitions (van Thor et al. 1998; Mullineaux 2008). As a consequence of these state transitions, which occur at time scales of seconds to minutes, the PBSs associate with PSII (state 1) or PSI (state 2) and transfer the absorbed light energy to the reaction center of the photosystem they are associated with (Kirilovsky 2015). At longer time scales, cyanobacteria can also adjust their PSI: PSII ratio to optimize their photosynthetic activity under different environmental conditions (Fujita 1997). In cyanobacteria, the PSI: PSII ratio generally ranges between 5:1 and 2:1 depending on light quality and intensity, which is higher than the approximately 1:1 ratio often found in eukaryotic phototrophs (Shen et al. 1993; Murakami et al. 1997; Singh et al. 2009; Allahverdiyeva et al. 2014; Kirilovsky 2015).

Several studies have described that cyanobacteria use blue light less efficiently for photosynthesis than most eukaryotic phototrophs, but comprehensive studies of this phenomenon lack. Here, we study the effect of blue (450 nm), orange (625 nm), and red (660 nm) light on the growth of the model cyanobacterium Synechocystis sp. PCC 6803, the green alga Chlorella sorokiniana, and other cyanobacteria containing phycocyanin or phycoerythrin. Our results demonstrate that the cyanobacteria's specific growth rates were similar in orange and red light but much lower in blue light. Conversely, specific growth rates of the green alga C. sorokiniana were similar in blue and red light but lower in orange light. Oxygen production rates of Synechocystis sp. PCC 6803 was five-fold lower in blue than in orange and red light at low light intensities but approached the same saturation level in all three colors at high light intensities. Measurements of 77 K fluorescence emission demonstrated a lower ratio of photosystem I to photosystem II (PSI: PSII ratio) and relatively more phycobilisomes associated with PSII (state 1) blue light than in orange and red light. These results support the hypothesis that blue light, which is not absorbed by phycobilisomes, creates an imbalance between the two photosystems of cyanobacteria with an energy excess at PSI and a deficiency at the PSII-side of the photosynthetic electron transfer chain. Our results help to explain why phycobilisome-containing cyanobacteria use blue light less efficiently than species with chlorophyll-based light-harvesting antennae such as Prochlorococcus, green algae, and terrestrial plants.

Since blue and red light are both strongly absorbed by Chl a, and the intermediate wavelengths by the different phycobiliproteins, one would expect that these light colors are all used for photochemistry at approximately equal efficiency. However, several studies have described that blue light yields lower O2 production rates than red light in cyanobacteria (Lemasson et al. 1973; Pulich and van Baalen 1974; Jørgensen et al. 1987; Tyystjärvi et al. 2002), in cyanolichens (Solhaug et al. 2014), and also in PBS-containing red algae (Ley and Butler 1980; Figueroa et al. 1995). Furthermore, other studies noted that blue light resulted in lower growth rates in a variety of cyanobacteria (Wyman and Fay 1986), including Synechocystis sp. PCC 6803 (Wilde et al. 1997; Singh et al. 2009; Bland and Angenent 2016), Synechococcus sp. (Choi et al. 2013), and Spirulina platensis (Wang et al. 2007; Chen et al. 2010).

A possible explanation for their poor performance in blue light might be that most chlorophyll of cyanobacteria is located in PSI (Myers et al. 1980; Fujita 1997; Solhaug et al. 2014; Kirilovsky 2015), and hence, blue light induces high PSI but low PSII activity. This phenomenon is also known from fluorescence studies, where the use of blue measuring light complicates interpretation of the fluorescence signal of cyanobacteria (Campbell et al. 1998; Ogawa et al. 2017). However, although several of the above-cited studies measured growth rates and/or pigment composition in different light colors, they did not report on, e.g., O2 production, PSI:PSII ratios, or state transitions. Conversely, other studies measured O2 production rates or PSI:PSII ratios but did not measure growth rates or other relevant parameters. To our knowledge, more comprehensive studies of the photophysiological response of cyanobacteria to blue light are largely lacking, and no clear consensus has yet been reached on the question why their photosynthetic activity might be hampered by blue light.

Brainwaves - Get to Know your Brain

Brain waves are oscillating electrical voltages in the brain, measuring just a few millionths of a volt. At the root of all our thoughts, emotions, and behaviors are the communication between neurons within our brains. Brainwaves are produced by synchronized electrical pulses from masses of neurons communicating with each other.

Brainwaves are detected using sensors placed on the scalp. They are divided into bandwidths to describe their functions but are the best thought of as a continuous spectrum of consciousness, from slow, loud, and functional — to fast, subtle, and complex.

It is a handy analogy to think of brainwaves as musical notes — the low-frequency waves are like a deeply penetrating drum beat, while the higher frequency brainwaves are more like a subtle high pitched flute. Like a symphony, the higher and lower frequencies link and cohere with each other through harmonics.

Our brainwaves change according to what we’re doing and feeling. When slower brainwaves are dominant, we can feel tired, slow, sluggish, or dreamy. The higher frequencies are dominant when we feel wired or hyper-alert.

The descriptions that follow are only broad descriptions — in practice, things are far more complex, and brainwaves reflect different aspects of different locations in the brain.

Brainwave speed is measured in Hertz (cycles per second), and they are divided into bands delineating slow, moderate, and fast waves.

Infra-low (

Infra-Low brainwaves (also known as Slow Cortical Potentials) are thought to be the basic cortical rhythms that underlie our higher brain functions. Very little is known about infra-low brainwaves. Their slow nature makes them difficult to detect and accurately measure, so few studies have been done. They appear to play a major role in brain timing and network function.

Delta (δ) Waves (0.5 TO 4HZ) — Sleep

Delta brainwaves are slow, loud brainwaves (low frequency and deeply penetrating, like a drumbeat). They are generated in deepest meditation and dreamless sleep. Delta waves suspend external awareness and are the source of empathy. Healing and regeneration are stimulated in this state, and that is why deep restorative sleep is so essential to the healing process.

Theta (θ) Waves (4 TO 8 HZ) — Deeply Relaxed, Inward-focused

Theta brainwaves occur most often in sleep but are also dominant in deep meditation. Theta is our gateway to learning, memory, and intuition. In theta, our senses are withdrawn from the external world and focused on signals originating from within. Twilight states that we normally only experience fleetingly as we wake or drift off to sleep. In theta, we dream; vivid imagery, intuition, and information beyond our normal conscious awareness. It’s where we hold our ‘stuff,’ our fears, troubled history, and nightmares.

Alpha (α) Waves(8 TO 12 HZ) — Very relaxed, Passive Attention

Alpha brainwaves are dominant during quietly flowing thoughts and in some meditative states. Alpha is ‘the power of now,’ being here, in the present. Alpha is the resting state of the brain. Alpha waves aid overall mental coordination, calmness, alertness, mind/body integration, and learning.

Beta (β) Waves(12 TO 35 HZ) — Anxiety dominant, Active, External Attention

Beta brainwaves dominate our normal waking state of consciousness when attention is directed towards cognitive tasks and the outside world. Beta is a ‘fast’ activity, present when alert, attentive, engaged in problem-solving, judgment, decision making, or focused mental activity.

Beta brainwaves are further divided into three bands; Lo-Beta (Beta1, 12–15Hz) can be thought of as a ‘fast idle’ or musing. Beta (Beta2, 15–22Hz) is the high engagement or actively figuring something out. Hi-Beta (Beta3, 22–38Hz) is a highly complex thought, integrating new experiences, high anxiety, or excitement. Continual high-frequency processing is not a very efficient way to run the brain, as it takes a tremendous amount of energy.

Gamma (γ) Waves(35 TO 42 HZ) — Concentration

Gamma brainwaves are the fastest brain waves (high frequency, like a flute) and relate to the simultaneous processing of information from different brain areas. Gamma brainwaves pass information rapidly and quietly. The most subtle of the brainwave frequencies, the mind has to be quiet to access gamma.

Gamma was dismissed as ‘spare brain noise’ until researchers discovered it was highly active in states of universal love, altruism, and the ‘higher virtues.’ Gamma is also above the frequency of neuronal firing, so how it is generated remains a mystery. It is speculated that gamma rhythms modulate perception and consciousness and that a greater presence of gamma relates to expanded consciousness and spiritual emergence.

New Trial to Test Brain Wave Stimulation as Alzheimer’s Preventative

With a new $1.8 million grant from the Part the Cloud-Gates Partnership Grant Program of the Alzheimer’s Association, researchers at Massachusetts Institute of Technology and Massachusetts General Hospital are launching a new clinical trial to test whether stimulating a key frequency of brain waves with light and sound can prevent the advance of Alzheimer’s disease pathology even before volunteers experience symptoms such as memory impairment.

“Because Alzheimer’s disease leads to neurodegeneration and cognitive decline, the best time for intervention may be before those symptoms even begin,” said Dr. Li-Huei Tsai, Picower Professor of Neuroscience and director of The Picower Institute for Learning and Memory at MIT. “We are hopeful that our safe, non-invasive approach of sensory stimulation of 40Hz gamma brain rhythms can have a preventative benefit for patients. We are very grateful to Part the Cloud-Gates Partnership Grant Program for their support in funding rigorous research to test this exciting possibility.”

In extensive testing in Tsai’s lab with multiple mouse models of Alzheimer’s, the light and sound stimulation technique, called Gamma ENtrainment Using Sensory Stimuli (GENUS), improved cognition and memory, prevented neurodegeneration, and reduced amyloid and tau protein buildups. The research showed that increasing 40Hz brain rhythm power and synchrony stimulated the brain’s immune cells and blood vessels to clear out the toxic proteins. Early results from human testing at MIT show that GENUS is well tolerated and increases 40Hz power and synchrony, just like in the mice.

The new study, conducted in collaboration with neurologist Dr. Keith Johnson at MGH, will enroll 50 volunteers aged 55 or older who show signs of amyloid protein plaque buildup in PET scans but remain cognitively normal. Experimental volunteers will receive an hour of GENUS light and sound stimulation in their homes daily for a year. At regular checkups, the team will monitor GENUS's effect on amyloid buildup via PET scans as well as other biomarkers such as tau and for changes in cognition, sleep, structural and functional MRI, and other indicators of brain function and health.

The trial will be double-blinded, randomized, and controlled, meaning that some volunteers will be exposed to non-GENUS light and sound during the trial to provide a non-treatment comparison group. To ensure that bias does not influence the results, neither the volunteers nor the experimenters will know which group's volunteers are.

References

https://picower.mit.edu/news/new-trial-test-brain-wave-stimulation-alzheimers-preventative

https://brainworksneurotherapy.com/what-are-brainwaves

Story - Green Light for Benign Prostatic Hyperplasia

Paul Hamernik says that “green light” laser surgery has meant he can enjoy his life again. As a stock car racer, Paul Hamernik thought his frequent restroom breaks were an occupational hazard. He accepted that his bladder was small, and his nerves ran wild — until he learned his PSA level was increasing.

“PSA, or prostate-specific antigen, is a normal substance produced by the prostate, usually found in an increased amount in the blood of men who have prostate cancer, infection or inflammation of the prostate, and benign prostatic hyperplasia,” explains Lance Mynderse, M.D., a urologist at Mayo Clinic in Rochester.

“My local doctor suggested I go to Mayo and be evaluated,” says Paul. “He said Mayo had advanced tests and procedures to diagnose and treat prostate conditions that weren’t widely available.”

Fortunately, Paul didn’t have prostate cancer. But, because of his age and PSA level, the clinic invited him to participate in a pharmaceutical trial studying the effect of dutasteride in preventing prostate cancer in men with elevated PSA levels.

“I didn’t know anything about the drug, but I wanted to help advance medical science, so I decided to enroll,” says Paul. “I’ve always been proactive with my health. That’s why I started having my PSA tested early.”

During the four-year, double-blind study, Paul took a medicine — the drug or a placebo — every day. Half-way through the study, he had a prostate biopsy and urine flow analysis.

“I remember having an ultrasound on my bladder after emptying it,” recalls Paul. “The technician thought the ultrasound machine wasn’t working, and she went to get help.”

The equipment was working, and what the technician initially saw proved accurate. Paul’s bladder was holding three times the amount of urine that it should. It had become distended, and he was unable to empty it.

“If I hadn’t been in this clinical trial, being monitored the way I was, this urine flow problem probably would not have been diagnosed until after my kidneys were involved,” says Paul.

“Paul’s bladder problem was caused by an enlarged prostate, which often leads to bladder outlet obstruction and restriction of urine flow,” says Dr. Mynderse. “Paul’s condition was benign prostatic hyperplasia or BPH — a natural aging process that happens in all men.” While all men experience BPH, not all have symptoms — and certainly not as severe as Paul.

This clinical trial identified a problem that normal healthcare wouldn’t have found since Paul didn’t have any complaints, and a urine flow analysis wouldn’t normally be done. Unfortunately, Paul wasn’t a candidate for surgery when his enlarged prostate was diagnosed because his bladder had lost function. “When the bladder becomes that enlarged, it loses much of its elasticity and squeeze,” explains Dr. Mynderse.

At that point, reducing the size of the prostate might not help, as the bladder still can’t empty if it’s not capable of squeezing, even when you eliminate the prostate obstruction. “Therefore, we needed to ensure bladder function would return before scheduling surgery,” says Dr. Mynderse.

What this meant for Paul was regular self-catheterization five times per day. “I was terribly bummed,” says Paul. “First, it’s challenging to find a sterile environment & many places aren’t accommodating.” Paul’s employer offered a special restroom, and he learned some other tricks that helped but didn’t change his situation.

“I ended up clinically depressed because the catheter interfered with my ability to race stock cars, which I’ve done almost all my life,” says Paul. “There’s no support group for catheters, and I felt alone and very odd.”

“Going green” with surgery.

Paul’s diligence paid off. “His bladder function returned, and we were able to schedule a special surgery called photoselective vaporization of the prostate or PVP,” says Dr. Mynderse.

This surgery is often called green light laser surgery because it emits a highly visible green light. “The green light is created by lithium triborate, a chemical used as the lasing medium,” says Dr. Mynderse.

Mayo Clinic urologists pioneered the use of laser energy to treat benign prostatic hyperplasia in the 90s. In fact, Mayo’s Department of Urology is the” green light” laser's birthplace to treat BPH. Today, Mayo Clinic is only one of a handful of medical centers in the U.S. that are considered “Centers of Excellence” using PVP laser therapy to treat BPH.

“During the surgery, we vaporize the prostate through an instrument placed down the urethra, called transurethral — and there’s no cutting,” explains Dr. Mynderse. “We direct the light on the inner surface of the prostate, and there’s minimal bleeding. The by-products of the light energy interaction with the prostate and hemoglobin are bubbles and fine debris.”

Imagine the prostate as an orange. The laser vaporizes or shrinks the fruit or tissue occupying the core and leaves the rind intact. The procedure is performed on an outpatient basis, under anesthesia. “After 12 hours, we remove the catheter, and the patient can urinate immediately,” says Dr. Mynderse. “This is a significant shift in inpatient treatment from the historical standard TURP method.”

Transurethral resection of the prostate (TURP) has been the gold standard surgical treatment for enlarged prostate for decades. However, up to 25% of patients experience complications after TURP, including excessive bleeding, urinary incontinence, and sexual impotence. TURP also subjects patients to risks inherent in any surgical procedure and a hospital stay of 1 to 3 days and a 4 to 6 weeks recovery time.

“I left the hospital the same day and with no pain,” says Paul. “Dr. Mynderse is my hero because he got rid of my catheter, and I enjoy life the way I use to.”


References

https://sharing.mayoclinic.org/2012/12/18/green-light-laser-surgery-treats-bph/

The Frozen Healer - Cryotherapy

Cryotherapy is a trend with a cult following in the recovery, wellness, and beauty industries. It can be used in combination with light therapy for better results. You may have heard people talking about it or seen celebrities or athletes posting themselves coming out of icy cold chambers on social media, but what is Cryotherapy? Why is everyone talking about it?

In its most basic form, Cryotherapy is simply the use of cold temperatures to heal the body. Using the cold to help our bodies recover from injury, inflammation, soreness, or relaxation has been used since the beginning. Putting ice on a wound or bruise, jumping in a cold lake, or taking an ice bath are basic cryotherapy forms. These methods cause stagnant blood to start moving again, promoting new blood flow, which brings healing. It is a fundamental, well-understood principle that has been widely accepted and used as a means of after the fact recovery but can be quite uncomfortable, inconvenient, and extremely inefficient compared to modern-day cryotherapy through the use of cryotherapy chambers.

Day by day

Modern-day cryotherapy lends from past cold modalities to provide a much more comfortable, convenient, and effective recovery through cryotherapy chambers. Cryotherapy chambers provide a quick, 2–3 minute private session of whole-body exposure to shallow temperatures in a dry, contained, breathable air environment. Add in some music, light therapy, and awesome fog from the cold, and it becomes a fun experience that completely distracts from how cold you just got!

The goal of true whole body cryotherapy is to expose as much skin as possible to temperatures of -166F or below for a short period of time (2–3 minutes) to create a drop in the external skin temperature of 30–40 degrees. The best way to measure this is to use an infrared temperature device before and after the session on the upper arm's back, measuring the two temperature readings' delta.

Effects of Cryotherapy

Blood rushing to the core is our body’s natural way of protecting our core organs from extreme cold. When exposed to freezing temperatures, blood rushes from our extremities to our core, creating a systemic response throughout the body that produces many benefits. Cold promotes increased blood flow, bringing fresh, oxygenated blood full of white blood cells to the body's areas that need it. Cryotherapy amplifies these positive effects and adds many more incredible benefits by activating the vagus nerve and causing vasoconstriction and vasodilation. The vagus nerve is responsible for the regulation of internal organ functions [NCBI]. The vagus nerve is activated by cold on the back of the neck and touches every major organ in the body.

Whole Body Cryotherapy is not just for extreme athletes or those with present injuries, either. The best practice is for healthy, normal adults (minors with doctors) to regularly practice whole body cryotherapy 3–5 times per week. It is important to maintain a constant cryotherapy regimen and not just use it when you feel you need it or are injured. It is a continual recovery modality that helps the body stay healthy and even resist injuries and illness.

How Intense Light can Protect Against Heart Attacks

Researchers at the University of Colorado Anschutz Medical Campus have found that intense light amplifies a specific gene that bolsters blood vessels and offers protection against heart attacks.

"We already knew that intense light can protect against heart attacks, but now we have found the mechanism behind it.”

Study’s senior author Tobias Eckle, MD, PhD, professor of anesthesiology, University of Colorado School of Medicine

The study was published recently in the journal Cell Reports.

The scientists discovered that housing mice under intense light conditions for one week robustly enhances cardioprotection, which resulted in a dramatic reduction of cardiac tissue damage after a heart attack. They also found that humans could potentially benefit from a similar light exposure strategy.

To find out why they developed a strategy to protect the heart using intense light to target and manipulate the function of the PER2 gene, which is expressed in a circadian pattern in the part of the brain that controls circadian rhythms.

By amplifying this gene through light, they found that it protected cardiovascular tissues against low oxygen conditions like myocardial ischemia, caused by reduced oxygen flow to the heart.

They also discovered that the light increased cardiac adenosine, a chemical that plays a role in blood flow regulation.

Mice that were blind, however, enjoyed no cardioprotection indicating a need for visual light perception.

Next, they investigated whether intense light had similar effects on healthy human volunteers. The subjects were exposed to 30 minutes of intense light measured in lumens. In this case, volunteers were exposed to 10,000 LUX, or lumens, on five consecutive days. Researchers also did serial blood draws.

The light therapy increased PER2 levels as it did in mice. Plasma triglycerides, a surrogate for insulin sensitivity and carbohydrate metabolism, significantly decreased. Overall, the therapy improved metabolism.

Eckle has long known that light plays a critical role in cardiovascular health and regulating biological processes. He pointed out that past studies have shown an increase in myocardial infarctions during darker winter months in all U.S. states, including sunnier places like Arizona, Hawaii, and California. The duration of the light isn’t as important as the intensity, he said.

“The most dramatic event in the history of the earth was the arrival of sunlight,” Eckle said. “Sunlight caused a great oxygen event. With sunlight, trillions of algae could now make oxygen, transforming the entire planet.”

Eckle said the study shows, on a molecular level, that intensive light therapy offers a promising strategy in treating or preventing low oxygen conditions like myocardial ischemia.

He said if the therapy is given before high-risk cardiac and non-cardiac surgery, it could offer protection against injury to the heart muscle, which can be fatal.

“Giving patients light therapy for a week before surgery could increase cardioprotection,” he said. “Drugs could also be developed that offer similar protections based on these findings. However, future studies in humans will be necessary to understand the impact of intense light therapy and its potential for cardioprotection.”

Source:

University of Colorado Anschutz Medical Campus

Journal reference:

Oyama, Y. et al. (2019) Intense Light-Mediated Circadian Cardioprotection via Transcriptional Reprogramming of the Endothelium. Cell Reports. doi.org/10.1016/j.celrep.2019.07.020.


Fetuses May be Able to See More Light than you Think

By the second trimester, long before a baby's eyes can see images, they can detect light.

But the light-sensitive cells in the developing retina -- the thin sheet of brain-like tissue at the back of the eye -- were thought to be simple on-off switches, presumably there to set up the 24-hour, day-night rhythms parents hope their baby will follow. University of California, Berkeley, scientists have now found evidence that these simple cells actually talk to one another as part of an interconnected network that gives the retina more light sensitivity than once thought, and that may enhance the influence of light on behavior and brain development in unsuspected ways.

In the developing eye, perhaps 3% of ganglion cells -- the retina cells that send messages through the optic nerve into the brain -- are sensitive to light. To date, researchers have found about six different subtypes that communicate with various places in the brain. Some talk to the suprachiasmatic nucleus to tune our internal clock to the day-night cycle. Others send signals to the area that makes our pupils constrict in bright light.

But others connect to surprising areas: the perihabenula, which regulates mood, and the amygdala, which deals with emotions.

Recent evidence suggests that in mice and monkeys, these ganglion cells also talk with one another through electrical connections called gap junctions, implying much more complexity in immature rodent and primate eyes than imagined.

"Given the variety of these ganglion cells and that they project to many different parts of the brain, it makes me wonder whether they play a role in how the retina connects up to the brain," said Marla Feller, a UC Berkeley professor of molecular and cell biology and senior author of a paper that appeared this month in the journal Current Biology. "Maybe not for visual circuits, but non-vision behaviors. Not only the pupillary light reflex and circadian rhythms, but possibly explaining problems like light-induced migraines, or why light therapy works for depression."

Parallel systems in developing retina

The cells, called intrinsically photosensitive retinal ganglion cells (ipRGCs), were discovered only 10 years ago, surprising those like Feller, who studied the developing retina for nearly 20 years. She played a major role, along with her mentor, Carla Shatz of Stanford University, in showing that spontaneous electrical activity in the eye during development -- so-called retinal waves -- is critical for setting up the correct brain networks to process images later on.

Hence her interest in the ipRGCs seemed to function in parallel with spontaneous retinal waves in the developing retina.

We thought they (mouse pups and the human fetus) were blind at this point in development. We thought that the ganglion cells were there in the developing eye, that they are connected to the brain, but that they were not really connected to much of the rest of the retina, at that point. Now, it turns out they are connected to each other, which was a surprising thing."

Marla Feller, the Paul Licht Distinguished Professor in Biological Sciences and a member of UC Berkeley's Helen Wills Neuroscience Institute.

UC Berkeley graduate student Franklin Caval-Holme combined two-photon calcium imaging, whole-cell electrical recording, pharmacology, and anatomical techniques to show that the six types of ipRGCs in the newborn mouse retina link up electrically, via gap junctions, to form a retinal network that the researchers found not only detect light but respond to the intensity of the light, which can vary nearly a billionfold.

Gap junction circuits were critical for light sensitivity in some ipRGC subtypes. Still, not others, providing a potential avenue to determine which ipRGC subtypes provide the signal for specific non-visual behaviors that light evokes.

"Aversion to light, which pups develop very early, is intensity-dependent," suggesting that these neural circuits could be involved in light-aversion behavior, Caval-Holme said. "We don't know which of these ipRGC subtypes in the neonatal retina actually contributes to the behavior, so it will be fascinating to see what role all these different subtypes have."

The researchers also found evidence that the circuit tunes itself in a way that could adapt to the intensity of light, which probably has an important role in development, Feller said.

"In the past, people demonstrated that these light-sensitive cells are important for things like the development of the blood vessels in the retina and light entrainment of circadian rhythms, but those were kind of a light on/light of the response, where you need some light or no light," she said. "This seems to argue that they are actually trying to code for many different intensities of light, encoding much more information than people had previously thought."
Source:

University of California, Berkeley

Journal reference:

Caval-Holme, F., et al. (2019) Gap Junction Coupling Shapes the Encoding of Light in the Developing Retina. Current Biology. doi.org/10.1016/j.cub.2019.10.025.


Light Therapy can Benefit Patients with TBI (Traumatic Brain Injury)

According to a pioneering study by researchers from the Wellman Center for Photomedicine at Massachusetts General Hospital (MGH), light therapy is safe and has measurable effects on the brain.

Senior investigators Rajiv Gupta, MD, Ph.D., director of the Ultra-High Resolution Volume CT Lab at MGH and Benjamin Vakoc, Ph.D., at the Wellman Center led the study, which was supported by a grant from the Department of Defense (DOD) and published in JAMA Network Open September 14th.

This study is one of the first, if not the first, prospective, randomized, interventional clinical trials of near-infrared, low-level light therapy (LLLT) in patients who recently suffered a moderate brain injury. If further trials support these findings, light therapy could become the first widely-accepted treatment for this type of injury.

TBI is the leading cause of traumatic injury worldwide, and an estimated 69 million people experience such an injury every year. However, there are no treatments for this condition yet, largely because the underlying biological mechanisms are not well understood. It is so challenging to do studies with actual patients in the acute stage of trauma.

"The Gulf War put TBI in the headlines because body armor had been greatly improved by then. But there were still brain injuries caused by the shock waves from high powered explosives.”

Rajiv Gupta, MD, PhD, Director, Ultra-High Resolution Volume CT Lab

For various reasons, the number of TBIs has increased around the globe since then, but effective treatments are still sorely needed. For this study, a special helmet had to be designed specifically to deliver the therapy, an undertaking that required a mix of medical, engineering, and physics expertise.

This multidisciplinary team included Gupta, a neuroradiologist, Vakoc, an applied physicist, and others specializing in developing and translating optical instrumentation to the clinic and biologic laboratories. Both Gupta and Vakoc are also associate professors at Harvard Medical School.

“For this study, we designed a practical, near-infrared treatment based on Wellman Center research and working directly with DOD on the vexing problem of TBI, a condition faced by so many,” says Rox Anderson, MD, the center’s director.

Another challenge was optimizing the wavelength of the near-infrared LLLT.

“Nobody knows how much light you need to get the optimal effect,”

explains Lynn Drake, MD, one of the study co-authors and director of business development at the Wellman Center.

“We tried to optimize the wavelength, dosing, timing of delivery, and length of exposure.”

This was done through a series of pre-clinical experiments led by Anderson. These included multiple preclinical studies led by Michael Hamblin, Ph.D. Anderson and Hamblin are both co-authors of this paper.

Near-infrared LLLT has already been considered for multiple uses, but to date, few if any studies of this technology have been tested and none in patients with TBI.

It has been studied in stroke patients, and Wellman's basic laboratory research suggests it is neuroprotective through a mechanism mediated by specialized intracellular organs called mitochondria. It took several years of research at Wellman to understand the basic mechanism before the clinical trial.

The randomized clinical trial included 68 patients with moderate traumatic brain injury who were divided into two groups. One group received LLLT via the special helmet, which delivered the light. Patients in the control group wore the helmet for the same amount of time but did not receive the treatment.

Vakoc’s team at Wellman designed the helmet. During the study, the subjects’ brains were tested for neuron activity using quantitative magnetic resonance imaging (MRI) metrics, and the subjects also underwent neurocognitive function assessment.

MRI was performed in the acute (within 72 hours of the injury), early subacute (2–3 weeks), and late subacute (approximately three months) stages of recovery. During each visit and at six months, clinical assessments were performed using the Rivermead Post-Concussion Questionnaire, with each item assessed on a five-point scale.

Twenty-eight patients completed at least one LLLT session, and none reported any adverse reactions. Also, the researchers found that they could measure the effects of transcranial LLLT on the brain.

The MRI studies showed statistically significant differences in myelin's integrity surrounding the neurons of treated patients versus the control group. Both these findings support follow-up trials, especially since there are no other treatments for these patients.

The study also showed that light does impact the cells. While it is well established that cells have light receptors, “going into this trial, we had several unanswered questions such as whether the light would go through the scalp and skull, whether the dose was sufficient, and whether it would be enough to engage the neural substrates responsible for repair after TBI,” says Gupta.

It’s important to note, and he adds that for this initial study, the researchers focused on patients with moderate traumatic brain injury. That helped ensure their study could have statistically significant findings because patients in this category are more likely to demonstrate a measurable effect.

“It would be much more difficult to see such changes in patients with mild injuries, and it is quite likely that in patients with severe brain injuries, the effect of light therapy would be confounded by other comorbidities of severe trauma,”

says Gupta.

He adds that researchers are still very early in the development of this therapy. It is unknown if it could be applied to other types of brain injury, such as chronic traumatic encephalopathy (CTE), which has received a lot of public attention over the last few years.

CTE is a progressive degenerative disease associated with a history of repetitive brain trauma such as that experienced by certain athletes, most notably football players.

This study opens up many possibilities for the broader use of photomedicine. “Transcranial LED therapy is a promising area of research, with potential to help various brain disorders where therapies are limited,” says Margaret Naeser, Ph.D., a prominent researcher in photomedicine and research professor of Neurology at Boston University School of Medicine. She was not affiliated with this particular study.

Source:

Massachusetts General Hospital

Journal reference:

Longo, M, G. F., et al. (2020) Effect of Transcranial Low-Level Light Therapy vs. Sham Therapy Among Patients With Moderate Traumatic Brain Injury. doi.org/10.1001/jamanetworkopen.2020.17337.

The Bright Hope for Allergic Rhinitis

As the name suggests, Allergic rhinitis (also known as hay fever) is an inflammatory disorder of the nasal mucosa, which occurs when the immune system overreacts to allergens in the air. This might sound small, but it affects 20% of the adult population and up to 40% of children.

Allergic rhinitis is biologically associated and equated with decreased learning, performance, productivity at work and school, and reduced life quality. It affects the quality of life, including fatigue, irritability, memory deficits, and depression. It is reflecting the social-economic costs and the negative impact on the quality of life.

Light Therapy for Rhinitis

If we talk about the current therapeutic options like allergen avoidance, medication, and immunotherapy, they are quite far from ideal. Light therapy has been treating immune-mediated dermatological conditions, e.g., psoriasis and atopic dermatitis.

Light Therapy has been There!

It is one of the oldest treatments that has been practiced in ancient times. Red light therapy has profound immunosuppressive effects on the human body.

As per ARIA guidelines, Red light therapy has been recommended for patients with allergic rhinitis who do not respond to standard medical treatment.

Now, the questions arise what the benefits of red light therapy are? Why should you opt for it?

Well, there are many benefits to using red light therapy:

  • Better and increased blood circulation in the nasal tissues
  • Enhanced local blood oxygen saturation
  • Reduced nasal obstruction (congestion) caused by nasal swelling
  • Improved nasal anti-virus ability
  • Repaired local blood capillaries
  • Strengthened detoxification ability of the nasal mucosa
The Mechanism

Light therapy treatment delivers light to pathological areas to promote tissue regeneration, reduce inflammation, and relieve pain. This treatment improves the nasal obstruction caused by Allergic rhinitis. The sessions involve illuminating the nasal cavity through specific wavelength log light ((660nm — 810nm) to the nose for a certain amount of time.

Most light therapy devices include one or two small LED light-emitting probes, which quickly stimulate the nasal cavity's blood capillaries.

Light therapy mechanisms reduce the number and function of dendritic cells and induce immunomodulatory cytokines like IL-10. Cytokines are a large group of proteins, peptides secreted by specific cells of our immune system. The Red Light therapy generates little heat, modulating mucosal blood supply and histamine release (organic nitrogenous compound involved in local immune responses). This heat alters mucosal blood supply.

The therapy shows improvement in the symptoms of nasal congestion and a decrease in nasal resistance. Studies showed that Phototherapy resulted in a significant improvement of clinical symptoms for nasal itching, rhinorrhea, sneezing, and total nasal score.

Red light therapy resulted in a remarkable improvement of clinical symptoms for nasal itching, rhinorrhea, sneezing, and total nasal score.

Adopt light therapy and give your life a better quality. Improve the shape of your life; let the negativity and obstructions be at bay!

References:

What You Need to Know About Red Light Therapy and Homeostasis

Our bodies are in constant need of replenishing our cells with oxygen, nutrients, and ATP energy to stay on top of our day to day activities. Also, the optimal function of our cells boils down to maintaining the balance that our body needs. This is also known as homeostasis.

Homeostasis Defined

The scientific definition of homeostasis is in a state of equilibrium, wherein the body’s chemical and physical processes are stable. The balance of the body is dependent on a plethora of factors, such as body temperature, calorie intake, level of blood sugar, the balance of fluid, and pH levels.

These factors are constantly changing and require regulation. They also adapt to changing environments like temperature, light, and activities. Reaching homeostasis requires balance for the body to reach its optimal state. This is present in humans' biology and animals' biology because it determines physical and mental performance, even stress response.

Homeostasis in Cellular Energy

The mitochondria break down food and oxygen to produce ATP energy for the body during the cellular respiration process. Healthy light intake is important in cellular energy to stimulate the mitochondria and efficiently produce ATP energy without inflammation and oxidative stress that may disrupt the cellular respiration process. Red and NIR light therapy enhances cellular and mitochondrial function to ensure that the cellular respiration process works efficiently.

Homeostasis in Body Temperature

Our bodies respond to changes in external temperature through sweating and shivering. These internal temperature processes regulate the body to maintain a temperature balance. The normal body temperature is about 98.6 degrees Fahrenheit. When the body is at a normal temperature, it’s easier to perform well. It can also indicate homeostasis and balance in the body, which we naturally try to achieve. On the other hand, experiencing a fever or being exposed to the cold can make it hard to function well for a long time.

Homeostasis and Calcium Levels

The body’s calcium is usually found in the bones and teeth, but the calcium in the blood requires constant maintenance at about 10 mg/dL. Calcium is essential for blood circulation, coagulation, and bone mineralization. When calcium is low, you may suffer from an irregular heartbeat and other health risks. Meanwhile, when calcium is high, the body may feel exhausted and sluggish because of the nervous system's inactivity. Skeletal, endocrine, and digestive systems in the bodywork hand in hand to maintain basic calcium homeostasis and balance.

Imbalance in the Body

The natural and continuous goal of the body in homeostasis, but many factors are at play. When we use our digestive, respiratory systems, and all the other organs, we need the necessary energy to process nutrients from food, oxygen, and light. The bodily systems are interdependent with one another and need each other to maintain balance.

When one system is lacking, the body naturally compensates by getting from another system to maintain balance. An example is a homeostasis in calcium levels in the bloodstream, which relies on food intake. If the diet lacks calcium, the body gets calcium from the bones, which technically regulates the calcium needed in the bloodstream, but eventually, it will make the bones weak and brittle.

The resourcefulness of the body to shift functions is a great deal. Still, in the long run, it may lead to serious health problems, possibly building up deficiencies and difficulties over time. It is imperative to be aware of the body’s balance and how diet, exercise, and light exposure are interconnected.

Healthy Light’s Effects on Biological Balance and Good Health

Light empowers the cells and enhances the cellular respiration process, creating ATP energy more efficiently. Aside from being essential for our life on earth, having enough light intake is an indication of biological balance. In fact, not getting your regular dose of sunlight may result in inflammation, sluggishness, off circadian rhythms, and poor sleeping habits. Most of the time, people don’t get enough light from their environment since they stay indoors and are surrounded by artificial light.

Being indoors is not how bodies are designed. We are programmed to thrive when our cells intake a good amount of healthy light. Not enough sunlight exposure can make the body imbalanced and lead to decreased energy production and Vitamin D.

Red Light Therapy and Homeostasis

You must be intentional in spending time outdoors to ensure that your body gets the amount of healthy light it requires. However, given the circumstances and limitations that we have, most people really do not get enough natural light, which red light therapy can solve.

Red light therapy is a non-invasive treatment that delivers red and NIR light wavelengths to the skin and cells and helps the mitochondria in cells produce enough ATP energy. Red light therapy helps keep the body and cells balanced, giving enough energy and power to the body even if there’s not enough light in the environment.

Final Thoughts

Our bodies function better when we reach biological balance or homeostasis. A balanced cellular environment indicates good health, and getting healthy light is an important variable to biological balance, on top of exercise, diet, and sleep. Red light therapy helps promote homeostasis and improve overall health by supporting a more efficient cellular environment. Red and NIR light wavelengths stimulate the mitochondria, producing more ATP energy that empowers the body.

If you want to read more about red light therapy and its benefits, you may go to our red light therapy blog. On the other hand, if you want to see our red light therapy devices breakdown, please don’t hesitate to browse through our catalog.

References

Menon S.G. Goswami P.C. A redox cycle within the cell cycle: ring in the old with the new. Oncogene. 2007;26:1101–1109. [PubMed] [Google Scholar]

Burdon R.H. Superoxide and hydrogen peroxide in relation to mammalian cell proliferation. Free Radic. Biol. Med. 1995;18:775–794. [PubMed] [Google Scholar]

Young S. Bolton P. Dyson M. Harvey W. Diamantopoulos C. Macrophage responsiveness to light therapy. Lasers Surg. Med. 1989;9:497–505. [PubMed] [Google Scholar]

el Sayed S.O. Dyson M. Comparison of the effect of multi-wavelength light produced by a cluster of semiconductor diodes and of each individual diode on mast cell number and degranulation in intact and injured skin. Lasers Surg. Med. 1990;10:559–568. [PubMed] [Google Scholar]

5. el Sayed S.O. Dyson M. Effect of laser pulse repetition rate and pulse duration on mast cell number and degranulation. Lasers Surg. Med. 1996;19:433–437. [PubMed] [Google Scholar]

Karu TI, Pyatibrat LV, Kalendo GS, Esenaliev RO. Effects of monochromatic low-intensity light and laser irradiation on adhesion of HeLa cells in vitro. 1996

Castro KMR, de Paiva Carvalho RL, Rosa Junior, GM et al. Can Photobiomodulation Therapy (PBMT) Control Blood Glucose Levels and Alter Muscle Glycogen Synthesis?

OpenStax, Anatomy & Physiology. Rice University. OpenStax CNX. 2016 Feb.

Klepeis NE, Nelson WC, Ott WR, et al. The National Human Activity Pattern Survey (NHAPS): a resource for assessing exposure to environmental pollutants. Journal of Exposure Analysis and Environmental Epidemiology. 2001 May.

How Effective is Blue Light Therapy for Spider Veins?

Medical spas often recommend Blue light therapy for spider veins because they don’t have to be administered by trained doctors. And, yes, after several expensive sessions, you might start seeing a difference. The most effective method to treat spider veins is Sclerotherapy. We’ll also discuss the benefits of using Sclerotherapy is an effective alternative.

What are Spider Veins?

Before discussing how to treat spider veins with blue light therapy or sclerotherapy, we need to discuss what causes spider veins.

Spider Veins, scientifically called Telangiectasias, are a small network of blood vessels visible just under the skin's surface. They are called “spider veins” because they look like red spider webs.

Spider veins generally occur on the legs, feet, thighs, and face. They can also cause slight pain and discomfort.

Causes and Dangers of Spider Veins

While spider veins aren’t dangerous in and of themselves, they can indicate underlying vein disease.

Vein Disease, also known as Chronic Venous Insufficiency, is a disease in which the valves in the veins malfunction. The valves are usually supposed to act as one-way doors and facilitate blood flow to the heart. However, when they malfunction, blood flows back down and pools around the legs. This can put pressure on the veins and lead to spider veins or varicose veins.

While spider veins themselves aren’t dangerous, vein disease is hazardous and needs to be treated immediately. If left untreated, venous insufficiency can result in bleeding, skin infections, and ulcers.

In the worst-case scenario, vein disease can also lead to Deep Vein Thrombosis, a medical condition in which blood clots in the veins. If the clotted blood breaks, it can get carried to the lungs, leading to a potentially fatal condition called Pulmonary Embolism.

What is Blue Light Therapy for Spider Veins?

Blue Light Therapy for spider veins is a method in which blue light or laser is used to treat spider veins. The laser is non-UV in nature and emits photons that generate heat. The heat can destroy the damaged blood vessel over time. As such, the damaged vein shrinks and eventually dissolves.

Advantages of Blue Light Therapy for Spider Veins

The only time that blue light therapy for spider veins has an advantage over sclerotherapy is when it comes to the foot or face.

Both the face and the foot are dense with venous-arterial connections. When using Sclerotherapy, the Sclero has to be injected into the veins. Injecting it into the arteries can be dangerous. Most conservative physicians prefer not to use Sclerotherapy for spider veins in the face or foot.

As such, it’s better to go for blue light therapy for spider veins in the face or foot.

Sclerotherapy: An Alternative to Blue Light Therapy for Spider Veins

Sclerotherapy is the most effective and permanent method to treat spider veins. It is a minimally-invasive procedure in which a medicine called Sclerosant is injected into the damaged vein.

The Sclerosant inflicts some chemical damage to the veins, which leads to the vein walls sticking together and eventually closing up. The blood is then routed to healthier veins, and the damaged vein eventually gets reabsorbed.

Advantages of Sclerotherapy for Spider Veins

There are multiple advantages of using Sclerotherapy to treat spider veins:

  • The process is minimally-invasive and non-surgical in nature.
  • Sclerotherapy doesn’t hurt or cause much discomfort.
  • It works immediately, and you don’t need to come back for multiple treatment sessions.
  • It can get rid of spider veins permanently.
  • The entire process takes just about 30 minutes.
  • You can resume your daily activities immediately after.
  • It is cheaper than Blue Light Therapy.


Red Light Therapy Can Help Reduce Inflammation

We can usually identify inflammation when we see it. The inflamed part of the body looks red and swollen, and it feels hot and painful. But in this article, we’ll find out why we experience inflammation, as well as its causes, risk factors, and how red light therapy devices can help reduce it.

What Really is Inflammation?

Inflammation is our body’s natural response to pain, irritation, damaged cells, exposure to germs, and potential danger. There are two types of inflammation:

1. Acute inflammation

This type of inflammation happens as our body’s healthy response to injury or stress. We mean “healthy” because it helps the body recover faster. The inflammation happens only for a few hours and then starts to repair the damaged tissue.

2. Chronic inflammation

On the other hand, chronic inflammation can be excruciating and may cause discomfort or inconvenience. It causes an imbalance in the body, making it operate inefficiently over time. Chronic inflammation can be caused by viral infections, repetitive tissue damage, autoimmune reactions, and persistent and recurring acute inflammation. At its worse, this type of inflammation may lead to more serious diseases and/or conditions such as cancer, stroke, depression, and heart disorder.

Common Causes of Inflammation

Anything that causes stress on your body may lead to inflammation. These include:

  • Bruises
  • Bumps
  • Burns
  • Chemical irritants
  • Dehydration
  • Diseases
  • Excessive alcohol
  • Infection
  • Irritants
  • Poor nutrition
  • Poor sleep
  • Splinters
  • Toxin exposure
  • Wounds and injuries

Signs of Inflammation

There are five common signs of inflammation:

  • Heat on the inflamed area
  • Loss of function (i.e., you can’t move your arms or legs)
  • Pain
  • Redness
  • Swelling
Treatment Options for Inflammation

For acute inflammation, doctors normally recommend nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and paracetamol. Meanwhile, chronic inflammation may also be prescribed with NSAIDs, along with steroids and supplements.

However, these common treatment options help prevent inflammation symptoms but do not deal with the root cause, including improper cellular function, biological imbalance, and damaged tissues. This is also why lifestyle changes (improved diet, regular exercises, and high-quality sleep) and red light therapy could be of great help.

How Red Light Therapy Works Against Inflammation

Red light therapy, also referred to as low-level laser therapy (LLLT) or photobiomodulation (PBM), is a non-invasive treatment option. This kind of therapy delivers wavelengths of red and near-infrared (NIR) light to your skin and cells for multiple benefits. When it comes to inflammation, it can help cut down oxidative stress and activate protective cellular mechanisms to boost your immune system and protect you from diseases that may cause inflammation. It can also boost the generation of healing agents and antioxidants in the body to speed up damaged tissues' healing process.

Red light therapy can give your body the light exposure needed to function more efficiently, improve blood flow, and limit inflammation.

Conclusion

Inflammation is a natural part of our biological processes, but chronic cases may also lead to serious health risks that can affect the quality of your life. Therefore, if you’re experiencing signs of inflammation, regardless if it’s acute or chronic, please schedule an appointment with your doctor to get the care and treatment you need as early as possible.

In the meantime, to protect your body from the stress that may cause inflammation, you can do red light therapy either through a health provider or from the comfort of your home. If you need to purchase red light therapy devices, you can browse through our catalog to see the brands and products that we offer.


Keep Your Skin Healthy with Red Light Therapy

Skincare doesn’t just affect the way you look. It also plays a huge role in your overall health — from body temperature to hormone regulation to your immune system. If you’re into skincare as much as we are, one of the many ways that can help you keep your skin healthy is red light therapy. In this article, we’ll take a deep dive into why you should take care of your skin, and we’ll also discuss how red light therapy devices can help you achieve your skin goals.

Are you ready? Let’s go straight into it.

Why Do You Need to Take Care of Your Skin?

As the largest organ in our body, your skin is your body’s first defense line to bacteria, germs, viruses, etc. It’s a vital part of the immune system and some processes in your body, such as temperature control, blood circulation, and hormone production.

Main Functions of the Skin

Let’s take a look at the skin's main functions to help you understand how essential it is for you to take care of this vital organ.

1. Defense and Immunity

The skin is an active immune organ, and it serves as our physical barrier from the dangers of the environment. It helps protect our bodies from diseases, germs, viruses, dirt, UV radiation, and potential thermal and physical injuries. It also helps detect and fight off infection, toxins, allergens, hazardous substances, and carcinogens.

2. Temperature Regulation

Aside from protecting us from extreme cold or heat, the skin also helps prevent moisture loss, keeping us from being dehydrated.

3. Sense of touch

The skin has a somatosensory system that is composed of touch receptors and nerve endings. This system is responsible for the sensations we feel, including pain, pressure, vibrations, smoothness, roughness, heat, cold, tickle, itch, and more.

4. Storage and Production of Vitamin D

Your body also uses your skin's deeper layers to store metabolic products, fat, and water. The skin is also responsible for producing vitamin D, supplied in the body when the skin gets enough sunlight exposure.

5. Beauty

Need we say more? Your skin plays a huge part in your appearance. Of course, when your skin is healthy, you also look glowing, radiant, and definitely more attractive.

Red Light Therapy and Keeping Your Skin Healthy

Before we proceed with the “how,” let’s first define what red light therapy is. Red light therapy is a non-invasive treatment option for different kinds of medical conditions. It is also used for health improvement and various aesthetic procedures.

Decades ago, red light therapy machines were only available in clinics, high-end salons, and spas. Nowadays, red light therapy devices can be bought and used by anyone. In fact, you can do red light therapy at the comfort of your home and incorporate it into your skincare routine.

How Does Red Light Therapy Work?

Red light therapy works by delivering wavelengths of red and near-infrared (NIR) light to our cells and skin. Besides helping enhance cellular function, red light therapy also helps stimulate the mitochondria and produce ATP (adenosine triphosphate) energy. This treatment option usually takes only about 10 minutes per session.

How Does Red Light Therapy Help Keep Your Skin Healthy?

Our skin relies on millions of cells to be able to perform its functions. When our cells experience homeostasis or a state of balance, our skin and body perform (and look) better. And as mentioned above, red and NIR light enhances cellular function while also preventing inflammation and oxidative stress. Red light therapy helps make your skin look and feel softer, smoother, and healthier.

Besides, red light therapy also helps damaged tissues heal and regenerate faster. It also has anti-inflammatory benefits, potentially increasing blood flow to damaged and inflamed tissues and reducing oxidative stress.

Final Thoughts

Skincare is self-care, as keeping your skin healthy also produces multiple benefits to your health. Thankfully, aside from proper hygiene, regular exercise, a balanced diet, and an established skincare routine, red light therapy can also improve your overall skin health.

For more information about red light therapy or to view our catalog of red therapy devices, click here.

Sources:

https://www.hse.gov.uk/skin/professional/causes/structure.htm

Red Light Therapy for Enhanced Cellular Function

The one thing we have in common with animals, plants, and other living organisms is that we are all made of tiny little cells. The intricate human body in itself houses trillions of cells. Without cells, there wouldn’t be any life on Earth at all.

In this article, we discuss cellular anatomy and cellular function. Here, we understand how light plays a role in the support and acceleration of cellular respiration.

What is a cell?

Think of cells as the basic building block of all living organisms. As the smallest unit of life, cells contain many parts, each with a different and specific function. The command center of the cell is called the nucleus that contains the human DNA.

As these cells combine to form into an organism, they become responsible for vital activities like nutrient intake, energy production, structure building, and hereditary material processing. They make sure that your body gets enough energy and nutrients to function 24/7.

What is ATP?

One essential activity that our cells do for us is by taking in oxygen and nutrients to fuel body energy. This energy unit that is converted by the cells is called Adenosine Triphosphate (ATP) Energy.

The ATP itself is a molecule packed with high energy that empowers cellular function. ATP is required by the body to do every activity. Other cells that do more strenuous activities like muscle cells would need more ATP than others. The ideal optimal cellular function would allow cells to produce and use enough energy to achieve body balance or homeostasis.

How is ATP produced?

The mitochondria are the powerhouses of the cell. They are responsible for the production of ATP. Aside from cellular energy, this double-membrane powerhouse does protein synthesis, cell signaling, and cell apoptosis. ATP is produced with oxygen (aerobic) or without oxygen (anaerobic), the former being more beneficial because it converts more energy. Thus, 95% of cellular energy goes through an aerobic process.

Our cells go through a process called Aerobic cellular respiration to convert oxygen, food, and water into the body’s energy currency, which is ATP. This process is a well-organized metabolic pathway that consists of four stages. Our bodies take in nutrients from the food we eat for the first two stages to convert them into carbon compounds. Then for the next steps, these carbon compounds are transformed into the energy that our cells use.

How does light therapy support cellular function?

Light can sometimes be less attributed to improve our body’s physiology. However, light has benefits that go beyond aesthetic and technological purposes. Just like how light plays a role in plants' photosynthesis, it also benefits human cellular function.

Red light therapy from Kaiyan Medical composes of Red and Near-Infrared Wavelengths that aid in the Mitochondria's function to produce more ATP energy. It works by increasing the number of Mitochondria in our cells and by boosting their function.

The electron transport chain heavily governs the cellular respiration process. Red Light therapy has photons that can boost the mitochondria to function better through the Cytochrome C Oxidase. It plays an essential role in the cellular respiration process by improving the cell's electron transfer process. In this way, more ATP can be produced by the body for an enhanced cellular function.

As mentioned earlier, oxygen plays an essential role in the cellular respiration process. The infamous Nitric Oxide can take the rightful place of oxygen to limit ATP production that causes stress and cellular death. Red light therapy also gets rid of a harmful roadblock to ATP in the dissociation of Nitric Oxide and the Cox. The photons from Red light therapy prohibits the production of nitric oxide.

The effect that Red Light therapy does on our body is that by improving cellular function, our body can achieve these benefits:

  • Improved blood Flow
  • Increased Energy Build up
  • Enhanced Healing Response
  • Reduced Inflammation
  • Reduced Stress
  • Balanced Cellular Function

As you do daily activities such as eating, drinking, walking, or working out, think of the massive role that your cellular system plays to make these activities possible. In this way, you can put conscious efforts into improving your cellular system through a healthy diet and lifestyle and by integrating Red Light Therapy.

References:

https://www.healthline.com/health/red-light-therapy#how-does-it-work?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215870/

https://www.medicalnewstoday.com/articles/325884

https://www.britannica.com/science/cell-biology

https://www.britannica.com/science/mitochondrion

https://www.nationalgeographic.org/media/cellular-respiration-infographic/

Improving Mental Acuity with Light Therapy

It’s common knowledge that as we age, our normal brain function gets disrupted. We tend to find it harder to recall information, memorize names, and respond with reason. The decline of our mental acuity causes these commonplace mental problems. Contrary to popular belief, aging is not the sole culprit for mental deterioration. Many factors, such as aging, lifestyle changes, and environmental stress, contribute to the decline of mental acuity.

As cognitive decline progresses, significant mental changes can result in disorders such as dementia, Alzheimer’s disease, and Parkinson’s disease. While these can be common aspects of life, they aren’t inevitable. Many medical experts believe that there are many lifestyle changes that you can take to prevent the degradation of Mental Acuity.

What is Mental Acuity?

Mental acuity is known as the sharpness of the mind. It involves our cognitive ability to concentrate, process, understand, reason, and memorize. On the other hand, intelligence means the extent to which our brains absorb and process a specific amount of information at a given amount of time. Mental acuity is a natural and essential aspect of our brain health and is not a measure of how “smart” we are.

Mental acuity allows us to perform daily activities effectively and efficiently. When our cognitive ability functions well, we’re more capable of doing things without damage or conflict.

What are the symptoms of a Deteriorating Mental Acuity?

Some signs of a deteriorating cognitive ability may be subtle. However, when left untreated could progress over time to more serious mental disorders. According to the National Institute on Aging, 8 out of 10 people who experience amnestic mild cognitive impairment develop into having Alzheimer’s disease.

Here are some early symptoms of a deteriorating mental acuity:

  • Absent-mindedness and having trouble concentrating
  • Forgetfulness of specific details like names, dates, events, and facts
  • Inability to reason and make vital decisions
  • Difficulty in retrieving information
  • Memory loss
  • Difficulty in following simple instructions

How to Improve Mental Acuity

Prevention is better than cure when it comes to developing chronic brain disorders. Here’s how you can take your brain health into your own hands by observing these lifestyle habits:

  1. Ensure a well-balanced diet

Getting enough nutrition is the key to ensure mental sharpness. Making sure you eat a well-balanced diet can help your body supply enough nutrients to your brain. Omega 3 Fatty Acids are essential nutrients that help build and restore brain cells. The brain also needs antioxidants to prevent inflammation.

Excessive intake of toxins such as alcohol and drug can depreciate your mental ability. Experts agree that poor gut health also results in a weakened immune system. As a result, it weakens your body’s inflammatory response. A poor inflammatory response causes mental disorders such as schizophrenia and dementia.

  1. Have Enough Sleep

Irregular sleep patterns and sleep deprivation disrupt your body’s circadian rhythm that can lead to short-term mental problems as well as long-term chronic health problems.

Your body’s circadian rhythm is a natural body clock that controls your sleep-wake schedule as well as your digestive patterns. When you’re sleep-deprived, these rhythms get disturbed. As a result, you experience headaches, mood swings, and difficulty to focus and recall information. Aside from these unwanted effects, not having enough sleep also negatively impacts your overall brain health.

  1. Get Yourself Moving

Exercise isn’t just for physical and aesthetic purposes. It also affects brain function in multiple ways. When you exercise, your body pumps more oxygen into your brain through an increased heart rate. Exercise allows your body to release hormones that are vital in nourishing your brain cells. It also promotes growth factors in your brain to assist in the growth of neuronal connections.

A study at the University of Georgia shows that a 20-minute exercise daily can improve memory retention and information processing. Many experts agree that a sedentary lifestyle may accelerate your way into cognitive decline.

  1. Use Red Light Therapy

Red Light therapy is a more modern approach to non-invasive and low-risk medical treatments. It is a form of photobiomodulation that allows light to change human cells' physiology that causes a wide range of benefits such as biological balance and cellular energy.

Kaiyan Medical is one of the pioneers of Red light therapy that uses red wavelengths to deliver benefits to the skin and near-infrared lights to penetrate deeper within the skin’s surface. This dual technology allows for better absorption and effectiveness of the benefits of Red light therapy.

As near-infrared wavelengths penetrate the brain’s cellular system, it promotes energy production by stimulating the mitochondria. It also prevents stress by keeping away oxidative stress. Thus, it delivers multiple benefits such as better blood flow, faster cell regeneration, and improved healing.

A study shows that red light therapy has significantly improved brain function when given to patients with cognitive dysfunction. All these benefits are vital in promoting and maintaining a healthy mental acuity. Red light therapy delivers all these cellular benefits to promote better sleep quality and a more balanced circadian clock.

As you maintain these lifestyle changes, you can experience a more improved brain function and better brain health. Now you can defy all odds and allow your brain to perform at its peak by having a healthy lifestyle and a balanced body.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4043367/

https://www.medicalnewstoday.com/articles/324044#oily-fish

https://pubmed.ncbi.nlm.nih.gov/12595152/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5403829/

https://www.healthline.com/health/mental-health/brain-exercises

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4870908/


The Effect of Green & Red Light Therapy on Hearing

Low-level laser therapy

Low-level laser therapy (LLLT) has been practiced for over 20 years in Europe and has been introduced in the United States as a treatment for pain and postsurgical tissue repair. It has been proposed that laser energy in the red and near-infrared light spectrum may aid in the repair of tissue damage. A proposed mechanism for this therapeutic effect is the stimulation of mitochondria in the cells to produce more energy through the production of adenosine triphosphate.

Studies in humans have investigated the effects of LLLT on both hearing loss and tinnitus, with equivocal results. Some studies have found an improvement in hearing thresholds and tinnitus symptoms.

The Subjects

A total of 35 adult subjects were enrolled in the study. Two subjects withdrew from the study due to loss of interest and/or scheduling difficulty. The data from three additional subjects were not included in the analysis. One subject yielded unreliable audiometric and speech understanding data, speech scores could not be obtained from one subject with a profound hearing loss, and calibration problems compromised data from the third subject. Data from the remaining 30 subjects were included in the analyses. The experimental protocol was approved by the Institutional Review Board of The University of Iowa, and written informed consent was obtained from all participants.

The Device

An Erchonia EHL laser was used to provide the laser stimulation. The device was a portable unit that consisted of a hand-held probe and a main body. The probe contained two laser diodes. One diode produced light in the green part of the visible light spectrum (532 nm wavelength), and the other diode produced light in the red part of the visible light spectrum (635 nm wavelength). Both diodes produced energy levels of 7.5 mW (class IIIb). The laser beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. A second Erchonia EHL device served as the placebo. It was identical to the treatment device, except that the laser diodes were replaced with nonfunctioning standard light-emitting diodes.

The Groups

The study used three groups: treatment, placebo, and control. Subjects were pseudorandomly assigned to one of the three groups.

Initial group assignment was random with occasional adjustment to ensure that the three groups were similar in terms of number of participants, female/male ratio, mean age of participants, and mean pure-tone audiometric thresholds. The treatment group received the laser treatment protocol using the functional laser device. The placebo group also received the laser treatment protocol, but using the nonfunctioning laser device. The control group made similarly timed visits to the laboratory but received no real or feigned “treatment.” The study used a repeated-measures design, with each subject taking a battery of pretests, followed by treatment followed by a battery of posttests.

Analysis

Data were obtained from both ears of each subject. Since no obvious differences were seen between left and right ears, data from both ears were combined in the following analyses. Strictly speaking, this likely violates the statistical assumption of independent sampling, since the test results from left and right ears of a single subject are likely to be highly correlated. None of the statistical tests used in the analyses are robust to the assumption of independent sampling, and the effect of including both ears is likely to be that of artificially increasing the sample size, making it more likely that a statistically significant result will be found. All statistical tests were conducted using a significance level of .

Conclusions

No statistically significant effect of LLLT on auditory function was found, as assessed by pure-tone audiometry, speech understanding, and TEOAEs in this test. Additionally, no individual subjects showed any clinically significant change. It remains possible that other methods of LLLT could have an effect on hearing. The type of device used was not the best one for this type of study. Further research elucidating the anatomic and physiologic bases for therapeutic effects of LLLT on hearing are needed before further clinical testing is warranted.

More References

Clinical Study | Open Access. Volume 2013 |Article ID 916370 | https://doi.org/10.1155/2013/916370

ClinicalTrials.gov (NCT01820416)

T. I. Karu, “Molecular mechanism of the therapeutic effect of low-intensity laser radiation,” Lasers in the Life Sciences, vol. 2, no. 1, pp. 53–74, 1988.View at: Google Scholar

L. Wilden and R. Karthein, “Import of radiation phenomena of electrons and therapeutic low-level laser in regard to the mitochondrial energy transfer,” Journal of Clinical Laser Medicine and Surgery, vol. 16, no. 3, pp. 159–165, 1998.View at: Google Scholar

J. Kujawa, L. Zavodnik, I. Zavodnik, V. Buko, A. Lapshyna, and M. Bryszewska, “Effect of low-intensity (3.75–25 J/cm2) near-infrared (810 nm) laser radiation on red blood cell ATPase activities and membrane structure,” Journal of Clinical Laser Medicine and Surgery, vol. 22, no. 2, pp. 111–117, 2004.View at: Google Scholar

C. K. Rhee, C. W. Bahk, P. S. Chung, J. Y. Jung, M. W. Suh, and S. H. Kim, “Effect of low-level laser treatment on cochlea hair-cell recovery after acute acoustic trauma,” Journal of Biomedical Optics, vol. 17, no. 6, Article ID 068002, 2012.View at: Google Scholar

G. I. Wenzel, B. Pikkula, C. H. Choi, B. Anvari, and J. S. Oghalai, “Laser irradiation of the guinea pig basilar membrane,” Lasers in Surgery and Medicine, vol. 35, no. 3, pp. 174–180, 2004.View at: Publisher Site | Google Scholar

P. Plath and J. Olivier, “Results of combined low-power laser therapy and extracts of Ginkgo biloba in cases of sensorineural hearing loss and tinnitus,” Advances in Oto-Rhino-Laryngology, vol. 49, pp. 101–104, 1995.View at: Google Scholar

S. Tauber, W. Beyer, K. Schorn, and R. Baumgartner, “Transmeatal cochlear laser (TCL) treatment of cochlear dysfunction: a feasibility study for chronic tinnitus,” Lasers in Medical Science, vol. 18, no. 3, pp. 154–161, 2003.View at: Publisher Site | Google Scholar

A. Gungor, S. Dogru, H. Cincik, E. Erkul, and E. Poyrazoglu, “Effectiveness of transmeatal low power laser irradiation for chronic tinnitus,” Journal of Laryngology and Otology, vol. 122, no. 5, pp. 447–451, 2008.View at: Publisher Site | Google Scholar

D. Cuda and A. de Caria, “Effectiveness of combined counseling and low-level laser stimulation in the treatment of disturbing chronic tinnitus,” International Tinnitus Journal, vol. 14, no. 2, pp. 175–180, 2008.View at: Google Scholar

A. H. Salahaldin, K. Abdulhadi, N. Najjar, and A. Bener, “Low-level laser therapy in patients with complaints of tinnitus: a clinical study,” ISRN Otolaryngology, vol. 2012, Article ID 132060, 5 pages, 2012.View at: Publisher Site | Google Scholar

M. Rogowski, S. Mnich, E. Gindzieńska, and B. Lazarczyk, “Low-power laser in the treatment of tinnitus — a placebo-controlled study,” Otolaryngologia Polska, vol. 53, no. 3, pp. 315–320, 1999.View at: Google Scholar

F. Mirz, R. Zachariae, S. E. Andersen et al., “The low-power laser in the treatment of tinnitus,” Clinical Otolaryngology and Allied Sciences, vol. 24, no. 4, pp. 346–354, 1999.View at: Publisher Site | Google Scholar

T. Nakashima, H. Ueda, H. Misawa et al., “Transmeatal low-power laser irradiation for tinnitus,” Otology and Neurotology, vol. 23, no. 3, pp. 296–300, 2002.View at: Google Scholar

R. Teggi, C. Bellini, B. Fabiano, and M. Bussi, “Efficacy of low-level laser therapy in Ménière’s disease: a pilot study of 10 patients,” Photomedicine and Laser Surgery, vol. 26, no. 4, pp. 349–353, 2008.View at: Publisher Site | Google Scholar

R. Teggi, C. Bellini, L. O. Piccioni, F. Palonta, and M. Bussi, “Transmeatal low-level laser therapy for chronic tinnitus with cochlear dysfunction,” Audiology and Neurotology, vol. 14, no. 2, pp. 115–120, 2009.View at: Publisher Site | Google Scholar

C. H. Graham, “Behavior, perception and the psychophysical methods,” Psychological Review, vol. 57, no. 2, pp. 108–120, 1950.View at: Publisher Site | Google Scholar

M. Nilsson, S. D. Soli, and J. A. Sullivan, “Development of the hearing in noise test for the measurement of speech reception thresholds in quiet and in noise,” Journal of the Acoustical Society of America, vol. 95, no. 2, pp. 1085–1099, 1994.View at: Google Scholar

R. M. Cox, G. C. Alexander, and C. Gilmore, “Development of the connected speech test (CST),” Ear and Hearing, vol. 8, no. 5, supplement, pp. 119S–126S, 1987.View at: Google Scholar

R. M. Cox, G. C. Alexander, C. Gilmore, and K. M. Pusakulich, “Use of the connected speech test (CST) with hearing-impaired listeners,” Ear and Hearing, vol. 9, no. 4, pp. 198–207, 1988.View at: Google Scholar

R. Probst, B. L. Lonsbury-Martin, and G. K. Martin, “A review of otoacoustic emissions,” Journal of the Acoustical Society of America, vol. 89, no. 5, pp. 2027–2067, 1991.View at: Google Scholar

D. H. Keefe, “Double-evoked otoacoustic emissions — I: measurement theory and nonlinear coherence,” Journal of the Acoustical Society of America, vol. 103, no. 6, pp. 3489–3498, 1998.View at: Publisher Site | Google Scholar

G. A. Studebaker, “A “rationalized” arcsine transform,” Journal of Speech and Hearing Research, vol. 28, no. 3, pp. 455–462, 1985.View at: Google Scholar

R. S. Schlauch and P. Nelson, “Puretone evaluation,” in Handbook of Clinical Audiology, J. Katz, L. Medwestsky, R. Burkard, and L. Hood, Eds., pp. 30–49, Lippincott Williams & Wilkins, Baltimore, Md, USA, 2009.View at: Google Scholar

L. E. Humes, D. L. Wilson, N. N. Barlow, and C. Garner, “Changes in hearing-aid benefit following 1 or 2 years of hearing-aid use by older adults,” Journal of Speech, Language, and Hearing Research, vol. 45, no. 4, pp. 772–782, 2002.View at: Google Scholar

M. S. Robinette, M. J. Cevette, and R. Probst, “Otoacoustic emissions and audiometric outcomes across cochlear and retrocochlear pathology,” in Otoacoustic Emissions: Clinical Applications, S. Robinette and T. J. Glattke, Eds., pp. 227–272, Thieme, New York, NY, USA, 2007.View at: Google Scholar


How to Prevent Jet Lag with Light Therapy

How to Prevent Jetlag with Light Therapy Treatment

Globetrotters know flying across time zones can be all fun and games until headaches start to kick in, sleep cycles get disturbed, and frequent moments of inappetence prevents them from enjoying even the most sumptuous local cuisine. If you’ve had any of these unfortunate events disturb your travel plans and work productivity, you’ve most likely experienced a jet lag.

What is Jet Lag?

Jet lag, also known as jet lag disorder is our body’s reaction to abrupt changes in new environments that are two or more time zones ahead/delayed. This can affect even the most seasoned flyers like pilots and business travelers.

What causes Jet lag disorder?

Your body has a clock system called circadian rhythm that schedules your body for its sleep and wake up time. Your circadian clock is synced depending on your original time zone.

Jet lag is caused by a temporary discoordination with your circadian clock and your new time zone or sleep-wake schedule. This is why when you expose your body to abrupt schedule changes, its normal functions related to sleep, coordination, and gastrointestinal processes are disrupted. While your mind may be ready to fly west, your body may still be stuck home and is still hours ahead.

Treating Jet Lag with Light Therapy

Jet lag can take days, weeks, or longer to improve, which may affect daily activities. In addition, although jet lag may be a temporary disorder, frequent exposure also poses significant long-term risks such as disturbances in menstrual cycle, cognitive defects, and temporal lobe atrophy.

One popular and effective treatment for jet lag disorder is Light therapy. Light therapy has been considered as a popular and effective treatment for jet lag disorder and has been backed by research since 1980.

Your body clock is largely influenced, among other factors by light, which is indicative of the rising and setting of the sun. This means that adjusting to a new time zone also means adjusting to a new daylight-night time and awake-sleep schedule.

Essentially, light therapy assists your brain and body in adjusting to a new time zone by conditioning yourself to light at an appropriate time. This allows your normal body functions to be in sync with your new schedule. By regulating light exposure, you can adjust faster with new conditions.

Studies show that exposure to light therapy helps people adjust their circadian clocks to new time zones more efficiently and effectively. Treatment of jet lag by Light therapy involves an exposure to natural or artificial light such as red light therapy.


How does Red light therapy work?

Red light therapy is a non-invasive, quick and easy treatment for jet lag that brings concentrated natural light to your body cells in order to condition it for a new day-light schedule. Red light therapy emits natural light that can boost cell energy without the putting your body at risk of the damaging UV rays from the sun.

If you travel westwards, you can use Red Light in the evening to help you adjust to a later time. On the other hand, if you travel eastwards, you can expose yourself to red light in the morning in order to acclimate your body to an earlier time zone.

Kaiyan produces high-quality Red light therapy home devices that utilize medical-grade LED (Light-emitting Diode) in order to produce a natural red light that is ideal for adjusting to new time schedules.

The great thing about this device is that, if you often work away from sunlight, this indoor light therapy device can be a convenient way to adopt your circadian clock to a new time zone. Check out our top picks for the best FDA-cleared light therapy masks.

Experiencing jet lag may be the ultimate bummer for travelling, but sufficient knowledge and proper treatment can keep you away from ruining your travel plans and goals.

References:

https://www.scientificamerican.com/article/how-to-prevent-jet-lag/
https://www.mayoclinic.org/diseases-conditions/jet-lag/diagnosis-treatment/drc-20374031
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2829880/


The Brain in Our Skin

Dr. Claudia Aguirre which has a Ph.D. in neuroscience from USC and travels the world lecturing on a broad range of topics from neuroscience to skin care has been researching the power of the skin and its connection with the brain.

The skin is highly innervated and intricately connected to the brain and central nervous system, just as other sensory organs are. Dr. Claudia Aguirre is discovering that the skin has a lot of neuro potential, or neuroplasticity, that has gone unrecognized. For example, just as our eyes have receptors that transduce light photons into signals to the brain that we process as vision, we’re discovering that our skin also has light receptors. Although we don’t yet know how they work, we speculate that they might be signaling the brain to make systemic changes that affect the full nervous system. Similarly, olfactory receptors in the hair follicles, just as we do in the nose.

Examples

Another example is touch, for which our skin is the primary sense organ. Skin is also our largest organ, which gives us a clue as to how important touch is. Different receptors in the skin can tell us not only whether what we touch is hot or cold, rough or smooth. Skin can even sense the intention behind the touch. A gentle touch feels much different than an aggressive one. We can tell whether the person giving us a massage is paying attention or whether they’re distracted. Moreover, different kinds of touch elicit different biochemical and hormonal responses, which have systemic results. A hug or kiss stimulates the release of oxytocin, the bonding hormone, through the bloodstream, while a punch or shove will release adrenaline and cortisol. All of these capabilities are what we say by the hidden brain in the skin.

Nervous System

The skin is connected to the nervous system; it’s connected to the endocrine system. The skin is impacted by our emotional states and, conversely, our skin can impact how we feel about ourselves. Cultural stress and anxiety can trigger or aggravate many skin conditions—from acne to eczema to herpes, psoriasis, and rosacea. Conversely, a disfiguring skin condition can trigger stress, anxiety, depression, and even suicide. Chronic, generalized anxiety can create chronic inflammation and exacerbate inflammatory skin conditions, such as the ones mentioned previously. Chronic stress can result in chronic anxiety, hypervigilance, poor sleep, and a whole cascade of effects resulting in a constant breakdown of tissues and organs, including the skin. There’s a whole new field of medicine being developed called psychodermatology, which is the study and treatment of the psychological component of skin conditions. Better understanding of the neuropotential of skin also opens the possibility of whole new avenues of treatment with light therapy for many of our chronic conditions.

In Kaiyan Medical we have understood that neuroscience should absolutely be part of the conversation about skincare and beauty because the brain and the skin are intimately connected. Skincare is important not only for the skin, but also the brain. That's why we keep developing light therapy devices for skin and brain. In Kaiyan we always recommend to listen for all the little signs that your skin tells you that you tend to ignore. You get a rash, and you brush it off: “Maybe it’s just dry out. Maybe I need to switch creams.” But if it occurs repeatedly, you need to look more closely and ask, “What could my skin be trying to tell me?” Are you repressing emotions? Is there a relationship issue you’re avoiding? Is there some other life circumstance that’s “gotten under your skin”? The body has a wisdom we should listen to.

References

https://drhowardmurad.com/the-brain-in-our-skin-an-interview-with-dr-claudia-aguirre/

http://doctorclaudia.com/about

https://www.janinerod.com/the-hidden-brain-in-your-skin-claudia-aguirre-tedxucla/

Treating Glaucoma with Green Light Therapy

According to the National Eye Institute, glaucoma is the third leading cause of blindness in the U.S cataracts and macular degeneration rank first and second, respectively. There are an estimated 2,218,000 patients who suffer from glaucoma (approx. 1 in 136 or 0.74%).

What is Glaucoma

Glaucoma is a disease of the optic nerve often caused by an abnormally high pressure the eye (also called IOP, intra-ocular pressure). It is one of the leading factor for blindness. It can occur at any age but is more common for people over the age of 60. The vision loss due to glaucoma can't be recovered and many forms of glaucoma have no warning signs at an early stage, so it is important that we do regular eye exam or get prevention as early as possible.  

Currently, there are 3 Keys that allow for a more accurate diagnosis of glaucoma:
An elevation of intraocular pressure
Changes in the optic nerve
• Peripheral field loss

Diagnosis

Your doctor will review your medical history and conduct a comprehensive eye examination. He or she may perform several tests, including:

  • Measuring intraocular pressure (tonometry)
  • Testing for optic nerve damage with a dilated eye examination and imaging tests
  • Checking for areas of vision loss (visual field test)
  • Measuring corneal thickness (pachymetry)
  • Inspecting the drainage angle (gonioscopy)
Medical Treatment

The damage caused by glaucoma can't be reversed. But treatment and regular checkups can help slow or prevent vision loss, especially if you catch the disease in its early stages.  Glaucoma is treated by lowering your eye pressure (intraocular pressure). Depending on your situation, your options may include prescription eyedrops, oral medications, laser treatment, surgery or a combination of any of these.

However, the method of treatment of glaucoma is mainly of medication, which can lower the intra-ocular pressure, but also many medication would also block aqueous production. It is similar to the condition that a patient with hypertension taking medications to decrease the production of blood to reduce the blood pressure. That is harmful to the eye health.

In Singapore, the mean direct cost of glaucoma treatment with glaucoma medications alone per patient over 10 years was SGD 2042.47 (± 2078.54) or US$1,592.86 (±1620.99), while the mean cost of surgery was SGD 8038.75 (± 2829.4) or US$6,269.18 (± 2206.56) and laser was SGD 1163.63 (± 532.9) or US$907.48 (± 415.59).

Green light therapy is way cheaper and can lead to great results


Green Light Treatment

One of the biggest advantage of light therapy is that there is no side-effect like medication and it can be used at an early stage for prevention.

Scientists and researchers first began to study light therapy in the treatment of glaucoma in 1948. According to R. B. Zaretskaya, MD’s research, published in American Journal of Ophthalmology, it shows that, while the red light has a pressure raising effect, the effects of green light are greater than white light even at a higher brightness. So, green light should be considered a therapy for the reduction of intra-ocular pressure in glaucoma.

The following important experiment was done by R. B. Zaretskaya, MD, also published in the American Journal of Ophthalmology, showed that eye pressure was lowed for patients wearing green spectacles, also with fluctuation of eye pressure decreasing. These patients were required to a 10 minute exposure of green light with an intensity of 1.4 lux. Pressures were then measured at every half hour until pressures returned to baseline.

The conclusion indicates that green light (mu delta) has a pressure lower affect in the majority of patients 82% and the average pressure lower affect was 5 mm Hg and this effect persisted for 4 hours after a brief 10 minute exposure.  

The second article also by R. B. Zaretskaya, MD, which was published in the American Journal of Ophthalmology 1948 31: 985-989 refers about 19 patients that were studied and pressures were determined 3 times a day. Once at 7:00 AM (still in bed), 1:00 PM and then between 7:00 and 8:00 PM. Medications were withheld for a day or two and then green spectacles were given on the second day for full time wear. The spectacles were a hue corresponding to 511 nm and a daylight transparency of 21%. In a certain number of cases, the green spectacles were combined with a greatly reduced strength of pilocarpine. One group had a combination of green glasses and adrenalin (1:1,000) which was also made to test Kravkov’s statement that the installation of adrenalin might increase the eyes sensitivity to green.

Results of this study showed that IOP showed a pronounced tendency to decrease in patients wearing green spectacles.  The fluctuation of IOP during the day was also found to decrease in patients wearing green glasses.  There was an appreciable effect when the use of green spectacles was combined with very small dosages of pilocarpine (0.5 percent).  20 out of 25 eyes had an expressed decrease in IOP as well as a decrease in fluctuations. The pressures decreased by  6.0 mm Hg in 8 cases, 10 mm Hg in 9 cases and 10 mm Hg and more in 3 cases. The results were more striking when combined with small dosages of adrenalin.

Conclusions:
Green spectacles prescribed with a total withdrawal from Pilocarpine produces a decrease in IOP
The affects are most pronounced when used with the administration of small doses of adrenalin
• Mechanism of action is proposed to be on the color receptors of the human eye
• Green light brings about a definite arrangement in the autonomic nervous system and thus affects the neurovascular system of the eye

How to Do a Green Light Therapy Treatment?

Consistency and proper use is key for effective green light therapy. For optimal results with a high-quality device like the ones in Kaiyan, follow these basics for general wellness benefits:

  • Expose your eyes for best results
  • 10-minute treatment each time
  • Daily use is ideal
  • Any time of day
The Future for Green Light and Glaucoma

As we also know that green light could also treat migraine as well as glaucoma, and both migraine and glaucoma are disease of nerve, we may want to know is there connection between these two illness, both of which would cause the pain in the front part of our brain. Hope future research would find out.

References

Conference speech presented at the International Syntonic Light Conference held in St. Pete Beach, Fl , April 28th – May 1st

https://www.healingtheeye.com/Articles/Syntonic_Light_Therapy_Glaucoma.html

https://www.healingtheeye.com/Articles/AJO_IOP_%20light.pdf

https://www.mayoclinic.org/diseases-conditions/glaucoma/diagnosis-treatment/drc-20372846#:~:text=Glaucoma%20is%20treated%20by%20lowering,combination%20of%20any%20of%20these.

https://iovs.arvojournals.org/article.aspx?articleid=2360086#:~:text=The%20mean%20direct%20cost%20of,US%24907.48%20(%C2%B1%20415.59).

R. B. Zaretskaya, MD. Intraocular Pressure of Normal and Glaucomatous Eyes as Affected by Accessory Light Stimuli. American Journal of Ophthalmology 1948 – 31-721-727.

Light Therapy - Color Meaning

Introduction to Color Light Therapy

Color Light therapy is based on the idea of restoring balance by applying color to the body. Its history is rooted as far back as the Mayan culture.

In India, Ayurveda, an ancient form of medicine practiced for thousands of years, is based on the idea that every individual contains five elements of the universe that are present in specific proportions unique to each individual, including their personality type and constitution. When these elements are out of balance, Ayurveda works with the energies inherent in the colors of the spectrum to restore this balance.

In ancient Egypt the art of healing with color was founded in the Hermetic tradition, the Ancient Egyptians and Greeks used colored minerals, stones, crystals, salves, and dyes as remedies, and painted treatment sanctuaries in various shades of color.

In China, traditional Chinese medicine incorporates color to be associated with each organ and elemental system. This healing method looks at the idea that every individual is a balance. The first color wheel was invented by Sir Isaac Newton. He split white sunlight into red, orange, yellow, green, cyan, and blue. He then joined the two ends of the color spectrum together to show the natural progression of colors.

Light Therapy has been valued throughout history as a remarkable source of healing. Today, the therapeutic applications of light and color are being investigated in major hospitals and research centers worldwide. Results indicate that full-spectrum, ultraviolet, colored, and laser light can have therapeutic value for a range of conditions from chronic pain and depression to immune disorders.

Wellness Benefits

Light Therapy has been reported, as part of a healthy lifestyle, to temporarily reduce swelling, relieve pain, decrease inflammation, accelerate open wound healing and greatly reduce overall recovery after medical/surgical procedures. Patients have demonstrated an increased range of motion, decreased muscle tension and spasm, and improved circulation.

Rejuvenating LED light therapy can be used for temporary pain management such as joint and back pain, sore or torn muscles, sprains, arthritis, post-surgical scars, burns, wounds, and more. When used with infrared technology, light therapy (phototherapy) is one of the most effective and non-invasive ways to improve overall wellness.

Light therapy is also used to temporarily relieve Seasonal Affective Disorder (SAD). SAD affects individuals when the lack of sunlight results in seasonal depression. Phototherapy helps with SAD by resetting the internal biological clock (Circadian rhythms), helping individuals sleep better, and regulate their mood. Even companies, such as GE and Philips, have created phototherapeutic products to improve and regulate mood.

Cosmetic Benefits

Light therapy is also a growing treatment for anti-aging. Many individuals have seen a temporary reduction in the appearance of fine lines, wrinkles, crow’s feet, and age spots.

Light therapy is “effective at improving the appearance of the face, neck, and chest by reducing the signs of aging, wrinkles and age spots”, says Web M.D. Combined with infrared therapy, LED phototherapy can be a great way to revitalize skin.

Healing With Color

Color is light split into different wavelengths vibrating at different speeds and at different frequencies. Objects that ABSORB all wavelengths and DO NOT reflect are black in nature. Objects that REFLECT all wavelengths and DO reflect are white in nature. Between black and white lies COLOR. Colors are wavelengths of energy that, to us, appear as color because of the potential and capabilities of the object to either absorb or reflect the energy.

Red Light

In the early 1990s, RLT was used by scientists to help grow plants in space. The scientists found that the intense light from red light-emitting diodes (LEDs) helped promote the growth and photosynthesis of plant cells.

The red light was then studied for its potential application in medicine, more specifically to find out if RLT could increase energy inside human cells. The researchers hoped that RLT could be an effective way to treat the muscle atrophy, slow wound healing, and bone density issues caused by weightlessness during space travel.

You may have heard of red light therapy (RLT) by its other names, which include:

  • photobiomodulation (PBM)
  • low-level light therapy (LLLT)
  • soft laser therapy
  • cold laser therapy
  • biostimulation
  • photonic stimulation
  • low-power laser therapy (LPLT)

Red is called “The Great Healer”. So far is the most popular light therapy. To wind down before bed, use red light. “The color signals that it’s night, which may encourage the body to produce melatonin,” says Michael Breus, Ph.D., an advisory board member for SleepScore Labs.

Red light can also improve your workout. Just one to five minutes of exposure to red and infrared light right before exercise boosted strength and prevented soreness, says Ernesto Leal-Junior, Ph.D., the head of the Laboratory of Phototherapy in Sports and Exercise at Nove de Julho University in Brazil. “Certain wavelengths of red and infrared light-660 to 905 nanometers-reach skeletal muscle tissue, stimulating the mitochondria to produce more ATP, a substance that cells use as fuel,” he says.

Green Light

Green is the universal healing color. Originally, the color of love. Green is midway in the color spectrum; therefore, it contains both a physical nature and a spiritual nature, in equal balance and in equal harmony.

Gazing at green light can reduce chronic pain (caused by fibromyalgia or migraines, for example) by up to 60 percent, according to a study in the journal Pain, and animal studies have shown that the beneficial effects can last up to nine days. “Looking at green light seems to lead to an increase in the body’s production of enkephalins, pain-killing opioid-like chemicals. And it reduces inflammation, which plays a role in many chronic pain conditions,” says researcher Mohab Ibrahim, M.D., Ph.D.

More studies are needed before doctors can make recommendations on how and how often to use green light to treat migraines and other pain, and Dr. Ibrahim says you should see a physician before trying to treat yourself at home. But at this point research indicates that exposing yourself to an hour or two every night-either by using a green light bulb in a lamp or by wearing glasses fitted with tinted optical filters-may decrease migraines and other types of chronic pain

Helps to treat and prevent hyper-pigmentation by inhibiting the production of excess melanin which then prevents it from traveling to the surface. It will help break up the melanin clusters that are already on the surface.

Yellow Light

Yellow helps awaken mental inspiration arousing a higher mentality. Thus, it is an excellent color for nervous or nerve-related conditions or ailments; fueling the solar plexus. Yellow has a very enriching effect upon the intellect. Yellow can be used for conditions of the stomach, liver, and intestines. It can help the pores of the skin by repairing scarred tissue. These rays have an alkalizing effect which strengthens the nerves. Awakening, inspiring, and vitally stimulating the higher mind promoting self-control. Typical diseases treated by yellow are constipation, gas, liver troubles, diabetes, eczema, and nervous exhaustion. Providing clarity of thought, increasing awareness, stimulating interest, and curiosity yellow energy is related to the ability to perceive or understand.

The yellow is used for treating redness, flushing, irritation, and Rosacea. It may also reduce the appearance of the tiny blood vessels on the nose and face.

Blue Light

Blue light therapy technology is an additional option for the treatment of acne. Research has shown in-office and at-home systems produce positive results.

“Blue light therapy effectively helps alleviate this common skin condition affecting 50 million Americans and 94 percent of all females, according to Judith Hellman, MD, a board-certified dermatologist, in practice in New York City. Dr. Hellman, who practices medical dermatology and specializes in dermatological surgery, laser surgery, and anti-aging skin treatments, explains how the blue light treatment system works for acne, its uses, and her clinical experience with the technology.

Cyan Light

It is used as a gentle acne treatment to control oil production in the skin as well as reduce inflammation. It also promotes the synthesis of protein and collagen.

Orange Light

Orange has a freeing action upon the mind, relieving repression. Because orange is a blend of red and yellow, it combines physical energy with mental wisdom, inducing a transformation between lower physical reaction and higher mental response. Thus, it is often referred to as “The Wisdom Ray.” Orange is warm, cheering, and non-constricting.

Through orange, we are able to heal the physical body (red) and, at the same time, induce within the mind (yellow) greater understanding. Orange helps assimilate new ideas. Orange is the best emotional stimulant, helping to remove inhibitions paving independent social behavior. Bring joy to your workday and strengthen your appetite for life. Orange aids in repairing inflammation of the kidneys, gallstones, menstrual cramps, epilepsy, wet cough, and all sinus conditions.

Purple Light

Violet is the last color we can see before light passes on to ultra-violet. Violet purifies our thoughts and feelings giving us inspiration in all undertakings. The violet energy connects us to our spiritual self bringing guidance, wisdom, and inner strength and enhances artistic talent and creativity. Leonardo da Vinci proclaimed that you can increase the power of meditation ten-fold by meditating under the gentle rays of Violet, as found in church windows.

Light therapy uses colors for their proposed wellness abilities in treating emotional and physical disturbances. Light therapy is based on the premise that different colors evoke different responses in people. For example, some colors are considered to be stimulating, whereas others may be soothing. Color therapy has been suggested for many uses, based on tradition or on scientific theories. Consult with a health care provider before using color therapy for any use.

Infrared Light

Infrared light penetrates to the inner layers of the skin at about 2 to 7 centimeters deep. Hence, it reaches the muscles, nerves, and even the bones. Many studies have shown that a frequency of infrared light, with wavelengths from 700 to 1,000 nanometers, is best used for healing inflammatory conditions.

The use of electricity for healing purposes began in 2,750 BC when people used electric eels to give electric shocks. Electricity and magnetism were used in people with just little success. However, in 1975, transcutaneous electrical stimulation (TENS) was developed to treat chronic pain. It was not until recently that infrared therapy was developed to improve wound healing, reduce the pain caused by arthritis, boost endorphin levels, and bioactivate neuromodulators.

Infrared therapy technology allows people to harness the benefits of the sun, without being exposed to harmful ultraviolet rays. Also, infrared therapy is safe and effective, without adverse side effects. As a matter of fact, infrared light is safe and is used even for infants in neonatal intensive care.

Infrared light is absorbed by the photoreceptors in cells. Once absorbed, the light energy kickstarts a series of metabolic events, triggering several natural processes of the body on a cellular level.

Kaiyan Medical

In Kaiyan, we are in love with light therapy. We believe in the natural balance in our bodies. We develop devices such as the Aduro mask which will provide you with the full range of color light therapies.

References

https://www.estyspot.com/blogs/esthetician-tips/an-estheticians-view-of-led-therapy-benefits-for-all-7-colors

https://www.the-dermatologist.com/content/acne-treatment-blue-light-therapy-benefits-0#:~:text=A%3A%20Blue%20light%20kills%20the,oil%20glands%20in%20the%20skin.

https://www.healthline.com/health/red-light-therapy#summary

https://www.estyspot.com/blogs/esthetician-tips/an-estheticians-view-of-led-therapy-benefits-for-all-7-colors

Deppe A. Ocular light therapy: a case study. Aust J Holist Nurs 2000;7(1):41.

Geldschlager S. Osteopathic versus orthopedic treatments for chronic epicondylopathia humeri radialis: a randomized controlled trial. Forsch Komplementarmed Klass Naturheilkd 2004;Apr, 11(2):93-97.

Maher CG. Effective physical treatment of chronic low back pain. Orthop Clin North Am 2004;Jan, 35(1):57-64.

Natural Standard Research Collaboration, Chief Editors: Ulbricht C, Basch E, Natural Standard Herb and Supplement Reference: Evidence-Based Clinical Reviews, USA. Elsevier/Mosby, 2005.

Ohara M, Kawashima Y, Kitajima s, et al. Inhibition Of lung metastasis of B16 melanoma cells exposed to blue light in mice. Int J Molecular Medicine 2002;10(6):701-705.

Wileman SM, Eagles JM, Andrew JE, et al. Light therapy for seasonal affective disorder in primary care: randomised controlled trial. Br J Psych 2001;178:311-316.

Wohlfarth H, Schultz A. The effect of colour psychodynamic environment modification on sound levels in elementary schools. Int J Biosocial Res 2002;(5):12-19.

Zifkin BG, Inoue Y. Visual reflex seizures induced by complex stimuli. Epilepsia 2004;45(Suppl 1):27-29.

Fighting Breast Cancer with Light Therapy

Researcher fighting breast cancer with light therapy
"Metastatic breast cancer can be a devastating diagnosis with high rates of relapse and death, and there are currently no effective therapies,"

Nalinikanth Kotagiri, MD, Ph.D. says.

"Despite newer treatments, many patients still succumb to the disease. Major limitations include acquired resistance to therapies and serious side effects from treatment. Due to the widespread location of breast cancer cells, particularly in the bone marrow, which harbors the tumor cells as well as vital stem cells, the risk of toxicity is even higher with conventional therapies. Therefore, new therapeutic strategies that selectively destroy tumor cells, increase treatment efficacy, prevent relapse and reduce side effects by sparing the healthy stem cells are necessary."


This is why Nalinikanth Kotagiri, MD, Ph.D., assistant professor in the James L. Winkle College of Pharmacy and a cluster hire for the Cincinnati Cancer Center, is hoping to study ways ultraviolet light can activate light-sensitive drugs to treat this invasive breast cancer and provide that light at the end of the tunnel patients yearn for.

Kotagiri has been awarded the Department of Defense Breast Cancer Breakthrough Award—over $600,000 for three years—to try to do just that. His project will focus on light-mediated therapies, which could activate light-sensitive drugs to target only the cancerous cells.

"Therapies such as photodynamic therapy (PDT), involving light and a photosensitizing chemical substance, which used in conjunction with molecular oxygen can cause cell death, offer a high degree of control that is effectively used to manage cancer in early to advanced stages," he says. "It operates on a simple principle where a light-sensitive drug, which is otherwise nontoxic, introduced into certain tissues can cause cell death when activated by light. Despite the promise of PDT, it can't penetrate tissue deeply so its use is limited. Also, current light-sensitive drugs require oxygen to be effective, but many tumors, including breast tumors, have pockets of low oxygen or grow in regions where oxygen is either low or absent, which could prevent effective application of PDT in cancer treatment."

However, Kotagiri says recent work in the lab has led his team to a "two-pronged approach" in addressing these issues.

"We've been using ultraviolet (UV) light from radionuclides (radioactive nuclide or atom), which are already used to image tumors and tissues, and tried to solve oxygen dependence by using metal-based light-sensitive drugs for depth- and oxygen-independent PDT," he says. "By replacing the external light source, such as lasers and lamps, with light from radionuclides as an 'internal' light source, we've been able to better control therapy in the body.
"This could mean more effective therapies with minimal toxicity to vital organs and tissues. Since radionuclides are used in imaging and locating tumors, we can now simultaneously image and treat breast cancer metastasis using the same radionuclide."

Using animal models, researchers in Kotagiri's lab will test whether radionuclide light activation of tumor targeting, light-sensitive drugs will destroy metastatic cancer cells—including those that are resistant to traditional therapies.

"Since how we're killing the cells is not dependent on a certain molecular pathway, the technology could be applicable to treat a wide variety of breast cancers," he adds. "This has the potential to be a common image-guided treatment strategy to treat patients in early as well as advanced stages of the disease, and because of the safety of this treatment strategy, it could be effectively used alongside other treatments, like chemotherapy and immunotherapy, without the risk of additional side effects.
"This could tremendously benefit patients, as it could potentially improve therapeutic outcomes in addition to setting a precedent to tailor other FDA-approved light-sensitive drugs as radionuclide activated therapies, expanding the scope and range of the diseases these drugs currently treat. If proven beneficial, this treatment could be ready for a patient population in 5 to 10 years, since all the materials involved have already been used in humans—this could be an exciting breakthrough."
Clinical Trial - The Effects of Light Therapy to Treat Cancer-related Side Effects

ClinicalTrials.gov Identifier: NCT04418856

Besides what Kotagiri said, severe fatigue, depression, sleep problems and cognitive impairment are the most commonly reported side effects of cancer treatment. These aversive side effects are hypothesized to be related to the disruption of circadian rhythms associated with cancer and its treatment. Exposure to Bright White Light (BWL) has been found to synchronize the circadian activity rhythms but research with cancer patients has been scarce. Therefore, the proposed randomized control trial (RCT) will test if systematic light exposure (sLE) will minimize overall levels of cancer-related fatigue (CRF), depression, sleep problems and cognitive impairment among breast cancer patients undergoing breast cancer treatment (i.e., surgery, chemotherapy). SLE incorporates the delivery of harmless UV-protected BWL or Dim White Light (DWL - standard comparison in light studies) delivered to patients by using special glasses for 30 minutes each morning, during their treatment.

Learn more about the how to improve your circadian rhythm and light therapy & breast feeding

References

https://medicalxpress.com/news/2018-10-breast-cancer-therapy.html

https://www.mayoclinic.org/tests-procedures/photodynamic-therapy/about/pac-20385027#:~:text=Photodynamic%20therapy%20(PDT)%20is%20a,energy%2C%20usually%20from%20a%20laser.

https://clinicaltrials.gov/ct2/show/NCT04418856

5 Biohacking Techniques

What is Biohacking?

Biohacking is the practice of changing our chemistry and our physiology through science and self-experimentation to energize and enhance the body. It’s a broad definition, but that’s also because the concept is constantly evolving. It includes implementing lifestyle and dietary changes that improve the functioning of your body, as well as wearable technology to help you monitor and regulate physiological data. It can even run to extremes such as using implant technology and genetic engineering.

The possibilities are endless, but they are all rooted in the idea that we can change our bodies and our brains, and that by doing so we can ultimately become smarter, faster, and better as human beings.

Start biohacking your body by using wearables like the FitBit or the Apple Watch to track the way you operate. You could also start experimenting with the power of music in your everyday life and adopting a sustainable healthy diet. But if you’re ready for something new, and something different, consider one of these non-invasive methods from our biohacking guide:

Biohack Tip 1: Red Light Therapy

Have you ever spent a lot of time indoors and begun to feel… off? Our bodies and brains need light to function at their best. Not only does the sun give us an important dose of vitamin D, but it helps us in a number of other physiological and emotional ways. Let’s look a little closer – specifically at the light wavelengths between 600 and 900 nanometers (nm). How does this range of light waves impact us and how can we use it to biohack the body?

Studies have shown that your body responds particularly well to red and near-infrared wavelengths, which range from 600 to 900 nm. This particular range of light waves is absorbed by the skin to a depth of about 8 to 10 millimeters, at which point your mitochondrial chromophores absorb the photons. This activates a number of the nervous system and metabolic processes.

In plainer terms, red light therapy has become an increasingly popular form of biohacking used to treat a number of conditions. It has been proven to relieve pain, reduce inflammation, and restore mood. And because it is a non-invasive and non-chemical treatment, it’s not as intimidating as other forms of biohacking.

Biohacking Tip 2: Functional Music

With over 100 billion neurons that are constantly using electricity to talk to each other, your brain is like Grand Central Station. If everyone is chattering loudly at the same time, it can be tough to concentrate on what you need to get done. That’s where music biohacking comes in. Brain activity can be measured in a wave-like pattern and determines if you feel alert, sleepy, relaxed, or stressed. Things that can affect your brainwaves include the activity you are currently performing, how much restorative rest you’ve had, and what you’ve just eaten or drank.

One of the most reliable ways to change your brainwaves is through a consistent sound wave. Audio entrainment, a form of music biohacking, uses binaural beats and tones to synchronize with your brain waves and induce a meditative, relaxed state. You can access programs developed specifically for your own brain and the activities you want to accomplish at Brain.fm. If you’re not ready to go that far, you can still change your mood and mindset by queuing up your favorite playlist and listening while you work out, cook breakfast, or commute to work.

Biohacking Tip 3: Osteostrong

We talk a lot about cardiac health. After all, heart disease is the #1 killer of women in the United States. Everyone needs to be aware of cardiovascular diseases and how to protect themselves as best they can. As a culture, we also talk a lot about skin health – slathering on sunscreen as part of our daily routine and supplementing our diets with collagen-boosting foods. Weight loss, inflammation, memory, GI health, and how an unhealthy diet and lack of exercise can prematurely age you – these are all at the forefront of our minds. But how often do we think about the health of our bones?

A decrease in bone health creeps up on you and most people are unaware of how bone density changes over time. Roughly up until the age of 30, men and women actually build more bone than they lose, so we are constantly strengthening our bones and working on bone density. But when we hit our mid-30s, things change. And if you’ve passed that benchmark, you may have felt that shift.

After reaching their mid-30s, women lose about 2% of bone density every year, and that continues for a few years following menopause. This leaves women with a high likelihood of experiencing osteoporosis.

So what do you do? Consider trying OsteoStrong, a non-pharmaceutical way of improving bone density, strength, and balance as one of your biohacking techniques.

According to OsteoStrong’s website, research indicates that the stimulus required to activate the growth of healthy bone tissue is 4.2 multiples of body weight. However, this level of force would be exceptionally difficult to achieve on your own. That’s why OsteoStrong utilizes the Spectrum System, which is part of a new category of devices called the Robotic Musculoskeletal Development System (RDMS).

Biohacking Tip 4: Gratitude

How we view life has a huge effect on our moods, how we treat others, and our general levels of fulfillment. When you have an abundance mindset, you’re consistently grateful for everything that comes your way and is always focused on the positive. Have a hard time adopting this type of perspective? Changing your mindset is really about nothing more than practice. You need to consistently refocus your brain to see the positive in every situation until it becomes second nature. These biohacking techniques and tools can help:

  • A gratitude journal in which you write three to five things you’re grateful for helps you reframe the day to focus on the positive and reflect on all the good things that happen to you.
  • Take a gratitude walk where you give thanks and send positive energy to every living thing you see. If you walk to work or take a morning jog, you can easily incorporate this into your normal routine.
  • Write a weekly letter of gratitude to someone who has helped you or who means a lot to you. It could be a family member, a long-lost friend, or even a coworker who always remembers to stock your favorite coffee.
  • Begin the day with a ritual, such as meditating, and set an intention to be grateful for all you encounter.
Biohacking Tip 5: Supplements

Exercising, eating right, and developing the right mindset are important steps to unlocking an extraordinary life. Biohacking helps you take this to the next level by incorporating supplements that improve focus, increase energy, and help your body benefit from the most bioavailable forms of nutrients available.

We often don’t get all the vitamins and minerals we need to keep us at peak performance. High-quality supplements in the form of pills, shakes, bars, or drinks can fill the nutritional gap and help boost performance, detoxify our systems, and achieve daily energy.

Tony has created a variety of health supplements, drinks, and bars that help you feel your best every day and make biohacking the body easy.

Red Light Therapy - 101

We are not just made of biochemical matter. We are charged energy beings, constantly interacting with the environment. Light plays a crucial role in this natural process. Comprehensive new research has unearthed a full new understanding of how our cells function optimally. Food is not the only way we obtain energy; the light also charges us.

Science now shows your body operates like a battery. Certain wavelengths of sunlight power it, and your general health is determined by your ability to receive and maintain a charge. This is what light therapy is about.

What is Red Light Therapy

Light at certain wavelengths is scientifically proven to interact with the body in beneficial ways.

Red light, comprising both red and near-infrared wavelengths, is a unique healing part of the electromagnetic spectrum, and it is one of the most natural ways to charge the body. It is now used as a new form of therapy under the umbrella term Photobiomodulation(PBM)

Red light wavelengths ranging from 600–680nm. Red light boosts the formation of collagen and elastin and assists in cell communication. It penetrates superficially and can be used for skin conditions.

Near-Infrared wavelengths ranging from 750–850nm. NIR stimulates healing, increases mitochondrial function, and improves blood flow and tissue oxygenation. It penetrates deeper into the body.

A high-quality home device like those produced by Kaiyan uses medical-grade LEDs to shine natural red and near-infrared light on your body. Like the wavelengths of light your body needs from natural sunlight, without the heat or UV rays that cause sun damage and without the need for sunny weather. Check the list of best light therapy masks.

How to Recharge your Body

Electric charge is a fundamental property of the body. The surfaces in our bodies — such as membranes, proteins, and DNA — are all charged, negatively or positively, depending on whether they lose or gain electrons.

At the core of your body’s power to heal itself are sub-cellar organelles called mitochondria. The number of mitochondria in a cell varies widely by organism, tissue, and cell type and are concentrated in organs with high energy demands such as the brain, heart, liver, skin, and muscles.

This is because mitochondria generate most of the body's chemical energy supply via the ATP (adenosine triphosphate). They also regulate various other tasks, such as signaling, cellular differentiation, and maintaining control of the cell cycle and cell growth. This is why they are often referred to as the powerhouse of the cell.

Mitochondria
  1. LED light at a wavelength from 600–680nm(red) and between 810–850nm(infrared) is delivered to the tissue via the red light therapy device.
  2. The light enters the cell’s mitochondria and is absorbed by the chromophores, including the protein cytochrome c oxidase(CCO) and EZ water, increasing its activity.
  3. As a result of this highlighted activity, three molecules are affected. Adenosine Triphosphate(ATP), Reactive Oxygen Species (ROS), and Nitric Oxide (NO).
Water

Approximately 70% of our body weight and 99% of our bodies ’ molecules are made of water, and this water is in a charged state.

Recent research by Prof Gerald Pollock of the University of Washington has shown that water adjacent to a cell or mitochondrial membrane is so-called structured water. This is also called EZ (exclusion zone) water because it creates a separation of charge. Positive proton is excluded and pushed to the bulk water, and a lattice-like negatively charged water for near the membrane. This increases the voltage across the membrane—this charge separation of water in the body functions as the positive and negative poles of a battery.

What Does “Red Light Therapy” Mean?

As a term, “red light therapy” refers to treatments from LEDs or cold lasers that deliver wavelengths of natural red and near-infrared light.

The term does not include white light, blue light, or blue LED masks, and it is not the same as full-spectrum light. Some people may include infrared or far-infrared wavelengths along with red light therapy, but those are typically used in dry saunas because of their ability to produce heat. Red light therapy does not rely on heat, a major difference between natural light treatments and heat-based modalities like an infrared sauna, traditional sauna, or other heat therapy type.

Generally, “red light therapy” describes natural light treatments that deliver the same therapeutic red and near-infrared wavelengths as natural sunlight. This differs from artificial light treatments like tanning — or bright light therapy from light therapy lamps, lightboxes, or happy-light if you’re interested in natural light treatments for seasonal affective disorder.

The following terms may also call red light therapy: RLT, photobiomodulation (PBM), phototherapy, LED therapy, LED light therapy, infrared therapy, low-level laser therapy, or low-level light therapy (LLLT).

A Multilevel Treatment

Red light therapy works on multiple levels in the body.

Molecular

  • Chromophores, cytochrome c oxidase, water, opsins
  • Retrograde mitochondrial signaling
  • Light-sensitive ion channels
  • Adenosine triphosphate ATP
  • Reactive Oxygen Species ROS

Calcium

  • Heat-shock proteins
  • Melatonin
  • Brain-derived neurotrophic factor
  • Gene transcription factors
  • Akt/mTOR/CyclinD1 pathway

Cellular

  • Inflammation, Cytoprotection, Proliferation
  • Protein synthesis
  • Stem cell production and migration
  • Immune cell viability
  • Retrograde mitochondrial signaling
  • Transforming growth factor
  • Pro-and anti-inflammatory cytokines
  • Vascular endothelial
  • Mitochondrial membrane potential

Tissue

  • Muscles: Increase endurance, tone density
  • Brain: Improves cognition and immune
  • Nerves: Repair and pain relief
  • Healing: Bones, tendons, and wounds
  • Hair: Increases growth
  • Skin: Improvements of the collagen network, anti-aging, skin disorders
  • Fat: Fat re-absorption improved by enhanced micro-circulation
  • Lymph: Improved immunity
Systemic Effects

Red light therapy affects multiple bodily systems:

Fascia

The fascia is a complex web of sensitive and highly interconnected connective tissue beneath the skin that attaches, stabilizes, encloses, and separates muscles and other internal organs.

Fascia is primarily made from hydrated collagen-Protein chains in a triple helix formation surrounded by water, with a capacity to generate an electric charge in response to applied mechanical stress (piezoelectric).

The bio-electrical nature of the collagen-rich matrix is the key to understanding how pathological changes in one part of the body may cause a cascade of “remote effects” in seemingly unrelated areas and organ systems. The fascia is the long-overlooked but absolutely crucial interconnecting organ of the human body. The therapeutic effect of red light energy can be carried through the fascia network to other parts of the body where it is needed. This is turn, elevates the body’s capacity to communicate via this charged matrix in a positive feedback loop.

The well-known energy meridians of traditional Chinese medicine may actually be low resistance pathways operating through the fascia, conveying energy to the rest of the body.

Gut-Brain Axis

The gut-brain axis links the emotional and cognitive center of the brain with peripheral intestinal functions. Red light energy applied to the abdomen area can therefore influence mood and neuropsychological issues via several mechanisms:

  • Reduction in bowel inflammation and gut spasms.
  • Stimulation of neurotransmitters and hormones in the gut, including serotonin, leptin, and ghrelin.
  • Modulation of the micro-biome. The gut microbes are sensitive to light energy and respond to light energy with differences in growth, migration, and proliferation of the different species.
  • The increasing availability of neurotransmitters activates the brain’s immune system, increases blood flow, and removes toxins.
  • Increased blood circulation and reduced blood pressure leading to a reduction of anxiety and brain fog.
  • Modulation of the vagus nerve, one of the biggest nerves connecting the gut and brain. This plays an important role in stress and social communication, communicating motor and sensory impulses to every organ in the body.

Immune System

Beaming red light and near-infrared light onto cells creates a short, low-dose metabolic stress that builds up the cells' anti-inflammatory, anti-oxidant, and natural defense systems, making the body stronger and more resilient to infections.

This is the concept of hormesis; safe, low-level exposure to stressor results in increased resistance to illness. Red light has been shown to influence the immune response in several ways:

  • Activation of the mast cells leading to the movement of leukocytes and reduced inflammation.
  • Mast cell DE-granulation and the release of pro-inflammatory cytokines.
  • Increased infiltration of the tissues by leukocytes.
  • Enhanced proliferation, maturation, and motility of fibroblasts
  • Increased production of fibroblast growth factor.
  • Lymphocyte activation and proliferation.
  • Macro-phages activated to act as phagocytes.

Circulatory System

Red light therapy has been shown to aid the circulatory system's functioning and increase the micro-circulation of blood, one of the most recognized and well-documented effects of this therapy.

Red light stimulates the formation of new capillaries carrying more oxygen to the body.

A good oxygen supply is intricately involved in numerous biological processes, including cell proliferation, angiogenesis, and protein synthesis, required to restore tissue function and integrity.

Increased circulation allows for waste products to be carried away more effectively. It triggers and heightens the body’s own scavenging process for and ingesting degenerated cells for clean-up.

In fact, increased micro-circulation of blood is thought to be the most vital function for healing the body for almost every illness. For general well-being, Nutrient-rich blood and efficient waste removal is strongly linked to good health.

Nervous System

The nervous system is a complex electrical system, including the brain and spinal cord. It collects, processes, and responds to the input of energy-be it light, sound, heat, or pressure — and it relays these messages to the brain and around the body.

Red light energy affects the nervous system in several crucial ways:

  • Myelination of fibers and a better lamellar organization of the myelin sheath.
  • Improvement of electrophysiological function.
  • Facilitation of neural regeneration.
  • Release of growth factors.
  • Increase of vascular network and collagen.
  • Faster regeneration of nerve lesions and functional improvement of damaged nerves.

The peripheral nerves can be damaged by infection or high sugar levels in the case of diabetic neuropathy.

Red light therapy is being explored as a promising drug-free therapy for all kinds of nerve damage.

Stem Cells

At the frontier of science, red light therapy shows huge promise in current research to stimulate the growth of stem cells in the body and maximize the effect of stem cell implantation for a wide variety of medical purposes.

Therefore, red light may be useful after surgery to stimulate stem cells to aid the repair of tissues and possibly organs.

Light at certain wavelengths has also been shown to coax stem cells to repair teeth, so red light therapy could soon revolutionize dental treatments. Indeed, some progressive dental clinics now offer red light therapy as an alternative to conventional drug and drill treatments.

Red light therapy has been shown to stimulate mesenchymal stem cells in the bone marrow to enhance their capacity to infiltrate the brain.

This has implications for healing degenerative conditions such as dementia, Alzheimer’s, and Parkinson’s disease , currently lacking any orthodox treatment solution.

Where Did Red Light Therapy Come From?

Red light therapy has become a popular natural health intervention, both in professional settings and with home devices.

Light therapy technology has been used in medicine for decades, and NASA experimented with red light therapy use in space in the 1980s and 1990s. In the last 10–20 years, red light therapy has become more widely used thanks to breakthroughs in LED lighting technology that have made affordable home devices possible.

Major advances in clinical light therapy research, and increased public interest in natural health technologies, have also contributed to the growing use and popularity of red light therapy.

In 2016, Kaiyan Medical was the first red light therapy manufacturer to offer affordable, medical-grade devices to consumers for convenient, at-home use.

Relieve Pain And Discomfort

In humans, photobiomodulation is reportedly effective against various pain conditions, including mucositis, carpal tunnel syndrome, orthodontic pain, temporomandibular joint pain, neck pain, neuropathic pain from amputation, and menstrual cramps.

Red light therapy significantly reduces the severity of pain hypersensitivity while improving sensorimotor function.

These improvements are preceded by an anti-inflammatory microglia/macrophage cell population in the injury zone, thereby providing a lasting pain relief effect.

Red light therapy has been shown to yield effective pain relief via the modulation of multiple mechanisms:

  • Inhibitory cyclooxygenase and prostaglandins
  • Modulating nerve transmission
  • Increasing endorphins serotonin release
  • Stimulating metabolism
  • Activating peripheral opioid receptors
Repair Skin

Red light therapy is used for the rapid and safe healing of wounds from burns, surgery incisions, scars, diabetic neuropathy, ulcers, and bedsores.

Faster and better wound healing was one of NASA’s original findings and one of the key recognized uses for this technology. Red and near-infrared light promote beneficial effects during all four phases of the wound-healing process:

  • Coagulation
  • Inflammation
  • Migration
  • Remodeling

These processes are regulated by many growth factors connected with nitric oxide (NO) signaling release, which is modulated by light energy.

A major typical inhibiting factor for the body’s ability to recover from a wound is low oxygen flow. Therefore, the unique ability of red light to increase oxygen flow to the affected area has a massive effect on the healing process.

By reducing inflammation, oxygenation of the area, and formation of new blood vessels, a rapid healing process unfolds with less pain and scarring.

Red light energy may also reduce or prevent the need for pharmaceutical painkiller medication during the healing process.

Revive Immunity

If your body is energized on a cellular level and communication between the organ systems is efficient, your body will naturally develop disease resistance.

Your immune defense works to fend off bacteria and viruses all the time. Red light therapy boosts this system in several ways.

It releases nitric oxide and melatonin, which are involved in DNA repair and have a powerful antimicrobial effect.

It also works through a process known as hormesis. When red and near-infrared light is beamed into cells, it causes mild metabolic stress, which results in cells engaging their anti-inflammatory and antioxidant response.

In this way, the body is primed and ready to respond better to infections. Boosted immunity is also a natural consequence of other systemic effects of red light therapy.

Studies have shown a variety of benefits to the immune system:

  • Improved melatonin production
  • Improved antioxidant production
  • Increased micro-circulation enabling the transportation of immune cells.
  • Promotes activity in the lymph nodes
  • Increased NO levels
  • Better flow of neurotransmitters
  • Boosted collagen and elastin production
  • The more efficient function of cells and organelles
  • Boosts T cells pre-operatively
  • Improved thyroid function
Reduce Inflammation

Inflammation can be acute and topical ( short-lived, caused by accidents, sprains, and infections ), chronic and general ( long-term, caused by persistent conditions ).

While acute inflammation is a healthy physical healing response, chronic and general inflammation can be detrimental to health and often goes undetected.

Currently, the main treatment for inflammation in the body is NSAID or steroid drugs, both of which have side effects and disrupt the body's healing process. Red light therapy stimulates the body to activate its own healing mechanism, dramatically reducing the health risks associated with long term drug use.

Red light therapy works by decreasing the number of inflammatory cells, increasing fibroblast proliferation ( the cell that synthesizes the extra-cellular matrix and collagen ), stimulating angiogenesis ( the formation of new blood vessels ), and activating the body’s innate anti-inflammatory, antioxidant defenses.

The following conditions, associated with chronic and acute inflammation, are currently being investigated as highly promising targets for red light therapy.

  • Arthritis
  • Asthma
  • Sinusitis
  • Muscular sprains
  • Fibro-myalgia
  • Neuron inflammatory disorders such as Alzheimer’s
  • Irritable bowel syndrome and colitis
  • Rheumatic conditions
Regain Performance

Red light therapy has become a hot topic in sports and performance. Not only is it safe and non-toxic-it yields rapid and lasting results in many areas of application.

Besides the overwhelmingly beneficial effects on health overall, red light therapy supports muscle growth and repair by increasing the amount of ATP available, which allows for better performance and faster recovery.

Red light therapy used before training is known to prepare and strengthen the body and physical exertion to help with recovery.

Documented effects from red light therapy include:

  • Reducing DOMS ( Delayed Onset Muscle Soreness )
  • Greater endurance and performance
  • Improving sleep quality
  • Increasing sexual function and libido ( Including Testosterone )
  • Aiding weight loss
  • Boosting cognitive function
  • Reversing skin aging
  • Reducing cellulite
Red Light Therapy for Depression and Seasonal Affective Disorder

Seasonal affective disorder (SAD) is a type of depression that impacts at least 5% of Americans, especially in the winter months, when natural light exposure is lowest. SAD is also called seasonal depression, winter depression, or the winter blues.

Some people treat SAD symptoms with treatment options like bright white light therapies that mimic the sun’s light intensity at a bright time of day.

More researchers and physicians have used natural light treatments like red light therapy to help with natural light deficiency and the winter blues in recent years in conjunction with antidepressant medication and psychotherapy.

Who Uses Red Light Therapy?

In addition to the growing number of people using red light therapy devices in their home, red light therapy systems can be found in many professional and clinical settings:

Skincare Professionals: Red light therapy is a popular skin treatment among Hollywood celebrities for anti-aging, and it’s used by leading skincare professionals like estheticians and dermatologists to treat skin conditions and promote collagen production.

Health Practitioners: Red light therapy is an emerging subspecialty of medicine in a wide range of fields. From oncologists treating cancer side effects, to dentists reducing oral inflammation, to physicians treating mental health conditions, red light therapy is becoming more widespread in clinical practice.

Natural Health Experts: Leading voices in natural health and wellness like Dr. Sarah Ballantyne, Dave Asprey, and Ben Greenfield use red light therapy. So do Paleo and Keto health experts like Mark Sisson, Dr. Anthony Gustin, Luke Storey, and Robb Wolf.

Sports Medicine Pros: Light therapy companies work side by side with the National Association of Sports Medicine (NASM), and red light therapy is used to heal sports injuries by sports medicine professionals across the globe. Including the top trainers and doctors on the PGA Tour, like Dr. Troy Van Biezen and Dr. Ara Suppiah.

Elite Pro Athletes: Red light therapy is a popular training tool across pro sports, from NFL stars like Patrick Peterson, to UFC champs like Anthony Pettis, to gold medal gymnast Sanne Wevers.

Fitness & Training: World-class personal trainers like Lacey Stone and Jorge Cruise use red light therapy to both enhance performance and improve the muscle recovery process.

Supportive Cancer Care: The Multinational Association of Supportive Care in Cancer (MASCC) recommends red light therapy for the treatment of oral mucositis (OM), a common and debilitating symptom of cancer treatment.

Sources and References:

Klepeis N., Nelson W., Ott W., Robinson J., Tsang A., Switzer P., Behar J., Hern S., Engelmann W. “The National Human Activity Pattern Survey (NHAPS): a resource for assessing exposure to environmental pollutants”. Journal of Exposure Analysis and Environmental Epidemiology 2001.

Hamblin M. “Mechanisms and applications of the anti-inflammatory effects of photobiomodulation.” AIMS Biophys. 2017.

LED Lights Used in Plant Growth Experiments for Deep Space Missions. NASA.

Gál P,  Stausholm MB, et al. Should open excisions and sutured incisions be treated differently? A review and meta-analysis of animal wound models following low-level laser therapy. Lasers in Medical Science. 2018 Aug.

John Foley, David B Vasily, et al. 830 nm light-emitting diode (led) phototherapy significantly reduced return-to-play in injured university athletes: a pilot study. Laser Therapy. 2016 Mar.

Kim HK, Choi JH. Effects of radiofrequency, electroacupuncture, and low-level laser therapy on the wrinkles and moisture content of the forehead, eyes, and cheek. Journal of Physical Therapy Science. 2017 February.

Wunsch A and Matuschka K. A Controlled Trial to Determine the Efficacy of Red and Near-Infrared Light Treatment in Patient Satisfaction, Reduction of Fine Lines, Wrinkles, Skin Roughness, and Intradermal Collagen Density Increase. Photomedicine and Laser Surgery. Feb 2014.

Barolet D, Roberge CJ, et al. Regulation of skin collagen metabolism in vitro using a pulsed 660 nm LED light source: clinical correlation with a single-blinded study. Journal of Investigative Dermatology. 2009 December.

Morita T., Tokura H. “ Effects of lights of different color temperature on the nocturnal changes in core temperature and melatonin in humans” Journal of Physiological Anthropology. 1996, Sept.

Naeser M., Zafonte R, Krengel MH, Martin PI,  Frazier J, Hamblin MR, Knight JA, Meehan WP, Baker EH. “Significant improvements in cognitive performance post-transcranial, red/near-infrared light-emitting diode treatments in chronic, mild traumatic brain injury: open-protocol study”  Journal of Neurotrauma. 2014, June.

Liu KH, Liu D, et al. “Comparative effectiveness of low-level laser therapy for adult androgenic alopecia: a system review and meta-analysis of randomized controlled trials.” Lasers in Medical Science. 2019 Aug.

Gupta AK, Mays RR, et al. “Efficacy of non-surgical treatments for androgenetic alopecia: a systematic review and network meta-analysis.” JEADV. 2018 Dec.

Afifi L, Maranda EL, et al. “Low-level laser therapy as a treatment for androgenetic alopecia.” Lasers in Surgery and Medicine. 2017 Jan.

Hofling DB, Chavantes MC, et al. Low-level laser in the treatment of patients with hypothyroidism induced by chronic autoimmune thyroiditis: a randomized, placebo-controlled clinical trial. Lasers in Surgery and Medicine. May 2013.

Hofling DB, Chavantes MC, et al. Assessment of the effects of low-level laser therapy on the thyroid vascularization of patients with autoimmune hypothyroidism by color Doppler ultrasound. ISRN Endocrinology. 2012.

Hofling DB, Chavantes MC, et al. Low-level laser therapy in chronic autoimmune thyroiditis: a pilot study. Lasers in Surgery and Medicine. 2010 Aug.

Vladimirovich Moskvin S., Ivanovich Apolikhin O. Effectiveness of low level laser therapy for treating male infertility. Biomedicine (Taipei). 2018 June.

Ban Frangez H., Frangez I., Verdenik I., Jansa V., Virant Klun I. Photobiomodulation with light-emitting diodes improves sperm motility in men with asthenozoospermia. Laser in Medical Science, 2015 Jan.

Salman Yazdi, R., Bakhshi, S., Jannat Alipoor, F. et al. Effect of 830-nm diode laser irradiation on human sperm motility. Lasers Med Sci. 2014.

Chow KW, Preece D, Burns MW. Effect of red light on optically trapped spermatozoa. Biomedical Optics Express. 2017 Aug.

Preece D., Chow KW, Gomez-Godinez V., Gustafson K., et al. Red light improves spermatozoa motility and does not induce oxidative DNA damage. Scientific Reports. 2017 Apr.

American Psychiatric Association

Cassano P, Petrie SR, et al. Transcranial Photobiomodulation for the Treatment of Major Depressive Disorder. The ELATED-2 Pilot Trial. Photomedicine and Laser Surgery. 2018 October.

Barrett DW, et al. Transcranial infrared laser stimulation produces beneficial cognitive and emotional effects in humans. 2013 Jan.

Blanco NJ, Maddox WT, Gonzalez-Lima F. Improving executive function using transcranial infrared laser stimulation. Journal of Neuropsychology. 2017 Mar.

Paolillo FR, Borghi-Silva A, et al. New treatment of cellulite with infrared-LED illumination applied during high-intensity treadmill training. J Cosmet Laser Ther. 2011 Aug;13(4):166-71.

Caruso-Davis MK, Guillot TS, Podichetty VK, Mashtalir N, Dhurandhar NV, Dubuisson O, Yu Y. Efficacy of low-level laser therapy for body contouring and spot fat reduction. Obes Surg. 2011. Jun;21(6):722-9.

Jackson RF, Dedo DD, Roche GC, et al. Low-level laser therapy as a non-invasive approach for body contouring: a randomized, controlled study. Lasers in Surgery and Medicine. Dec 2009;41(10):99-809.

McRae E and Boris J. Independent evaluation of low-level laser therapy at 635 nm for non-invasive body contouring of the waist, hips, and thighs. Lasers in Surgery and Medicine. Jan 2013.

Avci P, Gupta A, et al. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Seminars in Cutaneous Medicine and Surgery. Mar 2013; 32(1): 41-52.

Light Therapy - The Future to Treat Addiction

Based on the article of Joseph Nordqvist.

Using light therapy to eradicate addictive behaviors in rats.

They targeted light in the prelimbic region of the brain in rats who were addicted to cocaine. They found that after exposure to light therapy the rats demonstrated a significant reduction in addictive behavior.

The lead author of the study, Antonello Bonci, MD, scientific director of the intramural research program at the NIH’s National Institute on Drug Abuse (NIDA), said: “When we turn on a laser light in the prelimbic region of the prefrontal cortex, the compulsive cocaine seeking is gone.”

The study, published in Nature, highlights the role that the prefrontal cortex has in cocaine addiction and could help drive further testing in humans.

As one of the major health concerns in the U.S., cocaine addiction affects close to 1.2 million Americans and is responsible for a total of 482,188 emergency room visits every year.

One of the main problems with cocaine addiction is that people start taking the drug compulsively and lose the ability to function without it. About 80 percent of people who try to kick their cocaine addiction end up experiencing a relapse within six months.

There’s been a lot of focus on cocaine addiction, recently scientists at the University of Wisconsin-Milwaukee discovered a new potential means of developing a first-ever pharmacological treatment for cocaine addiction.

Eliminating addiction

Rats that were addicted to cocaine expressed low patterns of activity in their prefrontal cortex region of the brain – responsible for decision-making and behavioral flexibility.

Previous studies conducted on humans compulsively addicted to cocaine have found a similar pattern of low activity in this area of the brain as well.

The researchers measured the impact that laser light had on brain activity and addiction using a technique called optogenetics.

Through the use of genetic engineering they inserted proteins called rhodopsins into neurons located in the prefrontal cortex of rats. By activating this region of the brain with the laser they were able to turn the nerve cells on and off.

They observed that after turning the cells on there was a significant reduction in addictive behaviors in the rats compared to when the cells were turned off.

Among humans, the therapy would likely not involve the use of lasers, but instead the use of electromagnetic stimulation outside the scalp, with a technique called transcranial magnetic stimulation (TMS).

Other alternatives

A common beta blocker, propranolol, currently used to treat people with hypertension and anxiety, has shown to be effective in preventing the brain from retrieving memories associated with cocaine use in animal-addiction models, according to Devin Mueller, UWM assistant professor of psychology and a co-author with James Otis of the research.

"Right now, there are no FDA-approved medications that are known to successfully treat cocaine abuse," says Mueller, "only those that are used to treat the symptoms of cocaine withdrawal, which are largely ineffective at preventing relapse."

The effects of propranolol were long-lasting and could be permanent, he says, even without subsequent doses and even in the presence of stimuli known to induce relapse.

References:

https://www.medicalnewstoday.com/info/addiction/

Light Therapy Helping the Crisis that’s Being Ignored: PTSD

Post-traumatic Stress Disorder

Post-traumatic stress disorder (PTSD) is a mental health condition that’s triggered by a terrifying event — either experiencing it or witnessing it. Symptoms may include flashbacks, nightmares, and severe anxiety, as well as uncontrollable thoughts about the event.

Most people who go through traumatic events may have temporary difficulty adjusting and coping, but with time and good self-care, they usually get better. If the symptoms get worse, last for months or even years, and interfere with your day-to-day functioning, you may have PTSD.

Getting effective treatment after PTSD symptoms develop can be critical to reduce symptoms and improve function.

PTSD symptoms are generally grouped into four types: intrusive memories, avoidance, negative changes in thinking and mood, and changes in physical and emotional reactions. Symptoms can vary over time or vary from person to person

The Light Helper, the EMDR Therapy

Eye Movement Desensitization and Reprocessing (EMDR) therapy is an interactive psychotherapy technique used to relieve psychological stress. It is an effective treatment for trauma and post-traumatic stress disorder (PTSD).

During EMDR therapy sessions, you relive traumatic or triggering experiences in brief doses while the therapist directs your eye movements.

EMDR is thought to be effective because recalling distressing events is often less emotionally upsetting when your attention is diverted. This allows you to be exposed to the memories or thoughts without having a strong psychological response.

Over time, this technique is believed to lessen the impact that the memories or thoughts have on you.

What are the Benefits of EMDR Therapy?

People who are dealing with traumatic memories and those who have PTSD are thought to benefit the most from EMDR therapy.

It’s thought to be particularly effective for those who struggle to talk about their past experiences.

Although there is not sufficient research to prove its effectiveness in these areas, EMDR therapy is also being used to treat:

How Does EMDR Therapy Work?

EMDR therapy is broken down into eight different phases, so you’ll need to attend multiple sessions. Treatment usually takes about 12 separate sessions.

Phase 1: History and treatment planning

Your therapist will first review your history and decide where you are in the treatment process. This evaluation phase also includes talking about your trauma and identifying potential traumatic memories to treat specifically.

Phase 2: Preparation

Your therapist will then help you learn several different ways to cope with the emotional or psychological stress you’re experiencing.

Stress management techniques such as deep breathing and mindfulness may be used.

Phase 3: Assessment

During the third phase of EMDR treatment, your therapist will identify the specific memories that will be targeted and all the associated components (such as the physical sensations that are stimulated when you concentrate on an event) for each target memory.

Phases 4–7: Treatment

Your therapist will then begin using EMDR therapy techniques to treat your targeted memories. During these sessions, you will be asked to focus on a negative thought, memory, or image.

Your therapist will simultaneously have you do specific eye movements. The bilateral stimulation may also include taps or other movements mixed in, depending on your case.

After the bilateral stimulation, your therapist will ask you to let your mind go blank and notice the thoughts and feelings you’re having spontaneously. After you identify these thoughts, your therapist may have you refocus on that traumatic memory, or move on to another.

If you become distressed, your therapist will help bring you back to the present before moving on to another traumatic memory. Over time, the distress over particular thoughts, images, or memories should start to fade.

Phase 8: Evaluation

In the final phase, you’ll be asked to evaluate your progress after these sessions. Your therapist will do the same.

How Effective is EMDR Therapy?

Multiple independent and controlled studies have shown that EMDR therapy is an effective treatment for PTSD. It’s even one of the Department of Veterans Affairs’ strongly recommended options to treat PTSD.

A 2012 study of 22 people found that EMDR therapy helped 77 percent of the individuals with a psychotic disorder and PTSD. It found that their hallucinations, delusions, anxiety, and depression symptoms were significantly improved after treatment. The study also found that symptoms were not exacerbated during treatment.

An older study trusted Source that compared EMDR therapy to typical prolonged exposure therapy, found that EMDR therapy was more effective in treating symptoms. The study also found that EMDR therapy had a lower dropout rate from participants. Both, however, offered a reduction in the symptoms of traumatic stress, including both anxiety and depression.

Several small studies have also found evidence that EMDR therapy is not only effective in the short term but that its effects can be maintained long term. One 2004 study evaluated people several months after they were given either “standard care” (SC) treatment for PTSD or EMDR therapy.

During and immediately after treatment, they noticed that EMDR was significantly more efficient in reducing symptoms of PTSD. During the three- and six-month follow-ups, they also recognized that participants maintained these benefits long after the treatment had ended. Overall, the study found that EMDR therapy gave people a longer-lasting reduction in symptoms than SC.

EMDR therapy has proven to be effective in treating trauma and PTSD. It may also be able to help treat other mental conditions like anxiety, depression, and panic disorders.

Some people may prefer this treatment to prescription medications, which can have unexpected side effects. Others may find that EMDR therapy strengthens the effectiveness of their medications. In Kaiyan Medical, we can help you create your own EMDR therapy device.

References
  • Berg DP, et al. (2012). Treating trauma in psychosis with EMDR: A pilot study. DOI:
    10.1016/j.jbtep.2011.09.011
  • Eye movement desensitization and reprocessing therapy. (2017).
    apa.org/ptsd-guideline/treatments/eye-movement-reprocessing.aspx
  • Hase M, et al. (2015). Eye movement desensitization and reprocessing (EMDR) therapy in the treatment of depression: A matched pairs study in an inpatient setting. DOI:
    10.1002/brb3.342
  • Ironson G, et al. (2002). Comparison of two treatments for traumatic stress: A community-based study of EMDR and prolonged exposure.
    ncbi.nlm.nih.gov/pubmed/11748600
  • Oren E, et al. (2012). EMDR therapy: An overview of its development and mechanisms of action. DOI:
    10.1016/j.erap.2012.08.005
  • Shapiro, F. (2014). The role of eye movement desensitization and reprocessing (EMDR) therapy in medicine: Addressing the psychological and physical symptoms stemming from adverse life experiences. DOI:
    10.7812/TPP/13–098

The Sleeping Beauty Secret: The Red Light Therapy

Lack of sleep is a villain in America and Europe. Light intake is a big part of the problem. Over 65% of adults say they don’t get enough good sleep every week. Most people also don’t get nearly enough natural light for optimal health: the average American spends over 90% of their time indoors.

In addition to not getting enough natural light, people today are surrounded by artificial blue light from screens and overhead lighting. An overload of artificial blue light can cause headaches and make it harder to get to sleep and stay asleep. When we take in all that bright blue light from laptops, TVs, and phones, especially before we go to bed, our bodies get the signal that it's time to be awake, even if we're tired.

Melatonin is the naturally-occurring hormone that regulates sleep and wakefulness. Emerging research is showing that red light therapy treatments can help people produce more of their own, natural melatonin than exposure to other light sources like blue light. Red light therapy is natural light. It’s much less bright than blue light, with a lower color temperature than daytime sun, as the image above shows. Research has shown that red light doesn’t upset your sleep cycle like bright blue light. Red light therapy is showing great clinical results for people with insomnia and sleep disorders.

The light therapy is a simple, non-invasive treatment that delivers concentrated natural light to your skin and cells. Clinical research is showing that red light therapy can improve sleep quality and duration, and help people produce more of their own melatonin.

Light plays a major role in your sleep cycle. The body’s circadian clock interprets light as a sign of when to sleep and when to be awake. Artificial blue light from phones, computers, and other screens is extremely bright and can knock your circadian rhythm out of whack. Red light has the opposite effect: it’s ideal for evenings because it has a low color temperature—far lower than blue light and much closer to the natural sunset.

Red light therapy treatments are quick and simple: you just sit or stand in natural light for 5 to 15 minutes, ideally every day. This stimulates your mitochondria and gives your cells the natural light they need to make energy.

How Does Red Light Therapy Help You Sleep?

Natural light is a key ingredient for a healthy circadian rhythm and restful sleep. If you struggle to sleep, your light intake could be a big factor. Red light therapy delivers natural light like you’d get from the sun, but without UV rays, excess heat, or the need for sunny weather.

Red light therapy treatments supercharge your cells with the natural light they need to make more core ATP (adenosine triphosphate) energy. This helps your body run more efficiently, heal faster, and has shown great results for producing more natural melatonin and improving sleep disorders like insomnia.

Red light therapy treatments have shown great sleep results in a range of peer-reviewed clinical studies. One study on the sleep of pro basketball players showed that a 2-week course of red light therapy in the evening improved players’ sleep quality in the short term. Based on the results, the researchers suggested red light therapy would be a good non-invasive, drug-free solution to sleep struggles.

Overcoming Sleep Disorders with Red Light Therapy

Kaiyan's light therapy products are registered with the FDA as class II medical devices for the treatment of pain, strain, and inflammation. While the existing clinical research has been very positive for red light therapy and sleep, keep in mind that Kaiyan's devices are not cleared with the FDA for the treatment of various sleep disorders or melatonin.

Recent research on sleep disorders among people with migraine headaches has shown that red light therapy both decreased headache frequency, and was the only treatment that improved patients’ sleep disorders.

A 2014 study on cognitive function and traumatic brain injury (TBI) recorded that participants had significantly decreased episodes of post-traumatic stress disorder (PTSD), and improved sleep.

Analyzing patients’ electrical brain activity, a 2013 sleep study concluded that red light therapy was especially effective at helping people with sleep disorders fall asleep.


When I’m indoors training under the buzz of artificial lights, my body doesn’t get the natural light it needs. Add computers, cell phones, televisions, etc. and it’s easy to overload yourself with blue light. I used to have trouble sleeping after long training days, but since adding more natural light to my routine with red light therapy, I’ve been falling asleep as soon as I lie down, and I’ve been staying asleep all night.*

Sanne Wevers

Gold-Medal Winning Dutch Gymnast

Red Light Therapy, Sleep, Depression, and Seasonal Affective Disorder (SAD)

Research is showing how closely mood and sleep disorders are interconnected. Parts of the brain that regulate sleep have also been found to closely affect mood. A 2013 review concluded that “nearly all people suffering from mood disorders have significant disruptions in circadian rhythms and the sleep/wake cycle.”

This Greatist post on natural light and serotonin gives good background on the connections between natural light intake, mental health, and sleep. It also mentions using Kaiyan's red light therapy devices to get more natural light, even when you can’t get more sunlight.

Trouble sleeping is one of the most common symptoms of seasonal affective disorder, a type of depression most common in the darker winter months. Some physicians treating patients with mental health disorders have said red light therapy both improves mood, and helps people with depression get better sleep.

Sources and References:

Morita T., Tokura H. “ Effects of lights of different color temperature on the nocturnal changes in core temperature and melatonin in humans” Journal of Physiological Anthropology. 1996, September

Lirong Z., Phyllis Z. “Circadian Rhythm Sleep Disorders” Neurologic Clinics. 2012, November.

Color Temperature

The State of Sleep Health in America.

Klepeis N., Nelson W., et al. “The National Human Activity Pattern Survey (NHAPS): a resource for assessing exposure to environmental pollutants”. Journal of Exposure Analysis and Environmental Epidemiology 2001.

Sheppard A and Wolffsohn J. “Digital eye strain: prevalence, measurement and amelioration.” BMJ Open Ophthalmology. 2018 April.

Gooley, J., Chamberlain, K., Smith, K., Khalsa, S., et al. “Exposure to Room Light before Bedtime Suppresses Melatonin Onset and Shortens Melatonin Duration in Humans” J Clin Endocrinol Metab. 2011 Mar.

Hamblin M. “Mechanisms and applications of the anti-inflammatory effects of photobiomodulation”. AIMS Biophys. 2017.

Zhao J., Tian Y., Nie J., Xu J., Liu D. “Red light and the sleep quality and endurance performance of Chinese female basketball players” Journal of Athletic Training. 2012, November-December.

Loeb LM, Amorim RP, et al. “Botulinum toxin A (BT-A) versus low-level laser therapy (LLLT) in chronic migraine treatment: a comparison.” Arquivos de neuro-psiquiatria. 2018 Oct;76(10):663-667.

Naeser MA, Zafonte R, et al. “Significant improvements in cognitive performance post-transcranial, red/near-infrared light-emitting diode treatments in chronic, mild traumatic brain injury: open-protocol study.” Journal of Neurotrauma. 2014 Jun 1;31(11):1008-17.

Wu JH, Chang YC. Effect of low-level laser stimulation on EEG power in normal subjects with closed eyes. Evidence Based Complementary and Alternative Medicine. 2013; 2013:476565.

Vadnie C, and McClung C. Circadian Rhythm Disturbances in Mood Disorders: Insights into the Role of the Suprachiasmatic Nucleus. Neural Plasticity. 2017 November.

McClung C. How might circadian rhythms control mood? Let me count the ways. Biological Psychiatry. 2013 April.

Nutt D, Wilson S, et al. Sleep disorders as core symptoms of depression. Dialogues in Clinical Neuroscience. 2008 September.

Avci P, Gupta A, et al. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Seminars in Cutaneous Medicine and Surgery. Mar 2013.

Can LED Light Give me The Perfect Skin?

Following the article from the New York Times.

One day, shining light on your face may be the most important part of your skin care routine. We take a look at the newest devices.

The MMSphere, a ring of LED lights, casts a red glow over my face. It sits adjacent to my laptop so that as I write, research and procrastinate, I can simultaneously calm a fiery constellation of acne on my left cheek.

Red light’s anti-inflammatory and collagen-building effects on the skin are well documented. But this hands-free device, designed by Ellen Marmur, a dermatologist in New York, has settings for blue, green, amber and purple light too.

“It has just enough variety that people stay excited to use it,” Dr. Marmur said.

I, too, begin cocktailing. I bathe my face in blue light to kill acne bacteria while watching reruns, and immediately follow up with a FaceTime call to my mother, my face lit up in a bright green light to fight hyperpigmentation.

Skin care efficacy lives and dies by patient compliance. Most at-home LED skin care devices are small and hand-held, requiring time set aside to treat the entire face. People eventually stop using them.

Even with persistent acne as a motivator, I’ve always had trouble following LED protocols. The MMSphere ($495) is a big deal for me because it harnesses a powerful fix-everything-while-doing-nothing ease that makes it almost addictive. You actually want to use it.

“It makes people feel good, like they’re taking care of themselves,” Dr. Marmur said. “You can treat your skin while doing other things, so it’s easier to form the habit of doing it every day.”

Because, really, if we’re just sitting around — talking, eating, working — shouldn’t we be fixing our skin, too?

So How Does LED Work?

First, LED therapy is not the same as a laser treatment, which creates controlled damage to the skin to promote healing. The easiest way to understand the light-as-skin-care concept is to think of skin-friendly visible light as ultraviolet light’s benevolent counterpart.

In a process called photobiomodulation, light alters biological material; for example, UV rays from the sun change our skin in ways that can catalyze cancer and aging.

But some wavelengths of visible light alter our skin for the better, and light-emitting diodes (LED) are a source that delivers that energy.

Jared Jagdeo is an associate professor of dermatology and director of the Center for Phototherapy, SUNY Downstate Health Science University, where he studies LED therapy.

“You can alter the skin through photo-damaging with lasers, or photobiomodulation, which is a much more gentle way of changing the way the skin functions,” Dr. Jagdeo said. Red and blue light are the heavy hitters. He explained why red light in particular works so well.

“There’s a specific receptor in the mitochondria of the skin cells that red light specifically acts upon,” he said. “And that’s why red light is an ideal wavelength for changing the way the skin functions.”

Red light penetrates the skin deeper than other visible light and stimulates the mitochondria, which has an anti-inflammatory and rejuvenating effect. Collagen is built in the dermis, the skin is calmed, and wrinkles eventually fade.

Blue light doesn’t penetrate the skin as deeply but zaps acne-causing bacteria on the surface. The science on green light isn’t as solid, but in theory, it targets melanocytes, discouraging excess melanin production.

Rigorous independent studies have yet to be conducted, but Dr. Marmur did a very small clinical trial on green light for the MMSphere in which subjects self-reported a 32 percent decrease in “brown spots” after a week of green light treatment.

Is All of This Light Ok for my Eyes?

Eye safety is a valid concern, particularly because earlier this year Neutrogena recalled its LED mask over fears that it could cause eye injuries.

Brian S. Biesman, an assistant clinical professor of ophthalmology, dermatology and ENT at Vanderbilt University Medical Center in Nashville, said that most home devices aren’t powerful enough damage the eyes. The MMSphere comes with opaque goggles, but, Dr. Biesman said, the device is low energy, so it should be safe to use without them.

“Just normal blinking and eye movements should be sufficient to protect the eyes,” he said. “But never stare at a bright light source.”

More Thoughts

“As far as the F.D.A. is concerned, if I use CO2 laser resurfacing, it better work because of the amount of risk involved,” said Suzanne Kilmer, a clinical professor of dermatology at the UC Davis School of Medicine in Sacramento and director of the Laser and Skin Surgery Medical Group.

“Compare that to a home device,” Dr. Kilmer said. If it doesn’t kill you, blind you or make things much worse, it’s probably going to get approved. So it’s actually more incumbent upon the people selling home devices to show efficacy. You have to trust the people who are selling them.”

“LED is real, but it’s probably not optimized yet,” Dr. Kilmer said.

Many factors determine the amount of light your skin needs and receives: the strength of the light, the distance from source to skin, how long the light is used, and your skin color.

“Some of these lights on the market are very weak, and they may not have enough energy output to actually have a biological effect,” Dr. Jagdeo said. “Imagine a glow stick. It produces a color. But you could shine it on your face all day, and it’s not going to change the way your skin works.”

Furthermore, the medical community has yet to establish standard doses for treating conditions like hyperpigmentation and acne at home. Dr. Marmur based her MMSphere dosing on Blu-U, an in-office blue light that is commonly used as an alternative therapy for precancerous lesions.

“Consistent Sphere treatment for seven weeks will equal the energy given in the office with the Blu-U,” she said.

Another device, the Dr. Dennis Gross DRx SpectraLite FaceWare Pro, $435, emits red and blue light in a mask format, and each session is only three minutes. The mask’s LEDs are in contact with the skin, which may be a more effective treatment. Dr. Jagdeo said that you lose some energy on the way from device to skin, a potential downside of the MMSphere design.

“This is a tremendously undertapped area in medicine,” he said. “But LED light therapy is going to revolutionize the way home medical treatment is delivered for skin care over the next 10 to 15 years.”

Kaiyan Medical

In Kaiyan Medical you can create your own LED facial mask. We have developed Aduro mask who is one of the top facial masks in the beauty industry. Julia Roberts is a big fan of Aduro Mask. For more information visit https://www.aduroled.com/

Sculpting your Body with Green Light

Wouldn’t it be great if we could each reduce a couple of inches off our waist without having to diet or exercise for so long? Losing weight and fat is one of the most common health goals, both for medical and cosmetic reasons. For years, millions of people have tried different pills, injections, “natural” herbs, and many products that are supposed to help us reduce weight. Unfortunately, these usually don’t work

Clinical trial

Many people trying to lose weight just want to look better in the mirror, or at the beach. A wide variety of therapies to target fat and improve appearance are called “body contouring” or “body sculpting”, some surgical, others noninvasive. But many of them don’t work, or produce troublesome side effects. Green light therapy is completely natural & noninvasive and has proven to be an effective option for changing the way your body looks.

In the clinical trial NCT03647748 a double-blind, placebo-controlled randomized evaluation of the effect of Cellulize, a green light low-level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring and reduction of cellulite.

Device Description

The Cellulize is a non-invasive green light system with a power output of 105mW/cm2, consisting of 150 light-emitting diodes (LEDs) that emit visible light at a nominal wavelength of 532nm ± 3nm (visible green light spectrum) and a spectral bandwidth of 10nm. Cellulize® is indicated for uses non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The Massager component is indicated for the temporary reduction in the appearance of cellulite.

Clinical Testing

Cumulative circumferences of waist, hip, left and right thighs for each patient was calculated before and after treatment. Three main points were concluded as a result of the study:

1. Cellulize causes immediate inch loss in subjects after a regimen of six treatments of 32 minutes (8 minutes on each of four positions) compared to individuals subjected to a placebo device for equivalent treatment. In a typical regimen, patients lost an average cumulative of 2.67 inches of circumference compared to the placebo average of 0.5 inches. This meets the anticipated primary outcome measure “Average Change in Inches of Total Circumference Measurements for the effect of Cellulize, a LED 532nm green light low-level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring from baseline measurements, and after treatment. ”

Figure 1, below, shows the graphical summary of inch loss for patients in the Cellulize active group and the Placebo control group respectively. Table 1 gives the mean values for both groups as well as the standard deviation for the “after” measurements, as well as 7-day and 14-day follow-ups relative to the “before” measurements for each patient:

Figure 1

2. While the durability of effect is also impacted by extrinsic factors after treatments such as diet, it was demonstrated that subjects were more likely to show continued inch loss upon following up with each subject at 7 days and again at 14 days. In general, patients undergoing active Cellulize 532nm green light continued losing some inch with an average continued loss of an additional 1.20 inches for a total average inch loss of 3.87 inches where average placebo measurements after 14 days yielded a net gain (not a loss) of 0.875 inches. This implies that the green light treatment meets the expected primary outcome of demonstrated durability of effect after a short -term follows up of 2 weeks.

3 Finally, the effect of Cellulize LED 532nm green light without any other intervention was measured for its effect on cellulite as part of the study. The Nurnberger-Muller Scale (NMS), a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine the change in stage or degree of cellulite following treatment intervention, was used to ensure consistent evaluation standards. Results from the active device as well as placebo both showed that cellulite, in general, did not decrease on the back of thigh/buttocks for subjects after a single treatment of 532nm green light. This result failed to meet the anticipated primary outcome measure of decreasing the appearance of cellulite as a measure of the Nurnberger-Muller Scale (NMS) from baseline to completion of treatment for the thigh/buttock area.

Fat Reducing Low-Level Laser — OLI

The FDA product classification code, OLI, has a guidance document which is the special control for this product, Guidance for Industry and FDA Staff — Class II Special Controls Guidance Document: Low-Level Laser System for Aesthetic Use. According to the guidance document, FDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the low-level laser system for aesthetic use. Cellulize complies with all of the standards outlined in the special controls consensus standards.

To learn more about OLI products, you can visit https://fda.report/Product-Code/OLI

Kaiyan Medical

Here in Kaiyan Medical, we are pioneers and innovators with light therapy. We keep developing technologies with green light and trying to reach more markets.

kaiyanmedical.com


References

Effects of Green Light Therapy on Body Contouring and Cellulite - Full Text View …
Primary Outcome Measures : Average Change in Inches of Total Circumference Measurements [ Time Frame: 2 weeks ] Average…clinicaltrials.gov

Duarte FO, et al. Can low-level laser therapy (LLLT) associated with an aerobic plus resistance training change the cardiometabolic risk in obese women? A placebo-controlled clinical trial. J Photochem Photobiol B. 2015 Dec;153:103–10.

da Silveira Campos RM, Dâmaso AR, et al. The effects of exercise training associated with low-level laser therapy on biomarkers of adipose tissue transdifferentiation in obese women. Lasers in Medical Science. 2018 Aug;33(6):1245–1254.

Best Practices for Leading Manufacturing Medical Device Teams During the COVID-19 Pandemic

COVID-19 has created challenges for nearly every market, and the medical device manufacturing industry is no exception. As the virus sweeps the globe, it’s becoming increasingly difficult for leaders to overcome the arising challenges and prepare for the future.

While I firmly believe the key to navigating this evolving landscape is putting quality at the forefront of all activities, a function made seamless through best of breed quality management tools, I was curious what other industry leaders had to say.

The following are some of their best tips for effectively leading and managing teams during the COVID-19 pandemic and preparing your organization for what’s to come.

Communication is the Key

Keep in touch. Let your people know where things stand with the business. At home or in the office practicing social distancing, each of your workers will be dealing with different issues, both private and professional. The distributed workforce requires even more channels to help people stay connected.

“Leadership needs to provide regular communication, be transparent about the impact of the pandemic on your company, and set expectations with your team, investors, partners, and customers. There is a great deal of uncertainty in the world, and clarity from management is one of the keys to a healthy organization.” — Paul Grand, CEO, MedTech Innovator

Be Sensitive to Personal Issues

Be sensitive to employees’ personal situations. Every member has their own worries and family needs during this crisis. Review goals and when needed realign expectations to match current circumstances.

Quick and Efficient Meetings

Balance the content. Focus on efficiency in meetings to ensure your team still has time to do their work and manage their personal situation. The recommended time for meetings should be 15 minutes with no more than 4 people per meeting

Manage your Expectations

Office time should be reduced. To avoid conflicts, make sure yo manage expectations. Be clear about your expectations and the expectation from your team during these challenging times. The last thing you want to do is have misunderstandings or conflicts with a good working team.

Be Mindful About the Mental Health

The key purpose of a leader is to continuously motivate and support the team. Talk about work-life structures, supporting flexible working arrangements, and vocalizing empathy towards your workmates. As a leader, you must empower them to deliver their best work while being absolutely empathetic towards challenges in their life.

Focus on the Future

Focus on the fact that COVID-19 is temporary. The natural instinct may be to slow down and withdraw resources. Instead, this is an excellent time to strategically plan and dedicate time, staff, and resources to ensuring that the post-pandemic time capitalizes on key changes.

Creative Research Methods

Just because you can’t conduct research the way you always have doesn’t mean you can’t conduct research at all. It is important to stay flexible with the research methods you use. Understanding the pros and cons of each method and their overall ability to contribute to your research goal is critical to conducting meaningful and useful research.

All companies are working to lead their teams through today’s challenges with confidence. By taking care of your team and keeping quality you will improve the teamwork collaboration, communication, and transparency.


The 5 Best LED Pain Relievers

What is Holistic Medicine?

Holistic medicine is a whole-body approach to healthcare. It aims to improve health and wellness through the body, mind, and soul.

Principles of Holistic Medicine

Holistic medicine is based on several core values:

  • Good health is a combination of physical, emotional, mental, spiritual, and social wellness.
  • Prevention first, treatment second.
  • The disease is caused by a problem with the whole body, rather than a single event or body part.
  • The goal of treatment is to fix the underlying cause of disease, instead of just improving the symptoms.
LED Light Therapy: What is it, and Does it Work?

LED stands for light-emitting diode. These lights have been in use since the 1960s, but people have only recently begun to use them as a skin treatment.

NASA originally developed LED lights for plant growth experiments in space.

However, since then, LEDs have shown promising results in wound healing and human tissue growth.

Different wavelengths of light in LED lights, including blue and red, penetrate the skin at different depths. This penetration may trigger biological processes that help the skin rejuvenate and heal.

LED light therapy is a popular non-invasive skin treatment for acne, sun damage, wounds, and other skin problems.

If you prefer to avoid the pharmaceutical way to manage issues with joints or muscles, you might want to try one of these LED pain relievers instead. Using a combination of wavelengths from the visible and infrared light spectrum, you can help to relieve many conditions, including arthritis, without the risk of potentially harmful side effects.

Here the Top 5 Pain Relief Devices


5) Double Side FDA Cleared Red/Infrared Lights Therapy Glove

People suffering from arthritis or a repetitive strain injury to their fingers or wrists can appreciate the design of the Red Light Therapy Double Side. It surrounds your hand for complete coverage.


4)The Multifunction Pen LED

For a portable solution, the multifunction pen LED is about the size of a small flashlight. It uses a special wavelength that’s supposed to offer antiinflammatory effects in localized areas of application.

3) Handheld Device with LED Red Light

The handheld device boasts an ergonomic handle that has comfortable rests for your fingers to provide you with a firm grip as you use it. Its compact design makes it a good option for travel.



2)Light Therapy Infrared Light Panel for Whole Body

With a bigger number of diodes, this panel is designed for deeper penetration than many of its competitors. It claims to be able to help reduce inflammation, stimulate cell growth, and increase circulation.

1. FDA Cleared Red/Infrared Led Light Therapy Pad

The sheer size of the therapy pad makes it suitable for treating a wide number of areas on the body, most notably the lower back. With only 15minutes of therapy needed, is the best balance between convenience and LED power.

To order or discuss your LED light medical device don’t hesitate to contact us at info@kaiyanmedical.com


The Top 100 Medical Device Acronyms you Should Know

In collaboration with the work of Jon Speer in July 19, 2020

Every industry in the world uses acronyms, and the overlap between multiple fields can be a source of confusion for professionals. There’s no room for confusion in the medical device industry, as a miscommunication could potentially lead to a product defect or adverse event with serious consequences.

Here the list:

21 CFR PART 11

Part 11 of Title 21 in the Code of Federal Regulations, commonly referred to as 21 CFR Part 11 or Part 11 for shorthand, establishes the acceptance criteria by FDA of electronic records, electronic signatures and handwritten signatures executed to electronic documents.

Compliance of quality systems with 21 CFR Part 11 requirements applies to the medical device industry, in addition to pharmaceutical, biotechnology, and other FDA-regulated industries.

21 CFR PART 820

FDA maintains quality system regulations, or QSR, found in 21 CFR Part 820, which establishes the quality system requirements for all medical device manufacturers in the United States. Manufacturers are required to establish and maintain a quality system that is appropriate for the medical device to ensure both the safety and efficacy for its intended use, per the requirements of 21 CFR Part 820.

483 OBSERVATION

A 483 observation, or “inspectional observation,” is a notice issued by an FDA inspector to flag potential regulatory violations found during a routine inspection. A Form 483 observation may be issued regarding any violation under FDA jurisdiction. Failure to demonstrate handling of the observed problems can be escalated to a warning letter.

510(K) PREMARKET NOTIFICATION

A 510(k) is a regulatory premarket submission made to FDA for a Class I, II, or III medical device that doesn’t otherwise require premarket approval. The purpose of a 510(k) submission must demonstrate a safe and effective device that is substantial equivalent to an existing legally marketed device.

APPLICATION LIFECYCLE MANAGEMENT (ALM)

Application Lifecycle Management, or ALM, involves the specification, design, development and testing of software tools. ALM systems are used to manage quality and demonstrate compliance during the software delivery process.

AUDITING ORGANIZATION (AO)

An Auditing Organization, or AO, is responsible for auditing medical device manufacturers to evaluate conformity with quality management system requirements and other medical device regulatory requirements. An AO may be an independent organization or a Regulatory Authority (RA).

AOs participating in the Medical Device Single Audit Program (MDSAP) may conduct a single regulatory audit of a manufacturer which satisfies the relevant requirements of RAs participating in MDSAP.

APPROVED SUPPLIER LIST (ASL)

An Approved Supplier List, or ASL, is an internal list kept by medical device manufacturers to record suppliers known to meet the quality and performance standards of the manufacturing organization.

BILL OF MATERIALS (BOM)

A Bill of Materials, or BOM, is a complete list of raw materials, assemblies, and subassemblies required to produce a device, as well as the quantities required for each. A BOM is required to carry out change management processes for a medical device.

COMPETENT AUTHORITY (CA)

A Competent Authority, or CA, is a body within the government of a Member State in the European Union. A CA transposes the requirements of Europe's medical device regulation (MDR) into the national law of each Member State. For example, the Federal Institute for Drugs and Medical Devices (BfArM) is the the CA for Germany.

CONFORMITY ASSESSMENT (CA)

A Conformity Assessment, or CA, is carried out by an EU Notified Body to determine that a medical device is safe and performs as intended by the manufacturer. Medical devices must pass a conformity assessment in order to obtain CE Marking.

COMPUTER-AIDED DESIGN (CAD)

Computer-Aided Design (CAD) software allows device manufacturers and designers to draft detailed designs, including precise specifications and measurements. CAD software files can be stored on a digital database for reference.

CORRECTIVE AND PREVENTIVE ACTION (CAPA)

Corrective and Preventive Action, or CAPA, is a quality system process carried out by a medical device organization to reduce and/or eliminate potential sources of risk and regulatory non-conformance or noncompliance.

CE MARKING (CE MARK)

A CE Marking, or CE Mark, certification must be obtained by medical device manufacturers for product distribution into the European Union (EU) marketplace. CE Marks are issued by third-party organizations, known as a Notified Bodies, and indicate compliance with the applicable EU medical device regulations (MDR).

EUROPEAN COMMITTEE FOR STANDARDIZATION (CEN)

The European Committee for Standardization, or CEN, is a public standards organization that develops standards for medical devices for sale in the European Union (EU). CEN can be compared to the Food and Drug Administration (FDA), which maintains and enforces medical device regulations in the U.S. marketplace.

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

The Center for Devices and Radiological Health, or CDRH, is a branch of the U.S. Food and Drug Administration (FDA) responsible for overseeing the approval of medical devices for sale in the U.S. market and also monitors the manufacturing, performance, and safety of those medical devices.

CLINICAL EVALUATION REPORT (CER)

A Clinical Evaluation Report, or CER, provides clinical evidence that a medical device will perform as expected, such that no safety issues occur while using it. European regulations require medical device manufacturers to perform a conformity assessment, of which include CER documentation, in order to legally market a product in the EU.

COST OF QUALITY (COQ)

Cost of Quality, or CoQ, is a system for measuring the financial impact that a quality system and its processes has on a business. Medical device companies can use CoQ to calculate potential savings and weigh those against the costs associated with internal process improvements.

COMPUTER SYSTEM VALIDATION (CSV)

Computer System Validation, or CSV, is a process used to demonstrate that computer systems, including hardware and software, used in medical device manufacture meet the regulations outlined in 21 CFR Part 11.

CURRENT GOOD MANUFACTURING PRACTICES (CGMP)

Current Good Manufacturing Practices, or cGMP, are minimum standards provided by FDA for manufacturing processes and facilities. The FDA cGMP standards establish a framework for medical device manufacturers to follow and allow for greater flexibility in achieving various quality requirements.

DOCUMENT CHANGE ORDER (DCO)

A Document Change Order, or DCO, is a formalized process in medical device change management. The DCO process involves change requests to be made within an organization to a document or system in a standardized, traceable manner.

DE NOVO

The De Novo regulatory pathway is a classification process that uses a risk-based methodology for novel medical device to be granted market entry for sale in the U.S. For a de novo submission to be granted by FDA, general controls must indicate that the device is safe and effective for its intended use.

DEMING CYCLE

The Deming Cycle is a methodology for monitoring quality efficacy and serves as a basis for traditional quality assurance. The Deming Cycle model is comprised of four parts: plan, do, study, and act. These parts are often summarized as PDSA.

DESIGN CONTROLS (DC)

Design Controls or DC, as defined by FDA in 21 CFR 820.30, are a systematic process that ensures specific design requirements are met by documented procedures that control the design of the medical device. The purpose of DCs is to demonstrate that a medical device is safe, effective, and performs as expected.

DESIGN DOSSIER (DD)

A Design Dossier, or DD, includes all contents of the technical file (TF), which describe a device’s design, manufacturing, and performance, as well as the documentation that demonstrates conformity with applicable regulatory requirements.

DESIGN OF EXPERIMENT (DOE)

A Design of Experiment, or DoE, is a method for medical device manufacturers and engineers to validate internal processes and predict process variability in order to improve and maintain product quality.

DESIGN FOR MANUFACTURE (DFM)

A Design for Manufacture, or DFM, is a process for optimizing the design of a medical device for manufacturing. A DFM takes into account the cost of manufacture, as well as regulatory compliance and product performance.

DESIGN HISTORY FILE (DHF)

A Design History File, or DHF, contains all documentation related to the design and development of a medical device. Medical device manufacturers in the U.S. market are required by law under FDA 21 CFR Part 820 to maintain a DHF.

DEVICE HISTORY RECORD (DHR)

The Device History Record, or DHR, acts as a record of production for a medical device and demonstrates it was manufactured according to information stored in the device master record (DMR). Manufacturers operating in the U.S. are required under CFR Part 820.184 to maintain a DHR, which contains information such as acceptance records for units or batches of products, unique product identifiers, and product counts.

DEVICE MASTER RECORD (DMR)

A Device Master Record, or DMR, is a record of all the information and specifications required to produce a medical device. The DMR contains instructions for manufacturing, drawings and specifications for devices, and requirements for labeling and packaging. Manufacturers are required by FDA to maintain a DMR under CFR Part 820.181.

DOCUMENT MANAGEMENT SYSTEM (DMS)

A Document Management System, or DMS, is a tool used to store and manage documents related to medical device development, as well as track any changes made to documents throughout the product lifecycle on an ongoing basis. A DMS is not synonymous with a Quality Management System, or QMS, which stores documents but also has a regulatory compliance focus.

ENGINEERING CHANGE ORDER (ECO)

An Engineering Change Order, or ECO, is a process that is triggered when an issue is raised with a medical device in terms of performance, cost-effectiveness, or the process of manufacturing the device. An ECO is typically followed by an analysis to determine whether action should be taken. Depending on the nature of the change, an ECO may lead to a CAPA investigation.

ESTABLISHMENT INSPECTION REPORT (EIR)

An Establishment Inspection Report, or EIR, is made by FDA in the event a Form 483 is issued following an inspection. The next steps after receiving an official EIR from FDA will be determined by the severity of the issues observed, as well as the 483 response. If significant deficiencies are observed, FDA may decide to issue a warning letter.

ENTERPRISE RESOURCE PLANNING (ERP)

Enterprise Resource Planning, or ERP, refers to the management of business processes within the organization of a medical device organization. This is often carried out with the use of ERP tools that gather and organize business data and automate processes related to human resources and business practices.

IN VITRO DIAGNOSTIC REGULATION (IVDR)

The European Commission's new IVDR 2017/746, which is shorthand for In Vitro Diagnostic Regulation, is Europe's new regulation for in vitro diagnostic devices that is scheduled to go into effect 26 May 2022. The IVDR requires all existing IVD devices being sold in the EU market to undergo recertification for compliance with the new requirements, which supersede the previously held directives for in-vitro diagnostic devices (IVDD).

EU MEDICAL DEVICE DIRECTIVE (MDD)

MDD is the Medical Device Directive for medical devices sold in the European marketplace, which was replaced in 2017 by the medical device regulation (MDR. The purpose of the directive was to harmonize laws and standards around medical devices marketed in the European Union.

EU MEDICAL DEVICE REGULATION (EU MDR)

EU MDR is a common abbreviation for the medical device Regulation (EU) 2017/745, which mandates the quality and safety requirements for medical devices produced and marketed in the European Union (EU). The EU medical device regulation supersedes the previously held medical device directives (MDD) that were in place up until 2017 and places strong emphasis on a total product lifecycle approach.

EUROPEAN DATABASE ON MEDICAL DEVICES (EUDAMED)

The European Database on Medical Devices, or EUDAMED, is a database developed by the European Commission to facilitate compliance with European medical device regulations. It's intended to function as a multipurpose system for registration, collaboration, and communication for multiple stakeholders in the medical device industry.

FOOD AND DRUG ADMINISTRATION (FDA)

The Food and Drug Administration, or FDA, is a federal agency of the U.S. Department of Health and Human Services. The FDA is responsible for approving medical devices for manufacture and distribution within the U.S. Medical device manufacturers operating within the U.S. market are subject to FDA inspections and compliance with the requirements outlined in Title 21 of the Code of Regulations.

FAILURE MODES AND EFFECTS ANALYSIS (FMEA)

Failure Modes and Effects Analysis, or FMEA, is a method used to identify failures in a design or process associated with a medical device. FMEA is distinct from ISO 14971, the international standard for medical device risk management. The FMEA method can be broken into two parts: PFMEA for processes, and DFMEA for designs.

FAULT TREE ANALYSIS (FTA)

Fault Tree Analysis, or FTA, is an analytical method aimed at identifying points of failure and risk within a quality system. In medical device manufacture, FTA can be applied throughout the course of risk management activities to identify possible sources of risk.

FREEDOM TO OPERATE (FTO)

Freedom to Operate, or FTO, refers to product infringement on intellectual property. Device manufacturers typically declare whether they have FTO in each market in which they plan to sell a new product.

GENERAL SAFETY AND PERFORMANCE REQUIREMENTS (GSPR)

Medical device manufacturers are required to comply with the General Safety and Performance Requirements (GSPRs) of the new EU MDR. The regulation splits GSPRs into three chapters, general requirements, requirements regarding design and manufacture, and requirements regarding the information supplied with the device.

HAZARD IDENTIFICATION (HID)

Hazard Identification, or HID, is a risk management process in which device manufacturers determine whether situations, processes, or items associated with the production of their device may have the potential to cause harm.

INVESTIGATIONAL DEVICE EXEMPTION (IDE)

An Investigational Device Exemption, or IDE, is an FDA exemption that allows an investigational device to be used for testing a device against premarket approval standards. An investigational device can be used to gather data on the safety and effectiveness of the device, and this data is submitted as an IDE for review by FDA.

IEC 60601

IEC 60601 is a standard pertaining to electrical medical equipment. Any medical device containing electronics must pass the necessary requirements outlined in IEC 60601.

Programmable Electrical Medical Systems, or PEMS, is a key part of what's covered in IEC 60601. PEMS consists of software, firmware, and equipment that can be programmed to carry out functions that aid medical care or treatment. The standard also covers mechanical safety, labeling, and risk management.

IEC 62304

IEC 62304 is a software framework that outlines software engineering and documentation practices. It is also recognized by FDA and provides a risk-based framework that can be used throughout entire medical device software lifecycle.

INSTRUCTIONS FOR USE (IFU)

Instructions for Use, or IFU, are instructional materials used to convey relevant information to the end user. These materials must take into account the capabilities and limitations of the end user in order to communicate instructions as concisely and objectively as possible.

INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF)

The International Medical Device Regulators Forum, or IMDRF, is a voluntary working group of international medical device experts whose purpose is to harmonize medical device standards and regulations. The IMDRF supersedes the Global Harmonization Task Force.

INSTALLATION QUALIFICATION (IQ), OPERATIONAL QUALIFICATION (OQ), AND PERFORMANCE QUALIFICATION (PQ)

Installation Qualification, Operational Qualification, and Performance Qualification are terms that pertain to medical device software and equipment validation. IQ relates to the proper installment of software or equipment, OQ concerns meeting the necessary regulatory requirements, and PQ has to do with compliance of the software or equipment performance.

INSTITUTIONAL REVIEW BOARD (IRB)

An Institutional Review Board, or IRB, is a body that oversees human medical research in the U.S. and ensures that the human rights of all subjects are protected. An IRB has the authority to approve or disapprove research or to request modifications to research practices.

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)

The International Organization for Standardization, or ISO, is a non-governmental organization of experts providing voluntary international standards, based on the subject matter expertise of members, to enable and promote innovative solutions to worldwide challenges.

ISO 13485:2016

ISO 13485:2016 is the internationally harmonized standard for medical device quality management systems (QMS). To align with ISO 13485:2016, QMS contents should address the specific, applicable requirements outlined in the standard, in addition to the applicable regulatory requirements according to the markets where the medical device will be manufactured and marketed.

ISO 14971:2019

ISO 14971:2019 is the latest version of the international standard for medical device risk management. The globally recognized standard offers best practices for using a proactive approach to risk management throughout the entire lifecycle of a medical device.

ISO 9001

ISO 9001 is an international standard that specifies the requirements for a quality management system. Belonging under the umbrella of the ISO 9000 standard, 9001 is the only one that offers a certification pathway for manufacturers. This standard assumes a specialized focus on ensuring users receive good-quality products and services.

IN VITRO DIAGNOSTIC (IVD) DEVICES

IVD refers to In Vitro Diagnostic devices. As defined in IVDR (EU) 2017/746, IVD can describe devices or equipment “intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.”

MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE)

Manufacturer and User Facility Device Experience, or MAUDE, is a database for medical device electronic reporting (eMDR) submitted to the FDA by manufacturers, importers, device user facilities, health care professionals, patients, and consumers.

MEDICAL DEVICE REPORTING (MDR)

Medical Device Reporting, or MDR, refers to a surveillance tool maintained by FDA that is used to monitor the performance and safety of medical devices after being placed on the market. MDR provides voluntary reporting capabilities to both medical device manufacturers and consumers for public-use.

MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP)

The Medical Device Single Audit Program, or MDSAP, is a program allowing medical device manufacturers to gain access into multiple global markets through one audit event. There are currently five active participating regions of MDSAP, including Australia, Brazil, Canada, Japan, and the United States.

MEDICAL DEVICE USER FEE AMENDMENTS (MDUFA)

Medical Device User Fee Amendments, or MDUFA, refers to changes made to the fee structure in which medical device companies are expected to pay to FDA in order to register their establishments and devices. These fees also apply to application or notification submissions made to the FDA.

MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM (MDQMS)

A Medical Device Quality Management System, or MDQMS, is a quality management system built from the ground up for the medical device industry. Unlike a legacy QMS or ad hoc system, a MDQMS typically includes templates and workflows that align with medical device industry requirements and best practices.

MANUFACTURING RESOURCE PLANNING (MRP)

Manufacturing Resource Planning, or MRP, is a way of compiling, organizing, and planning various activities carried out by a medical device manufacturer (or with any business). The method involves simulating hypothetical scenarios to ensure resources are being used effectively. This term has fallen out of use in recent years and may also be referred to as ERP.

NOTIFIED BODY (NB)

A Notified Body, or NB, is a third-party auditing organization that assesses the quality and conformity of medical device products seeking market entry into the European Union.

NONCONFORMANCE REPORT (NCR)

A Nonconformance Report, or NCR, is used to document non-conforming material observed during quality control activities or inspection. A NCR details the identified issue(s) of nonconformance, the severity and impact of the non-conformance, how it occurred, and how nonconformance will be managed to prevent recurrence.

NONSIGNIFICANT RISK (NSR)

Nonsignificant Risk, or NSR, is a measure of risk as outlined by ISO 14971. Determining whether a risk is significant or nonsignificant involves assessing the probability of direct harm, probability of harm from not using the device, and probability of harm from misinformation.

OWN BRAND LABELING (OBL)

Own Brand Labeling, or OBL, occurs when a manufacturer sells a medical device in the EU that already has a CE Marking and does so under its own brand.

ORIGINAL EQUIPMENT MANUFACTURER (OEM)

An Original Equipment Manufacturer, or OEM, is an organization that produces goods which are used as subparts in products of a third-party company, which then sells the end products to consumers.

PERSONS RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)

The European Commission requires manufacturers to designate at least one person with the requisite expertise in the field of medical devices from within their organization as the Person Responsible for Regulatory Compliance (PRRC).

PRODUCT DEVELOPMENT (PD)

Product Development, or PD, is the pre-market process of building a medical device. In the medical device industry, this process encompasses the design and development of a product.

PRODUCT DATA MANAGEMENT (PDM)

Product Data Management, or PDM, is the handling of data as it relates to a medical device within a software system. Modern medical device companies often use PDM tools to compile product data and automate management protocols.

PRODUCT LIFECYCLE MANAGEMENT (PLM)

In the manufacturing sector, Product Lifecycle Management, or PLM, is a system for managing and overseeing the development and distribution of a product. This process applies to the inception, design, regulatory approval, manufacturing, marketing, and post-market phases of medical devices until the product is no longer on the market.

PREMARKET APPROVAL (PMA)

Premarket Approval, or PMA, is the regulatory pathway to market required for Class III devices under FDA regulations. The PMA submission process typically involves clinical trials with human participants, as well as laboratory testing, to demonstrate the safety and efficacy of the device.

POST-MARKET SURVEILLANCE (PMS)

Post-Market Surveillance, or PMS, is the process of monitoring a medical device after it has gained market entry for sale and distribution of use for use by patients within the marketplace. PMS involves gathering data and feedback on the performance of a device on the market, and it is a mandatory process for compliance with most regulations and standards, including 21 CFR Part 820, EU MDR, and ISO 13485:2016.

PROOF OF PRINCIPLE (POP)

Proof of Principle, or POP and also known as Proof of Concept, is the demonstration that the initial concept behind a medical device is feasible. The POP typically includes criteria for success that must be met in order to proceed with product development.

PRODUCTION PLANNING AND CONTROL (PPC)

Production Planning and Control, or PPC, is a process used to organize the production, including design and development activities, and the manufacture of a medical device. A PPC process is usually comprised of inputs, outputs, and control systems. Regulations for design and development planning are found under FDA CFR 21 Part 820.30.

QUALITY ASSURANCE (QA)

Quality Assurance, or QA, is a method used to prevent defective, nonconforming products. QA professionals engage in activities intended to improve the product development and testing processes, as well as maintaining compliant marketing and distribution processes.

A quality management system can be considered as a QA tool itself, as it serves as a single source of truth for all quality policies and procedures for the final product.

QUALITY CONTROL (QC)

While QA focuses on the process, Quality Control, or QC, focuses on the product. QC is system for identifying defects in a medical device during the post-production phase, prior to product distribution. The goal of quality control is to ensure the product conforms to specified requirements and will meet expected performance criteria upon end user interface. QC and QA are complementary aspects of a QMS.

QUALITY MANAGEMENT SYSTEM (QMS)

A Quality Management System, or QMS, is an organizational tool for implementing and maintaining activities, documents, and tasks as it relates to responsibilities, procedures, processes, and resources. A QMS is instrumental in achieving regulatory compliance and in producing safe and effective medical devices. At minimum, a quality system should include design controls, risk management, document control and records management, and supplier management.

QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT)

The Quality System Inspection Technique, also known as the QSIT method, is a type of FDA inspection that uses a top-down approach to reviewing the four main subsystems within a company's QMS. The top-down approach used by the FDA inspector begins with reviewing the company's procedures before drilling down into the quality records for those processes. The quality records serve as proof the company is following its written procedures.

QUALITY SYSTEM RECORD (QSR)

A Quality System Record, or QSR, is a record that acts as a source file for all documentation, procedures, and records that are located within a QMS. Medical device companies can use their QSR as a reference to navigate other aspects of their QMS. QSR can also refer to Quality System Regulation, shown below.

QUALITY SYSTEM REGULATION (QSR)

The Quality System Regulation, or QSR, for medical devices in the U.S. is outlined in FDA 21 CFR Part 820. The QSR requirements are based on methods for facilities, and controls used for, carrying out all phases of processes throughout the lifecycle of a medical device. These aspects include design, manufacture, packaging, labeling, storing, installing, and servicing of medical devices intended for use by humans.

REGULATORY AFFAIRS (RA)

Regulatory Affairs, or RA, professionals in the medical device industry play a strategic role throughout the product lifecycle, such as ownership of a company's go-to-market strategy for satisfying legal requirements of product commercialization, regulatory submission protocol, and postmarket surveillance methods. The RA role serves a critical function for effectively communicating and executing appropriate regulatory strategies to ensure compliance.

RISK ANALYSIS (RA)

Risk Analysis, or RA, is a method used in risk management to identify specific risks associated with a design, procedure, or process used in the manufacture of a medical device. The RA process will include identifying the medical device, the persons involved, the scope of the risk analysis, and relevant date(s). Preliminary hazard analysis, FMEA, and fault tree analysis are all methods used to carry out risk analysis for a medical device.

RISK MANAGEMENT (RM)

Risk Management, or RM, is a process used by medical device companies to identify, control, and prevent hazards and risks/sources of harm that might arise during the use of a medical device. The internationally recognized standard for medical device RM processes are outlined in ISO 14971:2019.

RESEARCH USE ONLY (RUO)

Research Use Only, or RUO, is a term used to indicate that a medical device product or instrument does not have an intended medical purpose and instead is to be used for research purposes only. Devices used for research in IVD product development are often labeled RUO.

SOFTWARE AS A MEDICAL DEVICE (SAMD)

Software as a Medical Device, or SaMD, is a class of software used for medical functions, without needing a hardware component to serve that function. An application or software that's used to diagnose, cure, prevent, or mitigate disease are all considered to be classes of SaMD.

SUPPLIER CORRECTIVE ACTION REQUEST (SCAR)

A Supplier Corrective Action Request, or SCAR, is a formal notice sent to a supplier by a medical device company upon the observance of issues related to nonconforming products or materials. Such issues impact the quality of the provided goods, and the purpose of the SCAR is to solicit action from the supplier to identify and correct the issue(s) raised.

SUBSTANTIAL EQUIVALENCE (SE)

Substantial Equivalence, or SE, is a regulatory requirement by FDA for market clearance of new products through a 510(k) premarket submission. To declare substantial equivalence, a company must prove their device is as safe and effective as a similar predicate device. SE is required for regulatory submissions for which a premarket approval (PMA) is not required.

SAFE MEDICAL DEVICES ACT (SMDA)

The Safe Medical Devices Act, or SMDA, is a law which passed in 1990 establishing HHS as the governing authority over device user facilities to report incidents in which a medical device may have caused or contributed to the serious injury, illness, or death of a patient.

STANDARD OPERATING PROCEDURE (SOP)

A Standard Operating Procedure, or SOP, is an internal procedure created by an organization to standardize a routine process for ease of repeatable. A SOP is typically a written document comprised of a series of prescriptive instructions to be followed by individuals and teams. Medical device companies are required to create and maintain SOPs for routine processes as part of their QMS.

STATISTICAL PROCESS CONTROL (SPC)

Statistical Process Control, or SPC, is a method used to control a process through the use of statistical techniques. This involves compiling data from a process and building cause and effect models to predict and account for various outcomes.

SIGNIFICANT RISK (SR)

Significant Risk, or SR, is a measure of risk as defined by ISO 14971. Any device that poses a serious risk to the health or safety of a human subject is categorized as SR.

SINGLE-USE DEVICES (SUDS)

Single-Use Devices, or SUDs, are disposable devices intended to be used for a singular event or procedure for one patient only. These devices are to be disposed after use rather than sanitized and re-used.

SUMMARY TECHNICAL DOCUMENTATION (STED)

Summary Technical Documentation, or STED, is format manufacturers can use to record required information about how a medical device was designed, developed, and manufactured for submission to a Regulatory Authority or Notified Body to demonstrate conformity. The STED format represents the documentation required for Technical Files.

TECHNICAL FILE (TF)

A Technical File, or Design Dossier  for Class III devices, includes specific details about a medical device's design, composition, intended use, function, and clinical evaluation. TF are a key requirement of obtaining CE marking for a device.

UNIQUE DEVICE IDENTIFICATION (UDI)

Unique Device Identification, or UDI, is a system established by the FDA to catalog and identify each individual device for sale in the U.S. market by assigning a custom identifier that can be read by both humans and machines. A UDI is distinct from a Universal Product Code (UPC), as the UDI is used to identify a medical device on the FDA website via the AccessGUDID portal.

UNIVERSAL PRODUCT CODE (UPC)

A Universal Product Code, or UPC, is a code printed on retail packaging consisting of a barcode and a 12-digit number. The code can be used to track inventory for retailers and is considered to be an alternative tracking method to UDI, the official identification system used by FDA.

VERIFICATION AND VALIDATION (V&V)

Verification and Validation, also known as V&V, are activities for testing and confirming whether a medical device meets the design procedures and is ready to be released for manufacture. Design verification ensures you designed the device correctly and design validation ensures you designed the correct device. These processes tend to involve careful tests, trials, and analyses.

VOLUNTARY ACTION INDICATED (VAI)

Voluntary Action Indicated, or VAI, is a term used by the FDA in establishment inspection reports (EIR) to indicate regulatory action is not required, following the observance of objectionable conditions or practices during an inspection. On the contrary, Official Action Indicated (OAI) would indicate regulatory or administrative action is required by FDA to correct an issue found during an inspection.

WARNING LETTER (WL)

A Warning Letter (WL) is an official notice made by FDA in response to regulatory violations that have been escalated from a 483 observation. Violations may include anything from wrongful claims about the device to missing design controls. A WL will provide a detailed explanation of the violation and what is required of companies for a corrective action plan.

WORK IN PROGRESS (WIP)

Work in Progress, or WIP, is a term used to refer to partially finished goods in manufacturing or within a design history record (DHR). Inventory that has entered the manufacturing process and can no longer be classed as raw materials but is not yet a finished product is classed as WIP.

The information provided in this article is for educational purposes only and is not intended to support the safety or effectiveness of any medical device, or diagnose, treat, cure, audit, procedure, quality standard or prevent any disease.

Your Baby, Jaundice, and Light Therapy

Bilirubin is a yellow substance that comes from the normal breakdown of red blood cells. The liver removes bilirubin from the blood and passes it into the bowels so it can leave the body.

A newborn baby’s liver does not remove bilirubin, as well as an adult, does. Jaundice happens when bilirubin builds up faster than the liver can break it down and pass it from the body.

Most types of jaundice go away on their own. Others need treatment to lower bilirubin levels.

What Causes Jaundice?

Jaundice can be caused by different problems:

  • Physiological jaundice: The most common cause of newborn jaundice and occurs in more than 50% of babies. Because the baby has an immature liver. Jaundice first appears at 2 to 3 days of age. It usually disappears by 1 to 2 weeks of age, and the levels of bilirubin are harmless.
  • Breastfeeding jaundice: Breastfeeding jaundice may occur when your baby does not drink enough breast milk. It occurs in 5% to 10% of newborns.
  • Breast-milk jaundice: Breast-milk jaundice occurs in 1% to 2% of breast-fed babies. It is caused by a special substance that some mothers produce in their milk. This substance causes the baby’s intestine to absorb more bilirubin back into his body than normal. This type of jaundice starts at 4 to 7 days of age. It may last 3 to 10 weeks. It is not harmful.
  • Blood group incompatibility (Rh or ABO problems): If a baby and mother have different blood types, sometimes the mother produces antibodies that destroy the newborn’s red blood cells. This causes a sudden buildup of bilirubin in the baby’s blood. This serious type of jaundice usually begins during the first 24 hours of life. Rh problems formerly caused the most severe form of jaundice.

How Is Jaundice Diagnosed?

Doctors can tell if a baby has jaundice based on the yellowing of the skin and whites of the eyes. Usually, all newborns are checked for jaundice before leaving the hospital or birth center.

Babies with jaundice will get a blood test to check bilirubin levels. Sometimes, a light machine that measures bilirubin in the skin is used. But if the level is high, a blood test must confirm the result.

High bilirubin levels can lead to serious problems. So doctors carefully watch babies with jaundice.

Treatments for Jaundice

Some types of jaundice will disappear within a week or two without treatment. Other babies will require treatment because of the severity of jaundice.

Light treatment is the process of using light to eliminate bilirubin in the blood. The baby’s skin and blood absorb these light waves. These light waves are absorbed by your baby’s skin and blood and change bilirubin into products, which can pass through their system.

For many years, phototherapy treatment in the hospital has been provided by a row of lights or a spotlight suspended at a distance form a baby. This would provide light shining directly on an undressed baby (with a diaper on) whose eyes would need protection from the light with soft eye patches applied. Today, advancements in technology have led to a new phototherapy system that gives effective treatment without the inconveniences of conventional phototherapy treatment.