Conducting a Well-Controlled Clinical Trial for the FDA

In a scientific experiment, the tighter the controls on the experiment’s variables are, the more accurate and insightful the research’s findings will be. It’s the same case for clinical trials in the life sciences industry. A well-controlled clinical trial rooted in the scientific method's foundation will produce more reliable data and conclusions.

But how do you define a “well-controlled” clinical trial? Much to the relief of the life sciences manufacturers and their research teams, the U.S. Food and Drug Administration (FDA) provides explicit guidance on what it means to conduct an adequate and well-controlled clinical trial in 21 CFR 314.126.

What Is a Clinical Trial?

According to clinicaltrials.gov, in a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or medical devices, procedures, or changes to participants’ behavior — for example, diet.

What’s the Difference Between Medical Device Clinical Trials and Drug Trials?

Many of the same factors that make a well-controlled clinical trial for medical devices are similar to what makes a well-controlled drug trial. Still, there are some fundamental differences researchers need to know.

Key differences between medical device trials versus drug trials include:

  • Differences in the Subjects who Participate. In most drug trials, the drug is tested on a small group of healthy individuals first, then administered to incrementally larger populations. Medical device trials typically only involve subjects with the condition for which the trial is designed.
  • Differences in who Administers Drugs versus Devices. In a drug trial, the patient or patient’s caregiver is typically the person who administers the drug. In a medical device trial, the person administering the device is typically the principal investigator.
  • Differences in who has Greater Responsibility. In a drug trial, the patient typically has a higher responsibility for taking the drug as required. In a device trial, the physician shares a greater part of ensuring the device is operated correctly.
  • Differences in Training Requirements. Because the physician has a greater responsibility to administer medical devices correctly, a medical device trial typically requires more practical experience — such as training in cadaver labs or proctoring during live cases.
  • Differences in the FDA Approval Process. The approval process for new drugs is typically longer than the approval process for medical devices. While it takes 12 years on average to bring a new drug to market, the average length of time it takes to bring a medical device to market is three to seven years. However, this does not always mean it’s easier to obtain approval for a new medical device. The extent of the approval process and whether a medical device requires premarket approval depends on its classification. Medical devices determined to carry significant risks to human subjects generally require premarket approval.

Which FDA Regulations Are Required in a Clinical Trial?

Both drug and device trials follow the same requirements for protecting human subjects, maintaining records, and disclosing financial relationships. Those requirements include:

  • 21 CFR 11 — Electronic medical records.
  • 21 CFR 50 — Human subject protection.
  • 21 CFR 54 — Financial disclosure.
  • 21 CFR 56 — Institutional Review Board (IRB) requirements.

While drug trials are required to follow 21 CFR 312, medical device trials are governed by 21 CFR 812.

What Makes A Well-Controlled Clinical Trial?

Whether it’s a drug trial or a medical device trial, the FDA makes it clear that all trials should have the following:

  • A clear statement of the investigation's objectives and a summary of the proposed methods of analysis in the protocol.
  • A design that permits a valid comparison with control to provide a quantitative assessment of the effect.
  • The subject selection provides adequate assurance that the subject has the disease or condition that the treatment is directed at.
  • A method of assigning patients to treatment and control groups minimizes bias and assures the groups' comparability.
  • Adequate measures to minimize bias by the subjects, observers, and data analysts.
  • Well-defined and reliable assessment of subjects’ responses.
  • Analysis of the results is adequate to assess the effect of the drug or device.

The experiment variables are designed to prove or disprove a causal relationship between the independent and dependent variables. This would be the drug or device versus the condition of the patient.

Control is a vital element of a well-designed experiment of the main variables. There needs to be a way to rule out the effects of extraneous variables other than the dependent and independent ones.

A good experiment, like a good clinical trial, often has blind controls or double-blind randomization to compare the results. The goal for a well-controlled experiment is for it to be repeated many times with the same or statistically similar results. Clinical trials are typically not repeated as much as they are designed with large numbers of subjects to remove the bias in a study with small subject sampling. This helps to rule out random samples or outliers in the “experiment.”

Many would argue other things go into the makeup of a well-controlled clinical trial, especially once sites and patients get involved. Having a research team with adequate facilities, knowledge of the federal regulations, and the time and staff to work on the project are also imperative. Additionally, having timely, well-documented data is vital to the trial’s continued success, which helps ensure the trial is being conducted in a way that will produce relevant results.

What Can We Do To Conduct Well-Controlled Clinical Trials?

A well-controlled clinical trial starts with a strong understanding of the risks involved and proper planning to mitigate those risks. Today, it increasingly requires deep knowledge of FDA regulations and global requirements like the European Union’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) requirements.

Managing the many risks of any trial and keeping it moving forward requires diligent monitoring, record-keeping, and seamless coordination between all parties involved.

Finally, as clinical trials wind down, researchers need to ensure they have all the correct documentation in order in their trial master file.

A full-service contract research organization (CRO) with expertise in conducting global clinical trials is invaluable when conducting a well-controlled clinical trial. They can assist with clinical planning and consulting before a trial begins. They can help with monitoring, auditing, project management, and safety management during the trial. And they can ensure all your documents are in order as you wrap up a trial so you can obtain approval.

FDA Premarket Requirements

Bringing a device to the market in the United States may appear complex. Following these four steps may assist you in navigating the process:

1) Classify Your Device and Understand Applicable Controls

The first step in preparing a marketing device in the United States is to determine how the FDA has classified your device. A medical device is defined by law in section 201(h) of the Federal Food, Drug and Cosmetic (FD&C) Act.

Medical devices are categorized into three classes (I, II, or III) based on the degree of risk they present. As device class increases from class I to class II to class III, the regulatory controls also increase, with class I devices subject to the least regulatory control and class III devices subject to the most stringent regulatory control.

2) Select and Prepare the Correct Premarket Submission

You should select and prepare the appropriate premarket submission if required for your specific product’s classification. For most medical devices, the appropriate submission type is identified within the product classification, which may be obtained from the public Product Classification database. Note some device types do not require a premarket submission. The most common types of premarket submissions include:

  • 510(k) (Premarket Notification)
  • PMA (Premarket Approval)
  • De Novo Classification Request
  • HDE (Humanitarian Device Exemption)

510(k)

Some class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed.

Some class I and class II devices are exempt from the 510(k) notification requirement if they do not exceed the exemption limitations stated in 21 CFR xxx.9, where xxx refers to 21CFR 862–892.

PMA

Class III devices require a PMA. A PMA is the most stringent type of premarket submission. Before the FDA approves a PMA, the sponsor must provide valid scientific evidence demonstrating reasonable assurances of safety and effectiveness for the device’s intended use.

De Novo Classification Request

The De Novo process provides a pathway to classify novel medical devices for which general controls alone, general and special controls, provide reasonable assurance of safety and effectiveness for the intended use. Still, there is no legally marketed predicate device.

HDE

HDE provides a regulatory pathway for class III devices intended to benefit patients with rare diseases or conditions. For a device to be eligible for an HDE, a sponsor must first obtain designation as a Humanitarian Use Device (HUD).

3) Prepare the Appropriate Information for the Premarket Submission

Once you have prepared the appropriate premarket submission for your device, you need to send your submission to the FDA and interact with FDA staff during its review. Before sending your submission to the FDA, you should be aware of the following:

  • Medical Device User Fees: There is a user fee associated with the submission of certain marketing applications.
  • Small Business Determination (SBD) Program: A qualified and certified business as a “small business” is eligible for substantially reducing most of these user fees.
  • eCopy: Premarket submissions must include an electronic copy (eCopy) on a compact disc (CD), digital video disc (DVD), or a flash drive.

Once the FDA has received your submission, you should be aware of the following:

  • Administrative Review: After a premarket submission is received, the FDA conducts an administrative review to assess whether the submission is sufficiently complete to be accepted for substantive review.
  • Interactive Review: While submission is under review, the FDA staff communicates with applicants to increase the review process's efficiency. Step Four: Comply with Applicable Regulatory Controls, Including Establishment Registration and Device Listing

Regulatory controls are risk-based requirements that apply to medical devices and give the FDA the oversight to ensure medical devices' reasonable safety and effectiveness.

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Light Therapy Can Help COVID-19 Patients Recover Faster

Light Therapy Can Help COVID-19 Patients Recover Faster

We all know what COVID-19 is, and many of us have had to deal with it ourselves. As much as the pandemic has slowed in many places, the world is far from going back normal. The struggle is not only in the disease, but the massive shift that it’s brought in the world. 

And there is such variance on the effect the virus can have if you do catch it – some people experience no symptoms, while others could fall into a critical state;  though the general consensus is that most COVID patients experience a string of similar symptoms, ranging from mild to extreme. Fever and coughing are some of the first symptoms patients experience, next to the infamous loss of smell and taste. While in some way, it presents itself much like a common cold, in many other ways, the symptoms can be stronger, long-lasting, and more intense.

We’ve even accepted that it’s normal to not fully recover immediately. Like with any virus, recovery often depends on a person’s immune system. It’s not a surprise that some people take much longer to get back to their optimal health once the COVID-19 virus sets it back for them. Many people have stated that even weeks or months after getting over the virus, they don’t feel fully recovered. 

As much as it is a unique experience for each person, certain symptoms and effects can linger after contracting COVID-19. Primarily what could remain affected are lungs, and studies suggest even the brain. Next to that, obviously, your immune system and overall health are affected.

Among the post-COVID symptoms reported are fatigue, brain fog, joint pain. chest pain, heart palpitations, headaches, dizziness, and insomnia — and these are all after people have technically “recovered” from the primary infection.

While recovering from COVID takes time, there are some things you can do to improve the healing process – taking immune supplements such as vitamin C and echinacea, getting ample rest, and, yes, with light therapy. 

The benefits of light therapy are vast, and the treatment has been proven to help improve overall well-being by amplifying cell turnover rate. Working deep at the cellular level, light therapy gives people the chance to rejuvenate their cells into healthier and stronger ones that can ultimately lead to overall better health. 

Light therapy creates and accelerates the release of ATP; this is what fuels our body, so it’s not surprising athletes use this form of therapy to not only heal their wounds and bodies but also refuel their muscles.  

So how can light therapy exactly help with COVID symptoms? Well, there have been studies to show that progress is accelerated with the aid of light therapy. What’s even better is that light-based technologies are currently cost-effective and widely available in the market. So, investing in a light therapy device can significantly improve your health without breaking the bank.

Photons can also be used to deactivate SARS-CoV-2 in air, liquids, and on surfaces. Phototherapy can be used as an aid to control virus infection and to modulate the host immune system. Light-based solutions can significantly contribute to mitigating the impacts of COVID-19 pandemic.

Light therapy use has been used for decades,  so it’s no surprise that doctors are implementing it now during these conditions. Light therapy essentials include using different lights to help with different problems, red light being the most commonly used. Light therapy can help improve the immune system by increasing the health and production rate of cells overall. It also helps with circadian rhythm, shifting us into the best schedule and sleep state and allowing our bodies to rest and recover better.  Brain fog and chronic fatigue are some of the COVID symptoms that can be improved via light therapy treatment as it aids with restoring sleep patterns, and reduces inflammation in the body. 

Studies show that through light therapy, your general wellness and overall health improves which can result in deep body healing, and accelerated recovery from symptoms caused by COVID-19. 


Thankfully, Kaiyan Medical produces MDA-certified and FDA-approved light therapy devices perfect for your own at-home treatment, or even for your patients. We’re honored to be able to provide solutions for both patients and healthcare practitioners for this virus that we’ve all been affected by in one way or another – and we’re confident that light therapy will continue to show incredible results for those affected by people across the globe.


Recommendations Post-COVID Vaccination

Recommendations Post-COVID Vaccination

Getting the Covid-19 vaccination shouldn’t change any of your typical health, fitness, or wellness routines, or at least not for more than a day or two. Still, it’s reasonable to have questions about whether you should hold off on certain things, such as working out, drinking alcohol, or taking certain medications. Below are some of the common questions people have about what they should or shouldn’t do after vaccination related to their own health.

Medications

A common circulating question is whether it’s okay to take painkillers and fever reducers, such as acetaminophen (Tylenol) or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or aspirin. In the big Covid-19 vaccine FAQ on Elemental, the CDC does not recommend taking any of these medications before vaccination for the sake of preventing fever, headache, or other aches. Physicians advise against it because limited evidence suggests it could blunt your body’s immune response.

Basically, wait until you get the vaccine, see what happens and how you feel, and if you experience fever, headache, or other pains, take your preferred painkiller/fever reducer then. There is no evidence to suggest taking acetaminophen or an NSAID after vaccination will negatively affect your immune response.

If you take any immunosuppressive medications, such as biologics for autoimmune diseases, or you’re receiving treatments for cancer, it’s best to check with your specialist (your oncologist, immunologist, rheumatologist, etc.) to find out if you need to skip any doses or wait to get vaccinated between cycles of medications or treatments. Not much data exists on the vaccine and immunosuppressive medication so far, so you’ll need to rely on your physician’s clinical expertise and what we know about other types of vaccines.

Exercise

No specific recommendations exist related to exercise after getting the Covid-19 vaccine. It’s all going to depend on how you feel. If you’re feeling tired from the vaccine, especially if you have muscle cramps or aches, skip the workout until they subside. Your body is telling you that you need rest, and your immune system probably needs the rest to do its job. If you have the stronger side effects of fever, chills, or fatigue, you should definitely wait until they pass before going for a run or doing a set of deadlifts. If you exercise at a class, it’s probably best not to schedule one in the first two days after each vaccine dose until you know how you’re feeling.

However, if you’re feeling fine, you can try physical activity in a day or two afterward as long as you start slowly and pay attention to your body. You might not have immediately felt any side effects, but once you start exerting yourself, you might find you tire more quickly or easily in the first few days after vaccination. Some physicians advise against any exercise in the first 24 hours after the vaccine, but that’s based more on a “take it easy and see how it goes” approach rather than any data showing that exercise could harm you or the vaccine response.

Drink Alcohol

Yes, you can, but it’s still not the best idea to consume alcohol in the first 24 to 48 hours after vaccination. First, you’re likely to feel tired or achy from the vaccine already, especially if it’s your second dose of one of the mRNA vaccines, so adding a toxin like alcohol to your body when it’s in the process of learning to fight off a specific pathogen could make you feel worse. Alcohol also contributes to dehydration, leading to headaches and muscle or joint pain.

Light Therapy After the Vaccine?

Of course, use red light therapy to improve your circadian rhythm to boost your recovery process. You can use red and infrared light if you feel your body sore and tired.

Build Immunity

Most of the vaccines require two doses. You aren’t automatically immune the day after you get your second dose of an mRNA vaccine. Your body needs time to detect the foreign substance in your body, identify it as an intruder, and build up antibodies to fight it. That takes about two weeks, so consider yourself truly, fully immunized two weeks after your second dose.

Light Therapy & Sleep Quality:  The Secret of the Chinese Female Basketball Players

Light Therapy & Sleep Quality: The Secret of the Chinese Female Basketball Players

Good sleep is a prerequisite for optimal performance. Given that people spend about one-third of their lives asleep, sleep has substantial development, daily functioning, and health. Perhaps no daytime behavior has been associated more closely with improved sleep than exercise. Researchers have shown that exercise serves as a positive function for sleep. Regular exercise consistently has been associated with better sleep. Moreover, the American Academy of Sleep Medicine considers physical exercise a modality of nonpharmacologic treatment for sleep disorders. When studying the influence of exercise on sleep, most investigators have compared acute and sedentary control treatments. In the study of regular moderate-intensity endurance exercise, researchers also provided compelling evidence that exercise promotes sleep.

However, exercise can negatively affect sleep quality. Exercising immediately before going to sleep is detrimental to sleep quality. Athletes train very hard to improve their on-field performances, but excessive training may decrease performance, known as overtraining syndrome. Researchers have shown that symptoms of overtraining indicate poor-quality sleep. Good sleep is an important recovery method for the prevention and treatment of overtraining in sports practice.

In a recent study in which red-light therapy (wavelength = 670 nm, light dose = 4 J/cm2) was used, researchers indicated that red light could restore glutathione redox balance upon toxicologic insult enhance both cytochrome c oxidase and energy production, all of which may be affected by melatonin. Melatonin is a neurohormone that is produced by the pineal gland and regulates sleep and circadian functions. No one knows whether sleep is regulated by melatonin after red-light irradiation in athletes. Researchers have demonstrated that phototherapy improves muscle regeneration after exercise. A red light could protect human erythrocytes in preserved diluted whole blood from the damage caused by experimental artificial heart-lung machines.

Participants

Twenty female athletes of the Chinese People’s Liberation Army team (age = 18.60 ± 3.60 years) participated in the study. All participants were healthy and were not using medications regularly or temporarily during the measurements. Athletes were excluded if they had participated in less than 80% of the scheduled team physical training and basketball sessions for the last 3 months or used any nutritional supplements or pharmacologic agents. All participants provided written informed consent, and the Ethical Committee approved the China Institute of Sport Science study.

Design

Participants were assigned randomly to either a red-light therapy intervention group (n = 10) or non–red-light therapy intervention group (placebo group, n = 10). Measurements were collected at preintervention (baseline) and postintervention (14 days). The exercise training schedule of the 2 groups was unchanged during the 14 days; the red-light treatment group used a red-light therapy instrument every night for total body irradiation for 30 minutes. The training routine of the athletes during the 14 intervention days included 12 exercise sessions with the following specifications: 2 hours of morning training, 2 hours of afternoon training, and no training on Sunday.

The red-light treatment participants lay in the supine position. Continuous illumination was performed using noncoherent red light from a whole-body red-light treatment machine-like Kaiyan’s red light therapy bed, with an average wavelength of 658 nm and a light dose of 30 J/cm2. The whole body received the phototherapy treatment. The placebo participants also lay in the supine position under the red-light device but did not receive any light illumination. All participants wore swimsuits to enhance irradiation from the device and were blind to the treatment.


Measurement

Sleep Quality

The Chinese version of the PSQI measured sleep quality. The 19-item measure assesses sleep quality and disturbances over a half-month time interval. The total PSQI score ranges from 0 to 21, and higher scores reflect poorer-quality sleep. The 7 items of this instrument measure several aspects of insomnia: difficulties with onset and maintenance of sleep, satisfaction with the current sleep pattern, interference with daily functioning, noticeable impairment attributed to sleep problems, degree of distress, and concern caused by any sleeping problems.

Cooper 12-Minute Run

Participants were instructed to complete as many laps as possible on a 400-m outdoor track during the 12-minute test period. Emphasis was placed on pacing oneself throughout the test. The test administrators counted the laps completed during the 12-minute test period while calling out the time elapsed at 3, 6, and 9 minutes and orally encouraging the participants. At the end of the 12-minute period, the test administrator instructed the participants to stop and used a measuring wheel to determine the fraction of the last lap completed by each participant. This distance was added to the distance determined by the number of laps completed to give the total distance covered during the test.

Serum Melatonin

In humans, the serum level of melatonin, derived mainly from the pineal gland, demonstrates a clear increase at night and a decrease during the day. Given that the masking effects of activities (e.g., exercise, sleep, and food intake) have little effect on the circulating melatonin level's daily pattern, melatonin secretion appears to directly reflect the function of the biological clock as a specific marker of the circadian rhythm.

Conclusions

The study has demonstrated that red-light illumination positively affected sleep quality and endurance performance variables in Chinese female basketball players. Based on previous studies, we can infer that red-light treatment contributes to increased melatonin secretion in the pineal gland and muscle regeneration. Although more studies involving phototherapy, sleep, and exercise performance need to be performed, red-light treatment is a possible nonpharmacologic and noninvasive therapy to prevent sleep disorders after training.

Acknowledgments

This research project was supported by the National Key Technologies R&D Program Fund of China (2006BAK37B06).

Originally from:


Red Light and the Sleep Quality and Endurance Performance of Chinese Female Basketball Players

Jiexiu Zhao, Ye Tian, Jinlei Nie, Jincheng Xu, Dongsen Liu

J Athl Train. 2012 Nov-Dec; 47(6): 673–678. doi: 10.4085/1062-6050-47.6.08

PMCID: PMC3499892

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Neonatal Care Taps into Light Therapy

Neonatal Care Taps into Light Therapy

When a baby is born, all parents hope for a healthy child—all ten fingers and toes, a strong heart, and an able body. However, between 10 and 15 percent of babies born within the U.S. require special care within the NICU (Neonatal Intensive Care Unit), which is where preterm or diseased babies are cared for. 

This time is crucial for babies; it's the stage in which we, as humans, are most sensitive. After the first hour of life, newborns should receive eye care, vitamin K, and recommended immunizations (birth dose of OPV and Hepatitis B vaccine). They should be assessed for birth weight, fetal age, congenital disabilities, and newborn illness signs. Special care is provided for sick newborns, preterm and/or low birth weight, and babies exposed or infected by HIV or have congenital syphilis.

One of the more common diseases for premature babies is jaundice, which refers to the yellowish discoloration of the skin, sclerae, and mucous membranes caused by an increase in bilirubin in the blood. This substance derives from the metabolism of hemoglobin contained in red blood cells. For the newborn, it is (in most cases) destined to disappear within a few days.

Jaundice becomes evident when the amount of bilirubin exceeds 3 mg per deciliter. The yellowish color occurs first in the face and sclerae (the white part of the eye) and then extends to the trunk and upper and lower limbs. Jaundice can be physiological or indicate a pathology.

However, jaundice can become severe. This happens when it goes untreated for too long, it can cause a condition called kernicterus. Kernicterus is a type of brain damage resulting from high levels of bilirubin in a baby's blood. It can cause cerebral palsy and hearing loss.

Babies are naturally sensitive, and premature newborns are even more at risk. Their immune systems are still developing due to being born prematurely, which increases their risk of getting sick. Skin conditions of many kinds are common; in addition to jaundice, many experience feeding issues, and fever (always the first sign of an infection). 

Due to the nature of premature babies, it's essential to consider a non-invasive, non-medical treatment. They're still growing, just fully coming into their own and catching up on time missed developing in mom’s belly. 

Light therapy is an incredible tool for these little humans, working inward and targeting the cellular level. It helps with both external and internal problems, which means that at the cellular level, light therapy alters and enhances the cell constitution. This, as a result, leads to faster and better reproduction, creating a healthier and stronger organism and body to function with. 

Light therapy is a non-invasive, non-pharmaceutical form of therapy. The way it can help with neonatal care is unique. During treatments, the babies are completely safe and protected, with their eyes covered. The skin gets exposed to the light therapy lamp to absorb its benefits. The lamp is positioned specifically for the baby, no closer than 30.5cm. 

Light therapy has successfully treated newborn jaundice by lowering the bilirubin levels in the baby's blood through a process called photo-oxidation. Photo-oxidation adds oxygen to the bilirubin, making it dissolve in water easily. 

Since light therapy also helps to regulate circadian rhythm and melatonin, the treatments can also help babies sleep, which is essential in their healing and development. 


You can customize and completely control light therapy consumption for babies, thanks to Kaiyan Medical’s state-of-the-art light therapy device manufacturing services. We have been working for 15 years to produce the best light therapy products on the market which are MDA-certified and FDA-approved light therapy devices, many of which are cleared for at-home treatments. Of course, before using a light therapy device, always consult your doctor.

Light Therapy Proves Effective in COVID-19 Treatment Once Again

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

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.

Light Therapy Used for Ulcerative Colitis & IBD Treatment

Light Therapy Used for Ulcerative Colitis & IBD Treatment

Living with any pain is miserable, and inflammatory digestive issues can be one of the most frustrating conditions out there — and it’s widespread, particularly as autoimmunity on the rise.

Inflammatory Bowel Disease (IBD) is a life-long chronic condition of the gastrointestinal tract. Among these conditions, various digestive system parts, including the bowels (intestines), become swollen, inflamed, and ulcerated. This inflammation leads to disruption of the natural processes of digesting food, absorbing nutrition, and healthily eliminating waste.

There are three forms of IBD: Crohn’s disease, Ulcerative colitis, and indeterminate colitis. The main differences between the three are in the areas affected and the depth of inflammation.

Friendly bacteria may cause it, but that doesn’t make it friendly one bit — ulcerative colitis is rather uncomfortable even if the symptoms are often mild. This condition happens when the immune system mistakes our bacteria, which aids in digestion as friendly, leading to the colon and rectum's inflammation.

The main symptoms of IBD are recurring diarrhea, which may contain blood, mucus, stomach, and abdominal pain, and needing to empty your bowels frequently. It is also possible to experience extreme tiredness (fatigue) and loss of appetite, leading to weight loss.

The severity of the symptoms varies, depending on how much of the rectum and colon is inflamed and how severe the inflammation is.

In 2015, an estimated 1.3% of US adults (3 million) reported being diagnosed with IBD (either Crohn’s disease or ulcerative colitis). This was a large increase from 1999 (0.9% or 2 million adults). In the latest years, autoimmune diseases have risen, including stress, diet, lack of exercise, insufficient sleep, and smoking. In general, people haven’t been leading healthy lifestyles, which results in a higher chance of developing an autoimmune disease. While there are ways to treat autoimmune diseases, they typically are conditions that stick with you as long as they can.

The number of ulcerative colitis cases was 40% higher, and Crohn’s disease was 80% higher in northern Europe than southern Europe. This gives more evidence to the theory of vitamin D deficiency coming from lack of light. In France, a study described a transparent north-south gradient for the incidence of Crohn’s disease, but not colitis.

Light therapy can help with a wide range of problems, autoimmune diseases being one of them. For different autoimmune conditions, incidences increase at ranges between 3% and 9% year on year. This includes a 7.0% increase per year of rheumatic diseases such as rheumatoid arthritis. 6.3% increase of endocrinological conditions such as type 1 diabetes.

This is where light therapy comes in as a form of non-invasive therapy. Aside from being non-invasive, it’s an excellent option for those seeking non-pharmaceutical treatment.

The Health benefits of led light therapy are many, and that’s because of how it works. In its essence, light therapy works directly on our cells. Light deposits into our skin cells, penetrating each cell in the targeted area. Then by activation of ATP, reproduction is accelerated, and cellular rejuvenation occurs throughout the whole body.

Use of light therapy at home is available simply by purchasing your own device, using it in the comfort of your own home. How does light therapy help with IBD and ulcerative colitis? Well, light therapy first and foremost helps with tissue repair. Again, through the process of cell rejuvenation and reproduction, our tissue gets the opportunity of healing as well.

By default, UV light is highly anti-microbial, which means it prevents the spread of microorganisms, which infiltrates and causes infection and inflammation. Making an adequate UV light means having the perfect wavelength, which isn’t corrupting to the genetic material and will penetrate and effectively work on the colon.

To alleviate autoimmune symptoms, red light therapy is the perfect non-invasive solution. By healing the body from the inside out, those suffering from autoimmune diseases can finally progress in the right direction. Kaiyan’s light therapy devices are MDA-certified and FDA-approved and perfect at-home treatments for people suffering from these conditions.

Conducting a Well-Controlled Clinical Trial for the FDA

Conducting a Well-Controlled Clinical Trial for the FDA

In a scientific experiment, the tighter the controls on the experiment’s variables are, the more accurate and insightful the research’s findings will be. It’s the same case for clinical trials in the life sciences industry. A well-controlled clinical trial rooted in the scientific method's foundation will produce more reliable data and conclusions.

But how do you define a “well-controlled” clinical trial? Much to the relief of the life sciences manufacturers and their research teams, the U.S. Food and Drug Administration (FDA) provides explicit guidance on what it means to conduct an adequate and well-controlled clinical trial in 21 CFR 314.126.

What Is a Clinical Trial?

According to clinicaltrials.gov, in a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or medical devices, procedures, or changes to participants’ behavior — for example, diet.

What’s the Difference Between Medical Device Clinical Trials and Drug Trials?

Many of the same factors that make a well-controlled clinical trial for medical devices are similar to what makes a well-controlled drug trial. Still, there are some fundamental differences researchers need to know.

Key differences between medical device trials versus drug trials include:

  • Differences in the Subjects who Participate. In most drug trials, the drug is tested on a small group of healthy individuals first, then administered to incrementally larger populations. Medical device trials typically only involve subjects with the condition for which the trial is designed.
  • Differences in who Administers Drugs versus Devices. In a drug trial, the patient or patient’s caregiver is typically the person who administers the drug. In a medical device trial, the person administering the device is typically the principal investigator.
  • Differences in who has Greater Responsibility. In a drug trial, the patient typically has a higher responsibility for taking the drug as required. In a device trial, the physician shares a greater part of ensuring the device is operated correctly.
  • Differences in Training Requirements. Because the physician has a greater responsibility to administer medical devices correctly, a medical device trial typically requires more practical experience — such as training in cadaver labs or proctoring during live cases.
  • Differences in the FDA Approval Process. The approval process for new drugs is typically longer than the approval process for medical devices. While it takes 12 years on average to bring a new drug to market, the average length of time it takes to bring a medical device to market is three to seven years. However, this does not always mean it’s easier to obtain approval for a new medical device. The extent of the approval process and whether a medical device requires premarket approval depends on its classification. Medical devices determined to carry significant risks to human subjects generally require premarket approval.

Which FDA Regulations Are Required in a Clinical Trial?

Both drug and device trials follow the same requirements for protecting human subjects, maintaining records, and disclosing financial relationships. Those requirements include:

  • 21 CFR 11 — Electronic medical records.
  • 21 CFR 50 — Human subject protection.
  • 21 CFR 54 — Financial disclosure.
  • 21 CFR 56 — Institutional Review Board (IRB) requirements.

While drug trials are required to follow 21 CFR 312, medical device trials are governed by 21 CFR 812.

What Makes A Well-Controlled Clinical Trial?

Whether it’s a drug trial or a medical device trial, the FDA makes it clear that all trials should have the following:

  • A clear statement of the investigation's objectives and a summary of the proposed methods of analysis in the protocol.
  • A design that permits a valid comparison with control to provide a quantitative assessment of the effect.
  • The subject selection provides adequate assurance that the subject has the disease or condition that the treatment is directed at.
  • A method of assigning patients to treatment and control groups minimizes bias and assures the groups' comparability.
  • Adequate measures to minimize bias by the subjects, observers, and data analysts.
  • Well-defined and reliable assessment of subjects’ responses.
  • Analysis of the results is adequate to assess the effect of the drug or device.

The experiment variables are designed to prove or disprove a causal relationship between the independent and dependent variables. This would be the drug or device versus the condition of the patient.

Control is a vital element of a well-designed experiment of the main variables. There needs to be a way to rule out the effects of extraneous variables other than the dependent and independent ones.

A good experiment, like a good clinical trial, often has blind controls or double-blind randomization to compare the results. The goal for a well-controlled experiment is for it to be repeated many times with the same or statistically similar results. Clinical trials are typically not repeated as much as they are designed with large numbers of subjects to remove the bias in a study with small subject sampling. This helps to rule out random samples or outliers in the “experiment.”

Many would argue other things go into the makeup of a well-controlled clinical trial, especially once sites and patients get involved. Having a research team with adequate facilities, knowledge of the federal regulations, and the time and staff to work on the project are also imperative. Additionally, having timely, well-documented data is vital to the trial’s continued success, which helps ensure the trial is being conducted in a way that will produce relevant results.

What Can We Do To Conduct Well-Controlled Clinical Trials?

A well-controlled clinical trial starts with a strong understanding of the risks involved and proper planning to mitigate those risks. Today, it increasingly requires deep knowledge of FDA regulations and global requirements like the European Union’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) requirements.

Managing the many risks of any trial and keeping it moving forward requires diligent monitoring, record-keeping, and seamless coordination between all parties involved.

Finally, as clinical trials wind down, researchers need to ensure they have all the correct documentation in order in their trial master file.

A full-service contract research organization (CRO) with expertise in conducting global clinical trials is invaluable when conducting a well-controlled clinical trial. They can assist with clinical planning and consulting before a trial begins. They can help with monitoring, auditing, project management, and safety management during the trial. And they can ensure all your documents are in order as you wrap up a trial so you can obtain approval.

FDA Premarket Requirements

Bringing a device to the market in the United States may appear complex. Following these four steps may assist you in navigating the process:

1) Classify Your Device and Understand Applicable Controls

The first step in preparing a marketing device in the United States is to determine how the FDA has classified your device. A medical device is defined by law in section 201(h) of the Federal Food, Drug and Cosmetic (FD&C) Act.

Medical devices are categorized into three classes (I, II, or III) based on the degree of risk they present. As device class increases from class I to class II to class III, the regulatory controls also increase, with class I devices subject to the least regulatory control and class III devices subject to the most stringent regulatory control.

2) Select and Prepare the Correct Premarket Submission

You should select and prepare the appropriate premarket submission if required for your specific product’s classification. For most medical devices, the appropriate submission type is identified within the product classification, which may be obtained from the public Product Classification database. Note some device types do not require a premarket submission. The most common types of premarket submissions include:

  • 510(k) (Premarket Notification)
  • PMA (Premarket Approval)
  • De Novo Classification Request
  • HDE (Humanitarian Device Exemption)

510(k)

Some class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed.

Some class I and class II devices are exempt from the 510(k) notification requirement if they do not exceed the exemption limitations stated in 21 CFR xxx.9, where xxx refers to 21CFR 862–892.

PMA

Class III devices require a PMA. A PMA is the most stringent type of premarket submission. Before the FDA approves a PMA, the sponsor must provide valid scientific evidence demonstrating reasonable assurances of safety and effectiveness for the device’s intended use.

De Novo Classification Request

The De Novo process provides a pathway to classify novel medical devices for which general controls alone, general and special controls, provide reasonable assurance of safety and effectiveness for the intended use. Still, there is no legally marketed predicate device.

HDE

HDE provides a regulatory pathway for class III devices intended to benefit patients with rare diseases or conditions. For a device to be eligible for an HDE, a sponsor must first obtain designation as a Humanitarian Use Device (HUD).

3) Prepare the Appropriate Information for the Premarket Submission

Once you have prepared the appropriate premarket submission for your device, you need to send your submission to the FDA and interact with FDA staff during its review. Before sending your submission to the FDA, you should be aware of the following:

  • Medical Device User Fees: There is a user fee associated with the submission of certain marketing applications.
  • Small Business Determination (SBD) Program: A qualified and certified business as a “small business” is eligible for substantially reducing most of these user fees.
  • eCopy: Premarket submissions must include an electronic copy (eCopy) on a compact disc (CD), digital video disc (DVD), or a flash drive.

Once the FDA has received your submission, you should be aware of the following:

  • Administrative Review: After a premarket submission is received, the FDA conducts an administrative review to assess whether the submission is sufficiently complete to be accepted for substantive review.
  • Interactive Review: While submission is under review, the FDA staff communicates with applicants to increase the review process's efficiency. Step Four: Comply with Applicable Regulatory Controls, Including Establishment Registration and Device Listing

Regulatory controls are risk-based requirements that apply to medical devices and give the FDA the oversight to ensure medical devices' reasonable safety and effectiveness.

How Light Therapy Enhances Physical Therapy Treatment

How Light Therapy Enhances Physical Therapy Treatment

Though laser technology started with Albert Einstein, the technology didn’t evolve until the 1960’s when a laser prototype at Hughes Research Laboratories in Malibu, California, was first built. However, its purpose wasn’t for the medical industry; instead, for the military.

It eventually trickled down into Hollywood when Sci-Fi directors realized its potential for visual effects. But, of course, it didn’t take long for other fields to jump on the laser light bandwagon, including the medicine and rehabilitation industries. From there, the medical industry began to understand laser light’s impact on the human body when it came to healing and recovery.

Low-level (light) laser therapy (LLLT) is used to treat various conditions, including pain relief and inflammation. Over the past ten years, research and technological advancements have fine-tuned low-level light therapy, making the treatment highly effective in providing pain relief and healing treatment.

What is Low-Level Laser Light Therapy?

Before we talk about its capabilities, it’s essential to understand how it functions. Low-level laser light therapy is a non-invasive technique that gives the body a low dose of light to stimulate cellular healing. Laser light therapy targets the specific area in need to increase mobility by reducing pain and inflammation.

Low-level laser light therapy works through a process called photobiomodulation. During this process, the light is absorbed by the body’s tissue, where the cells respond with a physiological reaction, promoting cellular regeneration. The light stimulates cellular metabolism to promote cell growth and the healing of damaged cells.

How Laser Light Affects the Body

There are a couple of ways laser light therapy affects the body. Here’s what laser light therapy does for the body:

  1. Light energy is absorbed by melanin, hemoglobin, and water. The energy dissolves into heat, creating a soothing and warm sensation. The warming sensation helps patients feel relaxed.
  2. There’s an increase in ATP production in the mitochondria through light energy, the cell’s powerhouse. With increased ATP production, more energy is available for the healing process.
  3. Light energy aids with the release of nitric oxide, which enhances the circulation of damaged tissue. Increased circulation allows for improved oxygen exchange, nutrient exchange, and waste removal.
  4. Light energy releases crucial chemicals that help reduce inflammation.

So can laser light therapy be used alongside physical therapy? The answer is yes. In fact, the two treatments complement each other perfectly.

The Perfect Pair: Laser Light Therapy and Physical Therapy

With patients experiencing chronic or acute pain, the feeling of pain isn’t the main issue. However, patients can reduce pain and inflammation symptoms through laser light therapy while undergoing physical therapy treatments. Laser light therapy is ideal for pre and post-surgical procedures and during rehabilitation.

Patients undergoing laser light therapy will feel warm and soothing healing sensations as well as an immediate reduction in pain after treatment. By reducing pain, patients will improve their physical therapy performance and reduce their healing time. Ideally, four to six laser light therapy sessions are recommended to patients to receive the best results.

Whether you’re looking to improve your chiropractic, dermatology, medical or physical therapy practice, laser light therapy can provide your patients with the extra care they need to reduce chronic or acute pain and inflammation symptoms.

With many laser light products on the market, you want to make sure you’re investing in a medical-grade laser light device for your practice. Kaiyan Medical manufactures MDA-certified and FDA-approved laser light therapy devices, ideal for various medical and rehabilitation industries.

Private Label Your Dream Light Therapy Product with Kaiyan

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

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.

Why Chiropractors Love Light Therapy

Why Chiropractors Love Light Therapy

Chiropractors Lead the Way

LED light therapy is not new to the medical industry and certainly not new to doctors of chiropractic.

Studied for decades, the use of low-level light therapy (LLLT) — both LED and laser — has been making its way into the medical mainstream in the U.S. since the 1990s. And chiropractors have taken the lead in the clinical use of LED light therapy and are advancing the use of this technology for new applications.

This is no surprise to industry professionals and medical providers because this technology is a perfect pairing to what chiropractors advocate and bring to the medical community: healthy, drug-free healing and pain management options that are highly efficacious. Compared to the high cost and side-effect spectrum of many pharmaceutical drugs, LED light therapy can be a cost-effective alternative to drugs and surgery.

LED light therapy has the ability to increase blood flow and lymphatic circulation, decrease pain, and stimulate many cellular processes that accelerate healing. Plus, it has a high safety level, no known negative side effects is easy to administer, and is non-invasive.

Because LED light therapy can provide pain relief, wound healing and address neuropathy discomfort and various musculoskeletal issues, it is a mainstay in many clinics. Some patients also purchase light therapy systems from their chiropractors for in-home use between office visits for long-term therapy needs such as chronic pain and neuropathy.

It is also an attractive option for new chiropractors just getting started because it can bring substantial benefits to their patients while offering a fast ROI.

How it Works

LEDs deliver wavelengths of incoherent (diffused) light to the body. LEDs are similar to laser diodes, but their light spreads out, unlike the highly focused beam of coherent light that emits from a laser. This more diffused light makes administration exceptionally safe.

This therapy is also known as photobiomodulation — meaning that light can produce a cellular change in the body. Photons of light stimulate the release of nitric oxide, which

is the body’s natural vasodilator, greatly increasing circulation in the local treatment area. Blood flow is increased to nerves and other tissues, improving tissue oxygenation that stimulates healing. This boost persists for several hours after a therapy session.

Research indicates that the benefits of LED light therapy include

  • Increased circulation
  • Decreased inflammation
  • Increased ATP production
  • Collagen production
  • Accelerated exercise recovery time
  • Increased relaxation
  • Decreased stress

LEDs have low power requirements and high efficiency with minimal heat production. Power levels are measured in mW/cm2 (milliwatts per centimeter squared). And LED lifetimes are rated up to 100,000 hours and can last for decades.

The most common device wavelengths are the following:

  • Near-infrared: Many LED therapy devices use the 800 nanometers (nm) range; however, infrared include a much wider spectrum with deep penetration up to 100 mm.
  • Red: 630 to 700 nm, with penetration up to 10 mm.
  • Blue: 405 to 470 nm, with penetration up to 3 mm (beneficial for skin and wound healing).
  • Pulsed frequency(s) or continuous wave devices provide timed sequences of light turning on and off during application, which is thought to accelerate change in the tissues.
  • Continuous-wave devices are always on; no frequency is added to the light.
Applications for Use

Light therapy is commonly used to treat acute and chronic joint pain in the neck, back, leg, shoulder, wrist, knee, and ankle. It can be helpful for arthritis pain, bruises, carpal tunnel syndrome, and musculoskeletal conditions. It is also used to treat skin conditions such as pressure ulcers, wound healing, and scar tissue reduction.

Even NASA has good things to say about light therapy. NASA issued a news release in December 2000, which stated that doctors at Navy Special Warfare Command centers in Norfolk, Virginia, and San Diego reported a 40 percent improvement in patients who had musculoskeletal training injuries treated with light-emitting diodes.1

There are distinct advantages to using LED therapy devices in your clinical practice. For example, Patients can be left unattended during therapy, maximizing staff resources. Large surface areas can be covered by the LED pad or panel, delivering therapeutic photons broadly and safely to the body's targeted area. And systems are generally portable and user friendly.

Moreover, LED light therapy can help you enter niche markets, such as peripheral neuropathy and brain injuries. These are areas where LED light therapy is appearing to be more effective than pharmaceutical approaches.

Brain injuries

An increasing number of scientific studies show expanded indications for LED light therapy to treat neurologic conditions, especially brain injuries and degeneration. The advanced research being done by Michael Hamblin, Ph.D., and his group and by Margaret A. Naeser, Ph.D., at Boston University demonstrates that LED light therapy can positively affect the brain. Naeser’s 2017 study with veterans showed significant improvement after 12 weeks of transcranial photobiomodulation.

Increased function, better sleep, fewer angry outbursts, and less anxiety and wandering were reported with no negative side effects.2

Preliminary brain studies conducted by other groups using transcranial LED light therapy show impressively improved brain blood flow verified before and after single-photon emission computerized tomography (SPECT) brain scans. These brain studies have implications for patients presenting with such conditions as traumatic brain injury (TBI), PTSD, Alzheimer’s, Parkinson’s, concussions, strokes, and depression.

Nearly all neurological disorders have one thing in common: diminished blood flow. And increased circulation and blood flow are precisely what LED light therapy promotes.

Peripheral Neuropathy

More than 3 million new cases of peripheral neuropathy are diagnosed each year in the U.S. alone. LED light therapy has shown significant results in relieving this condition's discomfort and improving sensation, as evidenced by several studies.

Adding LED light therapy systems can help you offer neuropathy therapy as a substantial part of your practice.

FDA Approved

LED light therapy devices have received FDA clearances that temporarily increase local circulation; and the temporary relief of pain, stiffness, and muscle spasms. Many practitioners are hopeful that the FDA will keep expanding clearances for this cutting-edge healing technology.

References
NASA/Marshall Space Flight Center. “NASA Space Technology Shines Light On Healing.” ScienceDaily. http://www.sciencedaily.com/ releases/2000/12/001219195848.htm. Published Dec. 2000. Accessed Jan. 2018.

Salmarche AE, Naeser MA, Ho KF, Hamblin MR, Lim L. Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation:

Case Series Report. Photomed Laser Surg. 2017;5(8):432–441.

Fallah A, Mirzaei A, Gutknecht N, Demneh AS. Clinical effectiveness of low-level

laser treatment on peripheral somatosen- sory neuropathy. Lasers Med Sci. 2017 Apr;32(3):721–728.

Mandelbaum-Livnat MM, Almog M, Nissan M, Loeb E, Shapira Y, Rochkind

Photobiomodulation Triple Treatment in Peripheral Nerve Injury: Nerve and Muscle Response. Photomed Laser Surg. 2016;34(12):638–645.



What Are the Different Types of Clinical Research?

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

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

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.

Sinus Infections & Low-level Laser Therapy

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.

With Autoimmunity on the Rise, Light Therapy is Here to Aid in Prevention and Treatment

With Autoimmunity on the Rise, Light Therapy is Here to Aid in Prevention and Treatment

The medical industry has taken great strides in helping to improve our understanding of the human body. We’ve found an effective treatment for Hepatitis C, eradicated smallpox and rinderpest, and are working on treatments to cure cancer. No one can say we haven’t been successful in the medical world, particularly with the help of incredible research and technology. 

However, there is one family of disease that continues to be somewhat of a mystery in the medical world. And while it’s being highly studied, more and more people are being diagnosed with it. 

What’s the mystery disease? It’s autoimmunity. 

Now, autoimmune diseases can vary greatly, as it's an umbrella term for many autoimmune-based disorders. However, they all have one common thread, in that the body's natural defense system cannot tell the difference between your own cells and foreign cells. This causes the body to attack its own cells healthy unknowingly. 

Under the term "autoimmune diseases," there are around 80 different types that affect various parts of the body, with some of the most common forms manifesting as celiac, IBS, multiple sclerosis, and rheumatoid arthritis.  

The symptoms of autoimmune diseases aren’t pleasant ones by any means. However, they do range depending on the specific condition. Many people with an autoimmune disease experience multiple symptoms such as severe inflammation, joint and pain swelling; as well as skin conditions, recurring fever, swollen glands, and digestive issues. 

Though we know the symptoms of autoimmune diseases, the underlying cause can be difficult to determine for patients – exact cause of autoimmune disorders is unknown. 

More importantly, autoimmune disorder cases are rising. A study published this year showed a staggering rise in autoimmunity in the U.S., particularly in the rate of people testing positive for antinuclear antibodies (ANA), the most common marker of autoimmunity. Over the course of 25 years, the researchers found an overall 50 percent increase. That is astounding. 

Even though we understand these diseases are increasing, we don't know why.

But there is more and more evidence that the balance of microbiome in our guts plays a significant role. Having a diverse range of microbes positively influences our immune systems. People living in developed countries have higher rates of autoimmune diseases due to our less microbially environments. In other words, we're inside more, overuse antibiotics, live with chronic stress, and have poor diets. Not a great combination for a long and healthy life. 

Autoimmune disorders are a reflection of the unhealthy environment we've created for ourselves. We're overworked, stressed, and not supplying our bodies with the proper nutrients. Of course, a lifestyle change is necessary to reduce autoimmune disorders cases and symptoms. But there's another thing you can do to help yourself, and that's by undergoing at-home light therapy treatment

First, light therapy helps to improve immune cells, which is crucial for those with autoimmune disorders. When undergoing red light therapy, cells respond to the wavelengths. Pro-inflammatory cytokine TNF-α is released from the cells, and leukocytes (white blood cells) can enter the body's tissue to promote healing. In addition, red light therapy aids in activating lymphocytes, which increases the movement of epithelial cells, thus healing wounded areas quickly and increasing cell turnover rates. 

But there are other symptoms red light therapy focuses on, and it's joint pain and inflammation. For people who have rheumatoid arthritis, fibromyalgia, and other autoimmune diseases, inflammation and pain are a daily struggle. One study found that light therapy significantly improved inflammatory cells during both the early and late stages of Rheumatoid arthritis. 

By using Lunas’ red light therapy devices, you’re able to tackle multiple symptoms of autoimmune disease, reduce your stress levels, and improve your immune system by investing a few minutes sitting or standing in front of your red light device.

PEMF Therapy in the Treatment of Osteoporosis and Similar Conditions

PEMF Therapy in the Treatment of Osteoporosis and Similar Conditions

Osteoporosis is a systemic skeletal disease, characterized by the reduction of bone mass and the skeletal architecture's impairment as a whole. Theron is essentially disease's definitions on anatomopathological criteria, which attribute to the skeleton particular characteristics of fragility, such as making bone prone to fracture even after minor trauma.

Skeletal fragility can be diagnosed, thanks to current sensitometric methods, even in the absence of symptoms and fractures. Being a condition that heightens the risk of fracture, but that does not make itself necessary for the definition of the disease, osteoporosis can evolve in a completely asymptomatic way for a long time, in some cases even for a lifetime.

The US FDA has approved pulsed electromagnetic fields (PEMFs) as a safe and effective treatment for nonunion of bone. Despite its clinical use, the mechanisms of action of electromagnetic stimulation of the skeleton have been elusive. Recently, cell membrane receptors have been identified as the site of action of PEMF and provide a mechanistic rationale for clinical use. This review highlights key processes in cell responses to PEMF as follows: (1) signal transduction through A2A and A3 adenosine cell membrane receptors and (2) dose-response effects on the synthesis of structural and signaling extracellular matrix (ECM) components. Through these actions, PEMF can increase bone and cartilage's structural integrityECM's structural integrity, enhance enhance repair, and alter the homeostatic balance of signaling cytokines, producing anti-inflammatory effects. PEMFs exert a pro anabolic effect on the bone and cartilage matrix and a chondroprotective effect counteracting inflammation's catabolic effects in the joint environment. Understanding of PEMF membrane targets and the specific intracellular pathways involved, culminating in the synthesis of ECM proteins and reducing inflammatory cytokines, should enhance confidence in the clinical use of PEMF and identify clinical conditions likely to be affected by PEMF exposure.

The musculoskeletal system is highly responsive to its physicochemical environment. Bone and cartilage cells respond to changes in mechanical stress, fluid flow, pH, and pO2 by altering their phenotype and expressing a range of signaling and structural molecules that result, in particular, in an altered extracellular matrix (ECM) organization and associated biomechanical properties. Response to mechanical stress is perhaps the best recognized and intuitively obvious skeletal environmental condition, facilitating adaptation and modeling to changing biomechanical and environmental requirements, perhaps through intermediary strain-associated signaling events. In addition to mechanical stress, skeletal tissues, both bone, and cartilage, demonstrate an exquisite sensitivity to electrical and electromagnetic stimulation.

Responses of skeletal cells to pulsed electromagnetic fields (PEMF) have been exploited therapeutically with devices that expose tissues to appropriately configured fields to stimulate ECM synthesis for bone and cartilage repair. This review highlights key processes in cell responses to PEMF as follows: (1) signal transduction through cell membrane adenosine receptors (ARs), (2) the activation of osteoinductive pathways, and (3) the synthesis of skeletal ECM including structural and signaling molecules. These actions are reflected physiologically in the bone as the healing of fractures, osteotomies, nonunions, and joints, as the modulation of cartilage damage and reduction in catabolic and inflammatory cytokines in arthritis. Understanding the cellular responses to PEMF will inform clinical studies, may point to key issues that need further investigation, and will be relevant in promoting bone and cartilage repair, tissue engineering and regeneration in a repair mode, and damping inflammation in arthritis. Understanding the pathways of the activity of PEMFs provides a solid mechanistic basis for their clinical use.

There is strong evidence supporting a role for adenosine and its receptors in bone homeostasis and skeletal pathology, including osteoporosis and arthritis.4 Furthermore, adenosine, acting through the A2A receptor, inhibits osteoclast differentiation, and increases the rate of new bone formation in bone defects.5 A2A signaling also promotes the Wnt/β-catenin pathway regulating bone formation.6

Although the transmembrane signal recognition processes of PEMF are incompletely understood, the specific mechanism of interaction between PEMF and the cell membrane was reported by Varani et al.7 They identified for the first time that ARs were the main target of PEMF stimulation in inflammatory cells; ARs play a pivotal role in the regulation of inflammatory processes, with both pro-inflammatory and anti-inflammatory effects.8 It has been demonstrated that PEMF exposure induces a notable increase in A2A and A3 AR density on the cell membrane of chondrocytes, synoviocytes, and osteoblasts8 (Figure 1). Notably, A1 and A2B receptors were not influenced by the same exposure conditions. Moreover, in the presence of the specific A2A receptor agonist, PEMF exposure synergized with the agonist and induced a notable increase in intracellular cyclic adenosine monophosphate (cAMP) levels. On the contrary, the specific A2A receptor antagonist's presence blocked the effects of both the agonist and PEMF stimulation, suggesting that PEMFs specifically act through the activation of A2A ARs with a pharmacologic-like mechanism. The agonist activity of PEMF for the A2A and the A3 ARs is particularly relevant because it inhibits the NF-kB pathway, a key regulator of the expression of matrix metalloproteinases and several genes involved in responses to inflammation.9 Cohen et al. 10 showed in vivo that an experimental A2A agonist drug reduced cartilage damage in a rabbit model of septic arthritis of the knee. These observations formed the basis for the application of PEMF for chondroprotection of articular cartilage from the catabolic effects of joint inflammation, as discussed in more detail later.

Despite its clinical use, the mechanisms of action of electromagnetic stimulation of the skeleton have been elusive, and PEMF has been viewed as a “black box.” In the past 25 years, research has successfully identified cell membrane receptors and osteoinductive pathways as sites of action of PEMF and provides a mechanistic rationale for clinical use. Understanding of PEMF membrane targets and the specific intracellular and extracellular pathways involved, culminating in the synthesis of ECM proteins and reduction in inflammatory cytokines, should enhance confidence in the clinical use of PEMF and the identification of clinical conditions likely to be affected by PEMF exposure.

The biological effects of PEMF treatment and favorable effects on the skeletal system are the results of notable research efforts conducted internationally by the orthopedic community. They have attracted much interest from other medical specialties such as wound and tendon healing, rheumatology, and neurology that may be able to take advantage of the experiences developed with bone and cartilage treatments.

References

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Parent D, Franco-Obregon A, Frohlich J, et al.: Enhancement of mesenchymal stem cell chondrogenesis with short-term low intensity pulsed electromagnetic fields. Sci Rep 2017;7:9421.

Aaron RK, Ciombor DM, Keeping H, Wang S, Capuano A, Polk C: Power frequency fields promote cell differentiation coincident with an increase in transforming growth factor-beta(1) expression. Bioelectromagnetics 1999;20:453–458.

Ham J, Evans BA: An emerging role for adenosine and its receptors in bone homeostasis. Front Endocrinol (Lausanne) 2012;3:113.

Mediero A, Wilder T, Cronstein B: Adenosine receptors stimulate bone regeneration, in Biology and Pathology of Bone and Joint: Osteoclasts, Osteoblasts and Bone Remodeling. Boston, MA, ACR/ARP Annual Meeting, 2014, Abstract 19.

Borhani S, Corciulo C, Larranaga Vera A, Cronstein B: Signaling at adenosine A2A receptor (A2aR) in osteoblasts; crosstalk with Wnt/β-catenin signaling pathway, in Osteoarthritis and Joint Biology — Basic Science Poster I. Chicago, IL, ACR/ARP Annual Meeting, 2018, Abstract 1047.

Varani K, Gessi S, Merighi S, et al.: Effect of low-frequency electromagnetic fields on A2A adenosine receptors in human neutrophils. Br J Pharmacol 2002;136:57–66.

Varani K, Vincenzi F, Ravani A, et al.: Adenosine receptors as a biological pathway for the anti-inflammatory and beneficial effects of low-frequency low energy pulsed electromagnetic fields. Mediators Inflamm 2017;2017:2740963.

Massari L, Benazzo F, Falez F, et al.: Biophysical stimulation of bone and cartilage: State of the art and future perspectives. Int Orthop, 2019;43:539–551.

Cohen SB, Gill SS, Baer GS, Leo BM, Scheld WM, Diduch DR: Reducing joint destruction due to septic arthrosis using an adenosine2A receptor agonist. J Orthop Res 2004;22:427–435.

Aaron RK, Boyan B, Ciombor DM, Schwartz Z, Simon BJ: Stimulation of growth factor by electric and electromagnetic fields. Clin Orthop Rel Res 2004;419:30–37.

Aaron RK, Wang S, Ciombor DM: Upregulation of basal TGFß1 levels by EMF coincident with chondrogenesis — skeletal repair and tissue engineering implications. J Orthop Res 2002;20:233–240.

13. Zhou J, He H, Yang L, et al.: Effects of pulsed electromagnetic fields on bone mass and Wnt/beta-catenin signaling pathway in ovariectomized rats. Arch Med Res 2012;43:274–282.

Lin CC, Lin RW, Chang CW, Wang GJ, Lai KA: Single-pulsed electromagnetic field therapy increases osteogenic differentiation through Wnt signaling pathway and sclerostin downregulation. Bioelectromagnetics 2015;36:494–505.

Cai J, Shao X, Yang Q, et al.: Pulsed electromagnetic fields modify the adverse effects of glucocorticoids on bone architecture, bone strength, and porous implant osseointegration rescuing bone-anabolic actions. Bone 2020;133:115266.

Zhai M, Jing D, Tong S, et al.: Pulsed electromagnetic fields promote in vitro osteoblastogenesis through a Wnt/beta-catenin signaling-associated mechanism. Bioelectromagnetics 2016;37:152–162.

Jing D, Li F, Jiang M, et al.: Pulsed electromagnetic fields improve bone microstructure and strength in ovariectomized rats through a Wnt/Lrp5/beta-catenin signaling-associated mechanism. PLoS One 2013;8:e79377.

Wu S, Yu Q, Lai A, Tian J: Pulsed electromagnetic field induces Ca(2+)-dependent osteoblastogenesis in C3H10T1/2 mesenchymal cells through the Wnt-Ca(2+)/Wnt-beta-catenin signaling pathway. Biochem Biophys Res Commun 2018;503:715–721.

Pan Y, Dong Y, Hou W, et al.: Effects of PEMF on microcirculation and angiogenesis in a model of acute hindlimb ischemia in diabetic rats. Bioelectromagnetics 2013;34:180–188.

Tepper OM, Callaghan MJ, Chang EI, et al.: Electromagnetic fields increase in vitro and in vivo angiogenesis through endothelial release of FGF-2. FASEB J 2004;18:1231–1233.

Hopper RA, VerHalen JP, Tepper O, et al.: Osteoblasts stimulated with pulsed electromagnetic fields increase HUVEC proliferation via a VEGF-A independent mechanism. Bioelectromagnetics 2009;30:189–197.

Goto T, Fujioka M, Ishida M, Kuribayashi M, Ueshima K, Kubo T: Noninvasive up-regulation of angiopoietin-2 fibroblast growth factor-2 in bone marrow by pulsed electromagnetic field therapy. J Orthop Sci 2010;15:661–665.

Petecchia L, Sbrana F, Utzeri R, et al.: Electro-magnetic field promotes osteogenic differentiation of BM-hMSCs through a selective action on Ca(2+)-related mechanisms. Sci Rep 2015;5:13856.

Pro Athletes Harnessing the Power of Red Light

Pro Athletes Harnessing the Power of Red Light

Originally from https://www.lunaspanel.com/post/pro-athletes-harnessing-the-power-of-red-light


Being a professional athlete is no joke, and when your body is a central part of your job, it needs to be very well taken care of. And even when athletes are doing all the right things to take care of their body, injuries are still widespread in professional sports; but it used to be that their career was over if an athlete was injured. But now, athletes can undergo surgery and pop back up on the court or field months later. How is that possible?

As most athletes know, a large portion of time is dedicated to repairing muscles and alleviating inflammation for the next game. Regardless of the sport, teams spend millions of dollars on professional physical therapists to guarantee their athletes receive the highest physical treatment standard.

The recovery process for an athlete is essential and a determining factor of how well they’ll perform during their careers. You’ll often hear the words “optimizing performance” when discussing the recovery process for athletes. Today, the recovery process isn’t just to heal an athlete but to naturally enhance their performance.

So, how do professional therapists optimize professional athletes’ performance and recovery? Well, red light therapy is turning out to be one of the most effective treatments for these high-performing individuals.

Professional trainers are always looking for natural ways to enhance their player’s performance. With light has proven to be a lead modality, many trainers and athletes use light therapy to enhance the body’s natural healing process. But how does it work?

When used, natural red light penetrates the skin and cells. When the light reaches the mitochondria, it stimulates the production of adenosine triphosphate (ATP). ATP is a natural energy currency in the human body. With an enhanced ATP production, cells in the muscle are optimized and repaired faster.

Hundreds of peer-reviewed clinical trials have backed up the results athletes see on the courts and fields. In 2015, researchers conducted a meta-analysis of placebo-controlled trials, and the results were astounding. They found that most clinical trials showed “significant improvement for the main measures related to performance,” including endurance and speed. And through this meta-analysis, it was concluded that “phototherapy (with lasers and LEDs) improves muscular performance and accelerates recovery when applied before exercise.”

However, red light therapy does more than recover muscle tissue. It also increases muscle strength, ultimately improving physical performance.

A 2016 study researched red light therapy on elite athletes and trained and untrained athletes. What was found was that red light therapy after training could increase muscle mass. So, not only does red light therapy accelerate the recovery process, but it also improves muscle strength.

But what about endurance? Being strong is only one aspect of being an athlete. Endurance is crucial when competing against an opponent. A triple-blind, placebo-controlled trial published in 2018 studied the effects of red light therapy on men and women undergoing endurance training on treadmills. It was found that red light therapy pre-exercise can “increase the time-to-exhaustion and oxygen uptake and also decrease the body fat in healthy volunteers when compared to placebo.”

Another study from 2018 completed by Brazilian researchers found that after their randomized, triple-blind, placebo-controlled trial on pro soccer players, those who underwent red light therapy stayed longer on the playing field. It was concluded that light therapy “…had a significant improvement in all the biochemical markers evaluated…pre-exercise [light] therapy can enhance performance and accelerate recovery…”.

Peer-reviewed clinical trials worldwide have all concluded the same thing: red light therapy works for increasing athletic performance levels. Luna’s red light therapy device can help professional athletes and the rest of us exercise regularly, recover from injuries, and improve our physical and muscular health.