Posts tagged with "FDA"

Elyptol Sanitizers Clean × Heal

Elyptol is the first Type 1 eco-certified and professionally registered hand sanitizer. It harnesses the healing properties of eucalyptus oil and naturally-sourced pure ethanol to bring you a product that sanitizes in a healthy and eco-friendly way. Despite its gentle feel, make no mistake that this hand sanitizer is FDA listed and hospital grade.

To Kill Germs Gently, Think Naturally with Elyptol

The sanitizer kills 99.99997% of germs with 70% alcohol. It contains eucalyptus oil and pure ethanol derived from sugar cane to eliminate germs gently and safely. And, it uses botanical food grade ethanol and eucalyptus ingredients that are known for soothing and healing aching bones and irritated skin.

Not only is Elyptol antibacterial, but it is antimicrobial as well. For this reason, it kills a wider range of germs.

“The perfect synergy of science and nature,” notes the company on their front page. “Elyptol harnesses nature’s strengths to create skincare and hard surface hygiene products that effectively kill germs harmful to your health.”

About Elyptol:

The USA/Australian company takes its natural inspiration from those putting their lives on the line for us every day. Elyptol founder Tim O’Connor recognized just how much health care workers used sanitizers when his daughter was born. These hospital grade formulas wreaked havoc on their hands. With years of extensive research and development using green chemistry, Elyptol became the first Type 1 eco-certified and professionally registered hand sanitizer. It expertly pairs eucalyptus oil, known for its healing properties, and natural sanitizing ingredient pure ethanol, derived from sugarcane and corn. The result is an efficient formula that eliminates germs, yet it’s gentle enough on skin and safe for the environment.

Vape pen and e-cigarette shot by Vaughn Lowery for 360 MAGAZINE

Do You Vape? How to Prepare for the Upcoming PMTA Deadline

Do you vape? If you do, there’s an important deadline coming up on September 9 – and if you haven’t already started preparing, now is the time. 

Are you left scratching your head after reading that first paragraph? If you have no idea what deadline is coming up or how it’s going to affect the vaping industry, this article is for you. We’re going to explain the upcoming PMTA deadline and describe exactly what you should be doing right now to prepare.

FDA Vaping Regulations: A Brief History

Ever since e-cigarettes and e-liquids first appeared in the United States, the FDA has attempted to exert regulatory control over the industry. The agency’s first attempt at vaping regulations ended in failure. In the late 2000s, the FDA began to seize incoming shipments of e-cigarettes entering the United States, saying that vaping products were unregulated drug delivery devices being sold without approval.

The vaping industry sued the FDA. The district and appeals courts involved in the lawsuit both ultimately decided in favor of the vaping industry, ruling that, as long as sellers didn’t claim that e-cigarettes could be used for quitting smoking, the FDA could only regulate those products as tobacco products – not as drug delivery devices.

The FDA finally announced its intention to regulate vaping products as tobacco products in 2016. Subjecting vaping products to the same legal requirements as tobacco products meant that every vaping product on the market had to comply with the U.S. Family Smoking Prevention and Tobacco Control Act, which said that, after 2007, all tobacco products must obtain FDA approval before entering the market.

No vaping product being sold today was on the market before 2007. Therefore, every vaping product is a “new tobacco product” that requires FDA approval.

What Is the Vaping PMTA Deadline?

We always knew that this day would come; it was just a matter of when. The vaping industry’s deadline for FDA compliance has been moved from August 2018 to August 2022 before being moved forward to May 2020 and finally pushed back to September 2020. At the time of writing, it appears that September 9, 2020 will be the final compliance date.

To start the process of FDA compliance, the manufacturer of a vaping product must submit an application showing the FDA that the product is beneficial to public health compared to the tobacco products that are already on the market. It costs nothing to file a premarket tobacco product application (PMTA), but the cost of gathering the required data for the application can exceed $100,000. Every e-liquid flavor, every nicotine strength of every flavor, every vaping device, every tank and every coil counts as a “new tobacco product” and requires a PMTA.

What Happens to the Vaping Industry on September 9?

When the PMTA deadline arrives, two things will happen.

  • Many e-liquid makers have the necessary funds to submit PMTAs for some or all of their products. Timely submission of a PMTA means that a product can remain on the market for another year while the FDA processes the application. If the FDA gets behind on processing applications, it’s possible that the grace period will be extended.
  • Many other e-liquid makers do not have the funds and are not planning to submit PMTAs. Those companies are required to pull their products from the market on September 9, although that may not happen all at once. Some companies may just continue what they’re doing now until they hear from the FDA.

What Does the PMTA Deadline Mean for Vapers?

The one certain thing is that, after September 9, there will be fewer vaping devices, tanks, coils and e-liquids on the market than there are today. Since most companies in the vaping industry aren’t talking about their plans for the PMTA deadline, it’s impossible to say exactly which products will and won’t be available. With that in mind, here’s how you need to prepare.

Stock Up on Your Favorite Vape Juice Flavors Now

Unless your favorite vape juice brands have already announced that they’re ready for the PMTA deadline, you shouldn’t assume that those brands’ products will still be around after September 9. There will definitely still be e-liquid available to buy after the PMTA deadline – but if you have a favorite brand or flavor and can’t bear to be without it, you should start stocking up right now.

Get a Vape Mod With Removable Batteries

It’s unknown which of the vaping hardware manufacturers – almost all of which are in China – have submitted PMTAs for their products or which products they’ve applied for permission to continue selling in the United States. Your best bet is to choose a vape mod with removable batteries and buy it right away. A mod with removable batteries can conceivably last for years because you can simply swap out the batteries when they stop working correctly. A mod with a permanent battery, on the other hand, is much more difficult to repair. The FDA doesn’t regulate batteries, so you can buy them freely.

Buy a Rebuildable Atomizer

It’s also unknown which vape tanks and coils will get through the PMTA process. If you have a favorite vape tank and want to ensure that you can continue using it, you should stock up on coils now. In the long run, though, it’s even better to grab a rebuildable atomizer and learn how to build your own coils. The FDA can regulate tanks and coils, but it can’t regulate wire and cotton – just like it can’t regulate batteries. Regardless of how FDA regulation shapes the future of the American vaping industry, you won’t ever have trouble finding coil building supplies.

Consider Learning How to Make Your Own E-Liquid

As mentioned above, you will definitely still be able to buy e-liquid after September 9. Many e-liquid companies have already submitted – or are about to submit – PMTAs for their products. They’ll be able to continue selling their products for at least another year, and it seems likely that many or all of those products will eventually receive full FDA approval.

Just in case those products don’t receive FDA approval, though, it’s a good idea to start learning how to make your own e-liquid now. You’re free to buy vegetable glycerin, propylene glycol and flavorings. Unless something changes from a legal standpoint, you’re also free to buy liquid nicotine if you’re an adult. As of right now, there’s nothing preventing you from making your own vape juice.

New approach to airborne disinfection uses food-coloring dyes

Purdue – Airborne Disinfection

By Chris Adam

The COVID-19 pandemic has shed new light on the needs for improved disinfection methods, both for individuals and facilities.

Purdue University innovators have developed an airborne disinfection method – using food-coloring dyes – to be applied to the entire body and rooms for sterilization purposes and lowering the risk of infection.

The Purdue team’s disinfection method uses edible materials. The Purdue team presented the technology in July during a COVID-19 virtual conference sponsored by the National Council of Entrepreneurial Tech Transfer.

“Most of the antiviral and antibacterial sprays used for airborne antiviral and antibacterial disinfectants, such as aerosolized hydrogen peroxide, ozone, and deep ultraviolet illumination, are a biohazard risk to humans,” said Young Kim, an associate professor of biomedical engineering at Purdue. “Additionally, disinfectants containing titanium dioxide and noble metal nanoparticles pose carcinogenic and cytotoxicity risks.”

Kim also said new methods are needed since transmission of pathogens (viruses and bacteria) often occurs in the air and infection with pathogens is transmitted by an airborne route. The Purdue method might also help in medical settings, where healthcare workers typically are exposed to the disease-causing agents when they take off their personal protective equipment.

The Purdue airborne antiviral phototherapy technique uses small aerosols FDA-approved food coloring dyes to mitigate the risks of airborne transmissions of pathogens. This is referred to as Photodynamic Airborne Cleaner (PAC).

“We have demonstrated with our novel solution how visible light activation of several FDA-approved food coloring dyes generate singlet oxygen, which can be used to kill airborne pathogens,” Kim said. “In the medical community, it is well known that singlet oxygen is effective to inactivate viruses. We are developing a scalable aerosol generation system for the dyes, allowing uniform fog-like dispersion lingering in the air to minimize wetting and surface staining. In addition, as health care workers are often infected when removing PPE, this technology can be installed in a confined chamber for health care professionals to change PPE in hospital settings.”

The novel photoreactive arrangement can be used in rooms where many people are present at risk of airborne pathogen exposure.

The innovators are working with the Purdue Research Foundation Office of Technology Commercialization to license this patented technology.

The researchers are looking for partners to continue developing their technology. For more information on licensing and other opportunities, contact D.H.R. Sarma of OTC at DHRSarma@prf.org and mention track code 2020-KIM-69064.

Kim also is receiving support from Purdue’s Trask Innovation Fund, which helps labs commercialize their innovations.

About Purdue Research Foundation Office of Technology Commercialization

The Purdue Research Foundation Office of Technology Commercialization operates one of the most comprehensive technology transfer programs among leading research universities in the U.S. Services provided by this office support the economic development initiatives of Purdue University and benefit the university’s academic activities through commercializing, licensing and protecting Purdue intellectual property. The office recently moved into the Convergence Center for Innovation and Collaboration in Discovery Park District, adjacent to the Purdue campus. In fiscal year 2020, the office reported 148 deals finalized with 225 technologies signed, 408 disclosures received and 180 issued U.S. patents. The office is managed by the Purdue Research Foundation, which received the 2019 Innovation and Economic Prosperity Universities Award for Place from the Association of Public and Land-grant Universities. In 2020, IPWatchdog Institute ranked Purdue third nationally in startup creation and in the top 20 for patents. The Purdue Research Foundation is a private, nonprofit foundation created to advance the mission of Purdue University. Contact otcip@prf.org for more information.

About Purdue University

Purdue University is a top public research institution developing practical solutions to today’s toughest challenges. Ranked the No. 6 Most Innovative University in the United States by U.S. News & World Report, Purdue delivers world-changing research and out-of-this-world discovery. Committed to hands-on and online, real-world learning, Purdue offers a transformative education to all. Committed to affordability and accessibility, Purdue has frozen tuition and most fees at 2012-13 levels, enabling more students than ever to graduate debt-free. See how Purdue never stops in the persistent pursuit of the next giant leap at purdue.edu.

Coronavirus Vaccine – Dr. Jeremy M. Levin

A story in USA Today this morning asks whether a coronavirus vaccine could repair the pharma industry’s reputation despite drug price increases. Dr. Jeremy M. Levin, an iconic biotech thought-leader who first introduced immuno oncology to the world 10 years ago, is quoted:

“The pandemic ‘has driven the public eye onto what the biotech industry does, which is change the dynamic of a disease,’ said Jeremy Levin, chairman of BIO and author of the recently published book Biotechnology in the Time of COVID-19: Commentaries from the Front Line. “In the noise that came from the bad actors, we basically lost sight of the essence of what the biotech is all about, which is patients and innovation.”

Here are some additional thoughts from Dr. Levin’s on developing a vaccine and the road forward:

What can you (and the biotech industry) tell the American people that they haven’t already heard? Unless we are able to get a handle on COVID-19, we as a society as a whole are at great risk. There has never been a greater risk from a transmissible disease to our nation, and the world at large.

There is incredible pressure to expedite a COVID-19 vaccine, even if it hasn’t been tested in the way it needs to be tested.

What are the risks/rewards? The risks of rushing a vaccine are  considerable, and the FDA will be acutely aware of this when making an approval. I expect there will be extraordinary diligence from the FDA, as well as from each company producing a vaccine. Despite this, the risk of not developing a vaccine are nearly unimaginable.

How long is the typical timeline for vaccine development? A typical timeline for vaccine development is at least a decade, but many variables go into this. This article in the NY Times is a useful explainer.

Dr. Levin is available for interviews on COVID-19 and other biotech topics. He is currently CEO and Chairman of OVID Therapeutics, Inc., and Chair of the global Biotechnology Innovation Organization (BIO). In 2018 Dr. Levin was named “one of the most influential figures in biopharmaceutical industry” by FierceBiotech, and one of the top three biotechnology CEOs in 2020 by The Healthcare Technology Report. See him interviewed HERE on CNBC.

FDA Accelerates E-Cigarette Review For New Rules

By Eric Van Buskirk

Suorin Air Starter Kit

In 2016, the Food and Drug Administration was expanded to regulate tobacco as well as nicotine products, including cigars and e-cigarettes. A year later, the FDA issued an ultimatum to manufacturers: provide sufficient information to justify the continued circulation of your tobacco and nicotine products on the market, and do so by May 2022.

The deadline was initially set in order to provide manufacturers ample time to produce studies and research against the charge that their products were both aimed at and increasingly consumed by American teenagers. However, the American Academy of Pediatrics (AAP) and their partners — responsible in large part for pressuring the FDA into action — immediately challenged the timeline, positing that such a long waiting period was unacceptable.

AAP President and Fellow of the American Academy of Pediatrics Kyle E. Yasuda, M.D. was quoted as saying, “the FDA oversight over the sales and marketing of these harmful products has languished for too long. With the epidemic of e-cigarette use by teens, it is incumbent on the FDA to act expeditiously to hold manufacturers accountable for products that contain nicotine and harmful chemicals.”

In March 2018, the AAP as well as the American Cancer Society, Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five pediatricians sued the FDA, Department of Health and Human Services (HHS) and the heads of both agencies. According to the suit, the coalition intended to take action against the FDA and HHS not only for their decision to provide manufacturers with such a generous grace period, but for allowing them to continue selling their products until the scheduled date of review.

Finally, in May this year, U.S. District Judge Paul W. Grimm of Maryland ruled in favor of the AAP and its partners, aiming pointed statements at the FDA in the process. “Arguably, the five-year compliance safe-harbor has allowed the manufacturers enough time to attract new, young users and get them addicted to nicotine before any of their products, labels, or flavors are pulled from the market, at which time the youth are likely to switch to one of the other thousands of tobacco products that are approved — results entirely contrary to the express purpose of the Tobacco Control Act,” he wrote.

Companies and manufacturers now have ten months before the FDA is set to begin their review in May 2020. Grimm’s remarks are worth exploring in detail, as there is recent data that bears out his point. A study by the Centers for Disease Control and Prevention (CDC) shows that vaping rates among high schoolers and middle schoolers increased by 78% and 48% respectively over 2017 — just one year of the six-year grace period originally afforded to cigar and e-cigarette manufacturers by the FDA.

An Accelerated Review & Its Impact on E-Cigarette Manufacturers

For e-cigarette giant Juul and tobacco juggernauts Philip Morris International, Imperial Brands and Altria, the next ten months will be a battle to continue selling their Juul e-cig and iQOS systems — but it’s a battle they’re confident they can win. Other manufacturers like Sourin Air, who really more on online sales, are a bit less concerned about sales since online purchases have getter systems in place to prevent under-age buying.

“We are secure in the content and quality of our application for May,” stated Juul spokesperson Ted Kwong in an interview with Forbes. “Our growing body of evidence as well as our industry-leading actions to combat underage access and use will ensure adult smokers continue to have a true alternative to cigarettes, the leading cause of preventable death worldwide.”

Representatives from the so-called “tobacco Big Five” expressed similar convictions.

For smaller companies and e-cigarette manufacturers, the FDA’s accelerated review represents an entirely different struggle. Until 2016, the vaping industry as a whole had gone largely unregulated, and products were able to enter the market without needing FDA approval. The processes of preparing applications, litigating their cases and abiding the coming surge of new regulations is very likely to decimate the profitability of smaller e-cigarette operations. For them, the next ten months will be a struggle for their continued existence.

Ironically, it may very well be the case that Juul — which is estimated to control three fourths of the e-cigarette market — and the tobacco Big Five will come away the biggest winners by the end the FDA’s accelerated review.

Toilet Seat Detects Congestive Heart Failure

Toilet seat that detects congestive heart failure getting ready to begin commercialization

Researchers developed the seats to measure biometrics during ‘natural’ processes

With 1 million new cases of congestive heart failure diagnosed each year, a revolutionary product is making it easier for hospitals to monitor patients with the condition in the comfort of their own homes.

A toilet-seat based cardiovascular monitoring system created by a team of Rochester Institute of Technology researchers, aims to lower the hospital readmission rates of patients with congestive heart failure. The toilet seats, which will be brought through the FDA clearance process by the researchers’ company Heart Health Intelligence, would be purchased by hospitals and issued to heart failure patients after discharge. The toilet seats are equipped to measure the electrical and mechanical activity of the heart, and can monitor heart rate, blood pressure, blood oxygenation levels, and the patient’s weight and stroke volume, which is the amount of blood pumped out of the heart at every beat. Algorithms analyze the data, and with further development, will alert advanced practice providers of a deteriorating condition. A report will be passed along to cardiologists who will then determine if intervention is necessary.

Nicholas Conn, a postdoctoral fellow at RIT and founder and CEO of Heart Health Intelligence, is part of the university team that developed the toilet seats.

“Typically, within 30 days of hospital discharge, 25 percent of patients with congestive heart failure are readmitted,” said Conn. “After 90 days of hospital discharge, 45 percent of patients are readmitted. And the Centers for Medicare and Medicaid Services is penalizing hospitals for readmitting patients for heart failure.”

Conn, the company’s chief executive officer, further explains that using the national average for readmission rates, the penalty alone for readmitting 150 patients is approximately $500,000 annually. The total cost of providing 150 patients with their own monitored toilet seats from HHI is $200,000. With that investment, he says, hospital systems will save more than double their initial investment within one year.

According to Conn, who earned three degrees from RIT—a bachelor’s degree and a master’s degree in electrical engineering in 2011 and 2013, respectively, and a doctoral degree in microsystems engineering in 2016—the system will pick up deteriorating conditions before the patients even realize they are symptomatic. And with the rapid data analysis, interventions can be as simple as a drug change or short office visit, instead of an admission to the hospital.

HHI, which joined RIT’s Venture Creations business incubator earlier this year, is now focused on moving the product forward. The team is heavily involved in writing grants for additional funding and networking, and human-subject testing and pre-clinical studies are well underway. Conn and his team are working on approving the product with the FDA and rolling it out across the country.

To read more about the research behind the project, go to here.

For more information, contact Vienna McGrain at 585-475-4952 or Vienna.Carvalho@rit.edu.

About Rochester Institute of Technology

Rochester Institute of Technology is home to leading creators, entrepreneurs, innovators and researchers. Founded in 1829, RIT enrolls about 19,000 students in more than 200 career-oriented and professional programs, making it among the largest private universities in the U.S.

The university is internationally recognized and ranked for academic leadership in business, computing, engineering, imaging science, liberal arts, sustainability, and fine and applied arts. RIT also offers unparalleled support services for deaf and hard-of-hearing students. The cooperative education program is one of the oldest and largest in the nation. Global partnerships include campuses in China, Croatia, Dubai and Kosovo. To follow RIT on social media, go to www.rit.edu/socialmedia.

CartiHeal

Seth L. Sherman, MD, a sports medicine orthopaedic surgeon at University of Missouri Health Care’s Missouri Orthopaedic Institute, recently became one of the first American surgeons to enroll patients in a clinical research study aimed at earning FDA approval for a new knee-cartilage implant.

Agili-C™ (CartiHeal, Israel) is a new implant designed to help patients with knee-cartilage defects regenerate their own healthy cartilage. The implant has been shown to be safe and effective in a series of clinical trials previously conducted in Europe and Israel. Sherman is one of 15 primary investigators in the United States conducting the FDA-approved study, which is the final step before earning FDA approval for the implant.

“We are thrilled to be on the leading edge of orthopaedic sports medicine and joint preservation,” Sherman said. “In the U.S., there are limited options for off-the-shelf cartilage repair that can be performed during a single surgical procedure. Benefits of this technology include its relative low cost, ease of use, and strong basic science and clinical track record.”

Cartilage damage is a common knee problem that occurs in patients of all ages. It can happen as a result of an injury, like a blow to the knee, or due to wear and tear over time. In any case, it causes knee swelling, stiffness and pain that can reduce function and decrease quality of life.

The Agili-C™ implant is a cell-free implant made of the inorganic exoskeleton of sea coral. The implant can be used in this study to treat a variety of cartilage defects and patient types, which is another reason it is attractive to orthopaedic surgeons.

“Often in studies like this one, we can enroll only a very strict subset of young, active patients with a single, isolated cartilage defect,” said Sherman. “In reality, that’s not the type of patient we see every day. This implant is different because it’s medically indicated for a wide range of situations, including patients with multiple cartilage defects and even those with mild to moderate osteoarthritis. We can use it in patients who are in their 20s or in those who are in their 60s. This versatility allows us to find more patients who may benefit from this procedure.”

Those who qualify for the study are randomly assigned either one of the traditional surgical options or the new implant. So far, Sherman has enrolled four patients in the study. He plans to enroll at least 25 before submitting his research to the FDA.

The implant is manufactured by CartiHeal, a medical device company headquartered in Kfar Saba, Isreal and Closter, New Jersey. To date, more than 400 patients in Europe and Israel — where the device has already been approved — have received the new implant. The Agili-CTM implant is not available for sale in the United States. It is an investigational device limited for use in the device study.

To find out if you qualify for this study, visit this link on the CartiHeal website.

Opioid Epidemic

The painful and prevalent problem of opioid addiction plaguing families across our country has sparked national attention as the overdose death rates of these individuals has skyrocketed the past few years. The pervasiveness of the opioid epidemic is due in large part to the over-prescription of opioid pain medication and the highly addictive nature of these medications. Pharmaceutical companies and morally-corrupt doctors threw caution to the wind as “pill-mills” popped up all over the US. Although opioid use often begins with a legitimate injury and prescription for pain medication, those unfamiliar with the dangers of addiction are naïve to the depths of depravity it can take even the most innocent of souls.

As tolerance to the drug builds, the individual takes more than prescribed to alleviate the pain. Eventually, the suggestion is made to crush the pill and snort it for a better, more immediate high. The treatment morphs into a habit, then an obsession. Most opioid addictions escalate to intravenous use. Though the person previously swore never to pick up a needle, the temptation outweighs the willpower, and life becomes consumed with chasing the euphoria of that first shot. At this point, the sheer financial burden of the habit is insurmountable. Lying, cheating, stealing, anything becomes justifiable in the name of the next fix.

Inevitably, the solution becomes substituting the FDA regulated pills for the significantly cheaper heroin, which promises a more intense high. The recent inclusion of fentanyl in heroin increases the potency and the likelihood of overdose and death. Suffering with addiction is painful, exhausting, and frightening. Attempting sobriety means enduring withdraws, reality, feelings, and memories. Negative experiences with shady recovery businesses leaves clients feeling jaded and mistrustful. Unfortunately, many treatment centers view clients as numbers or worse, dollar signs.

They treat clients according to insurance benefits rather than clients’ needs. Once insurance quits paying, clients are dropped off at bus stations to fend for themselves with no resources. Luckily, the substance abuse field is starting to shift, and task forces in South Florida are shutting down illegitimate “treatment centers” whose sole focus is greed. Cleaning up the reputation of the recovery realm paves the way for companies genuinely vested in the best interest of the clients and the communities, like Delphi Behavioral Health Group. With fifteen treatment facilities in various locations across the United States offering the spectrum of care, Delphi understands every client is unique and so too is the specific treatment needed. Willing to step outside the norm, Delphi launched New Perspectives in Boynton Beach, Florida, a medication-assisted treatment facility.

MAT, while still somewhat controversial, is becoming an optimal treatment option for those suffering from long-term opioid addiction that have tried and failed at traditional, abstinence-based treatment models. New Perspectives offers a contingency-based model with highly monitored and conservative doses of Suboxone films. Suboxone decreases cravings for opioids and initiates withdrawal symptoms if opioids are ingested. Clients must be compliant with the clinical program to receive their prescriptions. Suboxone, in conjunction with intensive therapeutic services, provides a real opportunity for those afflicted with opioid addiction to finally create a life of sobriety. True, there is an opioid epidemic afflicting our nation, but new medications and treatment modalities bring hope that its reign is nearing an end.

Jennifer Behnke, MS, LMFT, LMHC, QS
Jennifer Behnke, Clinical Director at New Perspectives, has worked in the field of mental health and substance abuse for over a decade. Jennifer graduated from Palm Beach Atlantic University in 2012 with a master’s degree in counseling psychology. In 2014, Jennifer became a licensed mental health counselor and licensed marriage & family therapist. At that time, she opened her private practice and took a position as a clinical director. Jennifer helped launch the medication-assisted treatment program at New Perspectives and became a qualified supervisor. She is currently pursuing a Ph.D. in marriage & family therapy with a specialization in couples therapy at Northcentral University.

Written by Jennifer Behnke

NasalGuard®

A Topical Gel that Reduces Inhalation of Harmful Airborne Contaminants Makes National Debut

Perfect for Flu and Cough Cold Season, Indoor Pollutants, Pet Allergies and More

Trutek Corp. announces the launch of NasalGuard®Airborne Particle Blocker®. NasalGuard is an electrostatic topical nasal gel that prevents airborne particles from entering the nose. The product is drug-free and safe for pregnant or nursing women, children, and those concerned about potential drug interactions with other medications. It is a perfect solution to guard you against the Flu/Cough/Cold and all indoor pollutants this winter season.

NasalGuard protects against virtually all types of contaminants in any location. Users can count on it to work in their homes, offices, and other environments where airborne particles may present a health hazard. The product works immediately upon application and lasts up to six hours. NasalGuard gel uses a cationic (positively-charged) polymer that creates a safe electrostatic field around the nasal passages that traps oppositely charged particles and repels similarly charged particles to reduce inhalation of most harmful airborne particles before they enter your body. NasalGuard gel can be purchased online, Amazon or by calling 855-627-2545 in a 3 gram tube for $11.85.

Every day, people are exposed to millions of airborne particles in crowded, confined spaces such as airports, airplanes, transportation centers and subways, homes and offices, hospitals, doctor’s offices and movie theaters. Using NasalGuard gel regularly will help protect against the immediate and long-term risk of breathing harmful contaminated air.

There has been a growing public health concern globally regarding the adverse health effects caused by the inhalation of microscopic airborne particles. Asthma, diabetes, lung cancer and cardiovascular disease are all proven to be linked to air contamination. In response to this widespread problem, Trutek has successfully advanced their technology which was originally focused on blocking allergens from entering the nose for preventing allergy symptoms. This breakthrough provides a greater electrostatic blocking effect that is effective against a much wider spectrum of microscopic indoor and outdoor contaminants including mold, pollen, pet dander, pollution, and virus-sized particles.

NasalGuard technology was invented by Ashok Wahi, the founder and CEO of Trutek Corp., an R&D Product Development Company. An engineer by training, Ashok was inspired to create this technology to aid his own daughter, Aikta, who suffered from severe allergies. “I developed this product because of the vital need to have some kind of personal air filter that was drug free and easy to use,” says Ashok Wahi.

About Trutek Corp.

Trutek Corp. has been marketing patented NasalGuard technology all over the world since 1995. Over 12 million tubes have been sold with no reports of adverse effects.

Follow us on Facebook @nasalguard

New AI app reduces back pain by 40%

Boston based digital therapy startup Kaia Health launches a new app that uses AI and patent pending motion tracking technologyto personalize treatment programs tomanage and treat chronic low back pain(LBP) which has been shown in clinical studies to reduce chronic back pain by 40% and could save the US economy billions each year.

Created by Kaia Health the motion tracking technology requires no additional hardware.The app has been registered as a Class 1 medical device with the FDA which allowsusers to self-manage their back pain through physical exercise, behavioural exercise (e.g. relaxation and meditation) and education.

Earlier this year the digital therapy startup launched the Perfect Squat Challenge App, the world’s first Artificial Intelligence-powered motion tracking fitness app that turns a smartphone into a personal trainer. In Q4 2018 the company intends to roll out20 more motion tracking exercises for the app.

According to the World Health Organization (WHO) LBP is the single leading cause of disability worldwide. In fact, according to the American Chiropractic Association(ACA) 31 million Americans experience LBP,and one half of all working Americans admit to having back pain symptoms each year.

The epidemic of prescription opioid overuse and abuse has also led many health groupsincluding the ACA, the American College of Physicians (ACP) and the American Association of Pain Management (AAPM) to reconsider the value of a non-pharmalogicalapproach to common conditions such asLBP.

The ACP, the largest medical specialty society in the world, updated its LBPtreatment guidelines in 2017 to support a conservative approach to care. Published in the Annals of Internal Medicine, and based on a review of randomized controlled trials and observational studies, the ACPguidelines cite heat therapy, massage, acupuncture and spinal manipulation (a centerpiece of chiropractic care) as possible options for non-invasive, non-drug therapies for LBP. The guidelines state that only when such treatments provide little or no relief should patients move on to medicines such as ibuprofen or muscle relaxants, which research indicates have limited pain relief effects. According to the ACP, prescription opioids should be a last resort for those suffering from LBP, as the risk of addiction and overdose may outweigh the benefits.

The Kaia app has been developed by aleading digital therapy company Kaia Health in conjunction with physiotherapists, pain management physicians and clinical psychologists.

The app uses a multidisciplinary digital approach which offers users online video-based learning programmes that covereducation, physiotherapy (includingexercises for the lower back and lateral muscles) and psychological strategies(including mindfulness and muscle relaxation).

The AI tailors treatment programs for each user from over 120 exercises, and motion tracking technology ensures that the exercises are performed correctly using a smartphone, tablet or iPad without the need for additional hardware.

Each session lasts for 15 minutes and can be accessed anywhere 24 hours a day. The app also features a chat function whichconnects users to a physiotherapist or sport scientist for motivation and exercise related questions.

Two clinical trials into the Kaia app show a significant reduction in LBP by 40%, well above the clinical threshold of pain improvement. The second study shows a40% long-term retention of users for aminimum of 6 months.

The Kaia app was developed in Germanywhere it has been downloaded over 100,000 times in its first year. The Kaia app is now being reimbursed for over 20 million patients globally.

Kaia Health is member of the Digital Therapeutics Alliance (DTA), an association of international manufacturers for digital therapeutic products that are evidence-based.

Konstantin Mehl, CEO of Kaia Health says:Opioid addiction and overdose is a huge issue in the US, and is, according to the ACP, a last resort for those suffering from LBP. Their 2017 LBP treatment guidelines support a non-pharmalogical approach to care using non-invasive, non-drug therapies. A holistic, multidisciplinary treatment of LBPhas always been a resource-intense, costlyundertaking which makes it hard forpatients to get access to the therapy.However, with the Kaia app we’re digitising therapy which offers as many patients as possible access to effective treatment ofLBP. This empowers and motivatesindividuals to take control, and self-manage their condition with evidenced-based, non-pharmacological, cost-effective alternatives and this could save the US economy billions each year. The Kaia app, and advances in technology, demonstrates why we need to rethink how we treat diseaseconditions such as LBP, and make digitalself-management a more realistic part of treatment.

The Kaia app is available on iOS and Android, and can be downloaded via GooglePlay and AppStore. The first 7 days of the program are free. To unlock the full functionality the costs are: 3 months: $23.99, 6 months: $64.99 and 12 months: $94.99.

About Kaia Health www.kaia-health.com
Founded in 2016, Kaia Health is a leading digital therapy company that creates evidence-based treatments for a range of disorders including back pain, Parkinson’s disease, osteoarthritis and chronic obstructive pulmonary disease. Kaia Health uses innovative technology including artificial intelligence and apps, and works with experts in each medical field to create an interdisciplinary digital approach. This empowers and motivates individuals to take control and self-manage their condition with effective, non-pharmacological, digital alternatives at low costs.