FDA awards first-ever 510(k) clearance to treat severe OSA with unique oral medical devices

R. Kirk Huntsman, CEO and Chairman of Vivos Therapeutics

Dentistry has waited 30 years for this moment—a moment when the medical and dental communities will finally be able to come together in a spirit of mutual respect to work collaboratively to treat all OSA patients, regardless of their severity.

On November 28, 2023, the US Food and Drug Administration (FDA) granted a first-ever clearance to Vivos Therapeutics (NASDAQ: VVOS) for its CARE oral medical devices to treat “moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older, along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.” To be clear, studies show that Vivos CARE devices can safely treat all levels of OSA severity, with or without adjunctive therapies, at the discretion of the treating doctors.

This is an unprecedented move by the FDA, as no other oral appliances have ever received a clearance to treat severe OSA in adults. However, Vivos was able to demonstrate convincingly to the FDA that clinical studies had proven both safety and efficacy of its CARE devices in adults with severe OSA.

One example of such studies was a landmark peer-reviewed study published by a renowned team of medical doctors and researchers in the prestigious Journal of Sleep Medicine in 2022. That study showed Vivos CARE oral medical devices were highly effective at reducing apnea hypopnea index (AHI) scores in a substantial portion (61%) of OSA patients while alleviating OSA altogether in a full 26% of patients. This represents the first time that any treatment modality for OSA has shown the ability to restore normal nocturnal breathing without lifetime intervention, as is required by all other oral appliances, CPAP, and neurostimulation implants.

David McCarty, MD, a board-certified sleep specialist and author, stated, “Make no mistake: this is a huge development on the landscape of treatments for OSA. As the medical profession has gained a better understanding of the complex factors contributing to OSA, we now recognize that a critical component to this condition is the form and functionality of the oral vault. This is where medical collaboration with an airway-centered dentistry approach like Vivos offers is a game-changer. This decision by the FDA could be life changing for patients who suffer from severe OSA and for whom other treatments have failed.”

That type of endorsement from a prominent medical sleep specialist has historically been rare, but it reinforces our belief that this clearance from the FDA is the catalyst that will forever change the relationship dynamics between MD’s and dentists. Dentists will now be seen as having not only a viable, but in many ways a superior, treatment option to what is otherwise available through medicine alone. The entire OSA treatment landscape shifted forever on November 28. And that’s why this approval from the FDA changes everything—for physicians, for dentists, and most of all, for their OSA patients.

In the wake of this huge development, Vivos is already fielding massive amounts of interest across the medical and dental professions. The much-needed interdisciplinary respect and communication essential for this monumental effort seem to be emerging in unprecedented ways. Long-standing barriers, such as skepticism, credibility issues, and mistrust, are now breaking down. With this announcement, physicians are already reaching out to express interest in collaborating directly with dentists and other healthcare providers.

And perhaps for the first time, dentists now have a legitimate and central role in the treatment of a large majority of OSA patients from mild to severe. Dentists will now have a voice and a seat at the same table with medical specialists—not to replace them, but as partners in the same quest to help patients. Working closely with their medical colleagues, dentists can now make a difference like never before in the lives of their patients while opening a whole new stream of patients and growth prospects.

One important reason why this latest development is so monumental is that severe OSA is where the greatest damage to patient health occurs. It's where patients are compromised by a myriad of corresponding conditions such as hypertension, stroke, cardiovascular disease, diabetes, depression, anxiety, early onset Alzheimer’s, ADHD, bedwetting, chronic pain, TMD issues, fibromyalgia, headaches, and more. It’s at the level of severe OSA where patients’ lives are at the greatest risk of being cut short and where they die prematurely.

Vivos believes that this is the biggest breakthrough in the treatment of severe OSA since the advent of CPAP more than 43 years ago. Prior to November 28th, 2023, patients with severe OSA had just two choices: use a CPAP machine nightly for life or undergo the risks of some form of surgery. For most patients, neither of those two options have much appeal. Today, they have a far better and more desirable option that studies have shown to be both safe and effective.

With this landmark decision, Vivos technology can finally take its rightful place alongside other viable and widely deployed treatment options for patients whose lives have been compromised by obstructive sleep apnea—regardless of the severity.

Now is the time for MDs, pediatricians, neurologists, pulmonologists, cardiologists, functional medicine doctors, dentists, chiropractors, and any other health professional who deals with OSA patients (and they all do), to leave behind old paradigms and outdated notions of what is possible and join forces to serve patients at a much higher level.

A few things of note about this approval and the data behind this FDA clearance for Vivos CARE:

No persistent safety issues were found in any patient cohort published or submitted to date
97% of patients got better or remained the same
80% of patients improved by at least 50% or 1 full category of severity
Average treatment time was just 9.7 months (i.e., many patients in the cohort had not completed treatment and were expected to realize further improvements up to or slightly beyond our current 12 month estimated treatment time)
Severe OSA patients responded better and improved more than mild or moderate patients
Some patients required aligners following treatment (largely for cosmetic reasons to close interproximal gaps)
It is unlikely that any other oral appliance can use our proprietary devices as predicates in future 510(k) applications due to our novel expansion in 3 dimensions along with the option of mandibular advancement
All OSA testing (both pre- and post-treatment) was conducted WITHOUT any active intervention in place. This is a key point: No one else has done that nor do we believe they can, and here’s why: If you turn off a CPAP machine or take any other oral appliance out in order to conduct a polysomnogram or HST, the patient's OSA (as measured by the AHI) would immediately (or very quickly) revert back
This speaks to a fundamental difference in the treatment objectives between CPAP or MADs and Vivos CARE. The first two are palliative, and intended to temporarily alleviate symptoms, while Vivos CARE devices and protocols are intended to treat the OSA condition and restore normal breathing and sleep. Also, the first two require (by definition) a lifetime of nightly intervention and use, while Vivos treatment typically does not.
Only Vivos has demonstrated the ability to reduce AHI and restore normal breathing and sleep without nightly intervention over a lifetime.
In a prior peer reviewed study published in the Journal of Sleep Medicine, Vivos CARE devices reduced and eliminated OSA symptoms in 1 out of 4 patients.
So as of November 28, 2023, severe OSA patients at risk of hypertension, or stroke, or cancer, or diabetes, or early onset dementia, or ED, or cardiovascular disease, or any one of the dozens of health conditions linked to OSA, even premature death, now have new hope and another option for a viable solution that potentially won't involve a lifetime of nightly intervention.

THAT is a big deal. Because now dentistry is front and center in sleep medicine.

And this movement is just getting started. Vivos is now being noticed by the medical community, medical insurance payors, functional care doctors, governmental agencies such as the VA and military, and desperate patients from around the world.

As expected, the company is actively engaging in opportunities to affiliate, collaborate, train, educate, acquire, merge and refer and these opportunities are everywhere.

Because no other company in the world can do what Vivos can.

Clearly this landmark FDA clearance is going to impact the lives of patients, physicians, dentists, and other healthcare providers across the country. No matter how this might affect you, we believe you should know all about this new treatment option, and we strongly encourage you to visit our website, Vivos.com or contact us today.

If you are a dental professional, you need to know what we know here at Vivos. Your patients need to know that now there is hope. That message should come from you! So, if you would like more information, please visit our website and fill out the contact form or call us at 720-399-9322 for more information.

We look forward to the positive impact this will have on patient care and the continued success of Vivos-trained providers and their patients.

R. Kirk Huntsman is a cofounder of Vivos Therapeutics and has served as its chief executive officer and a director since September 2016. In June 2020, he was elected chairman of the board by our board of directors. In 1995, he founded Dental One (now Dental One Partners), which, as president and chief executive officer, he grew to become one of the leading DSOs (dental service organizations) in the country, with over 165 practices in 15 states.