Vivos Therapeutics (VVOS) Receives First Ever FDA 510(k) Clearance for Oral Device Treatment of Severe Obstructive Sleep Apnea

Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders, today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances. Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance.

As a result of this FDA clearance, Vivos becomes the first company ever to have approved and bring to market a clear alternative treatment to CPAP or surgical neurostimulation implants for patients with severe OSA. This latest clearance comes just eleven months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA, and represents the first time the FDA has ever granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

Nationally renowned medical sleep specialist, author and lecturer, Dr. David McCarty, MD, elaborated on the impact of this landmark decision, stating “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.”

Kirk Huntsman, Chairman and CEO of Vivos, stated, “This achievement is a pivotal milestone for Vivos, and elevates our proven treatment options right into the mainstream of sleep medicine. It is even more important for the millions of severe OSA patients who are desperate for an effective alternative treatment. Before this, severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants or other invasive surgeries. Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention.”

“Vivos trained providers can now treat patients with OSA and conditions associated with OSA comprehensively using our suite of FDA cleared devices, without regard to the severity of their OSA condition and across a range of price point options,” continued Mr. Huntsman. “We believe this unprecedented decision by the FDA will generate broader acceptance throughout the medical community for Vivos treatment options, leading to the potential for higher patient referrals and case starts as well as collaboration with medical professionals. We also believe it will enhance our value proposition to third-party distribution partners such as durable medical equipment (DME) companies. This approval could also clear the way for greater reimbursement levels from medical insurance payors and Medicare. We believe that all these factors should favorably impact our ability to grow our revenues in 2024 and beyond.”

The statistically significant data submitted to the FDA from 73 severe OSA patients showed that 80% of patients experienced an improvement of at least 1 classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI), and 97% of patients improved or stayed the same. Average treatment time was just 9.7 months. Treatment results with severe sleep apnea patients were actually better than with mild and moderate patients. All pre- and post-treatment testing was conducted with no device in the mouth. Unlike all other oral appliances on the market, Vivos’ proprietary CARE appliances gradually reposition the hard and soft tissues that define the airway, thereby opening it up and optimizing its function and flow.

In a separate peer reviewed study published in the Journal of Sleep Medicine in 2022, 1 out of 4 Vivos patients experienced a complete resolution of their OSA symptoms. Vivos believes its products represent the first time that an effective resolution of OSA has been clearly demonstrated over a limited treatment time, unlike the lifetime intervention required for CPAP or surgical neurostimulation implants.

No persistent safety issues were found in any patient cohort published or submitted to date, although some patients required aligners following treatment.

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