FDA Grants 510(k) Clearance to Obstructive Sleep Apnea Oral Appliance

The FDA has granted 510(k) clearance to Vivos Therapeutics, Inc. for its removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances for adults with severe obstructive sleep apnea (OSA). The clearance includes the company’s flagship DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance.¹

Credit: Vivos Therapeutics

“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,” said medical sleep specialist David McCarty, MD, in a press release.¹ “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.”

The clearance makes Vivos the first company to receive FDA approval for, and to bring to market, an alternative to continuous positive airway pressure (CPAP) or surgical neurostimulation implants for patients with severe OSA. Eleven months earlier, the FDA granted Vivos 510(k) clearance for its DNA oral appliance that treats mild-to-moderate OSA. According to Vivos, this is the first time the FDA has granted clearance to an oral appliance indicated for moderate and severe OSA in adults, 18 years of age and older, along with positive airway pressure (PAP) and/or myofunctional therapy.

“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,” said Kirk Huntsman, chairman and CEO of Vivos, in a press release. “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.”

In patients with OSA, breathing is interrupted during sleep for at least 10 seconds for an average of at least five times per hour during sleep. Risk factors for OSA include excess weight, older age, narrowed airway, hypertension, smoking, chronic nasal congestion, diabetes, and asthma.²

Vivos reported that data submitted to the FDA from 73 patients with severe OSA showed 80% achieved an improvement of at least one classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI), whereas 97% of patients improved or stayed the same over an average treatment time of 9.7 months. The company reported that treatment results were superior among patients with severe OSA compared with patients with mild and moderate OSA.

“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,” Huntsman said in the release. “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.”

References

1. Vivos Therapeutics Receives First Ever FDA 510(k) Clearance for Oral Device Treatment of Severe Obstructive Sleep Apnea. Vivos Therapeutics. News release. November 29, 2023. https://www.biospace.com/article/vivos-therapeutics-receives-first-ever-fda-510-k-clearance-for-oral-device-treatment-of-severe-obstructive-sleep-apnea-/

2. Obstructive sleep apnea. Mayo Clinic. Webpage. Updated July 14, 2023, Accessed November 29, 2023. https://www.mayoclinic.org/diseases-conditions/obstructive-sleep-apnea/symptoms-causes/syc-20352090