Vivos Therapeutics, Inc. 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.

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.