Severe Sleep Apnea “Game-Changing” FDA Clearance

Vivos Therapeutics, Inc. says its removable CARE (Complete Airway Repositioning and/or Expansion) oral appliance has been granted U. S. FDA 510(k) clearance for treating severe obstructive sleep apnea (OSA) in adults.

Sleep Apnea

Vivos Therapeutics specializes in the development and commercialization of highly effective proprietary treatments for sleep-related breathing disorders. Vivos’ proprietary CARE appliances gradually reposition the hard and soft tissues that define the airway. As a result it is opened it up, thereby optimizing its function and flow.

This FDA clearance represents a milestone for patients with severe OSA. Vivos is the first company ever to have approved and bring to market a clear alternative treatment to CPAP or surgical neurostimulation implants for patients with the condition. Furthermore this is the first time the FDA has ever granted an oral appliance a clearance for an oral appliance 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 latest clearance comes after the FDA granted 510(k) clearance for Vivos’ flagship DNA oral appliance to treat mild-to-moderate OSA. Vivos’ CARE appliances also include the mRNA oral appliance and the mmRNA oral appliance.

Clinician comments

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. The decision by the FDA could be life changing for patients who suffer from severe OSA and for whom other treatments have failed.”

Company comments

Kirk Huntsman, Chairman and CEO of Vivos spoke. “This achievement is a pivotal milestone for Vivos. It 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.”

Sleep Apnea Study Findings

Statistically significant data was submitted to the FDA from 73 severe OSA patients. It showed that 80% experienced an improvement of at least 1 classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI). 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.

In addition the company references a separate peer reviewed study published in the Journal of Sleep Medicine in 2022. In that study 1 out of 4 Vivos patients experienced a complete resolution of their OSA symptoms. Vivos believes this the first time that an effective resolution of OSA has been clearly demonstrated over a limited treatment time. This is 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. However some patients required aligners following treatment.