By Alyx Arnett

Vivos Therapeutics has received 510(k) clearance from the US Food and Drug Administration (FDA) for treating moderate to 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.

The clearance represents the first time the FDA has granted an oral appliance clearance to treat moderate and severe OSA in adults. The devices are cleared for use on their own or along with positive airway pressure (PAP) and/or myofunctional therapy, as needed, according to Colette Cozean, PhD, regulatory consultant for Vivos, who did the data assessment and analysis and filing with the FDA.

Cozean notes the “as needed” designation allows for situations, for instance, in which a patient exhibits very severe clinical symptoms, and their healthcare provider may opt to prescribe PAP therapy initially and continue it as required.

“If they’re using an mRNA, they already have mandibular advancement, and they probably would not do that. But if they’re using DNA, they might use PAP to be sure that the patient’s clinical symptoms are not a problem at the beginning,” says Cozean. “Or if you want to train the tongue on where to go, you might use myofunctional therapy.” 

The statistically significant data submitted to the FDA from 73 severe OSA patients, including 37 who used the oral appliances as a standalone treatment, showed that 80% of patients experienced an improvement of at least one classification or at least a 50% improvement in the apnea-hypopnea index, and 97% of patients improved or stayed the same. The average treatment time was 9.7 months. 

Surprisingly, treatment results with severe sleep apnea patients were better than with mild and moderate patients. All pre- and post-treatment testing was conducted with no device in the mouth. Vivos’ 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, one out of four Vivos patients experienced a complete resolution of their OSA symptoms. No persistent safety issues were found in any patient cohort published or submitted to date, although some patients required aligners following treatment.

“Make no mistake: This is a huge development on the landscape of treatments for OSA,” says sleep specialist, author, and lecturer, David E. McCarty, MD, FAASM, in a release. “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.”

R. Kirk Huntsman, chairman and CEO of Vivos, says in a release, “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.”

The latest clearance comes 11 months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA.

Photo caption: Vivos’ DNA oral appliance

Photo credit: Vivos Therapeutics