FDA grants 510(k) market clearance to Vivos Therapeutics’ mmRNA Oral Appliance for treating mild to moderate sleep apnoea

Vivos Therapeutics, Inc., a medical technology company focused on developing and commercialising innovative diagnostic and treatment modalities for patients suffering from sleep-disordered breathing, including mild to moderate obstructive sleep apnoea (OSA), has announced that the US Food and Drug Administration (FDA) has granted 510(k) market clearance to Vivos’ mmRNA (modified mandibular Repositioning Nighttime Appliance) device for treating mild to moderate OSA, sleep-disordered breathing and snoring in adults.

This FDA clearance paves the way for expanded insurance reimbursement coverage for the mmRNA device, including Medicare, as well as for potential future government contracts and reimbursement from commercial payers that follow Medicare guidelines.

More than one billion people globally and 54 million Americans suffer from sleep apnoea, 80% of whom remain undiagnosed. A serious chronic illness, sleep apnoea increases the risk of comorbidities, including high blood pressure, heart failure, stroke, diabetes, dementia and other life-threatening diseases. Vivos’ oral appliances address the dental tissue anomalies and malformations known to be associated with OSA. Unlike current standard-of-care interventions, patients treated with the Vivos System typically complete their therapy in 12 to 24 months and, in most cases, do not require lifetime intervention.

“The FDA’s market clearance of Vivos’ newest device, the mmRNA appliance, represents a significant milestone in our ongoing efforts to provide the best possible treatment for people who continue to suffer needlessly from OSA, a debilitating condition that causes or contributes to a wide range of chronic health issues,” said Kirk Huntsman, chairman and chief executive officer of Vivos. “Next-generation products like the mmRNA are vital for allowing medical doctors and dentists to continue pushing forward in their joint mission to give patients a better alternative for effectively treating their OSA. Further, this FDA clearance for the mmRNA enables us to expand commercial insurance reimbursement, soon to include Medicare, making this a more cost-effective solution for patients suffering from OSA.”

In a separate and unrelated development, the FDA has denied Vivos’ previously submitted, additional 510(k) application for its DNA appliance. The DNA appliance is already registered with the FDA as a Class I device for palatal expansion and is currently being used by Vivos-trained clinicians accordingly. Vivos expects to appeal the FDA’s decision or resubmit the 510(k) application to the FDA in the coming weeks. This denial does not impact the existing use of the DNA appliance by licensed, trained dentists, and the company does not believe that this development will have a near- or long-term impact on its operational results or future prospects.