Vivos Therapeutics has secured 510(k) market clearance from the US Food and Drug Administration (FDA) for its modified mandibular Repositioning Nighttime Appliance (mmRNA) device to treat mild to moderate obstructive sleep apnea (OSA).
The mmRNA oral appliance is designed to treat sleep-disordered breathing and snoring in adults.
Part of the Vivos system treatment, the mmRNA device is a non-surgical, non-invasive and non-pharmaceutical alternative for patients suffering from OSA.
According to the company, over one billion people across the globe and 54 million Americans suffer from sleep apnea, of which 80% remained undiagnosed.
Vivos chairman and CEO Kirk Huntsman said: “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.”
Separately, the company has failed to secure 510(k) clearance from the FDA for its DNA appliance, which is already registered with the FDA as a class I device for palatal expansion.
The company is planning to appeal the FDA’s decision or resubmit the 510(k) application to the regulator within few weeks.
The firm stated: “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.”
In July this year, Vivos announced results from a national study to assess patients’ airway function and OSA symptoms after undergoing the Vivos treatment.
The study showed that 28% of the 74 adult patients reported no remaining OSA symptoms, after receiving treatment with the company’s FDA Class 1 DNA appliance for certain orofacial anomalies.
