Vivos Therapeutics highlights favorable market developments

Vivos Therapeutics highlighted certain significant favorable market developments creating new opportunities to widen its funnel of potential users of Vivos’ oral appliance therapies. On November 2, 2023, the U.S. Food and Drug Administration granted, for the first time ever, a 510(k) clearance to the Vivos CARE appliances to treat moderate and severe OSA in adults. Considering the very recent discontinuation of many devices by Philips Respironics, there will most likely be a ripple in the supply chain which ultimately will affect patient care. Vivos has demonstrated and proven to the FDA safety and efficacy for its CARE devices to treat severe OSA, and it is well positioned to assist patients and providers that have been or could be impacted by these latest industry developments. Kirk Huntsman, Chairman and CEO of Vivos, stated “We believe that CPAP recalls leaving millions of OSA sufferers looking for alternatives, together with United Healthcare’s recognition of oral appliance therapy as a prerequisite for surgical treatment in adult patients with moderate to severe OSA, create a significant opportunity for us to widen the funnel of potential users of our appliances. For the first time ever, adult patients with moderate to severe OSA now have a safe and highly effective alternative treatment option to CPAP through our CARE appliances, a treatment that has been proven to significantly improve and even clinically resolve OSA symptoms, over a limited treatment time.”