Vivos Therapeutics Inc highlighted certain market developments that it says are creating new opportunities to widen its funnel of potential users of Vivos’ oral appliance therapies.
On Nov 2, 2023, the US Food and Drug Administration (FDA) granted, for the first time, a 510(k) clearance to the Vivos CARE appliances 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.
“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,” reads a release from Vivos. “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.”
Vivos CARE devices are currently the only approved oral appliance option for severe OSA patients seeking alternatives to continuous positive airway pressure (CPAP).
In another development, in January 2024 United Healthcare issued a revised OSA medical treatment policy which requires as of March 2024 that all OSA patients who are candidates for hypoglossal nerve stimulation (HGNS) implants first complete a full regimen of oral appliance therapy (in addition to CPAP).
“Vivos-trained providers currently treat failed HGNS cases using Vivos CARE oral medical devices and treatment plans. Vivos believes most OSA patients seeking HGNS implants have high-moderate or severe OSA, leaving Vivos CARE oral medical devices as their only approved oral appliance therapy option. Industry analysts expect other US medical insurance payers could soon follow United’s lead on this policy,” reads the release from Vivos.
Kirk Huntsman, chairman and CEO of Vivos, adds in a release, “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 (AHI of less than 5), over a limited treatment time (or about 12 months). No other technology has ever shown that capability. All other oral appliances are for mild to moderate OSA patients only, and rely solely on mandibular advancement, a 40-year-old technology which must be worn for life.”