Vivos Therapeutics (NASDAQ:VVOS) sees significant new opportunities for its oral appliances targeting patients with sleep-related breathing disorders including obstructive sleep apnea (OSA) amid recent market developments.
The company’s Vivos CARE appliances in November 2023 were cleared by the US Food and Drug Administration (FDA) to treat moderate and severe OSA in adults along with positive airway pressure and/or myofunctional therapy as required, making them the only oral appliance to win FDA approval to treat severe OSA.
It highlighted that the discontinuation of other devices by ResMed and Philips Respironics, including the recall of continuous positive airway pressure (CPAP) units, will likely create a “ripple” in the supply chain and drive patients to alternative treatment options.
Another favorable development is United Healthcare’s revised OSA medical treatment policy which requires all patients who are candidates for hypoglossal nerve stimulation (HGNS) to first complete a full regimen of oral appliance therapy in addition to CPAP, starting in March 2024.
Vivos believes most OSA patients seeking HGNS implants have high-moderate or severe OSA, leaving its oral medical devices as their only approved oral appliance therapy option.
“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,” Vivos CEO Kirk Huntsman said in a statement.
“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 (or about 12 months).”
Vivos is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as OSA and snoring in adults.