Vivos Therapeutics, Inc. 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 (FDA) granted, for the first time ever, 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.

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. As previously stated, no other oral appliance has ever been granted a clearance to treat severe OSA., Vivos CARE devices are the only approved oral appliance option for the millions of severe OSA patients seeking alternatives to Continuous Positive Airway Pressure (CPAP). In one market development, members of Vivos' nationwide network of over 1,850 trained providers are actively treating current and former ResMed and Philips Respironics' CPAP device users with Vivos CARE oral medical devices.

Just one year ago, ResMed CEO Mick Farrell described the overall $6 billion U.S. CPAP market situation as ' a humanitarian emergency' after a string of FDA CPAP device recalls and product shortages. More recently, in late January Philips Respironics announced it has suspended U.S. sales of CPAP and other respiratory units, which has only added to patient concerns regarding these discontinued OSA treatment devices and treatment options that are available to them. To date, it is estimated that the Philips' recall alone has exceeded 5 million CPAP units.

Since April 2021, the FDA has received more than 116,000 medical device reports (MDRs), including 561 reports of death, reportedly associated with certain components of the Philips equipment. Other potential risks identified in the MDRs include toxic or cancer-causing effects, headache, dizziness, nausea or vomiting, asthma, and irritation to the skin, eyes, nose and respiratory tract. As a result, both medical providers and patients are seeking safe and effective alternative treatment options for patients with OSA.

In another critical 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 U.S. medical insurance payers could soon follow United's lead on this policy. 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.