VVOS Vivos Therapeutics Inc

Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ:VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders (including all severities of obstructive sleep apnea (OSA)) in adult patients, today 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.

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 (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. We believe all of these factors create very significant revenue opportunities for us as we continue to spread the word about our product offerings.”

About Vivos Therapeutics, Inc. 

Vivos Therapeutics, Inc. (NASDAQ: VVOS) 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 obstructive sleep apnea (OSA) and snoring in adults. The Vivos Method represents the first clinically effective nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for treating mild to severe OSA. It has proven effective in approximately 40,000 patients treated worldwide by more than 1,850 trained dentists. 

The Vivos Method includes treatment regimens that employ the proprietary CARE appliance therapy and other modalities that alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and/or palate. The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild-to-severe OSA, such as lowering Apnea Hypopnea Index scores. Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method. 

For more information, visit www.vivos.com. 

Cautionary Note Regarding Forward-Looking Statements 

This press release and statements of the Company’s management made in connection therewith may contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events, including the anticipated benefits of the 510(k) approval described herein. Words such as “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results (including the anticipated benefits of the market trends discussed in this press release and any potential impact on the Company’s revenues and results of operations) may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to: (i) the risk that Vivos may be unable to implement revenue, sales and marketing strategies that increase revenues, (ii) the risk that some patients may not achieve the desired results, (iii) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea treatment sector; (iv) the risk that Vivos may be unable to secure additional financing on reasonable terms when needed, if at all and (v) other risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based. 

Vivos Investor Relations Contact: Julie Gannon Investor Relations Officer 720-442-8113 jgannon@vivoslife.com