FDA Grants 510(k) Market Clearance to Vivos Therapeutics’ mmRNA Oral Appliance for Treating Mild to Moderate Sleep Apnea
Part of the Vivos System Treatment, the mmRNA Device Represents a Highly Effective Non-Surgical, Non-Invasive and Non-Pharmaceutical Alternative for Patients Suffering from OSA
Approval Expands Insurance Reimbursement Potential, Including the Opportunity for Medicare Coverage for mmRNA
Colorado, August 23, 2021
Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ:VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from sleep-disordered breathing, including mild to moderate obstructive sleep apnea (OSA), today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance to Vivos’ mmRNA (modified mandibular Repositioning Nighttime Appliance) device for treating mild to moderate OSA, sleep-disordered breathing and snoring in adults. This FDA clearance paves the way for expanded insurance reimbursement coverage for the mmRNA device, including Medicare, as well as for potential future government contracts and reimbursement from commercial payers that follow Medicare guidelines.
More than 1 billion people globally and 54 million Americans suffer from sleep apnea, 80 percent of whom remain undiagnosed. A serious chronic illness, sleep apnea increases the risk of comorbidities, including high blood pressure, heart failure, stroke, diabetes, dementia and other life-threatening diseases. Vivos’ oral appliances address the dental tissue anomalies and malformations known to be associated with OSA. Unlike current standard-of-care interventions, patients treated with the Vivos System typically complete their therapy in 12 to 24 months and, in most cases, do not require lifetime intervention.
“The FDA’s market clearance of Vivos’ newest device, the mmRNA appliance, represents a significant milestone in our ongoing efforts to provide the best possible treatment for people who continue to suffer needlessly from OSA, a debilitating condition that causes or contributes to a wide range of chronic health issues,” said Kirk Huntsman, Vivos Chairman and CEO. “Next-generation products like the mmRNA are vital for allowing medical doctors and dentists to continue pushing forward in their joint mission to give patients a better alternative for effectively treating their OSA. Further, this FDA clearance for the mmRNA enables us to expand commercial insurance reimbursement, soon to include Medicare, making this a more cost-effective solution for patients suffering from OSA.”
In a separate and unrelated development, the FDA has denied Vivos’ previously submitted, additional 510(k) application for its DNA appliance. The DNA appliance is already registered with the FDA as a Class I device for palatal expansion and is currently being used by Vivos-trained clinicians accordingly. Vivos expects to appeal the FDA’s decision or resubmit the 510(k) application to the FDA in the coming weeks. This denial does not impact the existing use of the DNA appliance by licensed, trained dentists, and the Company does not believe that this development will have a near- or long-term impact on its operational results or future prospects.
Vivos Therapeutics Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for adult patients suffering from mild-to-moderate obstructive sleep apnea (OSA). The Vivos treatment involves customized oral appliances and treatment protocols called the Vivos System. Vivos believes that its Vivos System oral appliance technology represents the first clinically effective non-surgical, non-invasive, non-pharmaceutical and cost-effective solution for adults with mild-to-moderate OSA. Vivos also sells orthodontic appliances for adults and children. Vivos’ oral appliances have proven effective in over 19,000 patients treated worldwide by more than 1,250 trained dentists.
Combining proprietary technologies and protocols that alter the size, shape and position of the tissues that comprise a patient’s upper airway, the Vivos System opens airway space and may significantly reduce symptoms and conditions associated with mild-to-moderate OSA, such as lowering Apnea Hypopnea Index scores. Vivos also markets and distributes VivosScore, powered by the SleepImage diagnostic technology, 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 System.
For more information, visit www.vivoslife.com.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management made in connection therewith 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, particularly with respect to the public offering described herein. Words such as “may”, “could”, “expects”, “projects,” “intends”, “plans”, “believes”, “predicts”, “anticipates”, “hopes”, “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve 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 mmRNA 510(k) approval or the Company’s future regulatory actions regarding its DNA device a described herein) 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, the 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.