Vivos Therapeutics, Inc. Shares Jump After FDA Grants Market Clearance for treatment of Mild to Moderate Sleep Apnea
Aug 23, 2021 By MarketDepth
Vivos Therapeutics, Inc. (NASDAQ: VVOS) shares jumped about 50% after 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.
Available in USA & Canada
Vivos Therapeutics is 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). The company markets and sells its Vivos System to licensed professionals, primarily general dentists in the United States and Canada.
According to the Company, the 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.
“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.”Kirk Huntsman, Vivos Chairman and CEO
“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.”
1 Billion Globally Affected
Vivos also indicated in a press release that 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.