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Vivos Therapeutics (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”), has received 510(k) market clearance from the FDA for its modified mandibular repositioning nighttime appliance (“mmRNA”). The device is designed to treat mild-to-moderate OSA in adults; it is also used for treating sleep-disordered breathing and snoring.
The FDA approval expands insurance reimbursement potential, including the potential for the device to be covered by Medicare. The FDA approval also opens the door for future government contracts and other commercial payers. According to the announcement, more than 1 billion people globally and 54 million Americans suffer from sleep apnea, so the potential market for the device is significant.
“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 Vivos chair and CEO Kirk Huntsman in the press release. “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.”
To view the full press release, visit https://ibn.fm/U5dHl
About Vivos Therapeutics Inc.
Vivos Therapeutics 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, nonsurgical, noninvasive, nonpharmaceutical 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 the treatment of more than 19,000 patients worldwide by more than 1,250 trained dentists. Combining technologies and protocols that alter the size, shape and position of the tissues 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 dentist training and other value-added services in connection with using the Vivos System. For more information about this company, visit www.VivosLife.com.
NOTE TO INVESTORS: The latest news and updates relating to VVOS are available in the company’s newsroom at http://ibn.fm/VVOS
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