Vivos Therapeutics (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative treatments for patients suffering from sleep-disordered breathing including obstructive sleep apnea (“OSA”), recently submitted an application to the U.S. Food and Drug Administration (“FDA”) for its mmRNA (“mmRNA”) oral appliance(TM). The 510(k) Class II application focuses on the oral appliance as a treatment for mild-to-moderate OSA, sleep-disordered breathing and snoring in adults. The company’s oral appliance is an updated version of the company’s existing mRNA appliance(R), which previously received FDA clearance as a Class II oral appliance. The company noted that once it received approval for the 510(k) application, it plans to submit an application to a pricing, data analysis and coding (“PDAC”) contractor for the appliance to be added to the Centers for Medicare and Medicaid Services’ list of approved sleep apnea appliances. The process could take anywhere from three to six months. “Following mechanical testing on the mmRNA, this 510(k) submission marks a significant step toward Vivos continuing to offer a state-of-the-art treatment alternative for people suffering from mild-to-moderate OSA,” said Vivos chairman and CEO Kirk Huntsman in the press release. “Furthermore, FDA clearance for the mmRNA will enable us to expand insurance reimbursement to include Medicare. Sleep apnea remains a serious, chronic disease that adversely impacts millions of people, and Vivos is steadfast in its mission to reach as many patients as possible around the country with our next-generation products.”
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About Vivos Therapeutics Inc.
Vivos Therapeutics is a medical technology company focused on developing and commercializing innovative treatments for patients suffering from sleep-disordered breathing including obstructive sleep apnea (“OSA”). The Vivos treatment for mild-to-moderate OSA involves customized oral appliances and protocols called the Vivos System. Vivos believes that its Vivos System technology represents the first clinically effective, nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for people with mild-to-moderate OSA. Vivos oral appliances have proven effective in more than 18,000 patients treated worldwide by more than 1,200 trained dentists. Combining technologies and protocols that alter the size, shape and position of the tissues of a patient’s upper airway, the Vivos System opens airway space and can eliminate or significantly reduce symptoms and conditions associated with mild-to-moderate OSA. The Vivos System has been shown to significantly lower Apnea Hypopnea Index scores and improve other conditions associated with OSA. The Vivos Integrated Practice (“VIP”) program offers dentists 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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