Vivos Therapeutics (VVOS) Submits FDA 510(k) Application for the Vivos mmRNA Oral Appliance

February 2, 2021 8:06 AM EST

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Vivos Therapeutics, Inc. (“Vivos”) (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative treatments for patients suffering from sleep-disordered breathing, including mild to moderate obstructive sleep apnea (OSA), today announced that it has submitted a 510(k) Class II application to the U.S. Food and Drug Administration (FDA) for its mmRNA oral appliance™ with indications to treat mild-to-moderate OSA, sleep-disordered breathing and snoring in adults.

Vivos’ mmRNA oral appliance (modified mandibular Repositioning Nighttime Appliance) is a new version of the company’s existing mRNA appliance®, which is an FDA-cleared Class II oral appliance. Assuming the mmRNA’s 510(k) Class II approval, Vivos expects to submit an application to a PDAC (Pricing, Data Analysis and Coding) contractor for the mmRNA to be added to the Centers for Medicare and Medicaid Services’ list of approved sleep apnea appliances. The process is expected to take approximately three to six months in total.

“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 Kirk Huntsman, Vivos Chairman and CEO. “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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