Vivos Therapeutics Submits FDA 510(k) Application for the Vivos mmRNA Oral Appliance
If Approved for Clearance, Vivos’ Updated Device Will Treat Mild to Moderate Sleep Apnea and Expand Insurance Reimbursement to include Medicare Coverage
HIGHLANDS RANCH, Colo., Feb. 02, 2021 (GLOBE NEWSWIRE) -- 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.”
About Vivos Therapeutics, Inc.
Vivos Therapeutics Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative treatments for patients suffering from sleep-disordered breathing, including obstructive sleep apnea (OSA). Vivos believes that its Vivos System technology represents the first clinically effective non-surgical, non-invasive, non-pharmaceutical and cost-effective solution for people with mild-to-moderate OSA. 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.
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Cautionary Note Regarding Forward-Looking Statements
This press release contains “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”, “should”, “expects”, “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates,” “assuming” 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 a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results (including, without limitation, the results of the FDA’s and PDAC review of the mmRNA device and the timing for such review to be completed as 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 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.
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