Vivos Therapeutics (NASDAQ: VVOS), a medical technology company focused on developing innovative treatments for patients suffering from dentofacial abnormalities and/or mild to moderate obstructive sleep apnea (“OSA”) and snoring in adults, has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for its own daytime-nighttime appliance (“DNA”). According to the announcement, the clearance for the DNA appliance as a Class II device “gives rise to a completely new treatment regimen for mild-to-moderate OSA.” Vivos noted that the device is the company’s longest standing appliance and sees the widest use among Vivos-trained dentists. “This clearance is the culmination of years of pioneering clinical work,” said Vivos Therapeutics chair and CEO Kirk Huntsman in the press release. “For the first time, the FDA has formally recognized the benefits of our proprietary core technology in our DNA appliance (without mandibular advancement) as an effective treatment for mild-to-moderate OSA in adults. The FDA now joins other international regulatory bodies in recognizing the efficacy of our patented technology in the reduction and resolution of many of the symptoms of OSA that result from a lack of development of the jaws and oral cavity. We believe the DNA treatment can be life changing for many OSA patients, and we look forward to continued market adoption of our expanded menu of treatments for this debilitating condition.”
To view the full press release, visit https://ibn.fm/Cs0RT
About Vivos Therapeutics Inc.
Vivos Therapeutics is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as mild-to-moderate obstructive sleep apnea (“OSA”) as well as snoring in adults. The Vivos Method represents the first clinically effective, nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution. It has proven effective in the treatment of more than 31,000 patients worldwide by more than 1,650 trained dentists. The Vivos Method includes the Vivos Complete Airway Repositioning and/or Expansion (“CARE”) appliance therapy and associated protocols that alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and palate. The Vivos Method 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 SleepImage diagnostic technology under its VivoScore program 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 Method. 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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