Vivos receives clearance for appliance to treat OSA 

LITTLETON, Colo. - Vivos Therapeutics, a medtech company focused on developing innovative treatments for patients suffering from obstructive sleep apnea, has received clearance from the U.S. Food and Drug Administration for its proprietary daytime-nighttime (DNA) appliance. With FDA clearance, the DNA appliance offers a new treatment regimen that opens the airway by expanding the palate and training the tongue to rest in the proper position, converting patients to nasal as opposed to oral breathing.  “This clearance is the culmination of years of pioneering clinical work,” said Kirk Huntsman, chairman and CEO of Vivos. “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.” The clinical data that Vivos submitted to the FDA as part of the clearance process for the DNA included pre- and post-treatment Apnea Hypopnea Index (AHI) scores obtained with no appliance in the mouth, demonstrating that: 28% of patients had their OSA resolved; 63% of patients improved by one AHI classification (i.e., severe to moderate, moderate to mild, or mild to no OSA); 86% of patients improved their airway size; and 97% of patients increased the width of their palate, allowing the tongue to rest in proper position and thus avoiding a potential airway obstruction. Additionally, in a study of patient satisfaction with DNA treatment, the company found 97% of patients achieved the desired outcome, while 98% of patients were highly satisfied or very satisfied and likely to recommend the treatment to a friend.