Business
Vivos Therapeutics Receives FDA 510(k) Clearance of its Flagship DNA Oral Appliance for Treatment of Obstructive Sleep Apnea
Approval represents third FDA clearance for Vivos’ oral appliances and first clearance specifically recognizing Vivos’ proprietary core technology LITTLETON,
About this update from Vivos Therapeutics, Inc.
[{"type":"text","content":"Approval represents third FDA clearance for Vivos’ oral appliances and first clearance specifically recognizing Vivos’ proprietary core technology\nLITTLETON, Colo., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company'') (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, today announced a brand new clearance from the U.S. Food and Drug Administration (FDA) for its proprietary DNA appliance (daytime-nighttime appliance). The FDA 510(k) clearance for the DNA appliance as a Class II device gives rise to a completely new treatment regimen for mild-to-moderate OSA. Making this development even more meaningful is that the DNA device for palatal expansion is Vivos’ longest standing appliance with the widest use among Vivos-trained dentists, which Vivos anticipates will now increase the ease of adoption of the DNA for treating OSA. Current modalities for the treatment of OSA include: (i)continuous positive airway pressure (CPAP). Approximately 50% of patients discontinue use of CPAP because it is uncomfortable to wear and cumbersome to transport, not to speak of the loud noise that disrupts your partner. (ii)mandibular advancement devices (MAD). Some people have issues using appliances that move the jaw forward causing temporomandibular joint pain and discomfort. (iii)surgical intervention, including hypoglossal nerve stimulation therapy. Many people simply do not want to undergo anesthesia or the cost of a surgical procedure. With the latest FDA clearance achieved, the DNA appliance offers a new treatment regimen (when combined with associated protocols that are a part of The Vivos Method) which opens the airway by expanding the palate and training the tongue to rest in proper position and converts patients to nasal as opposed to oral breathing. Unlike other treatments, The Vivos Method is differentiated in that it addresses the root cause of snoring and/or OSA in many patients. While the appliance is effective by itself, it can also be used in conjunction with other treatment modalities such as, myofunctional therapy or CPAP. The clinical data submitted to the FDA as part of the clearance process for the DNA included pre- and post-treatm...