Vivos Therapeutics (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep-related breathing disorders, has been granted 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for treating severe obstructive sleep apnea (“OSA”) in adults using the exclusive Vivos removable Complete Airway Repositioning and/or Expansion (“CARE”) oral appliances. According to the announcement, CARE appliances include Vivos’s flagship DNA oral appliance as well as its mRNA oral appliance and mmRNA oral appliance. This clearance makes Vivos the first company to have approved and brought to market a clear alternative treatment to CPAP or surgical neurostimulation implants for patients with severe OSA. The company noted that the clearance from the FDA came only 11 months after the agency granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA.
“This achievement is a pivotal milestone for Vivos and elevates our proven treatment options right into the mainstream of sleep medicine,” said Vivos chair and CEO Kirk Huntsman in the press release. “It is even more important for the millions of severe OSA patients who are desperate for an effective alternative treatment. Before this, severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants or other invasive surgeries. Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention. Vivos trained providers can now treat patients with OSA and conditions associated with OSA comprehensively using our suite of FDA-cleared devices, without regard to the severity of their OSA condition and across a range of price point options. We believe this unprecedented decision by the FDA will generate broader acceptance throughout the medical community for Vivos treatment options, leading to the potential for higher patient referrals and case starts as well as collaboration with medical professionals. We also believe it will enhance our value proposition to third-party distribution partners such as durable medical equipment (‘DME’) companies. This approval could also clear the way for greater reimbursement levels from medical insurance payors and Medicare. We believe that all these factors should favorably impact our ability to grow our revenues in 2024 and beyond.”
To view the full press release, visit https://ibn.fm/J8bc1
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”) and snoring in adults. The Vivos Method represents the first clinically effective, nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for treating mild to moderate OSA. It has proven effective in the treatment of approximately 40,000 patients worldwide by more than 1,850 trained dentists. The Vivos Method includes treatment regimens that employ the proprietary Vivos Complete Airway Repositioning and/or Expansion (“CARE”) appliance therapy and other modalities 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.Vivos.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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