24/7 Market News- Vivos Therapeutics Reports Receiving First FDA 510(k) Clearance to Treat Children’s Moderate to Severe Sleep Apnea and Snoring

September 18, 2024

DENVER, Colo., Sep 18, 2024 (247marketnews.com)- Vivos Therapeutics (NASDAQ: VVOS) reported receiving what Vivos believes is the first ever U.S. Food and Drug Administration (FDA) 510(k) clearance to treat moderate to severe OSA and snoring in children aged 6 to 17 using Vivos’ oral medical device, which, according to recently published studies, affects up to 10.1 million U.S. children.

Kirk Huntsman, CEO and Chairman of Vivos, commented, “The FDA 510(k) clearance announced today is, to our knowledge, the first time any oral medical device has ever been approved to treat moderate to severe OSA in children. This clearance is the latest in a series of regulatory wins for Vivos, not just in the United States, but globally. It represents the culmination of a growing body of research and regulatory approvals confirming and validating the extraordinary potential and efficacy of our proprietary Vivos technology. In addition, this landmark clearance opens up an exciting and vast new market and enables us to directly address the needs of millions of children who currently suffer from sleep-related breathing disorders such as OSA.

“Our recently announced alliance-based marketing and distribution model has the potential to widen the funnel of potential OSA patients we see. In our new strategic business model where we work closely with medical and dental providers, we already see significant opportunities opening up to treat multiple family members of all ages. When Vivos teams up with medical professionals who treat OSA, and when parents are fully informed as to the health risks of untreated OSA on their children, we believe they will overwhelmingly choose Vivos technology over other treatment options.”

“As we continue to expand beyond dentists and move more directly and vertically into affiliations and collaborations with medical specialists, functional medicine doctors, and other sleep-related healthcare practitioners, we expect this to positively impact our new case starts, revenue growth and gross profit,” Mr. Huntsman concluded.

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