Vivos Therapeutics, Inc.

Vivos Therapeutics manufactures FDA-cleared oral appliances for the treatment of obstructive sleep apnea (OSA) in adults and children. The company's primary product line consists of the Vivos CARE appliances (DNA, mRNA, mmRNA models), which are non-surgical, time-limited alternatives to CPAP therapy and other conventional OSA treatments. The DNA appliance is FDA 510(k) cleared (K234089) for moderate-to-severe pediatric OSA in ages 6–17 requiring orthodontic treatment. The mRNA and mmRNA appliances are FDA 510(k) cleared (K230947) for mild-to-severe OSA in adults. Unlike CPAP machines, which manage symptoms through continuous air pressure, Vivos appliances are designed to rehabilitate and restore proper airway form and function, with treatment typically lasting 9–12 months and designed to achieve lasting improvement or resolution. Clinical data reports 75,000+ patients treated and 60+ peer-reviewed studies supporting the approach. The company markets to both adult and pediatric populations through a network of certified providers and emphasizes insurance coverage via pre-authorization. Vivos serves the homecare and personal medical device market, positioning its appliance as a permanent solution alternative to lifetime nightly therapy.