Vivos Therapeutics Announces European Journal Of Pediatrics Publishes Results Of Multicenter Clinical Trial Results For Treatment Of OSA In Children Using Vivos' Patented Daytime-Nighttime Appliance

Vivos Therapeutics, Inc. ("Vivos" or the "Company") (NASDAQ:VVOS), a leader in proprietary, non-invasive treatments for obstructive sleep apnea (OSA), today announced that the European Journal of Pediatrics has published the results of a groundbreaking multicenter clinical trial evidencing positive results for the treatment of OSA in children using Vivos' patented Daytime-Nighttime Appliance (DNA).

The study importantly noted that "This is the first study demonstrating that the [Vivos DNA] device is safe and efficacious in treating children with OSA." In September 2024, Vivos received an unprecedented FDA 510(k) clearance for the DNA device to treat moderate to severe OSA in children. This latest study confirms and reinforces the safety and efficacy underlying that clearance.

In the study, 79% of patients showed OSA improvement, with 61.7% improving by 50% or more, and 17% experiencing resolution of their OSA. Ninety three percent (93%) of children in the study with severe OSA saw their symptoms decrease by at least 50%. There were no safety issues or concerns. The study examined recognized endpoints for measuring treatment of OSA, including a Pediatric Sleep Questionnaire (PSQ), apnea-hypopnea index (AHI), and intermolar width. Forty-seven participants were included in the analytic dataset following trial completion after 12–24 months.