Pediatric Obstructive Sleep Apnea (OSA) treatment

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Vivos Therapeutics Announces Landmark Clinical Trial Results in Pediatric Obstructive Sleep Apnea Treatment
Globenewswire· 2025-09-17 12:30
Core Insights - Vivos Therapeutics has published peer-reviewed data confirming the safety and efficacy of its Vivos DNA appliance in treating pediatric obstructive sleep apnea (OSA) [1][2][4] - The study highlights a significant milestone in addressing pediatric OSA, a condition affecting up to 20.4% of U.S. children, with many remaining undiagnosed [3][10] Group 1: Clinical Trial Results - The multicenter clinical trial results published in the European Journal of Pediatrics show that 77% of participants experienced at least a 50% reduction in OSA severity [7] - Among children with severe OSA, 93% achieved a 50% reduction in severity, and 17% of patients experienced complete resolution of their OSA [7] - The average airway volume increased by 67.8%, and Pediatric Sleep Questionnaire symptom scores decreased by 31%, indicating statistically significant improvement [7] Group 2: Treatment Alternatives - The Vivos DNA appliance is positioned as a non-surgical alternative to the current standard of care, which is adenotonsillectomy (AT) surgery, effective in only 20-40% of pediatric cases [3][4] - Vivos also offers Vivos Guides, which support proper craniofacial growth and have shown to alleviate symptoms associated with underdeveloped jaw growth, including ADHD behaviors and bedwetting [6][15] - Clinical data indicates that Vivos Guides can virtually eliminate bedwetting in children, with 50% seeing results within two weeks and 97.4% resolving within 60 days [6] Group 3: Industry Context - OSA affects over 1 billion people globally, with 90% undiagnosed, linking it to serious chronic health conditions [10] - Vivos Therapeutics aims to address the complex needs of OSA patients through innovative technology and collaborations with healthcare providers [11] - The company’s Complete Airway Repositioning and Expansion (C.A.R.E.) devices are the only FDA-cleared technology for treating severe OSA in adults and moderate to severe OSA in children [9]