Vivos Therapeutics announces additional data from use of Vivos DNA device

Vivos Therapeutics (VVOS) released previously unpublished clinical data confirming that treatment with Vivos’ FDA-cleared Daytime-Nighttime Appliance can provide children with Attention-Deficit/Hyperactivity Disorder and OSA significant relief and improvement in their quality of life. Vivos’ DNA appliance is the only FDA 510k cleared non-surgical, non-pharmaceutical treatment for moderate to severe pediatric OSA in children ages 6-17, and is increasingly seen as a viable alternative to adenotonsillectomy surgery for OSA. The DNA appliance is part of Vivos’ Complete Airway Repositioning and Expansion line of devices cleared by the FDA to treat OSA in both children and adults. The diagnosed rates of ADHD in the United States have roughly quadrupled since the 1980s-from an estimated 2-3% of school-aged children to just over 11% by 2022, according to the Centers for Disease Control and Prevention. The prevalence of OSA in a preschool pediatric population similarly increased from 3 – 9% before 2014, to 13 – 20% by 2022. Children with OSA are often misdiagnosed as having ADHD due to the bidirectional nature and overlap of these two conditions in the pediatric population. Multiple studies show a strong link between pediatric OSA and the incidence of ADHD symptoms, with attention deficits reported in up to 95% of pediatric OSA patients. Other studies show moderate to severe pediatric OSA patients are most likely to exhibit ADHD symptoms. By 2022, an estimated 7.1 million U.S. children and adolescents had been diagnosed with, according to the CDC. Multiple studies have shown that treatment for OSA can dramatically reduce or eliminate ADHD symptoms. In this current dataset just released by Vivos, children treated with the Vivos DNA appliance reported a 50% decrease in the validated Pediatric Sleep Questionnaire, which measures snoring, sleep apnea, and restless legs. Moreover, these children showed a 58% decrease in symptoms of sleep disordered breathing and ADHD symptoms such as disruptive behavior and hyperactivity. Forty-eight of the original 55 patients completed the clinical trial. There were 28 males and 20 females, with an average age of 10.6 years. As expected from previous studies, 100% of patients increased both their transpalatal width and their airway volume, while the severity of their OSA decreased by 51.4%. All improvements were statistically significant.