Vivos Therapeutics, known for its medical devices addressing sleep-related breathing disorders (SRBDs) like obstructive sleep apnea (OSA), has received FDA 510(k) clearance for its oral medical device designed to treat moderate to severe OSA and snoring in children. This is the first such clearance for a device targeting this condition in the pediatric population.

Recent studies suggest that up to 10.1 million children in the U.S. (ages 6-17) are affected by pediatric OSA, a condition that has more than doubled in prevalence over the past decade.

Pediatric OSA is associated with a range of health issues, including ADHD, lower IQ, chronic allergies, mouth breathing, swollen tonsils and adenoids, dental problems, bedwetting, restless leg syndrome, and more.

ADHD symptoms are observed in up to 95% of children with OSA, often leading to treatment with psychotropic medications.

The standard treatment for pediatric OSA is usually surgical removal of adenoids and/or tonsils (adenotonsillectomy), though this procedure may not always prevent OSA from recurring in 21% to 73% of cases and has mixed long-term benefits.

CPAP therapy is less commonly used in children due to potential impacts on normal cranial and facial growth.

The Vivos DNA appliance, part of the CARE line, offers a non-invasive, comfortable, and affordable alternative for treating moderate to severe OSA in children aged 6 to 17.

The device not only targets snoring and OSA but also provides orthodontic benefits, representing a significant advancement over traditional treatments.

The FDA clearance is backed by a clinical trial involving pediatric patients aged 6-17. This study evaluated the Vivos DNA appliance's effect on airway expansion and OSA symptoms, showing a 50% reduction in symptoms like fatigue and snoring and a 62.7% improvement in apnea-hypopnea index (AHI) measurements.

Airway volumes increased by an average of 40%, with all results being statistically significant (p<0.0001). No safety concerns were reported.

With this clearance, Vivos is positioned to expand its market reach and address the needs of children with sleep-related breathing disorders.

Source: globenewswire.com

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