- Clinical trial results show Vivos Therapeutics' (VVOS, Financial) device reduces pediatric sleep apnea symptoms by 79%.
- FDA 510(k) clearance received for moderate to severe pediatric obstructive sleep apnea (OSA) treatment.
- Non-surgical alternative proves effective, with 93% of severe cases seeing at least a 50% symptom reduction.
Vivos Therapeutics, Inc. (VVOS), a leader in non-invasive treatments for obstructive sleep apnea (OSA), has announced pivotal clinical trial results published in the European Journal of Pediatrics. The trial demonstrates the efficacy of their Daytime-Nighttime Appliance (DNA) in treating pediatric OSA, highlighting a 79% improvement rate among patients. Furthermore, 61.7% of participants showed at least a 50% reduction in symptoms, with 17% achieving complete resolution.
Remarkably, children with severe OSA experienced a 93% improvement rate, with their symptoms decreasing by at least 50%. This non-surgical approach presents a substantial advancement over traditional adenotonsillectomy, which impacts over 500,000 children annually in the U.S., where 68% face symptom relapse within three years.
In September 2024, Vivos received FDA 510(k) clearance for the DNA device, allowing it to treat moderate to severe pediatric OSA. This regulatory milestone aligns with the company's strategic expansion, including its recent acquisition of the Sleep Center of Nevada, to increase patient access to this innovative treatment solution. The DNA device offers a reliable alternative to surgery, promoting natural jaw development to address airway obstruction without the risks associated with invasive procedures.
