Vivos Therapeutics Gets FDA 510(k) Clearance To Treat Pediatric Sleep Apnea, Snoring; Stock Up

(RTTNews) - Vivos Therapeutics, Inc. (VVOS) announced on Wednesday that it has obtained 510(k) clearance from the FDA for its DNA oral medical device aimed at treating moderate to severe obstructive sleep apnea and snoring in children. The stock is currently up by 17% in pre-market trading.

The FDA's approval follows a multi-site clinical trial that demonstrated significant improvements in children aged 6 to 17 in symptoms of obstructive sleep apnea and airway volumes using the company's DNA appliance. Key results from the study show a 50% reduction in sleep-related breathing disorder symptoms, a 58% decrease in snoring, a 62.7% improvement in moderate and severe AHI measurements, and a 40% increase in airway volumes.

The company stated that this marks what is believed to be the first clearance for an oral medical device targeting pediatric OSA treatment.

In pre-market activity on the Nasdaq, the shares are trading at $3.19, up 17.50%.