On Wednesday, the FDA granted 510(k) clearance to Vivos Therapeutics, Inc.’s (NASDAQ: VVOS ) flagship oral medical device, which is used to treat moderate to severe obstructive sleep apnea (OSA) and snoring in children .

Recent published studies report up to 10.1 million U.S. children (ages 6-17) are estimated to suffer from pediatric OSA.

Vivos’ DNA appliance is non-invasive, safe, comfortable, affordable, and highly effective. It is designed to reduce nighttime snoring and treat moderate to severe obstructive sleep apnea in children aged 6 to 17.

The Vivos device is intended for those diagnosed with snoring and/or OSA requiring orthodontic treatment.

Also Read: What’s Going On With Vivos Therapeutics Stock?

Vivos believes this breakthrough regulatory clearance represents a huge opportunity to capture significant market share.

Further, Vivos believes it can immediately leverage this FDA clearance by quickly integrating pediatric care into its new provider-based marketing and distribution model and scale revenue relatively quickly with minimal investment.

The FDA approval was based on results from Groundbreaking Clinical Trial in Children with OSA. Forty-eight patients completed the study.

Symptoms of sleep-related breathing disorders (SRBD) (such as fatigue, lack of attention, and snoring) decreased from 0.28 to 0.14 (a reduction of 50%), while snoring decreased by 58%.

The improvement in moderate and severe AHI measurements was 62.7%. 96% of patients improved or stayed the same, while 92% improved by greater than 50% or 1 classification in the moderate and severe categories.

100% of the severe patients achieved this milestone. Airway volumes increased by 40% on average.

In November, Vivos received FDA 510(k) clearance for treating severe OSA in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances .

Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance.

Vivos became the first company ever to have approved and brought to market a clear alternative treatment to continuous positive airway pressure (CPAP) or surgical neurostimulation implants for patients with severe OSA.

Price Action: VVOS stock is up 37.80% at $3.86 at the last check Wednesday.

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This article Vivos Therapeutics Says It Is Poised To Disrupt Pediatric Sleep Apnea Market, Secures FDA Approval For DNA Appliance To Treat Snoring In Children originally appeared on Benzinga.com

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