On Wednesday, the FDA granted 510(k) clearance to Vivos Therapeutics, Inc.’s 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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