Why Vivos Therapeutics (VVOS) Shares Are Skyrocketing Wednesday

Vivos Therapeutics Inc VVOS shares are trading higher by 85.14% to after the company announced it received FDA 510(k) clearance for its DNA oral appliance for the treatment of obstructive sleep apnea.

Vivos says the clinical data submitted to the FDA as part of the clearance process for the DNA included pre- and post-treatment Apnea Hypopnea Index (AHI) scores obtained with no appliance in the mouth, demonstrating that:

• 28% of patients had their OSA resolved
• 63% of patients improved by one AHI classification (i.e., severe to moderate, moderate to mild, or mild to no OSA)
• 86% of patients improved their airway size
• 97% of patients increased the width of their palate which allows the tongue to rest in proper position, thus avoiding a potential airway obstruction

"This clearance is the culmination of years of pioneering clinical work," said Kirk Huntsman, Vivos' Chairman and Chief Executive Officer. "For the first time, the FDA has formally recognized the benefits of our proprietary core technology in our DNA appliance (without mandibular advancement) as an effective treatment for mild-to-moderate OSA in adults."

"The FDA now joins other international regulatory bodies in recognizing the efficacy of our patented technology in the reduction and resolution of many of the symptoms of OSA that result from a lack of development of the jaws and oral cavity. We believe the DNA treatment can be life changing for many OSA patients, and we look forward to continued market adoption of our expanded menu of treatments for this debilitating condition," Huntsman stated.

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According to data from Benzinga Pro, VVOS has a 52-week high of $3.69 and a 52-week low of $0.34.