Vivos Therapeutics (NASDAQ: VVOS), a leading medical-device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep-related breathing disorders (“SRBDs”) including obstructive sleep apnea (“OSA”) has received breakthrough clearance from the U.S. Food and Drug Administration (“FDA”). According to the announcement, the company has received approval to use its Vivos proprietary oral medical device to treat moderate to severe OSA and snoring in children; the company believes this is the first time the FDA has given 510(k) clearance for this type of treatment for children aged 6 to 17 years of age.
Current standard treatment for OSA in children is the surgical removal of adenoids and tonsils; however, following surgery, OSA can persist in 21% to 73% of children, with research showing mixed long-term benefits. In addition, children don’t often use continuous positive airway pressure (“CPAP”) devices because of potential negative effects on cranial and facial growth. The FDA approval was given following reported positive results from a multisite, multination, controlled, prospective study showing pediatric patients aged 6-17 years old benefitting from using Vivos’ flagship DNA oral medical device.
“The FDA 510(k) clearance announced today is, to our knowledge, the first time any oral medical device has ever been approved to treat moderate to severe OSA in children,” said Vivos chair and CEO Kirk Huntsman in the press release. “This clearance is the latest in a series of regulatory wins for Vivos, not just in the United States but globally. It represents the culmination of a growing body of research and regulatory approvals confirming and validating the extraordinary potential and efficacy of our proprietary Vivos technology. In addition, this landmark clearance opens up an exciting and vast new market and enables us to directly address the needs of millions of children who currently suffer from sleep-related breathing disorders such as OSA.”
To view the full press release, visit https://ibn.fm/rJxPI
About Vivos Therapeutics Inc.
Vivos Therapeutics is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (“OSA”) and snoring. The Vivos Method (comprised of Vivos’ Complete Airway Repositioning and/or Expansion [“CARE”] and other oral appliance therapy combined with adjunctive therapies) represents the first clinically effective nonsurgical, removable, nonpharmaceutical and cost-effective solution for treating mild to severe OSA in adults and moderate to severe OSA in children. It has proven effective in more than 45,000 patients treated worldwide by more than 2,000 trained dentists. The Vivos Method includes treatment regimens that employ the proprietary CARE appliance therapy and other appliances that alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and/or palate. The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild-to-severe OSA in adults, such as lowering Apnea Hypopnea Index scores. Vivos also employs a marketing and distribution model where it collaborates with sleep-treatment providers to offer patients OSA treatment options and help promote sales of its appliances. For more information about this company, visit www.VivosLife.com.
NOTE TO INVESTORS: The latest news and updates relating to VVOS are available in the company’s newsroom at http://ibn.fm/VVOS
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