FDA Clears Vivos Therapeutics Pediatric Sleep Apnea and Snoring Device

Vivos Therapeutics, a leading medical device and technology company specializing in the development and commercialization of proprietary treatments for sleep related breathing disorders (SRBDs), including obstructive sleep apnea (OSA), received U.S. Food and Drug Administration (FDA) 510(k) clearance to treat moderate to severe OSA and snoring in children using Vivos’ proprietary flagship oral medical device.
 
Vivos’ DNA appliance, which is part of its CARE line of advanced OSA treatment appliances, offers significant clinical advantages over existing therapies for moderate to severe pediatric OSA. 
 
It is non-invasive, safe, comfortable, affordable, and highly effective. Designed to reduce nighttime snoring and treat moderate to severe obstructive sleep apnea in children aged 6 to 17, this Vivos device is intended for those diagnosed with snoring and/or OSA who also require orthodontic treatment.
 
Kirk Huntsman, Chairman and CEO of Vivos, said, “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. 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.”
 
Vivos continues to experience consistently high levels of case acceptance across a wide range of patient demographics as it executes its recently announced marketing and distribution plan which is driven by alliances with medical sleep care professionals. 
 
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.
 
Huntsman added, “Our recently announced alliance-based marketing and distribution model has the potential to widen the funnel of potential OSA patients we see. In our new strategic business model where we work closely with medical and dental providers, we already see significant opportunities opening up to treat multiple family members of all ages. When Vivos teams up with medical professionals who treat OSA, and when parents are fully informed as to the health risks of untreated OSA on their children, we believe they will overwhelmingly choose Vivos technology over other treatment options.”
 
Vivos’ device underwent a multi-site, multi-nation, controlled, prospective study in pediatric patients (6-17 years of age) which served as the basis for this FDA approval. his study examined the effect of Vivos’ DNA oral medical device on increasing the pharyngeal airway, potentially reducing symptoms of OSA, and encouraging nasal breathing. 
 
Diagnosis of SRBD, including snoring, upper airway resistance syndrome, and OSA, and the need for orthodontic treatment was confirmed by clinical evaluation, orthodontic exam, a Pediatric Sleep Questionnaire, and a sleep study by the dentist and sleep physician. 
 
Each patient served as their own control, with measurements taken before and after treatment with the same devices, scorers, and questionnaires under the auspices of the WRG Institutional Review Board. All apnea-hypopnea index (AHI) measurements (a measurement that helps doctors determine the severity of OSA) were taken with no device in the mouth.
 
“As we continue to expand beyond dentists and move more directly and vertically into affiliations and collaborations with medical specialists, functional medicine doctors, and other sleep-related healthcare practitioners, we expect this to positively impact our new case starts, revenue growth and gross profit,” Huntsman concluded.