Vivos Therapeutics Receives Groundbreaking FDA 510(k) Clearance to Treat Moderate to Severe Pediatric Sleep Apnea and Snoring

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Vivos is poised to disrupt the very significant pediatric obstructive sleep apnea (OSA) market with new FDA clearance and new strategic marketing and distribution model Vivos’ DNA appliance now approved to reduce snoring and treat moderate to severe OSA in children aged 6 to 17 LITTLETON, Colo. , Sept. 18, 2024 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), 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), today announced receipt of what is believed to be the first ever 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. A Silent Epidemic: The Hidden Impact of Pediatric OSA Recent published studies report up to 10.1 million U.S. children (ages 6-17) are estimated to suffer from pediatric OSA, a condition often classified as an SRBD. This represents more than a doubling of U.S. children with OSA over the past decade. (1) Children with moderate to severe OSA often experience a myriad of other serious health conditions such as ADD / ADHD, lower IQ, chronic allergies, mouth breathing, swollen tonsils and adenoids, dental malocclusion, bedwetting, restless leg syndrome, aggression, anxiety, depression, night terrors, sleep fragmentation, obesity, asthma, and more. ADHD symptoms have been reported in up to 95% of pediatric OSA patients, who are often treated with psychotropic drugs. (2) The current medical standard for first-line intervention in pediatric OSA is the surgical removal of adenoids and / or tonsils (Adenotonsillectomy, or AT surgery). However, after AT surgery, OSA may relapse or persist in 21% to 73% of children, and some studies have shown mixed or questionable long-term benefit. (3) Moreover, CPAP usage in children is not widely prescribed, due to potential negative impacts on a child’s normal cranial and facial growth. Vivos' Breakthrough Treatment Offers New Hope for Parents and Children with OSA 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. Vivos believes this breakthrough regulatory clearance represents a huge opportunity to capture significant market share in a sector that is desperate for innovation and effective alternatives. 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. 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. Kirk Huntsman , Chairman and CEO of Vivos, stated, “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.” Mr. Huntsman continued, “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.” “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,” Mr. Huntsman concluded. Results from Groundbreaking Clinical Trial in Children with OSA A multi-site, multi-nation, controlled, prospective study in pediatric patients (6-17 years of age) served as the basis for this FDA approval. This 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 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. Forty-eight patients (with a mean age 10.6 years, and ranging from 4.5-14.8 years) completed the study. Symptoms of 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%. Ninety-six percent (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. All values were highly statistically significant (p

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