Vivos Therapeutics, Inc. (NASDAQ: VVOS) is seeing a notable increase in its stock value on the US stock charts today, up 22.14% to $3.42 as of the latest pre-market check. This substantial gain follows the recent announcement of a pivotal regulatory approval.
Vivos Received Breakthrough FDA Clearance
With the help of its patented oral medical device, Vivos Therapeutics has received what is regarded as the first-ever FDA 510(k) approval for treating moderate to severe obstructive sleep apnea (OSA) and snoring in children. With its approval, the range of treatments for children sleep problems has significantly expanded.
Prevalence and Impact of Pediatric OSA
Based on recent research, 10.1 million children in the United States between the ages of 6 and 17 suffer with pediatric OSA, which falls under the category of sleep-related breathing disorders (SRBD). This number represents the more than doubling of instances throughout the previous ten years. Notably, up to 95% of juvenile OSA patients have signs of attention deficit disorders (ADD/ADHD), for which psychiatric drugs are commonly used as a treatment.
Market Opportunity and Strategic Plans
Current standard treatments for pediatric OSA typically involve surgical removal of adenoids and/or tonsils (adenotonsillectomy). However, this approach has shown a relapse rate of 21% to 73% and mixed long-term benefits.
Additionally, continuous positive airway pressure (CPAP) therapy is not widely recommended for children due to potential adverse effects on normal cranial and facial development. Vivos Therapeutics views this FDA clearance as a major opportunity to capture a substantial market share in a field in dire need of innovative and effective treatments.
The company plans to capitalize on this regulatory achievement by integrating pediatric care into its new provider-based marketing and distribution model. This strategy aims to rapidly scale revenue with minimal investment, leveraging Vivos’ strong case acceptance and its alliances with medical sleep care professionals.
Global Impact and Future Prospects
This FDA clearance is the latest in a series of regulatory successes for Vivos Therapeutics (VVOS), extending beyond the U.S. to global markets. It underscores the growing recognition of Vivos’ technology and opens up a vast new market for addressing the needs of millions of children suffering from sleep-related breathing disorders such as OSA.
