Vivos Therapeutics, Inc. is celebrating a significant milestone with the FDA’s recent 510(k) clearance for its flagship oral medical device, designed to treat moderate to severe obstructive sleep apnea (OSA) and snoring in children. This clearance is a game-changer for Vivos, opening doors to a vast market of young patients struggling with sleep disorders.
Recent studies estimate that up to 10.1 million U.S. children between the ages of 6 and 17 suffer from pediatric OSA. Vivos’ DNA appliance offers a safe, comfortable, and highly effective non-invasive solution. This device is designed to reduce nighttime snoring and treat OSA in children, making it a viable alternative to traditional treatments that can be invasive and uncomfortable.
Vivos’ device is specifically intended for children diagnosed with snoring and/or OSA requiring orthodontic treatment. The company believes this FDA clearance represents a significant opportunity to expand its market share. Vivos plans to leverage this clearance by quickly integrating pediatric care into its existing provider-based marketing and distribution model, allowing for a rapid increase in revenue with minimal investment.
The FDA approval was based on robust clinical trial results in children with OSA. Forty-eight patients participated in the study, demonstrating substantial improvements in sleep-related breathing disorders (SRBD). Symptoms such as fatigue, lack of attention, and snoring significantly decreased. Snoring was reduced by an impressive 58%, while the improvement in moderate and severe AHI measurements was a remarkable 62.7%.
The study also revealed that 96% of patients experienced improvement or maintained their current status, with 92% showing an improvement of greater than 50% or one classification in the moderate and severe categories. A significant 100% of severe patients achieved this milestone. Airway volumes also showed significant improvements, increasing by an average of 40%.
This latest FDA clearance builds upon Vivos’ previous success in November when they received clearance for treating severe OSA in adults using their Vivos CARE (Complete Airway Repositioning and/or Expansion) oral appliances. The company’s CARE appliances include the flagship DNA appliance, the mRNA oral appliance, and the mmRNA oral appliance.
Vivos has established itself as a pioneer in the field, becoming the first company ever to develop and bring to market a clear alternative treatment to continuous positive airway pressure (CPAP) or surgical neurostimulation implants for patients with severe OSA.
Following this positive news, VVOS stock surged by 37.80% to $3.86 at the last check on Wednesday. This reflects the market’s strong confidence in Vivos’ potential to revolutionize the treatment of OSA in both children and adults.
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