On September 18, 2024, Vivos Therapeutics, Inc., a medical device and technology company, announced the receipt of a U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary CARE oral medical device to treat moderate to severe obstructive sleep apnea (OSA) in children aged 6 to 17. This groundbreaking clearance marks the first time an oral medical device has been approved for such treatment in children. The FDA's decision is based on a multi-site, multi-nation clinical trial that showed significant improvements in patients' conditions, with a 62.7% improvement in moderate and severe apnea-hypopnea index (AHI) measurements and a 40% average increase in airway volumes. Vivos Therapeutics believes this approval opens a new market opportunity and plans to leverage its new...Show More

On September 18, 2024, Vivos Therapeutics, Inc., a medical device and technology company, announced the receipt of a U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary CARE oral medical device to treat moderate to severe obstructive sleep apnea (OSA) in children aged 6 to 17. This groundbreaking clearance marks the first time an oral medical device has been approved for such treatment in children. The FDA's decision is based on a multi-site, multi-nation clinical trial that showed significant improvements in patients' conditions, with a 62.7% improvement in moderate and severe apnea-hypopnea index (AHI) measurements and a 40% average increase in airway volumes. Vivos Therapeutics believes this approval opens a new market opportunity and plans to leverage its new provider-based marketing and distribution model to scale revenue. The company's DNA appliance, part of the CARE line, is non-invasive, comfortable, and designed to treat OSA in children who also require orthodontic treatment. Vivos is collaborating with sleep treatment providers to promote its appliances and expects this to positively impact new case starts, revenue growth, and gross profit.