Vivos Therapeutics (NASDAQ:VVOS) announced that it has received US Food and Drug Administration (FDA) approval to treat moderate to severe obstructive sleep apnea (OSA) in children aged 6 to 17 using its proprietary oral medical device.
This non-invasive, orthodontic-based solution offers an alternative to traditional treatments like adenotonsillectomy, which may not always be effective long-term.
Pediatric OSA is linked to several health conditions, including ADHD, asthma, and obesity.
Vivos Therapeutics (NASDAQ:VVOS) believes the FDA 510(k) is the first time any oral medical device has ever been approved to treat moderate to severe OSA in children.
“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 CEO Kirk Huntsman said in a statement.
The approval was based on a multi-site, multi-nation study of the device in pediatric patients.
It showed a significant improvement in OSA symptoms, with a 62.7% reduction in apnea-hypopnea index (AHI) and no safety concerns.
Huntsman added that the FDA clearance is the latest in a series of regulatory wins for Vivos.
“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.”
He added that the company’s recently announced alliance-based marketing and distribution model has the potential to widen the funnel of potential OSA patients it works with.
“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,” the CEO said.
“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.”