Medical device company Vivos Therapeutics has received the US Food and Drug Administration (FDA) 510(k) clearance for its oral medical device to treat moderate to severe obstructive sleep apnoea (OSA) and snoring in children aged six to 17.
Nasdaq-listed Vivos Therapeutics is focused on developing and commercialising treatments for sleep-related breathing disorders (SRBDs).
The Vivos method combines complete airway repositioning and/or expansion (CARE) with other oral appliance therapies and adjunctive treatments.
It was first cleared in November 2023 for adults with OSA.
The DNA appliance is part of its CARE line of advanced OSA treatment solutions.
According to Vivos Therapeutics, the device provides clinical advantages over current therapies for moderate to severe paediatric OSA. This non-invasive device is safe, comfortable, affordable, and effective.
The Vivos device is ideal for those diagnosed with snoring and/or OSA who also need orthodontic treatment.
It reduces nighttime snoring and addresses moderate to severe obstructive sleep apnoea.
The medical device firm said the regulatory clearance will provide effective alternatives through partnerships with medical sleep care professionals.
Additionally, the company plans to integrate paediatric care into its new provider-focused marketing and distribution model.
Vivos Therapeutics chairman and CEO Kirk Huntsman said: “This clearance is the latest in a series of regulatory wins for Vivos, not just in the US, 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.”
The approval was based on results from a multi-site, international study. It assessed how the device increases pharyngeal airway size, potentially reducing OSA symptoms and promoting nasal breathing.
The study involved 48 participants with an average age of 10.6 years. Results showed that SRBD symptoms decreased from 0.28 to 0.14, marking a 50% reduction, while snoring decreased by 58%.
Improvements in moderate and severe apnoea-hypopnea index (AHI) measurements reached 62.7%.
96% of patients either improved or remained stable, and 92% experienced over a 50% improvement in severity classifications.
Average airway volume increased by 40%. All findings were statistically significant, and no safety concerns were reported.
