Vivos Therapeutics Inc announced it is seeing positive preliminary metrics after receiving US Food and Drug Administration (FDA) clearance in November for its CARE oral appliances to treat severe OSA in adults. 

The 510(k) clearance represents the first time the FDA has granted an oral appliance clearance to treat severe OSA.

Vivos reported that, during the fourth quarter of 2023, new dentist inquiries to participate in the Vivos Integrated Practice (VIP) program rose 600% over the previous month, and the VIP sales pipeline (meaning the number of dentists in VIP contract discussions) doubled. Signed VIP enrollment contracts increased by 38% sequentially compared to the third quarter of 2023.

In addition, average weekly CARE appliance orders increased 26% in the three weeks following the FDA clearance compared to the previous 12-week average for weekly sales for these same devices.

“Since announcing our new FDA clearance for severe OSA, we’ve seen a substantial increase in calls and inquiries from medical doctors, dentists, and patients regarding Vivos’ products,” says Kirk Huntsman chairman and CEO of Vivos, in a release. “We believe this significant uptick in business development and revenue-generating activity since achieving this important milestone highlights our overall value proposition across both the dental and medical communities as a highly effective treatment alternative for OSA patients.”

Huntsman adds in the release that the company, during the past few weeks, has also seen a 53% increase in sales of its pediatric-guided growth and development appliances, called Vivos Guides.

On Nov 28, Vivos was granted 510(k) clearance from the FDA for treating severe OSA in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances, along with positive airway pressure (PAP) and/or myofunctional therapy, as needed. Vivos’ CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance. 

Photo caption: Vivos’ mRNA oral appliance

Photo credit: Vivos Therapeutics