Vivos Therapeutics, Inc. announced that Vivos is seeing positive preliminary metrics following its November 28, 2023 announcement regarding FDA 510(k) clearance of its CARE oral medical devices 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. On November 28, 2023Vivos was granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for treating severe OSA in adults using the Vivos? removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances.

Vivos? CARE appliances include the DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance. This represents the first time the FDA has ever granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.