Shares of the Highlands Ranch, Colo., company recently traded at $6.09, up 59%. The stock on Monday has traded up as much as 85% at $7.09. For 2021 through the close of Friday trading, the stock had fallen 35%.
“The U.S. Food and Drug Administration has granted 510(k) market clearance to Vivos’ mmRNA (modified mandibular repositioning nighttime appliance) device for treating mild to moderate obstructive sleep apnea, sleep-disordered breathing and snoring in adults,” the company said.
“This FDA clearance paves the way for expanded insurance reimbursement coverage for the mmRNA device, including Medicare, as well as for potential future government contracts and reimbursement from commercial payers that follow Medicare guidelines.”
More than 1 billion people globally and 54 million Americans suffer from sleep apnea, and 80% are undiagnosed, Vivos said.
Sleep apnea increases the risk of comorbidities, including high blood pressure, heart failure, stroke, diabetes, dementia and other life-threatening diseases, the company said.
“Vivos’s oral appliances address the dental tissue anomalies and malformations known to be associated with" obstructive sleep apnea, Vivos said.
"Unlike current standard-of-care interventions, patients treated with the Vivos system typically complete their therapy in 12 to 24 months and, in most cases, do not require lifetime intervention.”
In a separate action, the FDA denied Vivos’s previously submitted additional 510(k) application for its DNA appliance, the company said.
“The DNA appliance is already registered with the FDA as a Class I device for palatal expansion and is currently being used by Vivos-trained clinicians accordingly. Vivos expects to appeal the FDA’s decision or resubmit the 510(k) application in coming weeks.”