Vivos Therapeutics Inc (NASDAQ:VVOS) found its stock soaring in Monday’s first hour, on clearance to its newest product by the U.S. Food and Drug Administrsation (FDA)
The product in question is an mmRNA (modified mandibular Repositioning Nighttime Appliance) obstructive sleep apnea (OSA) device.
The device is indicated for mild to moderate OSA, sleep-disordered breathing, and snoring in adults. The approval paves the way for expanded insurance reimbursement coverage for the mmRNA device and potential future government contracts and reimbursement.
Separately, the FDA has denied Vivos’ previously submitted, additional 510(k) application for its DNA appliance.
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 to the FDA in the coming weeks.
More than one billion people globally and 54 million Americans suffer from sleep apnea, 80% of whom remain undiagnosed. A serious chronic illness, sleep apnea increases the risk of comorbidities, including high blood pressure, heart failure, stroke, diabetes, dementia and other life-threatening diseases.
Vivos’ oral appliances address the dental tissue anomalies and malformations known to be associated with OSA. 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.
VVOS shares are climbing $2.60, or 67.7%, at $6.44 Monday.