Medical technology company Vivos Therapeutics (OTCMKTS:RDGL), on September 20, 2021, announced that the US Food and Drug Administration had allowed market clearance to Vivos’ mmRNA device to treat mild to moderate sleep-related breathing as well as snoring in adults.
Vivos focuses on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from sleep-disorder breathing. The FDA clearances enable the firm to expand insurance reimbursement coverage for the mmRNA device.
Over a billion people globally and more than 54 million Americans have issues from sleep apnea with 80 percent remaining undiagnosed. Chronic illness increases the risk of comorbidities including heart failure, high blood pressure as well as other life-threatening diseases. Patients getting treatment from Vivos System will finish therapy in 12 to 24 months with most not requiring lifetime intervention.
Kirk Huntsman, Vivos Chairman, and CEO, said that the clearance from FDA demonstrates a huge milestone in its efforts of providing the best treatment to people suffering from a debilitating condition.
Vivos also announced submitting Investigational Device Exemption for The Early Feasibility Medical Device Study, First in Human Study for Y-90 RadioGel to the Food and Drug Administration. The filing is a vital milestone for the firm and shows the efforts of a number of parties.