mmRNA is the first and only appliance of its kind covered by Medicare
Part of the Vivos System treatment, the mmRNA appliance represents a highly effective, nonsurgical, noninvasive, and nonpharmaceutical alternative for patients suffering from OSA and snoring.
Colorado, December 14, 2021
Vivos Therapeutics, Inc. (“Vivos” or “the Company”) (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from mild to moderate obstructive sleep apnea (OSA) and snoring, today announced that it has received acceptance from a Centers for Medicare & Medicaid Services Pricing, Data Analysis and Coding (“PDAC”) contractor for its mmRNA (modified mandibular Repositioning Nighttime Appliance) device for treating mild to moderate OSA and snoring in adults. This acceptance places the mmRNA device on the PDAC list of oral appliances covered by and billable to Medicare.
This development immediately makes benefits of the mmRNA device available to millions of Medicare beneficiaries who seek effective treatment for mild to moderate OSA. The mmRNA is the first and only appliance on the PDAC list that offers patients the compelling clinical advantages of Vivos’ proprietary technology.
Acceptance on the PDAC list marks a positive leap toward increasing commercial insurance coverage, making the mmRNA appliance a cost-effective solution for non-Medicare beneficiaries. With its novel design, the mmRNA appliance also allows Vivos-trained dentists to help patients in a variety of clinical applications, such as a standalone therapy for mild to moderate OSA or as an alternative to or an adjunctive therapy with continuous positive airway pressure (CPAP) therapy.
“This latest regulatory milestone opens the door for Vivos-trained dentists across the country to deliver our life-changing therapeutic technology to the millions of OSA sufferers in the US who are either on Medicare or who have commercial medical insurance coverage that follows Medicare guidelines,” said Kirk Huntsman, Vivos CEO and chairman. “The latest data from our SleepImage home sleep apnea test screening shows that 47% of patients screened were positive for OSA, a far higher prevalence of OSA than has previously been assumed in the industry.”
More than 1 billion people globally and 54 million Americans suffer from sleep apnea, 80 percent 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 nonsurgically address the dental tissue anomalies and malformations known to be associated with OSA. Unlike current standard-of-care interventions, such as lifetime use of CPAP machines or surgical procedures, patients treated with the Vivos System typically complete their therapy in 12 to 24 months, and in many cases do not require further intervention.