Vivos Therapeutics Inc. (NASDAQ:VVOS) saw its stock soar by 90% following a major regulatory win: the company’s VidaSleep oral appliance has secured approval from the Centers for Medicare & Medicaid Services (CMS) for the treatment of obstructive sleep apnea (OSA) and adult snoring.
The approval comes from CMS’s Pricing, Data Analysis, and Coding (PDAC) contractor, effectively placing VidaSleep among the limited group of oral devices eligible for Medicare reimbursement. This marks a significant milestone for Vivos, which now becomes the only company offering two distinct oral appliances—VidaSleep and the mmRNA device—both covered by Medicare and built on separate patented platforms.
VidaSleep incorporates the firm’s proprietary Unilateral Bite Block technology and previously received clearance from the U.S. Food and Drug Administration (FDA) for use in mild to moderate OSA cases. Analysts note that the CMS nod could have broader implications, as commercial insurers often align their coverage policies with Medicare decisions, potentially widening access to the device in the $36 billion sleep therapy market.
“The PDAC approval of VidaSleep is another milestone achievement for Vivos, strategically positioning us to significantly augment our presence in the value-based care segment of the sleep apnea market,” said Kirk Huntsman (NYSE:HUN), CEO and Chairman of Vivos Therapeutics.
The company emphasized that VidaSleep provides an affordable yet clinically effective treatment alternative. This flexibility enables providers to serve a broad range of patient needs while maintaining healthy profit margins. Both VidaSleep and mmRNA are designed to function independently or in conjunction with CPAP machines.
Obstructive sleep apnea remains a widespread health concern, impacting an estimated 80 million Americans. Alarmingly, nearly 80% of those cases go undiagnosed. The condition is associated with heightened risks for serious ailments such as cardiovascular disease, stroke, and neurodegenerative disorders like dementia.