Following a significant regulatory development, shares of Vivos Therapeutics, Inc. (NASDAQ: VVOS) increased significantly on Tuesday. VVOS stock was up 22.15% to $3.86 as of the last hour of trade. The spike follows the company’s big expansion of access to its oral appliance therapy with a major endorsement from the Centers for Medicare & Medicaid Services (CMS).
CMS PDAC Approval Broadens Market Reach
Vivos Therapeutics said that CMS’ Pricing, Data Analysis and Coding (PDAC) contractor has authorized its recently developed VidaSleep oral appliance, which has its unique Unilateral Bite Block technology and has been approved by the U.S. Food and Drug Administration (FDA). The device is currently covered by Medicare for the treatment of adult snoring and mild to moderate obstructive sleep apnea (OSA).
This approval positions VidaSleep alongside the company’s mmRNA appliance on the PDAC list, making Vivos the only company with two Medicare-reimbursable oral devices for OSA that feature proprietary technologies. With approximately 80 million Americans affected by OSA—80% of whom remain undiagnosed—Medicare coverage dramatically expands the company’s potential to serve a vastly underserved patient population.
Strategic Positioning Across the Sleep Therapy Market
Vivos’ dual-device strategy addresses diverse clinical and economic needs within the estimated $36 billion U.S. sleep therapy market. The recently authorized VidaSleep is intended for cost-conscious deployment, improving accessibility without compromising treatment quality, whereas the mmRNA device is a premium option for difficult OSA situations. Both devices can be used in combination with CPAP machines or as standalone therapy.
Implications for Providers and Payers
The PDAC approval is expected to strengthen provider adoption, giving clinicians more flexibility and reimbursement certainty. Moreover, the Medicare nod is likely to encourage broader private insurer coverage, further amplifying the addressable market for Vivos’ innovative solutions. The company’s efficient manufacturing and scalable design keep margins strong while delivering effective care to a wider patient base, reinforcing its leadership in value-based sleep health innovation.
