Vivos Therapeutics Secures Medicare Approval for VidaSleep Oral Appliance

2025-07-01 09:04:02 ET

DENVER, Colo., Jul 01, 2025 ( 247marketnews.com )- Vivos Therapeutics (NASDAQ:VVOS) reported that the VidaSleep oral appliance has been officially approved by the Centers for Medicare & Medicaid Services (CMS) Pricing, Data Analysis and Coding (PDAC) contractor. The device, which incorporates Vivos’ patented and FDA-cleared Unilateral Bite Block technology , is now authorized for use in the treatment of mild to moderate OSA and snoring in adults.

With an estimated 80 million Americans affected by OSA , and more than 80% of cases undiagnosed , Vivos is positioned to address one of the most pressing unmet needs in U.S. healthcare. The CMS decision also has broader implications: Medicare coverage often leads to adoption by commercial payers , significantly expanding the company’s total addressable market.

The PDAC approval adds VidaSleep to the same CMS coverage list as the Vivos mmRNA appliance, unlocking reimbursable access to millions of Medicare beneficiaries seeking alternatives to traditional CPAP machines and surgical procedures. Vivos now stands alone as the only company with two Medicare-covered oral appliances , both offering distinct, patented technologies designed to address the root causes of OSA, giving providers and patients multiple clinically validated and financially accessible treatment paths.

Kirk Huntsman, CEO and Chairman of Vivos Therapeutics, stated, “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. While mmRNA remains our premium solution for complex cases, VidaSleep delivers positive clinical outcomes through an optimized design that maximizes accessibility—proving that ‘cost-effective’ doesn’t mean ‘compromise.’ This dual-device approach allows us to serve every tier of the estimated $36 billion sleep therapy market, from Medicare beneficiaries to commercial payers, while maintaining our compelling gross profit margins. Just as importantly, it empowers thousands more clinicians to adopt our technology, knowing they now have multiple reimbursed options to match patient needs.”

The VidaSleep appliance employs Vivos’ proprietary Unilateral Bite Block technology for targeted airway support, while the mmRNA appliance is part of the FDA-cleared Vivos CARE product line , designed for moderate to severe OSA in both adults and children.

With this latest regulatory milestone, Vivos continues to solidify its role as a leader in non-invasive, next-generation OSA therapies, offering clinicians and patients broader access, flexibility, and confidence in treatment outcomes.

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