Vivos Therapeutics, Inc, a pioneering medical technology company revolutionizing the treatment of obstructive sleep apnea (OSA) and snoring, today announced that its VidaSleep™ oral appliance, featuring Vivos’ patented and U.S. Food and Drug Administration (FDA) cleared Unilateral Bite Block technology, has been approved by the Centers for Medicare & Medicaid Services (CMS) Pricing, Data Analysis and Coding (PDAC) contractor for the treatment of mild to moderate OSA and snoring in adults.

With over 80% of OSA cases in the United States undiagnosed and an estimated 80 million Americans affected, Vivos’ comprehensive portfolio of OSA treatments is poised to capture a significant share of the underpenetrated sleep therapy market. Medicare coverage opens the door to commercial payers that follow CMS guidelines, amplifying Vivos’ addressable market.

With this approval, VidaSleep™ joins the Vivos mmRNA® on the PDAC list of covered oral appliances, unlocking access for millions of Medicare beneficiaries seeking clinically advanced alternatives to CPAP machines or invasive surgeries. The dual-PDAC approval positions Vivos as the only company with two Medicare-covered oral appliances featuring differentiated and patented technologies designed to address the root causes of OSA while offering patients two distinct pathways and price points for therapy. The VidaSleep™ oral appliance features Vivos’ proprietary Unilateral Bite Block technology, while the mmRNA appliance is part of the FDA-cleared Vivos CARE product line for moderate to severe OSA cases in adults and children.

“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, CEO and Chairman of Vivos Therapeutics. “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.”

 

Source: globenewswire.com

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