Summary: CMS adds Vivos Therapeutics’ VidaSleep, a lower-cost oral appliance for mild to moderate OSA in adults than the company’s mmRNA device, to its PDAC-verified list.

Key takeaways:

  • VidaSleep targets mild to moderate OSA with a lower price point, aiming to broaden patient access.
  • Vivos says this positions them to serve multiple segments of the sleep therapy market, claiming both premium and budget offerings without compromising margins.

The Centers for Medicare & Medicaid Services (CMS) has Pricing, Data Analysis and Coding (PDAC)-verified the VidaSleep, Vivos Therapeutics Inc’s budget-conscious oral appliance for mild to moderate obstructive sleep apnea (OSA) and snoring in adults.

According to Vivos, VidaSleep offers a compelling value proposition, combining the clinical advantages of Vivos’ proprietary technology with a cost-effective price point designed to expand accessibility. Its streamlined design and efficient manufacturing process allow Vivos to deliver high-impact therapy at a budget-conscious rate.

With the verification, VidaSleep joins the Vivos mmRNA on the PDAC list, positioning Vivos as having two Medicare-covered oral appliances featuring differentiated, 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,” says Kirk Huntsman, CEO and chairman of Vivos Therapeutics, in a release. “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.”

PDAC approval not only benefits Medicare patients but also incentivizes private insurers to cover Vivos’ appliances. The VidaSleep device, like Vivos’ mmRNA device, is designed for use as a standalone therapy or adjunct to CPAP. 


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