LITTLETON, Colo. - Vivos Therapeutics, Inc. (NASDAQ: VVOS), a medical technology company, announced today that it has received all necessary regulatory approvals for Medicare reimbursement for its CARE oral appliances, designed to treat obstructive sleep apnea (OSA) in adults.
This approval enables Medicare beneficiaries to obtain coverage for the devices, which have been shown to improve or resolve OSA symptoms within approximately 12 months without further intervention in most cases.
The Centers for Medicare and Medicaid Services (CMS) now recognize the FDA-cleared devices as an effective treatment for OSA, a chronic condition that affects an estimated 54 million adults in the U.S. and can lead to serious health issues if left untreated. The CARE oral appliances work by reducing upper airway collapsibility without a fixed mechanical hinge, a method now aligned with standard commercial billing practices under code K1027.
Vivos Chairman and CEO Kirk Huntsman (NYSE:HUN) views this regulatory approval as a pivotal moment for the company, potentially increasing patient access to their treatment. The company's proprietary Vivos Method, which includes the CARE appliance therapy, has been effective in over 42,000 patients treated worldwide. This method is indicated for approximately 80% of OSA cases where patients are compliant with treatment.
Chris Farrugia, DDS, DABSB, a Vivos provider and medical billing expert, highlighted the significance of this coding decision from CMS, emphasizing the increased accessibility of Vivos therapy to Medicare beneficiaries and those covered by commercial insurers.
As of December 2023, 66.9 million people were enrolled in Medicare, many of whom may suffer from OSA. The approval of Vivos' CARE devices for Medicare reimbursement is expected to expand treatment options for these individuals, offering a nonsurgical and noninvasive solution.
The information in this article is based on a press release statement from Vivos Therapeutics, Inc.
InvestingPro Insights
As Vivos Therapeutics, Inc. (NASDAQ: VVOS) secures Medicare approval for its CARE oral appliances, investors are closely monitoring the company's financial health and stock performance. According to real-time data from InvestingPro, Vivos Therapeutics has a market capitalization of $8.28 million, reflecting its standing in the market. Despite the positive news, the company's stock has experienced significant volatility, with a price that has fallen by over 37% in the last month and over 64% in the last three months. This could indicate market uncertainty about the company's future performance despite the recent Medicare approval.
The company's financials also show challenges, with an adjusted P/E ratio for the last twelve months as of Q4 2023 at -0.61, suggesting that investors are not expecting profitability in the near term. This is echoed by one of the InvestingPro Tips, which indicates that analysts do not anticipate Vivos will be profitable this year. Additionally, the company's Price / Book ratio stands at a high 20.14, which may raise concerns about valuation among investors.
Investors looking to dive deeper into Vivos Therapeutics' financial metrics and stock performance can explore further with the comprehensive analysis available on InvestingPro. There are 12 additional InvestingPro Tips to help investors make informed decisions, such as insights on the company's cash burn rate and short-term obligations. For those interested in a more robust investment tool, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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