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LITTLETON, Colo. - Vivos Therapeutics, Inc. (NASDAQ:VVOS) announced Tuesday that its VidaSleep oral appliance has received approval from the Centers for Medicare & Medicaid Services (CMS) for the treatment of mild to moderate obstructive sleep apnea (OSA) and snoring in adults.
The approval from CMS’s Pricing, Data Analysis and Coding contractor means the device, which features Vivos’ patented Unilateral Bite Block technology, will be covered by Medicare. This makes VidaSleep the second Vivos product to receive Medicare coverage, joining the company’s mmRNA device.
"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.
The VidaSleep device is FDA-cleared and can be used either as standalone therapy or as an adjunct to CPAP treatment. According to the company’s press release, the device offers a more cost-effective option compared to their premium mmRNA solution while maintaining clinical efficacy.
OSA affects an estimated 80 million Americans, with approximately 80% of cases remaining undiagnosed, according to information provided by the company. The condition has been linked to various health issues including heart disease, stroke, and dementia. While Vivos maintains a healthy gross profit margin of 58.73% and achieved revenue growth of 9.47% in the last twelve months, InvestingPro analysis reveals several additional insights about the company’s financial health and market position. Get access to 8 more exclusive ProTips and comprehensive analysis in the Pro Research Report.
The Medicare approval potentially opens doors for coverage from commercial insurers that follow CMS guidelines, expanding the market for Vivos’ products. The company positions its oral appliances as alternatives to CPAP machines or surgical interventions for sleep apnea patients.
Vivos Therapeutics specializes in developing treatments that address structural causes of OSA. The company’s Complete Airway Repositioning and/or Expansion devices are cleared by the FDA for adult patients with all severity levels of OSA and for children ages 6 to 17 with moderate-to-severe OSA. Investors should note that the company’s next earnings report is scheduled for August 13, 2025, which could provide crucial updates on the commercial impact of these recent developments.
In other recent news, Vivos Therapeutics has reported a decline in revenue for the first quarter of 2025, with total revenue dropping to $3 million from $3.4 million in the same period of the previous year. Despite this, product sales increased by 8%, reaching $1.8 million. The company has recently completed the acquisition of The Sleep Center of Nevada for $6 million in cash and $1.5 million in company stock. This acquisition aligns with Vivos’ strategic shift towards collaborating with medical sleep practices, aiming to enhance revenue from sleep disorder diagnosis and treatment. In addition, Vivos secured an $8.2 million loan from Streeterville Capital and a $3.75 million investment from New Seneca Partners to finance this acquisition. Furthermore, Vivos has appointed Baker Tilly as its new auditor following a merger involving its previous auditor, Moss Adams. A clinical trial published in the European Journal of Pediatrics showed that Vivos’ Daytime-Nighttime Appliance effectively improved obstructive sleep apnea symptoms in children, with 79% of participants experiencing improvement. These developments highlight Vivos Therapeutics’ ongoing efforts to expand its presence in the sleep medicine market.
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