Vivos Therapeutics Inc, a maker of oral appliances for breathing-related sleep disorders, reported a decline in product revenue and Vivos Integrated Provider (VIP) enrollments in the second quarter. The company attributed this dip to governmental investigations into third parties offering non-US Food and Drug Administration (FDA)-approved sleep apnea treatments, despite having no involvement.

The declines in product revenue and enrollments, according to the company’s Q2 business highlights, were slightly offset by increased revenue from home sleep testing services and seminars conducted at the Vivos Institute.   

Revenue was $3.4 million for Q2 and $7.3 million for the first half of the year, compared to $4.2 million and $7.8 million for the three and six months ended June 30, 2022, respectively. 

“We believe revenues in our second quarter were adversely impacted by a widely publicized lawsuit and ensuing governmental, including criminal, investigations into a non-Vivos, non-FDA cleared oral appliance purporting to treat sleep apnea,” says Kirk Huntsman, Vivos’ chairman and CEO, in a release. “Although Vivos was uninvolved in these matters, we believe the negative publicity, rumors, and speculation created significant confusion and concern in the marketplace. Not long after reports of this matter began to circulate, we saw a decline in both new VIP enrollments and appliance sales, and these declines continued throughout the second quarter.”

Huntsman continues in the release, “What we know is this: Vivos products are FDA-approved for their indicated uses, and we believe this creates an opportunity for us to distinguish our products from lesser competition. So while we’ve faced some headwinds in the market on the revenue side, we also see new opportunities emerging as we seek to achieve revenue momentum across our entire suite of products.”

As for other highlights, the second quarter saw continued progress in pilot tests with certain dental service organizations, including the execution of new and existing pilots during the quarter with eight regional and national dental service organizations representing over 1,000 locations nationwide. Vivos executed its first non-exclusive distribution agreement for a 90-day pilot with a nationally recognized durable medical equipment (DME) company focused on the respiratory space that serves hundreds of thousands of CPAP patients nationwide who are seeking alternatives. 

“We hope to provide further public details about this DME collaboration following the conclusion of the 90-day trial, but so far it appears promising as a means of expanding our sales reach,” says Huntsman in the release. “Our team is very excited about these relationships, and we expect to enter into additional, similar relationships during the remainder of 2023 and beyond.” 

Additionally, as of June 30, approximately 40,000 patients had been treated with The Vivos Method totaled, compared to over 28,000 as of the second quarter of 2022. Vivos has also trained more than 1,800 dentists in the use of The Vivos Method and Vivos’ related value-added services, compared to over 1,600 as of the second quarter of 2022.

“In summary, while the larger economic and market environment is creating challenges for both the medical and dental communities, Vivos has taken steps to address those challenges, and our long-term growth drivers remain in place. With our innovative, evidence-based technology and network of trained providers, we remain committed to our core mission of addressing the crisis of sleep apnea and breathing-related sleep issues,” says Huntsman in the release.

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