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LITTLETON, Colo. - Vivos Therapeutics, Inc. (NASDAQ:VVOS), a small-cap medical device company with a market capitalization of $17.85 million, announced Thursday that a multicenter clinical trial published in the European Journal of Pediatrics demonstrated positive outcomes for its Daytime-Nighttime Appliance (DNA) in treating obstructive sleep apnea (OSA) in children.
The study showed 79% of patients experienced OSA improvement, with 61.7% improving by 50% or more, and 17% achieving complete resolution. Among children with severe OSA, 93% saw symptoms decrease by at least 50%. No safety issues were reported during the trial, which included 47 participants over a 12-24 month period. The positive trial results have contributed to the company’s recent stock performance, with InvestingPro data showing a 23% return over the past week, though analysts note the stock remains volatile with a high beta of 6.99.
According to the study, this is the first research demonstrating the Vivos device is safe and effective for treating pediatric OSA. The company received FDA 510(k) clearance for the DNA device to treat moderate to severe OSA in children in September 2024.
"This is welcome news for all parents with children who suffer from OSA," said R. Kirk Huntsman, Chairman and CEO of Vivos. "No longer is their only option to subject their children to a painful and often ineffective surgical procedure with a high relapse rate."
The current standard treatment for pediatric OSA is adenotonsillectomy surgery (removal of tonsils and adenoids), with over 500,000 children undergoing this procedure annually in the United States. While 51% to 83% initially experience symptom relief, 68% see their OSA symptoms return within three years, according to information provided in the press release.
An estimated 10 million children in the United States suffer from breathing and sleep disorders like OSA, with up to 90% remaining undiagnosed and untreated. Despite this large market opportunity, InvestingPro analysis shows Vivos maintains a healthy gross profit margin of 58.73% while growing revenue by 9.47% year-over-year. Get access to 10+ additional exclusive ProTips and comprehensive financial metrics with InvestingPro’s detailed research report.
The study concluded that the Vivos treatment is expected to have a permanent effect beyond the 24-month study duration, offering an alternative to current treatments that have limitations including adherence challenges, complications, and continuous usage requirements. While the company’s EBITDA remains negative at -$10.69 million, InvestingPro’s comprehensive analysis indicates the company operates with moderate debt levels as it works to capitalize on this breakthrough treatment opportunity.
The information in this article is based on a company press release statement.
In other recent news, Vivos Therapeutics reported a decline in its first-quarter 2025 revenue to $3 million from $3.4 million in the same period the previous year. Despite the overall revenue drop, product sales rose by 8% to $1.8 million, largely due to increased sales in the Pediatric Guide Appliance Line. The company has completed the acquisition of The Sleep Center of Nevada for $6 million in cash and $1.5 million in company stock, aiming to expand its presence in the sleep medicine market. To support this acquisition, Vivos secured an $8.2 million loan from Streeterville Capital LLC and an additional $3.75 million from New Seneca Partners. In another development, Vivos appointed Baker Tilly US, LLP as its new auditor following a merger involving its previous auditor, Moss Adams LLP. This change was approved by Vivos’ audit committee, and there were no disagreements reported during Moss Adams’ tenure. These recent developments reflect Vivos’ strategic pivot towards integrating sleep disorder diagnosis and treatment into its operations.
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