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IRVINE, CA - enVVeno Medical Corporation (NASDAQ:NVNO), a small-cap medical device company with a market capitalization of approximately $94 million, announced Wednesday preliminary findings from a health economic study indicating its VenoValve would be a cost-effective treatment option for patients with severe Chronic Venous Insufficiency (CVI) caused by deep valvular incompetency. The company’s stock has shown strong momentum, gaining over 56% in the past six months.
The study found the VenoValve demonstrated both clinical and economic advantages over standard care treatments, including cost savings of $32,442 per patient over five years, prevention of 2.2 venous ulcers per patient, and 0.33 additional quality-adjusted life years gained per patient.
According to the analysis, the device could potentially save $5.9 billion annually in healthcare costs for the approximately 2.5 million U.S. patients with severe CVI. The break-even point for the treatment would be achieved between years two and three. InvestingPro data shows the company maintains a strong liquidity position with a current ratio of 11.81, suggesting robust ability to fund its commercialization efforts.
Dr. Mark H. Meissner, surgeon at the University of Washington Medical Center and lead author of the study, noted that severe deep venous CVI "affects millions of Americans annually and accounts for 1-2% of total healthcare expenditures, roughly ~$90 billion."
The company has submitted a pre-market authorization application for the VenoValve to the U.S. Food and Drug Administration, with a decision anticipated in the second half of 2025. Wall Street appears optimistic about the company’s prospects, with analysts setting a price target of $12.50, according to InvestingPro data. Subscribers can access 8 additional exclusive ProTips and detailed financial metrics to better evaluate NVNO’s investment potential.
Robert Berman, enVVeno Medical’s Chief Executive Officer, stated that the cost-effectiveness data, combined with clinical evidence from the pivotal trial, "make a compelling package for commercial payors such as private health insurance providers and employers."
The VenoValve is a surgical replacement venous valve for patients with severe deep venous CVI, a condition that can cause leg swelling, pain, edema, and in severe cases, recurrent venous ulcers.
A manuscript describing the full methodology and findings has been submitted for peer review and publication, according to the company’s press release statement.
In other recent news, enVVeno Medical Corporation has appointed Jennifer Bright as its new Chief Financial Officer. Bright brings over 25 years of financial and strategic leadership experience to the role, having previously held positions at companies such as Biolase and Spectrum Pharmaceuticals. Her appointment comes as enVVeno transitions from a development-stage company to a commercial entity. This move is expected to enhance the company’s financial infrastructure, particularly in the commercialization of its VenoValve® and enVVe® devices. These devices are designed for the treatment of deep venous Chronic Venous Insufficiency. Bright’s background also includes expertise in technical accounting and auditing from her time at PricewaterhouseCoopers LLP. The company sees this leadership change as a strategic step in its growth phase.
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