The Fort Worth Press - Independent Health Economic Study Recently Published in Journal of Vascular Surgery Reports Economic Dominance of enVVeno Medical's Replacement Venous Valve Therapy Compared to Standard of Care Treatments

IRVINE, CA / ACCESS Newswire / August 4, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today highlighted the publication of a landmark, peer-reviewed health economic analysis in the Journal of Vascular Surgery: Venous and Lymphatic Disorders demonstrating the potential clinical and economic benefits of venous valve replacement therapy for patients with severe deep venous reflux.

The publication titled, "Cost-effectiveness of a prosthetic venous valve versus compression therapies and wound care for treatment of infra-inguinal deep vein reflux," concluded that venous valve replacement therapy has the potential to improve patient outcomes while reducing overall healthcare costs compared with current conservative management. The analysis found that VenoValve, enVVeno's first-generation surgical venous valve technology, was economically dominant versus standard of care over a five-year period, projecting average healthcare savings of more than $32,000 per patient, avoidance of approximately 2.2 venous ulcers per patient, improved quality-adjusted life years (QALYs), and lower overall healthcare costs. The study also projected that treatment became cost-effective by approximately Year 2 and generated net healthcare savings between Years 2 and 3. These findings provide important health economic support for the therapeutic potential of enVVeno's next-generation enVVe® device, which is currently being studied in the TAVVE pivotal trial.

The peer-reviewed publication further highlighted the significant burden of chronic deep venous insufficiency and estimated that broader adoption of effective venous valve replacement therapy could translate into approximately $5.9 billion in annual healthcare savings, underscoring the substantial clinical and commercial opportunity for therapies that address the underlying cause of deep venous disease.

"Publication in a peer-reviewed scientific journal represents one of the strongest forms of independent scientific validation, as the research undergoes rigorous evaluation by experts in the field," said Robert Berman, Chief Executive Officer of enVVeno Medical. "This first-of-its-kind, landmark economic study focused solely on the costs of treating deep venous CVI and will provide compelling evidence for a technology like our enVVe system, compared to standard of care treatments. Once we have the data that we need from the TAVVE pivotal trial, we can apply that clinical data to the results of this published health economic study to make a compelling argument for broad reimbursement coverage."

Chronic deep venous insufficiency affects millions of patients worldwide and remains one of the largest unmet needs in vascular medicine. As venous valves fail, patients often experience chronic pain, swelling, skin changes, recurrent venous leg ulcers and declining quality of life. Current treatment options primarily rely on lifelong compression therapy and wound care designed to manage symptoms rather than correct the underlying cause of disease.

Earlier this year, enVVeno received FDA Investigational Device Exemption (IDE) approval to initiate the TAVVE pivotal trial, representing the first FDA-approved U.S. pivotal study evaluating a minimally invasive replacement venous valve for patients suffering from severe deep venous reflux.

The Company is developing the investigational enVVe® System, the first minimally invasive transcatheter replacement venous valve designed to restore one-way blood flow in the deep veins and directly address the underlying cause of chronic deep venous insufficiency. Building on the clinical foundation established by the Company's pioneering first-generation VenoValve technology, the enVVe® System is designed to advance the field through a minimally invasive transcatheter approach with the potential to expand physician adoption and improve patient access.

About enVVeno Medical Corporation

enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, late clinical-stage medical device Company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease.

Cautionary Note on Forward-Looking Statements

This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

INVESTOR CONTACT:
JTC Team, LLC
Jenene Thomas
[email protected]
(908) 824-0775

SOURCE: enVVeno Medical Corporation

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L.Holland--TFWP