The Fort Worth Press - Health Economic Study Shows That enVVeno Medical's VenoValve(R) Would be a Cost-Effective Treatment Option for Patients with Severe Chronic Venous Insufficiency

IRVINE, CA / ACCESS Newswire / August 6, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announcedpreliminary findings from a VenoValve health economic study, which indicate that the VenoValve would be a cost-effective treatment option for patients with severe Chronic Venous Insufficiency (CVI) caused by deep valvular incompetency. The Company announced it will host a live webcast to discuss the cost-effectiveness analysis results today, Wednesday, August 6^th at 12:00 PM ET (details below).

Key Findings from the Study Include:

• VenoValve was dominant relative to standard of care (i.e., lower costs, higher quality-adjusted life years):

  • Cost savings: $32,442 per patient over 5 years

  • Clinical benefit: 2.2 ulcers avoided per patient

  • Quality of life: 0.33 additional QALYs gained per patient

• Additional economic value associated with use of the VenoValve:

  • $14,912 saved per each venous ulcer avoided

  • $4,101 cost per each rVCSS point improvement

  • Break-even achieved between years 2-3

Results remained consistent across multiple sensitivity analyses and scenarios (different age populations, various assumptions), confirming the model's reliability.

Mark H. Meissner M.D., surgeon at the Vascular and Endovascular Surgery Clinic at University of Washington (UW) Medical Center, a UW professor of Surgery, and the lead author of the manuscript added, "There remains a significant need for better treatment options for patients with severe, deep venous CVI, an advanced disease that affects millions of Americans annually and accounts for 1-2% of total healthcare expenditures, roughly ~$90 billion. These comprehensive economic analysis results, coupled with the robust clinical data demonstrated in the VenoValve U.S. pivotal trial, well positions the VenoValve to address the significant treatment gap while providing substantial economic value to the healthcare system."

"There are several factors that need to align in order to promote wide adoption of a first-in-class medical device. Two of the more important factors are good clinical results, and a willingness to pay for the device and the procedure. This health economic study provides evidence that the VenoValve would be extremely cost-effective, resulting in substantial health cost savings over time. This cost-effectiveness data, together with the strong clinical evidence from the pivotal trial, make a compelling package for commercial payors such as private health insurance providers and employers, that often make coverage decisions based upon both clinical and cost-effectiveness data", added Robert Berman, enVVeno Medical's Chief Executive Officer.

While private payors generally make coverage decisions based upon clinical evidence and cost effectiveness, Medicare makes coverage decisions based upon clinical effectiveness to support reasonable and necessary criteria for the Medicare population.

As part of the health economic study, a de novo cost-effectiveness model was developed to simulate clinical and economic outcomes for patients with deep venous CVI caused valvular incompetence. The model structure was based on health states defined by the revised Venous Clinical Severity Score (rVCSS), which were derived from a post-hoc analysis of the one-year results from the VenoValve U.S. pivotal trial. Key input values for transition probabilities, clinical events, costs of care, and utilities were sourced from the pivotal trial and publicly available sources. Six-month cycles were assumed for the first year, to match the VenoValve pivotal trial, followed by annual cycles; outcomes were compared over a 5-year time horizon.A manuscript describing the full methodology and findings has been submitted for peer review and publication.

The VenoValve is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that approximately 2.5 million people in the United States could be candidates for the VenoValve, including approximately 1.5 million diagnosed with venous ulcers. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025.

Webcast Details

The Company will host a webcast presentation to discuss the results for investors, analysts and other interested parties today, August 6, 2025, at 12:00 PM ET. Joining enVVeno management for the event will be Dr. Meissner. The live webcast will be accessible on the Events page of the enVVeno website, envveno.com, and will be archived for 90 days.

About CVI

Severe deep venous CVI is a serious and debilitating disease that is most often caused by blood clots (deep vein thromboses or DVTs) in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase (venous hypertension).

Symptoms of CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such as sleeping, bathing, dressing, and walking, and is known to result in high rates of depression and anxiety. There are currently no effective treatments that repair deep venous valve dysfunction, the #1 cause of severe CVI-a disease estimated to cost the U.S. healthcare system in excess of $26 billion each year.

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. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous CVI. The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVIcalled enVVe®. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the VenoValve U.S. pivotal study and the Company is currently performing the final testing necessary to seek approval for the pivotal trial for enVVe.

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

MEDIA CONTACT:
Glenn Silver, FINN Partners
[email protected]
(973) 818-8198

SOURCE: enVVeno Medical Corporation

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M.McCoy--TFWP