Three-Year VenoValve(R) First-in-Human Trial Data Published in the Annals of Vascular Surgery

Rhea-AI Summary

enVVeno Medical (NASDAQ:NVNO) has published promising three-year data from its first-in-human VenoValve® trial in the Annals of Vascular Surgery. The VenoValve, a surgical replacement venous valve for severe deep venous CVI, demonstrated continued safety and effectiveness after three years of implantation. Key findings from the study of 11 subjects include:

- 79% primary patency rate at three years
- 7-point improvement in Venous Clinical Severity Score
- 84% reduction in pain on the Visual Analog Scale

The company estimates 2.5 million potential new U.S. patients annually could benefit from VenoValve. A PMA application has been submitted to the FDA, with a decision expected in H2 2025.

Positive

• Strong clinical trial results with 79% primary patency rate after 3 years
• Significant pain reduction of 84% demonstrated on Visual Analog Scale
• Large market potential with 2.5 million annual potential new patients in the U.S.
• FDA decision on PMA application expected in H2 2025

Negative

• Small trial size with only 11 subjects initially and 8 completing follow-up
• Three subjects dropped out during the three-year follow-up period

Promising results from the first-in-human study demonstrated that, at three-years post implantation, VenoValve remained safe and effective--achieving a high rate of patency, restoring deep venous competence and maintaining clinical benefits

Company has submitted PMA application for the VenoValve to the U.S. Food and Drug Administration (FDA) with a decision anticipated in the second half of 2025

IRVINE, CA / ACCESS Newswire / May 13, 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 announced that its manuscript titled, "Three-Year Outcomes of Surgical Implantation of a Novel Bioprosthetic Valve for the Treatment of Deep Venous Reflux¹," has been published in the in the peer-reviewed journal, Annals of Vascular Surgery.

The VenoValve was surgically implanted in the femoral vein of eleven subjects with active or healed venous ulcers (CEAP classifications C5-C6). Eight subjects completed three years of follow-up, with key findings including:

• Primary patency: 79% (Kaplan-Meier curve) at three years

• Symptom relief: 7 point improvement Venous Clinical Severity Score; 84% reduction in pain on the Visual Analog Scale (VAS)

• The VenoValve remained safe and effective, achieving target patency and maintaining competence and clinical benefits

The VenoValve is a potential first-in-class, surgical replacement venous valve for patients with severe deep venous CVI. The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the VenoValve. 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.

About CVI

Severe, deep venous Chronic Venous Insufficiency (CVI) is a 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 severe 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 for severe CVI of the deep vein system caused by valvular incompetence. Estimates indicate that CVI costs the U.S. healthcare system in excess of $4 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 Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe®. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. 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 SAVVE 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
NVNO@jtcir.com
(908) 824-0775

MEDIA CONTACT:
Glenn Silver, FINN Partners
Glenn.Silver@finnpartners.com
(973) 818-8198

SOURCE: enVVeno Medical Corporation

View the original press release on ACCESS Newswire

FAQ

What are the key results from NVNO's VenoValve 3-year clinical trial?

The VenoValve showed 79% primary patency rate, 7-point improvement in Venous Clinical Severity Score, and 84% reduction in pain after 3 years of implantation.

When is the FDA expected to make a decision on NVNO's VenoValve?

The FDA decision on VenoValve's PMA application is anticipated in the second half of 2025.

How many potential patients could benefit from NVNO's VenoValve in the US?

According to enVVeno Medical, approximately 2.5 million new patients each year in the U.S. could be candidates for the VenoValve.

What medical condition does NVNO's VenoValve treat?

The VenoValve is designed to treat severe deep venous CVI (Chronic Venous Insufficiency) in patients with active or healed venous ulcers.

Where were NVNO's VenoValve 3-year trial results published?

The three-year VenoValve trial results were published in the peer-reviewed journal Annals of Vascular Surgery.