Positive Interim 2-Year Data from enVVeno Medical's VenoValve Pivotal Study to be Presented Today at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting

Rhea-AI Summary

enVVeno Medical (NVNO) reported positive interim 2-year data from its VenoValve pivotal trial, showing sustained clinical improvements in patients with severe deep venous CVI. Key findings include: 83.3% of subjects maintained clinically meaningful benefit with 3+ point improvement in rVCSS, 9.1 point average rVCSS improvement in responder cohort, and 74% median improvement in leg pain. The trial also demonstrated 60% complete healing of ulcers, with 100% valve patency rate among 30 subjects. The VenoValve, a potential first-in-class surgical replacement venous valve, targets approximately 2.5 million potential new U.S. patients annually. The company has submitted a PMA application to the FDA, with a decision expected in H2 2025.

Positive

• 83.3% of subjects maintained clinically meaningful benefit in rVCSS scores after 2 years
• Significant 74% median improvement in leg pain reported
• 60% of ulcers healed completely, with 24% showing size reduction
• 100% valve patency rate among monitored subjects
• Large market potential with 2.5 million annual potential U.S. patients

Negative

• 16% of ulcers increased in size during the trial
• FDA approval still pending with decision in H2 2025
• Trial data only covers 42 subjects out of 75 total participants

Insights

Medical Device Expert

enVVeno's VenoValve shows impressive 2-year data with 83% of patients maintaining meaningful benefits, bolstering FDA approval prospects.

The interim 2-year data from enVVeno Medical's VenoValve pivotal trial demonstrates sustained clinical improvement in patients with severe chronic venous insufficiency (CVI). The data shows that 83% of subjects maintained a clinically meaningful benefit with at least a 3-point improvement in the Revised Venous Clinical Severity Score (rVCSS). This is particularly significant as all enrolled patients had severe CVI that had failed all other treatment options.

The responder cohort showed an impressive 9.1 point average improvement in rVCSS, and patients experienced a median 74% reduction in leg pain. Additionally, the wound healing outcomes in 17 subjects with 25 ulcers revealed that 60% of ulcers healed completely, while 24% decreased in size. The 100% valve patency rate among 30 subjects further validates the device's durability.

These results are remarkable in the context of deep venous CVI treatment. The VenoValve represents a potential paradigm shift as a first-in-class surgical replacement venous valve. With approximately 2.5 million potential new candidates annually in the U.S. alone, the market opportunity is substantial.

The company has submitted a pre-market authorization application to the FDA, with a decision expected in the second half of 2025. If approved, the VenoValve would address a significant unmet medical need that has challenged vascular medicine for decades. The sustained efficacy at the 2-year mark is a strong indicator of the device's potential long-term clinical value and increases the likelihood of regulatory approval.

Interim two-year follow-up data from 42 subjects in the VenoValve pivotal trial show sustained clinical improvement and continued patient benefit at 24 months compared to baseline

83% of subjects maintained a clinically meaningful benefit with a 3 or more point improvement in Revised Venous Clinical Severity Score (rVCSS)

9.1 point average rVCSS improvement among the clinically meaningful benefit cohort

Subjects experienced a median 74% improvement in leg pain

Interim follow-up data indicate sustained improvements across all venous-specific quality-of-life (QoL) indicators

A decision from the U.S. Food and Drug Administration (FDA) on the VenoValve is anticipated in the second half of 2025

Company to host live webcast with presenting Principal Investigator, today, June 6^th at 11:20 AM ET / 10:20 AM CT - Access the Webcast Here

IRVINE, CA / ACCESS Newswire / June 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 announced that interim two-year follow-up data on 42 subjects from the 75 person VenoValve U.S. pivotal trial will be presented today by lead enroller Dr. Cassius Iyad Ochoa Chaar, at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting (VAM25) being held June 4-7, 2025 in New Orleans, LA. Additionally, the Company announced it will host a live webcast to discuss these interim results today, Friday, June 6^th at 11:20 AM ET / 10:20 AM CT (details below).

Key interim two-year follow-up data being presented at VAM25 include:

• 83.3% of subjects (n=35/42) maintained a clinically meaningful benefit, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS).

• 9.1 point average rVCSS improvement among the responder cohort.

• A median 74% improvement in leg pain, as measured by the Visual Analog Scale (VAS).

• Wound healing outcomes in 17 subjects with 25 ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in size.

• Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym).

• Among the subjects (n=30), a 100% valve patency rate.

All values were calculated comparing each patient's baseline levels to the reported values at the patient's 24-month visit. The Revised Venous Clinical Severity Score (rVCSS) is a clinically validated scoring system used to track the progression or regression of venous diseases.

"These interim two-year follow-up data demonstrate substantial and sustained improvement across all effectiveness endpoints at two years. This is extremely encouraging, especially when you consider that all the patients enrolled in the study had severe CVI and failed all other treatment options," said Robert Berman, enVVeno Medical's Chief Executive Officer. "Despite attempts over many decades, nobody has been able to create an effective treatment for severe CVI caused by malfunctioning valves in the deep veins of the leg. The VenoValve has the potential to change the treatment paradigm for deep venous CVI, both for the millions of patients suffering from severe CVI and the thousands of vascular surgeons who have been waiting for an effective treatment option."

Dr. Cassius Iyad Ochoa Chaar, who is the Associate Professor of Surgery, Division of Vascular Surgery and Endovascular Therapy, Yale School of Medicine, will present the abstract titled, "Patients with Deep Venous Reflux Continue to Experience Clinical Improvement 2-year after Implantation of the VenoValve" today at VAM 2025.

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.

Webcast Details

The Company will host a webcast presentation to discuss the results for investors, analysts and other interested parties today, June 6, 2025, at 11:20 AM ET / 10:20 AM CT. Joining enVVeno management for the event will be Dr. Chaar. 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 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®. 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
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 2-year interim data?

The interim data showed 83.3% of subjects maintained clinical improvement, with a 74% median improvement in leg pain, 60% complete ulcer healing rate, and 100% valve patency rate among monitored subjects.

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

The FDA decision on the VenoValve 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 potential new patients each year in the U.S. could be candidates for the VenoValve.

What is the VenoValve's success rate in treating deep venous CVI?

The interim data shows 83.3% of subjects maintained clinically meaningful benefit, defined as a 3 or more point improvement in the revised Venous Clinical Severity Score.

How effective is the VenoValve in treating leg ulcers?

Among 17 subjects with 25 ulcers, 60% healed completely, 24% decreased in size, and 16% increased in size.