Interim Two-Year Follow-Up Data from the VenoValve(R) U.S. Pivotal Trial to be Presented Today at the VESS 2025 Annual Winter Meeting

Rhea-AI Summary

enVVeno Medical (Nasdaq: NVNO) announced interim two-year follow-up data from the VenoValve U.S. pivotal trial, showing sustained clinical improvement in treating venous disease. Key findings include: 78% of subjects maintained clinically meaningful benefit with an average improvement of 8.2 points in rVCSS at 24 months, a median 75% reduction in pain, and sustained improvements across all venous quality-of-life indicators.

The company submitted a pre-market authorization (PMA) application for VenoValve to the FDA in November 2024, with a decision expected in second half of 2025. Among subjects with core lab-evaluable data at 24 months, a 100% device patency rate was observed in all 27 subjects. The data will be presented at the VESS 2025 Annual Winter Meeting by Dr. Matthew Smeds.

Positive

• 78% of subjects maintained clinically meaningful benefit in rVCSS at 24 months
• Average rVCSS improvement increased from 6.6 to 8.2 points from 12 to 24 months
• Median 75% reduction in pain maintained at 24 months
• 100% device patency rate in all 27 evaluable subjects
• FDA decision on PMA application expected in H2 2025

Negative

• None.

Insights

Medical Device Analyst

The latest VenoValve trial data presents compelling evidence of sustained therapeutic benefit, with several important implications for investors:

Clinical Excellence & Market Validation: The 78% responder rate at 24 months with an enhanced average rVCSS improvement from 6.6 to 8.2 points demonstrates not just efficacy maintenance but actually increasing benefits over time. The 100% device patency rate in evaluable subjects is particularly noteworthy for long-term commercial viability.

Regulatory & Commercial Trajectory: With the PMA submission completed and FDA decision expected in H2 2025, enVVeno is approaching a critical inflection point. The robust dataset exceeds the FDA's predetermined clinical benefit threshold of 3+ points in rVCSS improvement, potentially strengthening the approval case.

Market Opportunity Analysis: The $4 billion annual U.S. healthcare cost for CVI represents a substantial addressable market. With no effective treatments currently available for deep venous CVI, VenoValve could capture significant market share as a first-mover. The quality-of-life improvements demonstrated across multiple metrics (pain reduction, QoL indicators) could drive strong adoption among both physicians and patients.

Strategic Considerations: The company's focus on data presentation at prestigious medical conferences indicates a well-planned commercial awareness strategy. This approach typically aids in building key opinion leader support and establishing market presence pre-launch. The positive long-term data could also support favorable reimbursement discussions with payers, critical for widespread adoption.

Two-year follow-up data from 34 subjects in the VenoValve pivotal trial show sustained clinical improvement and continued patient benefit, from 12 months to 24 months.

78% of subjects maintained a clinically meaningful benefit of more than 3 points in rVCSS at 24 months, with an average improvement of 8.2 points among the responder cohort.

Subjects continued to experience a median 75% reduction in pain at 24 months.

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

PMA application for the VenoValve submitted in November 2024, with an FDA decision expected in the second half of 2025.

IRVINE, CA / ACCESS Newswire / February 7, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that interim two-year follow-up data on 34 subjects from the VenoValve U.S. pivotal trial will be presented today by Dr. Matthew Smeds, Professor of Surgery in the Division of Vascular and Endovascular Surgery at Saint Louis University and Principal Investigator for the trial, at the Vascular and Endovascular Surgery Society (VESS) 2025 Annual Winter Meeting, being held February 6-9, 2025 in Breckenridge, CO. The Company has submitted a pre-market authorization (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA), and the review process is ongoing, with a decision anticipated in the second half of 2025.

Key interim two-year follow-up data being presented at VESS includes:

• 78% of subjects (n=25/32) maintained a clinically meaningful benefit, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS).

• Among the responder cohort, the average rVCSS improvement increased from 6.6 points at 12 months to 8.2 points at 24 months, demonstrating increasing benefit over time.

• At 24 months, subjects continued to experience a median 75% reduction in pain, as measured by the Visual Analog Scale (VAS).

• Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym) from 12 months to 24 months.

• Among the subjects with core lab-evaluable data at 24 months, a 100% device patency rate was observed in all 27 subjects.

The rVCSS is a clinically validated scoring system used to track the progression or regression of venous diseases. The FDA previously indicated that an improvement of 3 or more points in rVCSS would be evidence of the VenoValve's clinical benefit.

"The growing body of evidence from our pivotal trial further supports the contention that the VenoValve and the SAVVE procedure is a safe and effective treatment for deep venous CVI," said Robert Berman, enVVeno Medical's Chief Executive Officer. "Positive data ultimately drives future adoption, and our plan is for our primary investigators to continue to present new VenoValve data at prestigious medical conferences in the U.S. and elsewhere throughout the year, in order to create awareness and spread the message that the long awaited solution for the millions of patients that suffer from deep venous CVI is closer to becoming a reality."

Severe, deep venous 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 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.

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INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(908) 824-0775

SOURCE: enVVeno Medical Corporation

View the original press release on ACCESS Newswire

FAQ

What are the 2-year follow-up results for NVNO's VenoValve trial?

The 2-year follow-up shows 78% of subjects maintained clinical improvement, with an average 8.2-point improvement in rVCSS scores, 75% reduction in pain, and 100% device patency rate in evaluable subjects.

When will the FDA decide on NVNO's VenoValve PMA application?

The FDA decision on the VenoValve PMA application is expected in the second half of 2025.

What is the device patency rate for NVNO's VenoValve at 24 months?

The VenoValve showed a 100% device patency rate in all 27 subjects with core lab-evaluable data at 24 months.

How much pain reduction did patients experience with NVNO's VenoValve at 24 months?

Patients experienced a median 75% reduction in pain at 24 months, as measured by the Visual Analog Scale (VAS).

What percentage of patients showed clinical improvement with NVNO's VenoValve?

78% of subjects (25 out of 32) maintained a clinically meaningful benefit, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS).