The Impact of the VenoValve(R) on Patients with Primary and Secondary Chronic Venous Insufficiency (CVI) to be Presented at the Society for Clinical Vascular Surgery 52nd Annual Symposium

Rhea-AI Summary

enVVeno Medical (NASDAQ: NVNO) announced that its abstract on the VenoValve® will be presented at the Society for Clinical Vascular Surgery 52nd Annual Symposium in Austin, TX. Dr. Cassius Iyad Ochoa Chaar from Yale School of Medicine will present 'Impact of the VenoValve on Patients with Primary and Thrombotic Deep Venous Reflux' on April 2, 2025.

The VenoValve is a potential first-in-class surgical replacement venous valve for severe deep venous CVI patients. The company estimates 2.5 million potential new patients annually in the U.S. could be candidates for the treatment. enVVeno has submitted a pre-market authorization (PMA) application to the FDA, with a decision expected in the second half of 2025.

Positive

• PMA application submitted to FDA with decision timeline established
• Large addressable market of 2.5 million potential new U.S. patients annually
• Potential first-in-class treatment for severe deep venous CVI

Negative

• FDA approval still pending with several months of waiting period
• No current revenue generation from VenoValve pending regulatory approval

IRVINE, CA / ACCESS Newswire / March 31, 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 its abstract has been accepted for presentation at the Society for Clinical Vascular Surgery (SCVS) 52^nd Annual Symposium being held March 29-April 2, 2025 in Austin, TX.

As part of the SCVS Symposium, Dr. Cassius Iyad Ochoa Chaar, Associate Professor of Surgery, Yale School of Medicine, Division of Vascular and Endovascular Surgery, Principal Investigator, and lead enroller for the VenoValve U.S. pivotal trial, will present the abstract titled, "Impact of the VenoValve on Patients with Primary and Thrombotic Deep Venous Reflux" on Wednesday, April 2, 2025 beginning at 8:20 AM CT.

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.

For more information about the SCVS Annual Symposium and to view the abstract, please visit the Symposium website here.

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 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

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

When will the FDA make a decision on enVVeno's VenoValve (NVNO) PMA application?

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 treatment annually?

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

Who will present the VenoValve research at the SCVS 2025 Symposium?

Dr. Cassius Iyad Ochoa Chaar, Associate Professor at Yale School of Medicine and Principal Investigator of the VenoValve U.S. pivotal trial.

What is the target medical condition for NVNO's VenoValve treatment?

The VenoValve is designed for patients with severe deep venous Chronic Venous Insufficiency (CVI).