enVVeno Medical Participates in a New Virtual Investor "What This Means" Segment to Discuss How President Trump's Recent CVI Diagnosis May Impact the Company

Rhea-AI Summary

enVVeno Medical (NASDAQ:NVNO) participated in a Virtual Investor segment discussing how former President Trump's Chronic Venous Insufficiency (CVI) diagnosis could impact awareness of their VenoValve treatment. The company's CEO Rob Berman and CMO Dr. Marc Glickman discussed the condition's progressive nature and potential treatment options.

The company's VenoValve targets approximately 2.5 million potential patients in the U.S. suffering from severe deep CVI. enVVeno has submitted a pre-market authorization (PMA) application to the FDA, with a decision expected in the second half of 2025.

Positive

• Large addressable market of 2.5 million potential U.S. patients
• FDA decision on VenoValve PMA expected in 2H 2025
• High-profile CVI case could increase disease awareness

Negative

• FDA approval still pending with no guaranteed outcome
• Product not yet commercially available for potential patients

News Market Reaction

-0.62%

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-0.62% News Effect

On the day this news was published, NVNO declined 0.62%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

- enVVeno is developing the VenoValve as a potential treatment option for the approximately 2.5 million patients in the U.S. suffering from severe deep Chronic Venous Insufficiency

- FDA decision expected in 2H'2025

- Access the "What This Means" segment here

IRVINE, CA / ACCESS Newswire / August 4, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it participated in a Virtual Investor "What This Means" segment entitled, "enVVeno Medical - Making Veins Work Again - How President Trump's CVI Diagnosis is Raising Awareness."

Rob Berman, CEO and Dr. Marc Glickman, CMO of enVVeno Medical discussed the progressive nature of chronic veinous insufficiency and whether President Trump may one day be a candidate for the VenoValve® following U.S. Food and Drug Administration (FDA) approval.

The Company estimates that there are approximately 2.5 million patients 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 FDA, with a decision anticipated in the second half of 2025.

The "What This Means" segment can be accessed here.

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 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.

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 is the potential market size for enVVeno Medical's VenoValve?

enVVeno Medical estimates there are approximately 2.5 million patients in the U.S. who could be candidates for the VenoValve treatment.

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

The FDA is expected to make a decision on the VenoValve's pre-market authorization (PMA) application in the second half of 2025.

How might President Trump's CVI diagnosis affect enVVeno Medical (NVNO)?

President Trump's CVI diagnosis could increase public awareness of Chronic Venous Insufficiency and potentially highlight enVVeno Medical's VenoValve as a treatment option, pending FDA approval.

What is enVVeno Medical's VenoValve designed to treat?

The VenoValve is designed to treat severe deep Chronic Venous Insufficiency (CVI), a progressive condition affecting blood flow in the deep veins of the legs.

What stage of approval is NVNO's VenoValve currently in?

enVVeno Medical has submitted a pre-market authorization (PMA) application to the FDA and is awaiting a decision expected in the second half of 2025.