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enVVeno Medical's First-in-Class enVVe System to Be Featured at The VEINS 2026 Innovation Summit as Company Advances Toward U.S. Pivotal Trial

Key Takeaway: enVVeno Medical Corporation will showcase its enVVe System at The VEINS 2026 Innovation Summit. This minimally invasive replacement venous valve aims to treat severe deep venous insufficiency, a condition affecting 3 million patients in the U.S. The company recently received FDA approval to initiate the pivotal TAVVE trial, with enrollment expected to start in Q4 2026.

Market Sentiment Analysis

POSITIVE FACTORS

  • enVVeno Medical's enVVe System addresses a significant unmet medical need.
  • The system is being presented at a prominent summit for vascular specialists.
  • FDA approval for the pivotal trial indicates regulatory confidence in the device.

CONCERNS & RISKS

  • The company faces significant risks and uncertainties related to its forward-looking statements.
  • Enrollment for the pivotal trial is not expected to begin until Q4 2026.

Full Press Release Details

Leading venous interventionalist Karen B. Garby, MD, DABVLM, RPhS, to present the enVVe ® System, a minimally invasive replacement venous valve currently being evaluated in a U.S. pivotal study
An estimated 3 million patients in the U.S. suffer from severe, deep venous insufficiency with no effective treatment
IRVINE, CA / ACCESS Newswire / October 2, 2026 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), today announced that the Company will present its investigational enVVe ® System at The VEINS 2026 in Las Vegas, Nevada.
The presentation will take place on Sunday, October 4, 2026 at the Blue Sky Breakfast consisting of a gathering of specialists focused on advances in venous and vascular disease. The presentation will be followed by panel discussion and Q&A session.
Earlier this year, the Company received FDA Investigational Device Exemption (IDE) approval to initiate the TAVVE pivotal trial for the enVVe System, a first in class, non-surgical replacement venous valve. The Company expects enrollment in its TAVVE study to begin in Q4 of 2026.
Karen B. Garby, MD, DABVLM, RPhS, Director of Venous Intervention at Comprehensive Integrated Care, will present the enVVe System. Dr. Garby is an interventional radiologist with 20 years of experience and specializes in venous disease, including central and peripheral vein disease. She is board certified in radiology and completed her interventional radiology fellowship at Case Western. Dr. Garby also holds the Diplomate in Vein and Lymphatic Medicine designation and is a Registered Phlebology Sonographer.
"The VEINS 2026 Summit is an important opportunity to introduce the enVVe ® System to the world's leading venous specialists who treat patients with severe deep venous disease on a daily basis," said Rob Berman, Chief Executive Officer of enVVeno Medical. "For decades, physicians have lacked the ability to replace damaged valves which are the most frequent cause of severe deep venous insufficiency."
Severe, deep venous insufficiency affects approximately 3 million patients in the U.S. and remains one of the largest unmet needs in vascular medicine. As venous valves fail, patients often experience chronic pain, swelling, skin changes, recurrent venous leg ulcers and declining quality of life. Current treatment options primarily rely on lifelong compression therapy and wound care designed to manage symptoms rather than correct the underlying cause of disease.
The enVVe ® System, is a non-surgical replacement venous valve designed to restore one-way blood flow in the deep veins and directly address the underlying cause of chronic deep venous insufficiency."
For more information about The VEINS Summit, please visit the conference website here .
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.
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.

Frequently Asked Questions

What is the enVVe System?

The enVVe System is a minimally invasive replacement venous valve designed to treat severe deep venous insufficiency.

When will the TAVVE pivotal trial begin?

Enrollment for the TAVVE pivotal trial is expected to start in Q4 of 2026.

Who is presenting the enVVe System?

Dr. Karen B. Garby, an experienced interventional radiologist, will present the enVVe System.

What is the significance of The VEINS 2026 Summit?

The VEINS 2026 Summit is a key event for introducing innovations in venous disease treatment to leading specialists.

How many patients suffer from deep venous insufficiency in the U.S.?

Approximately 3 million patients in the U.S. are affected by severe deep venous insufficiency.

Last updated: Oct 2, 2026