Initial 10-patient stage of U.S. pivotal study of the first-in-class enVVe non-surgical replacement venous valve on track to begin before year end

Cash and investments of $18.5 million expected to fund operations into Q4 2027, including the planned initiation of TAVVE

IRVINE, CA / ACCESS Newswire / October 30, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) (“enVVeno Medical” or the “Company”), today reported financial results for the third quarter ended September 30, 2026. Cash and investments at the end of the quarter were $18.5 million, with a quarterly burn of approximately $3 million. The Company is on track to begin Part 1 of the TAVVE® U.S. pivotal study for its enVVe® system, a first-in-class, non-surgical replacement venous valve, in the fourth quarter of this year. The study is being conducted under an FDA-approved Investigational Device Exemption (IDE).

“Clinical sites for Part 1 of TAVVE pivotal study are being activated and coming online and we are on schedule to enroll our first patient before the end of the year,” said Robert Berman, Chief Executive Officer of enVVeno Medical. “We did a nice job of managing our operating expenses in the quarter while still pursuing our immediate priority of getting the TAVVE pivotal study underway.”

Part 1 of the TAVVE pivotal study will consist of up to 10 patients who will initially be monitored for safety. Thirty-day safety data from the Part 1 patients will be submitted to the FDA, at which time the Company will seek to enroll Part 2 of the TAVVE pivotal study. Part 2 of the TAVVE study will consist of 220 randomized patients, 165 of which will receive the enVVe valve, and 55 of which will be in a control arm.

The primary safety endpoint for all TAVVE patients will consist of a composite of all cause mortaility, pulmonary embolism, enVVe Valve embolization, enVVe valve infection, thrombus in the treated vein segment (Target Vein Zone), Target vein Zone perforation and access site bleeding.

The enVVe System is a first-in-class, non-surgical replacement venous valve designed to treat permanently damaged valves in the deep veins of the leg. Delivered through a catheter, the enVVe valve is designed to restore one-way blood flow toward the heart and reduce backward blood flow. The Company estimates that approximately 3 million people in the United States suffer from severe deep chronic venous insufficiency (CVI).

Third Quarter 2026 and Recent Business Highlights

  • Readied TAVVE for launch: After the FDA approved the IDE, the Company advanced enVVe product development, testing and operational readiness for the TAVVE pivotal study.
  • Presented enVVe to specialists: Karen B. Garby, MD, DABVLM, RPhS, presented the investigational enVVe System at The VEINS 2026 Innovation Summit in Las Vegas, Nevada.
  • Kept spending disciplined: Total operating expenses were $4.5 million, compared with $4.9 million in the third quarter of 2025, even as the Company prepared to launch the TAVVE pivotal study.
  • Ended the quarter with $18.5 million in cash and investments: The Company believes these resources will fund operations into the fourth quarter of 2027, including the planned initiation of TAVVE.

Upcoming Clinical and Corporate Milestones

  • Initial 10-patient stage: Expected to begin before year end, the first stage will evaluate 10 patients whose 30-day safety results will be submitted to the FDA for review. These patients will continue to be followed as a separate cohort, with safety and efficacy results reported periodically.
  • Randomized 220-patient stage: Following submission of the initial cohort’s 30-day safety results and subject to applicable FDA requirements, the second stage is expected to enroll 220 patients randomized 3:1, with 165 receiving the enVVe System and 55 receiving standard-of-care treatment. Participating investigators are expected to include vascular surgeons, interventional radiologists and interventional cardiologists.
  • Potential PMA submission: Following completion of the randomized stage’s 12-month follow-up and analysis of the results, the Company intends to submit a premarket approval (PMA) application to the FDA, subject to the TAVVE pivotal study results and applicable regulatory requirements.

The TAVVE pivotal study’s primary efficacy endpoints will assess changes in backward blood flow, measured as regurgitant volume in the target vein zone at 12 months and evaluated by a core laboratory, and clinical improvement using the revised Venous Clinical Severity Score (rVCSS).

Summary of Financial Results for the Third Quarter 2026

As of September 30, 2026, enVVeno had cash and investments of approximately $18.5 million, consisting of $2.6 million in cash and cash equivalents and $15.9 million in short-term investments.

Cash burn for the quarter was $3 million. The Company anticipates that its cash burn rate will likely increase to between $4 million and $5 million in the first half of 2027 as the TAVVE study continues enrolling patients.

Net loss for the third quarter of 2026 was $4.4 million, or $6.29 per basic and diluted share, compared with a net loss of $4.5 million, or $7.89 per basic and diluted share, for the third quarter of 2025.

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.

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:

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

SOURCE: enVVeno Medical Corporation

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