Company Enters the Second Half of 2026 With Tailwinds From an FDA IDE Approval, With the TAVVE Pivotal Study Expected to Begin Enrolling Patients During the Second Half of This Year and Cash Runway Extending Into the Third Quarter of 2027
IRVINE, CA / ACCESS Newswire / July 31, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today reported financial results for the second quarter ended June 30, 2026, and highlighted by the significant regulatory milestone of receiving U.S. Food and Drug Administration (FDA) IDE approval to begin the TAVVE pivotal trial for its enVVe System, a first-in-class, minimally invasive replacement venous valve for patients suffering from severe deep chronic venous insufficiency (CVI).
Second Quarter 2026 Highlights
Achieved first-ever FDA IDE approval for a U.S. pivotal study evaluating a transcatheter replacement venous valve for severe deep CVI.
TAVVE pivotal trial expected to commence during the second half of 2026, representing a major value-driving catalyst. The study will ultimately enroll approximately 230 patients across up to 40 U.S. clinical sites.
Expanded intellectual property portfolio with a new U.S. patent covering key components of the enVVe System, further strengthening the Company's competitive moat ahead of pivotal development.
Maintained a strong balance sheet, ending the quarter with approximately $21.5 million in cash and investments, which management believes will fund operations into the third quarter of 2027, including the planned initiation of the TAVVE pivotal study.
Continued disciplined capital management, reducing quarterly net loss by approximately 46% year over year while advancing the Company's highest-priority clinical program.
"The second quarter represented a defining milestone for enVVeno, as we got the approval to move forward with the pivotal study for enVVe, our non-surgical replacement venous valve. enVVe has the potential to completely change the treatment trajectory for the 3 million U.S. patients in the U.S. that suffer from severe, deep venous CVI and have no effective treatment options," commented Rob Berman, Chief Executive Officer of enVVeno Medical.
"As we enter the second half of 2026, our focus is squarely on executing the TAVVE pivotal study, getting our clinical sites up and running, and treating the first patients," concluded Mr. Berman.
Summary of Financial Results for the Second Quarter 2026
As of June 30, 2026, the Company had total cash and investments of approximately $21.5 million, comprising $2.8 million in cash and cash equivalents and $18.7 million in short-term investments.
Cash burn for the second quarter was $3.4 million, consistent with the Company's projected cash burn rate of approximately $3 million to $4 million per quarter. The Company anticipates that its cash burn rate will likely increase to between $4 million and $5 million per quarter in the second half of 2026 as the TAVVE study begins enrolling patients.
Net loss for the second quarter of 2026 was $3.6 million, or $5.37 per basic and diluted share, compared to a net loss of $6.7 million, or $11.52 per basic and diluted share, for the second 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
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/envveno-medical-reports-second-quarter-2026-financial-results-and-advances-towards-fd-1199302
