Full Press Release Details
Receives Not-Approvable Letter from the FDA for the VenoValve
Calif. - August 20, 2025 - enVVeno Medical Corporation (Nasdaq: NVNO) ("enVVeno" or the "Company"),
a company setting new standards of care for the treatment of deep venous disease, today announced that it has received a not-approvable
letter from the U.S. Food & Drug Administration (FDA) in response to its Premarket Approval (PMA) application for VenoValve ,
a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).
letter indicates that the FDA completed its review of the VenoValve PMA application and determined that it is unable to approve the PMA
for the VenoValve in its current form. In particular, the FDA indicated that the favorable revised Venous Clinical Severity Score (rVCSS)
data generated by the study to show clinical improvement, together with the improvements in pain scores and venous specific quality of
life indicators was not sufficient on its own to determine favorability of the benefit risk profile for the VenoValve. Without a specific
hemodynamic measurement that correlates with patient improvement, the FDA raised concerns about bias and the possibility that clinical
improvement occurred as a result of the patients being enrolled in a study.
FDA also focused on safety concerns which were attributed to the VenoValve open surgical procedure, and that required re-hospitalizations.
The Company would not expect to see similar safety events with a non-surgical replacement valve.
are obviously disappointed by the FDA's decision. The results showed that a high percentage of the patients in the SAVVE study,
who all previously failed standard of care treatments, showed significant clinical improvement after receiving the VenoValve. With the
VenoValve being the only difference in their care, it is hard to not attribute the improvement to the VenoValve," said Robert Berman,
enVVeno Medical's Chief Executive Officer. "We remain committed to the 2.5 to 3.5 million patients suffering from severe
deep venous CVI in the U.S. and who have no effective treatment options and will continue to work with the FDA on new criteria to demonstrate
the safety and effectiveness of our devices."
Medical is reviewing the feedback from the FDA and is assessing all options, which may include a meeting to discuss requirements for
a potential resubmission of the VenoValve or appeal of the decision along with appropriate next steps. The Company also expects to apply
the key learnings from this FDA approval process as it advances enVVe, its non-surgical replacement venous valve for which it is preparing
enVVeno Medical Corporation
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 severe
deep 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 Company is currently performing the final testing necessary
to seek approval for the pivotal trial for enVVe.
Note on Forward-Looking Statements
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.
Thomas, JTC Team, LLC
Silver, FINN Partners