Full Press Release Details
– Cash burn of $3.8 million in Q2 remains in line with projected quarterly range
– Cash and investments are sufficient to fund operations through Q3’2026 at current cash burn rate
– Commercial readiness activities underway for a phased launch of VenoValve® subject to FDA decision expected in 2H’2025
– IDE submission for enVVe® on track for 2H’2025
IRVINE, CA / ACCESS Newswire / August 1, 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 reported financial results for the second quarter 2025.
“As the recent headlines around CVI confirmed, CVI is a pervasive and a progressive disease that is especially debilitating once it becomes severe. Our participation in several of the recent national news stories about CVI fits with our strategy of establishing enVVeno Medical as the world-wide leader in treatments for severe, deep venous disease. With several value driving milestones on the horizon, including FDA decisions on potential approval for the VenoValve and the pivotal study for enVVe, we continue to make strong progress in our mission to bring first-in-category, effective treatments to patients with severe CVI, and are well positioned to lead the ongoing national dialogue about CVI as further events are reported,” commented Robert Berman, CEO of enVVeno Medical.
Summary of Financial Results for the Second Quarter 2025 The Company ended the quarter with $35.1 million in cash and investments. Based on management’s current expectations, this capital has the potential to fund the Company through the third quarter of 2026, including pre-commercialization activities for the VenoValve, and the commencement of the enVVe pivotal study.
Cash burn for the quarter was $3.8 million, consistent with the Company’s projected cash burn rate of approximately $4-5 million per quarter. The Company anticipates that its cash burn rate will increase from current levels once commercialization of the VenoValve begins.
The Company reported net losses of $6.7 million and $5.0 million for the three months ended June 30, 2025 and 2024, respectively, representing an increase in net loss of $1.7 million, or 35%. This increase was primarily due to higher operating expenses of $1.6 million resulting from additional personnel costs, the issuance of option grants, and non-recurring reserve and severance expenses, as well as a decrease in other income of $0.1 million.
Clinical Program Progress VenoValve® : Novel, First-In-Class Surgical Replacement Venous Valve
• Amended VenoValve PMA application in response to formal questions from U.S. Food and Drug Administration (FDA)
• Continue to respond to FDA questions and inquiries as they arise
• Presented positive interm, two-year data at Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting
• PMA decision from FDA expected 2H’2025
Amended VenoValve PMA application in response to formal questions from U.S. Food and Drug Administration (FDA)
Continue to respond to FDA questions and inquiries as they arise
Presented positive interm, two-year data at Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting
PMA decision from FDA expected 2H’2025
enVVe® : Novel, First-In-Class Non-Surgical Transcatheter-Based Replacement Venous Valve
• Successfully completed final wave for the shorter-term subjects in 6-month pre-clinical GLP study
• Awaiting final pathology form the GLP study
• Successfully completed other testing necessary for IDE filing
• IDE filing for enVVe pivotal trial on track for 2H’2025
Successfully completed final wave for the shorter-term subjects in 6-month pre-clinical GLP study
Awaiting final pathology form the GLP study
Successfully completed other testing necessary for IDE filing
IDE filing for enVVe pivotal trial on track for 2H’2025
President Trump CVI Diagnosis Following President Trump’s recent diagnosis of what appears to be moderate CVI, Dr. Marc Glickman, Senior Vice President and Chief Medical Officer of enVVeno Medical was featured in several national television news segments, podcasts, radio reports, and news articles, including Fox News, NewsMax, Morning Wire, and the N.Y. Post. To view this media, click here .
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.
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: 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
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