enVVeno Medical Reports First Quarter 2025 Financial Results and Reiterates Progress Toward VenoValve FDA Decision Expected in 2H24

TECHNOLOGY 01.05.2025

Cash Burn of $4.0 million in Q1 remains in line with projected quarterly range

Cash and investments on hand are sufficient to fund operations beyond the anticipated FDA decision of VenoValve and the initiation of the enVVe pivotal trial

FDA decision on PMA application for the VenoValve expected in the second half of 2025

On track for enVVe IDE application submission in Q3 of 2025, pending GLP study results

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IRVINE, CA / ACCESS Newswire / May 1, 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 reported financial results for the first quarter 2025.

Robert Berman, enVVeno Medical's Chief Executive Officer, commented "In the first quarter, we continued to present our compelling 1-year data from the U.S. pivotal trial at leading global, scientific conferences to socialize and engage directly with leading vascular surgeons as we lay the foundation for the potential phased market entry of the VenoValve, pending FDA approval. We have also maintained a strong financial position - an important advantage in the current market conditions. We remain confident that 2025 will be a pivotal year as we prepare for our transition from a development-stage company to a commercial enterprise."

Summary of Financial Results for the First Quarter 2025

The Company ended the quarter with $38.9 million in cash and investments. Based on management's current expectations, this capital has the potential to fund the Company through the anticipated FDA decision for VenoValve, the initiation of commercialization preparations for VenoValve and the commencement of the enVVe pivotal study.

Cash burn for the quarter was $4.0 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 $4.5 million and $5.0 million for the three months ended March 31, 2025 and 2024, respectively, representing a decrease in net loss of $0.5 million, primarily resulting from a decrease in operating expenses.

Clinical Program Highlights

VenoValve®: Surgical Replacement Venous Valve

VenoValve PMA application seeking U.S. Food and Drug Administration (FDA) approval submitted; Decision expected in H2 2025.

The Company estimates that there are approximately 2.5 million potential new patients each year in the U.S. that could be candidates for the SAVVE procedure, including approximately 1.5 million with active venous ulcers.

enVVe®: Non-Surgical Transcatheter Based Replacement Venous Valve

Successfully completed final wave for the shorter-term subjects in 6-month pre-clinical GLP study. The follow-up period, which began with the first wave of implants, is ongoing as scheduled.

The GLP study should be the final step necessary before filing the Investigational Device Exemption (IDE) seeking FDA approval to start the enVVe pivotal study.

The Company expects to be in a position to file for IDE approval for the enVVe pivotal study mid-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. 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®. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. 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 has submitted a pre-market authorization (PMA) application for the VenoValve to the FDA, with a decision anticipated in the second half of 2025 and is currently performing the final testing necessary to seek approval from the FDA for the enVVe pivotal trial.

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
[email protected]
(908) 824-0775

MEDIA CONTACT:
Glenn Silver, FINN Partners
[email protected]
(973) 818-8198

SOURCE: enVVeno Medical Corporation

View the original press release on ACCESS Newswire

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