enVVeno Medical Reports First Quarter 2025 Financial Results and Reiterates Progress Toward VenoValve FDA Decision Expected in 2H24
- Strong cash position of $38.9 million, sufficient to fund operations through key milestones
- Reduced net loss by $0.5 million compared to Q1 2024
- Large market opportunity with 2.5 million potential U.S. patients annually
- Successfully completed shorter-term phase of enVVe GLP study
- Cash burn expected to increase once commercialization begins
- Still awaiting FDA approval with no guarantee of success
- Company remains in pre-revenue development stage
Insights
enVVeno reports stable $38.9M cash position with VenoValve FDA decision expected H2 2025, positioning for potential commercialization with manageable burn rate.
enVVeno's Q1 2025 financial results show a stable cash position of
The company reduced its net losses to
The VenoValve, targeting surgical replacement of venous valves, has completed its PMA submission with an FDA decision expected in H2 2025. The market opportunity is substantial, with an estimated 2.5 million potential new U.S. patients annually, including 1.5 million with active venous ulcers. This represents a significant addressable market for a condition with limited effective treatment options.
Meanwhile, the enVVe non-surgical transcatheter-based replacement valve is progressing through pre-clinical studies, with the company expecting to file for IDE approval by mid-2025. This two-product strategy gives enVVeno multiple pathways to market in the deep venous disease space.
The financial discipline demonstrated while advancing two clinical programs positions enVVeno well for its planned transition from development to commercialization. The anticipated increase in cash burn once VenoValve commercialization begins is a natural progression that appears to be well-planned for within their financial strategy.
Cash Burn of
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
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
Cash burn for the quarter was
The Company reported net losses of
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
NVNO@jtcir.com
(908) 824-0775
MEDIA CONTACT:
Glenn Silver, FINN Partners
Glenn.Silver@finnpartners.com
(973) 818-8198
SOURCE: enVVeno Medical Corporation
View the original press release on ACCESS Newswire
FAQ
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