Company accelerated development of the enVVe System, completing pre-clinical studies and progressing toward a 2026 pivotal trial initiation
Strong financial position expected to provide an operating runway into mid-2027 through the achievement of key clinical milestones
IRVINE, CA / ACCESS Newswire / March 27, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company"), today announced financial results for the year ended December 31, 2025 and provided a corporate update highlighting its strategic focus on the development of its next-generation enVVe System.
Robert Berman, Chief Executive Officer of enVVeno Medical Corporation, stated, "2025 represented a significant inflection point for the Company. Following the FDA's decision regarding the VenoValve, we made the strategic determination to accelerate development of the enVVe System, a less invasive, transcatheter-based approach designed to address prior regulatory considerations while broadening the potential physician adoption base." Mr. Berman added, "With pre-clinical development complete and active discussions underway with the FDA, we are now focused on initiating our pivotal trial in 2026 and believe the enVVe System represents a transformative opportunity to address a large and underserved patient population suffering from severe chronic venous insufficiency."
Chronic venous disease is the most prevalent chronic condition in the United States, affecting an estimated 70% of the adult population. Severe chronic venous insufficiency (CVI), a more advanced form of the disease, impacts approximately 3.5 million patients in the United States, including roughly 1.5 million individuals with venous leg ulcers. Currently, there are no approved surgical or non-surgical replacement venous valves available, highlighting a significant unmet medical need.
The enVVe System is a first-in-class, non-surgical, transcatheter-based replacement venous valve designed to treat severe deep CVI by restoring proper one-way blood flow in the leg veins. The system is intended to eliminate the need for open surgery, reduce procedural risk, expand adoption across multiple physician specialties and improve patient quality of life. Looking ahead, the Company's primary focus in 2026 will be advancing the enVVe System into clinical development, including finalizing alignment with the FDA on the pivotal trial design, initiating the pivotal trial and progressing toward potential regulatory approval.
Summary of Financial Results for the Full Year 2025
For the year ended December 31, 2025, the Company reported a net loss of $19.5 million, compared to a net loss of $21.8 million in 2024. Research and development expenses totaled $10.0 million, representing a 19% decrease year-over-year, while selling, general and administrative (SG&A) expenses were $10.9 million. As of December 31, 2025, the Company held $28.2 million in cash and investments. The Company expects its cash burn rate to increase modestly in 2026 to approximately $4 million to $5 million per quarter as it prepares for and initiates the enVVe system pivotal trial.
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:
Jenene Thomas, JTC Team, LLC
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-full-year-2025-financial-results-and-highlights-strategic-adv-1152454
