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enVVeno Medical Secures Transformational U.S. Patent for enVVe System, Strengthening Competitive Moat Ahead of Launch of Historic FDA Pivotal Trial
New Patent Broadly Protects Core Technology Behind Potential First Non-Surgical Replacement Venous Valve
Builds on First-Ever FDA IDE Approval for Pivotal Study of enVVe System Targeting Multi-Billion-Dollar Market Opportunity
enVVe Pivotal Study on Track for Enrollment to Commence and First Patients Data Release Expected by the End of Q4 2026
IRVINE, CA / ACCESS Newswire / July 7, 2026 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno Medical" or the "Company") today announced the issuance of U.S. Patent No. 12,575,932, further expanding its intellectual property portfolio supporting its enVVe® transcatheter replacement venous valve system for the treatment of venous disease.
The issued patent covers key components of the enVVe system, including the enVVe valve, valve support frame, crimping system, and delivery system, as well as methods for use in treating patients with deep venous insufficiency (DVI). The enVVe system is the transcatheter evolution of the clinically proven surgical device, designed to restore proper one-way blood flow in the deep veins of the leg.
Deep venous insufficiency is a progressive condition caused by damaged venous valves in the deep veins of the leg, resulting in reflux, venous hypertension, and, in advanced cases, venous leg ulcers. The Company believes a significant unmet need remains for effective and less invasive treatment options, particularly for patients who may not be candidates for surgical intervention.
"With the issuance of this first U.S. patent for the enVVe System and the first-ever FDA IDE approval for a pivotal trial of a non-surgical replacement venous valve, enVVeno has strengthened both the intellectual property and regulatory foundations of what we believe could become a category-defining therapy in a multi-billion-dollar market. As we advance toward treating the first patient in the TAVVE pivotal trial, we are building a powerful competitive moat around technology that has been proven surgically and has the potential to fundamentally change how severe chronic venous insufficiency is treated," said Rob Berman, Chief Executive Officer of enVVeno Medical.
The enVVe system is being developed as a non-surgical, catheter-based alternative to traditional open surgical approaches and will be evaluated in the Company's TAVVE U.S. pivotal trial following recent FDA IDE approval. In addition to treating DVI, the enVVe System is designed to reduce procedural invasiveness, eliminate the need for general anesthesia or overnight hospital stays, and expand access to treatment across a broader patient population.
This patent issuance represents another important milestone as enVVeno continues to build a robust intellectual property and regulatory foundation supporting the clinical advancement and future commercialization potential of its enVVe technology. The Company believes its expanding patent portfolio, combined with recent FDA IDE approval for the TAVVE pivotal study, further strengthens enVVeno's position as a leader in the emerging field of replacement venous valve therapy.
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
[email protected]
(908) 824-0775
SOURCE: enVVeno Medical Corporation
View the original press release on ACCESS Newswire
C.Garcia--AMWN