enVVeno Medical receives first U.S. patent for venous valve system

enVVeno Medical Corporation (NASDAQ: NVNO) announced the issuance of U.S. Patent No. 12,575,932, covering key components of its enVVe transcatheter replacement venous valve system, according to a company press release.

The patent covers the enVVe valve, valve support frame, crimping system, and delivery system, as well as methods for treating patients with deep venous insufficiency (DVI), a condition caused by damaged venous valves that can lead to reflux, venous hypertension, and venous leg ulcers.

The enVVe system is designed as a catheter-based, non-surgical alternative to open surgical venous valve replacement. The company states the system is intended to eliminate the need for general anesthesia or overnight hospital stays.

The company has received FDA Investigational Device Exemption (IDE) approval for its TAVVE pivotal trial, which it describes as the first-ever FDA IDE approval for a pivotal study of a non-surgical replacement venous valve. Enrollment is expected to commence with first patient data anticipated by the end of the fourth quarter of 2026.

"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," said Rob Berman, Chief Executive Officer of enVVeno Medical.

enVVeno Medical is based in Irvine, California, and describes itself as a late clinical-stage medical device company focused on bioprosthetic solutions for deep venous disease.

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