enVVeno receives unfavorable FDA appeal decision for VenoValve device

enVVeno Medical Corporation (NASDAQ: NVNO) announced the U.S. Food and Drug Administration upheld its previous rejection of the company's VenoValve surgical replacement venous valve device. The FDA's supervisory appeal decision maintained that the device did not meet the standard of reasonable assurance of safety and effectiveness.

The medical device company had initially received a not-approvable letter on August 19, 2025, in response to its Premarket Approval application for VenoValve, designed to treat severe deep chronic venous insufficiency. The company subsequently filed a supervisory appeal of that decision.

Chief Executive Officer Robert Berman stated the company will shift focus to its next-generation device called enVVe, a transcatheter-based replacement venous valve that is ready for human testing. Berman said the appeal decision provided insight into criteria necessary for approval of the newer device.

The company reported $31.5 million in cash and investments at the end of the third quarter, with quarterly cash expenditures of $4 million to $5 million. This funding level provides operational capacity into 2027, according to the company's statement.

Severe deep venous chronic venous insufficiency affects an estimated 2.5 million to 3.5 million patients in the United States, with approximately 1.5 million developing venous leg ulcers. The condition typically results from blood clots in deep leg veins and can significantly impact daily activities.

The Irvine, California-based company develops bioprosthetic solutions for deep venous disease treatment and continues to work with the FDA on its enVVe device development program.

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