enVVeno Medical Corp (NASDAQ:NVNO) saw its shares collapse 32.6% in premarket trading on Friday after the U.S. Food and Drug Administration upheld its earlier decision to reject the company’s VenoValve device, a surgical implant designed for patients suffering from severe deep chronic venous insufficiency.
The agency reaffirmed the “not-approvable” letter it issued on August 19, 2025, concluding that the venous valve system failed to demonstrate “reasonable assurance of safety and effectiveness.” The ruling was handed down in response to enVVeno’s supervisory appeal attempting to overturn the initial rejection.
In the wake of the decision, CEO Robert Berman said the company will now place greater emphasis on enVVe, its next-generation transcatheter venous valve that is prepared to begin first-in-human studies. Berman added that the FDA’s response offered “valuable insight” into the regulatory expectations that will guide development of the new device.
As of the end of the third quarter, enVVeno held $31.5 million in cash and investments, with a quarterly burn rate of $4 to $5 million, which the company believes should support operations into 2027 as it pivots its strategic focus.
Chronic Venous Insufficiency (CVI) affects an estimated 2.5 to 3.5 million people in the U.S., and roughly 1.5 million of them develop venous leg ulcers. The illness can dramatically impair quality of life, and severe cases linked to malfunctioning deep-vein valves currently have limited therapeutic options.