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Investing.com -- enVVeno Medical Corp (NASDAQ:NVNO) stock plummeted 32.6% in premarket trading Friday after the company received an unfavorable decision from the FDA regarding its VenoValve device for treating severe deep chronic venous insufficiency.
The FDA upheld its previous not-approvable letter from August 19, 2025, maintaining that the surgical replacement venous valve did not meet standards for "reasonable assurance of safety and effectiveness." This decision came in response to enVVeno’s supervisory appeal of the original rejection.
Despite the setback, CEO Robert Berman indicated the company would shift focus to enVVe, its next-generation transcatheter-based replacement venous valve, which is ready for human testing. Berman noted that the appeal decision provided "valuable insight" into approval criteria for the newer device.
The company reported $31.5 million in cash and investments at the end of the third quarter, with a quarterly burn rate of $4 to $5 million. This financial position should fund operations into 2027 as the company pivots its strategy.
Chronic Venous Insufficiency (CVI) affects approximately 2.5 to 3.5 million patients in the U.S., with about 1.5 million developing venous leg ulcers. The condition can severely impact daily activities and currently lacks effective treatments for severe cases caused by valvular incompetence in the deep vein system.
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