Nov. 14 at 3:33 PM
enVVeno Medical Corp shares fell premarket Friday after the FDA upheld its previous non-approval letter for the VenoValve device, designed to treat severe chronic deep venous insufficiency. The agency stated the surgical venous replacement valve did not meet standards for “reasonable assurance of safety and effectiveness,” denying enVVeno’s appeal of the original rejection.
CEO Robert Berman said the company will shift focus to enVVe, its next-generation catheter-based venous replacement valve, now ready for human trials. He noted the FDA decision offered “valuable insight” into approval criteria for the new device.
The company reported
$31.5 million in cash and investments at the end of Q3, with a quarterly burn rate of
$4–5 million, expected to fund operations through 2027 during the strategic pivot.
$NVNO