EnVVeno Medical Loses Appeal of FDA Not-Approvable Letter for VenoValve
By Josh Beckerman
EnVVeno Medical received an unfavorable appeal decision from the Food and Drug Administration, which upheld an August not-approvable letter for VenoValve, a surgical replacement venous valve for treating severe deep chronic venous insufficiency.
The medical device company's shares fell 36% to 42 cents after hours.
The company said that, assuming it can reach alignment with the FDA on achievable endpoints for another product, enVVe, "it makes sense to turn our attention and devote our resources to enVVe." EnVVeno said "although the appeal decision was not the result we are looking for, it did provide valuable insight into the criteria that would be necessary for approval of enVVe."
The company said enVVe, a non-surgical replacement venous valve, should have a different safety profile than an open surgical device and is ready for human testing.
With $31.5 million in cash and investments at the end of the third quarter and a quarterly cash burn of $4 million to $5 million, the company said it has sufficient cash to fund operations into 2027.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
November 13, 2025 18:59 ET (23:59 GMT)
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