EnVVeno Medical (NVNO) climbed 3.6% in recent Tuesday trading after the medical technology company said it had filed a premarket approval application with the US Food and Drug Administration for its VenoValve implants to treat severe chronic venous insufficiency.
The completed application is supported by clinical data from a pivotal trial and includes proposed labeling for the device, the company said.
Chief Executive Officer Robert Berman said he anticipates a decision from the FDA in H2 of 2025. The regulator previously designated VenoValve as a breakthrough device, helping expedite the agency's evaluations.
Price: 3.43, Change: +0.12, Percent Change: +3.60
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