03:52 PM EST, 03/06/2024 (MT Newswires) -- EnVVeno Medical ( NVNO ) announced "positive topline efficacy data showing significant clinical improvement" from the US pivotal trial for VenoValve, a surgical replacement being developed for severe chronic venous insufficiency.

The data indicates that 97% of VenoValve recipients in the study showed clinical improvement with 74% achieving a significant benefit of three or more points in the revised Venous Clinical Severity Score, the company said Wednesday in a statement.

The average per-patient improvement for those with clinically meaningful benefits is eight points, exceeding the US Food and Drug Administration's rVCSS requirement by more than two and a half times, "to show that the VenoValve provides clinically meaningful benefit," enVVeno said.

The FDA has asked enVVeno to collect one year of data on trial patients before filing its FDA approval application, which is expected to be completed by September, the company said.

Shares of enVVeno fell 4.4% in recent Wednesday trading.

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