enVVeno Medical shares fall 28.02% premarket after FDA upholds not-approvable decision for VenoValve, forcing pivot to enVVe.

EnVVeno Medical (NVNO) fell 28.02% in premarket trading following the FDA’s unfavorable appeal decision for its VenoValve device, which upheld a prior not-approvable letter. The agency maintained concerns over the device’s safety and efficacy for treating severe chronic venous insufficiency, prompting the company to shift focus to its next-generation enVVe valve. While management highlighted enVVe’s potential for human trials and a safer profile, the regulatory setback and lack of immediate alternative approvals weighed heavily on investor sentiment. The company confirmed $31.5 million in cash reserves, sufficient to fund operations through 2027, but the rejection underscored ongoing challenges in its product pipeline. The sharp premarket decline aligns with the news, reflecting market skepticism over regulatory hurdles and the absence of a viable path to commercialization for its flagship product.