美国食品和药物管理局由于证据不足而拒绝批准VenoValve;公司转向下一代设备. FDA denies approval for VenoValve due to insufficient evidence; company pivots to next-gen device.

enVVeno Medical 收到了FDA的不利决定,维持其对VenoValve的不批准信,这是一种用于治疗严重慢性静脉功能不充分的手术静脉,并指出安全性和有效性的证据不足. enVVeno Medical received an unfavorable FDA decision upholding its earlier not-approvable letter for the VenoValve, a surgical venous valve for severe chronic venous insufficiency, citing insufficient evidence of safety and effectiveness. 该公司说,反馈意见将为其下一代enVVe的发展提供参考,enVVe是一个较不受入侵的跨胃阀门,可以进行人类试验。 The company said the feedback will inform development of its next-generation enVVe, a less invasive transcatheter valve ready for human trials. enVeno报告说,截至2025年3季度,现金为3 150万美元,预计业务将延续到2027年。 enVVeno reported $31.5 million in cash as of Q3 2025, with projected operations extending into 2027. 这种状况影响到数百万美国人,每年需要花费数十亿医疗费用。 The condition affects millions of Americans and incurs billions in annual healthcare costs.