HJLI - Hancock Jaffe shares rise after IDE approval to begin venovalve U.S. pivotal trial
Hancock Jaffe Laboratories shares up ([[HJLI]] +4.3%) after the U.S. FDA approved the company's Investigational Device Exemption ((IDE)) application to begin the U.S. pivotal trial for the VenoValve.The VenoValve is an implantable valve designed to restore proper directional blood flow for patients with Chronic Venous Insufficiency ((CVI)) of the deep veins of the leg.The trial is a prospective, non-blinded, single arm, multi-center study of 75 CVI patients to be enrolled at up to 20 U.S. centers, with the primary effectiveness endpoint of reduction in reflux at six months.The company expects to begin patient enrollment in the third quarter of 2021.
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Hancock Jaffe shares rise after IDE approval to begin venovalve U.S. pivotal trial