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enVVeno Medical Successfully Passes Preliminary FDA Safety Review for the VenoValve U.S. Pivotal Study
The Company submitted safety data for the first 20 patients enrolled in the ongoing SAVVE U.S. pivotal study for the VenoValveFollowing the initial safety
About this update from Envveno Medical Corporation
[{"type":"text","content":"The Company submitted safety data for the first 20 patients enrolled in the ongoing SAVVE U.S. pivotal study for the VenoValveFollowing the initial safety data review by the FDA, the SAVVE study is cleared to continue without modification or interruptionThe Company currently has 33 patients enrolled in the study and expects to be fully enrolled by the end of Q2 of 2023With $42.7 million of cash and investments reported at the end of Q3 of 2022, the Company has sufficient cash to sustain operations through the end of 2024, including release of SAVVE topline pivotal trial dataIRVINE, CA / ACCESSWIRE / November 7, 2022 / enVVeno Medical Corporation (Nasdaq:NVNO) (\"enVVeno\" or the \"Company\"), a company setting new standards of care for the treatment of venous disease, today announced that the Company has successfully passed a preliminary safety review by the U.S. Food and Drug Administration (FDA) for the first twenty (20) patients enrolled in the ongoing SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal study for the VenoValve.The FDA had requested that enVVeno submit preliminary safety data at thirty (30) days post VenoValve implantation for the first twenty (20) patients enrolled in the study. The preliminary safety data submitted by the Company included one (1) device related (mild) and two (2) procedure related (moderate) adverse events. After review by the FDA, the study was cleared to continue without modification or interruption.The Company currently has thirty-three (33) patients enrolled in the trial and based upon the current pace of enrollment, expects to be fully enrolled by the end of the second quarter of 2023. With $42.7 million of cash and investments reported at the end of the third quarter of 2022, the Company has sufficient cash to sustain operations through the end of 2024, including past the expected release of thirty (30) day primary safety and one hundred eighty (180) day primary efficacy endpoint data from the study.\"It is not unusual for the FDA to request to closely monitor safety data for an initial group of patients in a study for a first-in-class device such as the VenoValve,\" said Robert Berman, enVVeno Medical's Chief Executive Officer. \"We are encouraged by the safety profile of the VenoValve for this initial group of patients and are pleased that the FDA permitted the stud...