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 VenoValve Following the initial safety data review by the FDA, the SAVVE study is cleared to continue without modification or interruption The Company currently has 33 patients enrolled in the study and expects to be fully enrolled by the end of Q2 of 2023 With $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 data

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