enVVeno Medical Corporation reported a net loss of $5.6 million for the third quarter of 2024, an increase from $5.0 million in the same period of 2023. The company ended the quarter with $48.4 million in cash and investments, following the recent capital raise, and reported a cash burn of $4.3 million, aligning with previous guidance.
The company confirmed that four out of five modules comprising the VenoValve Premarket Approval (PMA) application had been submitted, reviewed, and approved by the U.S. Food and Drug Administration. The fifth and final module, containing clinical data from the SAVVE U.S. pivotal trial, was on track for submission in the fourth quarter of the year.
Additionally, enVVeno successfully initiated its six-month pre-clinical GLP study for enVVe, with the first wave of implants completed and the final wave scheduled for December 2024. The company expects to be in a position to file for IDE approval for the enVVe pivotal trial mid-next year, demonstrating continued pipeline advancement.
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