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enVVeno Medical Reports Fourth Quarter and Year-End 2024 Financial Results and Progress Towards VenoValve FDA Approval Expected in 2H25

1. enVVeno reported a Q4 cash burn of $5.2 million, within expected range. 2. PMA application for VenoValve submitted; FDA decision expected in late 2025.

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FAQ

Why Bullish?

The successful submission of the PMA application indicates strong progress. Historical precedents show approval milestones often trigger positive price movements.

How important is it?

Insights about cash burn and FDA timelines are crucial. They indicate operational health and upcoming regulatory events directly affecting NVNO.

Why Long Term?

The FDA decision on VenoValve in 2025 could significantly influence NVNO stock. Long-term growth expected if VenoValve gains approval.

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Cash Burn of $5.2 million in Q4 remains in line with projected $4-5 million quarterly range Cash and investments on hand are sufficient to fund operations beyond the anticipated regulatory approval of VenoValve and the initiation of the enVVe pivotal trial PMA application for the VenoValve submitted, with FDA decision expected in the second half of 2025 On track for enVVe IDE application submission by mid-2025, pending GLP study results IRVINE, CA / ACCESS Newswire / February 28, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today provided a corporate update and reported financial results for the fourth quarter and year-end of 2024. "Throughout 2024, we executed on our primary objectives - the successful submission of our PMA application for the VenoValve®, and the advancement of enVVe towards its U.S. pivotal trial, both critical milestones for enVVeno Medical," commented Robert Berman, CEO of enVVeno Medical.

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