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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 Medical's cash burn aligns with projections, indicating financial stability. 2. FDA decision on VenoValve expected in 2025; pivotal trial submission on track.

Earnings
-9.92%Current Return
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+1.56%S&P 500
$3.5302/28 08:05 AM EDTEvent Start
$3.1803/03 08:19 AM EDTLatest Updated
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FAQ

Why Bullish?

The successful submission of the PMA application and FDA decision timeline are positive indicators. Historical patterns show FDA approvals often lead to stock surges in clinical companies.

How important is it?

The financial stability and successful regulatory submissions significantly enhance NVNO's market position and investor confidence.

Why Long Term?

The approval timeline for the VenoValve and enVVe trial will influence prices significantly as decisions approach in 2025 and beyond.

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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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