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enVVeno Medical Reports First Quarter 2025 Financial Results and Reiterates Progress Toward VenoValve FDA Decision Expected in 2H24

1. enVVeno maintains cash sufficient for operations until FDA decision in 2025. 2. CEO emphasizes ongoing engagement with vascular surgeons for VenoValve market entry.

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+2.23%S&P 500
$305/01 08:07 AM EDTEvent Start
$3.61505/02 02:52 PM EDTLatest Updated
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FAQ

Why Bullish?

The financial stability and strategic outreach indicate readiness for potential FDA approval, historically boosting stock prices for biotech firms prior to drug approvals.

How important is it?

The insights into financials and FDA timelines suggest NVNO is well-positioned for future growth, impacting investor perceptions positively.

Why Long Term?

The upcoming FDA decision and pivotal trial submissions are crucial steps influencing NVNO’s growth trajectory in the coming years.

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Cash Burn of $4.0 million in Q1 remains in line with projected quarterly range Cash and investments on hand are sufficient to fund operations beyond the anticipated FDA decision of VenoValve and the initiation of the enVVe pivotal trial FDA decision on PMA application for the VenoValve expected in the second half of 2025 On track for enVVe IDE application submission in Q3 of 2025, pending GLP study results IRVINE, CA / ACCESS Newswire / May 1, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today reported financial results for the first quarter 2025. Robert Berman, enVVeno Medical's Chief Executive Officer, commented "In the first quarter, we continued to present our compelling 1-year data from the U.S. pivotal trial at leading global, scientific conferences to socialize and engage directly with leading vascular surgeons as we lay the foundation for the potential phased market entry of the VenoValve, pending FDA approval.

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