Business
enVVeno Medical Reports First Quarter 2025 Financial Results and Reiterates Progress Toward VenoValve FDA Decision Expected in 2H24
Cash Burn of $4.0 million in Q1 remains in line with projected quarterly rangeCash and investments on hand are sufficient to fund operations beyond the
About this update from Envveno Medical Corporation
[{"type":"text","content":"Cash Burn of $4.0 million in Q1 remains in line with projected quarterly rangeCash and investments on hand are sufficient to fund operations beyond the anticipated FDA decision of VenoValve and the initiation of the enVVe pivotal trialFDA decision on PMA application for the VenoValve expected in the second half of 2025On 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. We have also maintained a strong financial position - an important advantage in the current market conditions. We remain confident that 2025 will be a pivotal year as we prepare for our transition from a development-stage company to a commercial enterprise.\"Summary of Financial Results for the First Quarter 2025The Company ended the quarter with $38.9 million in cash and investments. Based on management's current expectations, this capital has the potential to fund the Company through the anticipated FDA decision for VenoValve, the initiation of commercialization preparations for VenoValve and the commencement of the enVVe pivotal study.Cash burn for the quarter was $4.0 million, consistent with the Company's projected cash burn rate of approximately $4-5 million per quarter. The Company anticipates that its cash burn rate will increase from current levels once commercialization of the VenoValve begins.The Company reported net losses of $4.5 million and $5.0 million for the three months ended March 31, 2025 and 2024, respectively, representing a decrease in net loss of $0.5 million, primarily resulting from a decrease in operating expenses.Clinical Program HighlightsVenoValve®: Surgical Replacement Venous ValveVenoValve PMA application seeking U.S. Food and Drug Administration (FDA) approval submit...