enVVeno Medical reported its third‑quarter 2025 financial results, ending September 30, 2025, with $31.0 million in cash and investments.
The company recorded a net loss of $4.5 million for the quarter, a 20% decline from the $5.6 million loss reported for the same period in 2024, and a cash burn of $4.2 million, within the $4‑$5 million range it had projected.
Cash and investments are expected to fund operations through the second quarter of 2027, excluding the anticipated costs of VenoValve commercialization and the enVVe IDE study, which remain on hold pending the outcome of the FDA supervisory appeal.
The company is engaged in a supervisory appeal with the FDA regarding the VenoValve PMA decision, following a “not‑approvable” letter issued on August 20, 2025. Feedback on the appeal is expected by the end of 2025.
enVVeno also received a Nasdaq bid‑price notice on October 7, 2025, for failing to meet the minimum $1.00 closing bid price requirement. The company has until April 6, 2026, to regain compliance.
The company’s balance sheet remains strong, with a current ratio of 11.81 and a debt‑to‑equity ratio of 0.03, while it continues to focus on research and development and regulatory milestones for its venous valve programs.
Chronic venous insufficiency affects 2.5 to 3.5 million U.S. patients with severe disease, and enVVeno’s products aim to address this unmet need.
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