The U.S. Food & Drug Administration issued an unfavorable decision on November 13, 2025, rejecting enVVeno Medical’s supervisory appeal of the not‑approvable letter it received on August 19, 2025. The ruling confirms that the agency found the VenoValve’s clinical data insufficient to demonstrate a reasonable assurance of safety and effectiveness, effectively halting the device’s path to PMA approval.
The VenoValve, a bioprosthetic surgical replacement valve for severe chronic venous insufficiency, had earned Breakthrough Device designation in August 2021 and was awaiting a pre‑market approval. The not‑approvable letter cited gaps in safety data and concerns about the surgical procedure, and the appeal failed to address those deficiencies. The decision underscores the FDA’s stringent data requirements for devices that treat a high‑risk patient population.
Despite the setback, enVVeno remains well capitalized. At the end of Q3 2025, the company reported $31.5 million in cash and investments, with a quarterly burn of $4–$5 million. The balance provides a runway through 2027, giving the company time to navigate the regulatory path for its next‑generation product and to secure additional funding if needed.
CEO Robert Berman said the decision offers valuable insight into the criteria the FDA will expect for the company’s next‑generation transcatheter valve, enVVe. “The appeal decision was not the outcome we were hoping for, but it has clarified the data and safety profile the Agency will require for enVVe,” Berman said. He added that enVVe is ready for human testing and that the company will continue to engage with the FDA to align on endpoints and study design.
The market for treating severe chronic venous insufficiency is sizable, with an estimated 2.5 to 3.5 million U.S. patients lacking effective options. A successful enVVe product could capture a significant share of this unmet need, potentially offsetting the loss of the VenoValve pipeline. The company’s pivot to a non‑surgical, transcatheter approach also positions it to benefit from the broader trend toward less invasive therapies.
Berman emphasized that enVVeno remains committed to its patient base and to advancing the enVVe program. “We are well capitalized and will continue to interact with the FDA, providing periodic updates on our progress,” he said. The company’s strategy now focuses on securing regulatory alignment for enVVe while maintaining financial stability to support ongoing development and potential future approvals.
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