enVVeno Medical Corporation reported a cash burn of $4.0 million for the first quarter of 2025, which remained in line with its projected quarterly range. The company reiterated that its current cash and investments are sufficient to fund operations beyond the anticipated FDA decision for the VenoValve and the initiation of the enVVe pivotal trial.
The FDA decision on the Premarket Approval (PMA) application for the VenoValve is expected in the second half of 2025, maintaining the critical regulatory timeline. This decision is a key near-term catalyst for the company's potential commercialization.
Additionally, the Investigational Device Exemption (IDE) application submission for enVVe remains on track for the third quarter of 2025, pending GLP study results. This demonstrates continued progress on the company's next-generation transcatheter device, which aims to expand its addressable market.
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