enVVeno Medical Corporation reported its financial results for the fourth quarter and year-end of 2024, with a cash burn of $5.2 million in Q4. The company stated that its cash and investments on hand are sufficient to fund operations beyond the anticipated regulatory approval of VenoValve and the initiation of the enVVe pivotal trial.
The Premarket Approval (PMA) application for the VenoValve was submitted, with an FDA decision expected in the second half of 2025. This reiterates the critical near-term catalyst for the company's lead product.
Furthermore, the company remains on track for the enVVe Investigational Device Exemption (IDE) application submission by mid-2025, contingent on GLP study results. This indicates continued progress on its next-generation transcatheter device, expanding its future market opportunity.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.