EnVVeno Medical's Q3 2024 Financials and Upcoming FDA Milestones

enVVeno Medical Corporation, known for its advancements in venous disease treatment, announced its third-quarter financial results for 2024. The company is nearing completion of its FDA premarket approval application for the VenoValve, having already submitted four out of five modules. The final module is expected in the fourth quarter, with definitive data to be presented in November at the VEITHsymposium.

enVVeno also highlighted the progress of the enVVe, a non-surgical transcatheter-based valve, currently undergoing a crucial GLP study. The company aims to file for IDE approval by mid-2025 to commence a pivotal trial.

Financially, enVVeno closed the quarter with $48.4 million in cash, supported by recent fundraising efforts. The quarterly cash burn stood at $4.3 million, aligning with projections. However, net losses rose to $5.6 million, attributed to increased operational expenses.