EnVVeno Medical's Financial Results and Progress Toward FDA Approval

enVVeno Medical Corporation has reported its financial results for Q4 2024, along with progress towards FDA approval for its VenoValve®. The company maintained a cash burn of $5.2 million in Q4, aligning with the projected quarterly range. As of year-end 2024, enVVeno held $43.2 million in cash and investments, which is expected to support operations beyond the anticipated FDA decision in the second half of 2025.

The VenoValve PMA application is currently under FDA review, with a decision expected in late 2025. Clinical data from the SAVVE U.S. pivotal trial demonstrated sustained clinical improvement among subjects, with a 78% of subjects showing a significant reduction in pain and enhancement in quality-of-life indicators over a 24-month period.

The company also made strides with enVVe, a transcatheter-based venous valve, completing a pre-clinical GLP study. Plans are underway to submit the IDE application by mid-2025 to initiate the enVVe pivotal trial.