other material
confidence high
sentiment positive
materiality 0.75
enVVeno: 72% of VenoValve patients show clinically meaningful benefit; FDA filing on track for Q4 2024
enVVeno Medical Corp
- 72% of SAVVE trial patients achieved ≥3-point rVCSS improvement at a weighted average of 11 months post-surgery.
- Overall average rVCSS improvement of 8.46 points for meaningful-benefit cohort; 9.29 points at two-year milestone.
- 94% of patients showed clinical improvement (≥1 point rVCSS) at a weighted average of 11 months post-implant.
- Company expects to complete one-year data collection by September 2024 and file PMA for FDA approval in Q4 2024.
- Cash and investments of $46.4M at Dec 31, 2023 expected to fund operations through FDA decision and end of 2025.