regulatory
confidence high
sentiment positive
materiality 0.60
BioCardia to present CardiAMP HF II trial design at HFSA; FDA says trial may support approval
BioCardia, Inc.
- Poster titled "Cardiac Delivery of Autologous Minimally Processed Cell Therapy in HFrEF: Multicenter, Double Blind RCT (CardiAMP HF II)" to be presented at HFSA 2026 in Phoenix, Oct 9-12, 2026.
- Study objective: determine efficacy of high-dose autologous cell treatment for ischemic HFrEF patients on guideline-directed medical therapy but with elevated biomarkers of heart stress.
- FDA approved Category B designation for CardiAMP cell therapy system in three trials; FDA recently agreed ongoing CardiAMP HF II may support approval.
- CEO Peter Altman said the company is advancing the confirmatory CardiAMP HF II trial with world-class centers and has parallel regulatory submissions with FDA and Japan's PMDA.