Biocardia Phase 3 CardiAMP-HF Trial of Novel Cardiac Cell Therapy for Ischemic Heart Failure Shows Increased Survival, Decreased Cardiac Events, and Improved Quality of Life at Two Years

Core Insights - BioCardia, Inc. announced two-year outcomes from the Phase 3 CardiAMP-HF study, demonstrating the efficacy of CardiAMP autologous cell therapy for ischemic heart failure patients with reduced ejection fraction [1][2][3] Group 1: Clinical Trial Results - The CardiAMP-HF Trial involved 115 ischemic heart failure patients across 18 centers in the U.S. and Canada, showing that patients receiving CardiAMP therapy alongside medication experienced decreased mortality and major adverse cardiac and cerebrovascular events (MACCE) [2][4] - Statistically significant improvements were observed in patients with elevated NTproBNP, indicating greater benefits for those under active heart stress [4][5] - Treated patients exhibited a 13% reduction in heart death equivalents and a 47% relative risk reduction in heart death equivalents compared to those on medication alone [5] Group 2: Quality of Life Improvements - Patients receiving CardiAMP therapy reported a clinically meaningful 10.5-point improvement in quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) [5] - Improvements in physical capacity were noted, with a 13.9-meter increase in Six Minute Walk Distance for treated patients [5] Group 3: Mechanism and Market Potential - CardiAMP Cell Therapy is designated as a Breakthrough Therapy by the FDA, utilizing a pre-procedural cell analysis, a high target dosage of cells, and a minimally invasive delivery system [3][6] - The therapy targets mechanisms leading to microvascular dysfunction, potentially benefiting around one million patients in the U.S. who currently incur $30 billion annually in healthcare costs [7][8] Group 4: Future Directions - BioCardia plans to share the two-year data with the U.S. FDA and Japan PMDA to expedite the therapy's availability for patients [7] - The company emphasizes the potential of CardiAMP therapy to reduce healthcare costs associated with heart failure by improving patient health outcomes [7]