BioCardia Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial, with Compelling Data in Subgroup with Elevated NTproBNP Biomarker for Heart Failure

• CardiAMP cell therapy-treated patients had 37% relative risk reduction in heart death equivalent (death, heart transplant, left ventricular assist device implantation) and 9% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events (MACCE) at mean 20-month follow-up compared to control patients on guideline-directed heart medications alone
  
• Large sub-set of treated patients with elevated NTproBNP – a marker of heart distress – showed greater reductions, with 86% relative risk reduction in heart death equivalents and 24% relative risk reduction in non-fatal MACCE
• FDA-approved follow-on Phase III trial of high-responding patient population with elevated NTproBNP (CardiAMP HF II) has launched to validate positive interim results
  

SUNNYVALE, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, today announced positive interim results from the Phase III randomized controlled trial of its CardiAMP autologous cell therapy in 110 randomized patients with advanced chronic heart failure at a mean 20-month follow-up, (CardiAMP HF). Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress. The data was presented today by Amish Raval, MD, Director of Clinical Cardiovascular Research and Professor of Medicine at the University of Wisconsin-Madison at the Technology and Heart Failure Therapeutics (THT) 2024 annual meeting.

Over a mean 20 months of follow-up, patients with advanced chronic heart failure who received a single endomyocardial dose of autologous CardiAMP cell therapy while on maximal medical therapy had a 37% relative risk reduction in all-cause heart death equivalents and a 9% relative risk reduction in non-fatal incidence of heart attacks, strokes, and hospitalization due to heart failure (MACCE). Patients treated with CardiAMP cell therapy saw an almost 5% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (8.3% vs. 13.2%, respectively). CardiAMP cell therapy was also associated with trends toward reduced ventricular tachyarrhythmias, enhanced heart function as measured by left ventricular ejection fraction, and improved NTproBNP.