CardiAMP Heart Failure Trial Success
The CardiAMP Heart Failure treatment group showed lower incidence of all-cause death and nonfatal MACE compared to the control group over a 24-month period. Additionally, the composite endpoint of all-cause death, nonfatal MACE, and quality of life was statistically significant in patients with elevated NT-proBNP, with a p-value of 0.02.
Regulatory Progress in Japan
BioCardia has submitted the clinical package of the CardiAMP Heart Failure trial to Japan's PMDA and anticipates an in-person meeting in Q4 2025, potentially leading to market entry approval in Japan.
Data Safety Monitoring Board Review Success
A successful data safety monitoring board review was conducted for the CardiALLO allogeneic mesenchymal stem cell therapy in ischemic heart failure (BCDA-03) program.
Partnership Opportunities
Active discussions are ongoing for partnerships involving the Helix biotherapeutic delivery platform and the Morph DNA technology, with interest from firms in the cardiac electrophysiology market.