BioCardia provided update on its CardiAMP cell therapy programs

BioCardia announced a clarification and next steps on its autologous CardiAMP cell therapy programs. Based on the recent interim results in the CardiAMP autologous cell therapy for the treatment of heart failure, or BCDA-01, the Company is exploring development of a new Phase III clinical trial protocol. The Finkelstein Schoenfeld, or FS, primary composite endpoint used in the CardiAMP HF Trial has tiers of outcomes in decreasing order of importance: heart death equivalent, major adverse cardiac and cerebrovascular MACCE, and Six Minute Walk Distance, or 6MWD. Since the primary FS endpoint is a composite of these elements, meeting the FS endpoint may be met even if one or more of the components does not individually demonstrate statistical significance. This has implications for the future trial design. The CardiAMP HF Trial interim results showed that the first two most important tier outcomes, occurring in 30% of the study patients, could have contributed sufficiently toward efficacy given a longer follow-up period than one year. If these interim results are replicated in a future study in which the third tier 6MWD is replaced with a more objective endpoint, there may be a pathway to a successful trial for product registration in the U.S. The FDA has previously expressed a preference for replacing the 6MWD with Cardiopulmonary Exercise Testing, which is a more objective outcome.