Biocardia Announces FDA-Recommended Modifications to Primary Endpoint for Cardiamp Cell Therapy Heart Failure Trial to Support Marketing Approval

SAN CARLOS, Calif., April 30, 2020 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported that it has accepted and implemented FDA-recommended modifications to the primary endpoint for the CardiAMP Cell Therapy Heart Failure Trial and associated statistical analysis plan. The Agency proposed these modifications to support the potential for marketing approval for the therapy based on the currently enrolling pivotal trial.

The primary endpoint going forward will be an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis, an established outcomes design that has been used in other leading heart failure programs. The FS procedure is a ranked analysis that first compares each subject to each other subject for occurrence of first-tier events (time to death, in this case) and then compares patient outcomes for subsequent tiers. The tiers, starting with the most serious events, would be (1) all-cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal Major Adverse Coronary and Cerebrovascular Events (MACCE), excluding those deemed procedure-related occurring within the first seven days post-procedure (heart failure hospitalization, stroke or myocardial infarction), ordered by time to event, and (3) change from baseline in Six Minute Walk Distance at 12 months. 

BioCardia CEO Peter Altman, PhD, said, “The only major modification to our previous endpoint is that patients who experience a MACCE event and recover will not be factored into the benefit seen in the third-tier measure of Six Minute Walk Distance at one-year follow-up. Since we saw no incidence of MACCE at one year among treated patients in our Phase II trial, our probability of achieving a positive result in the primary endpoint in the ongoing pivotal CardiAMP Heart Failure trial remains unchanged, at greater than 95 percent. Because the FS composite outcomes endpoint is already established for heart failure trials, we expect it to significantly enhance understanding and confidence in our trial results among physicians and payers alike.”