BCDA - BioCardia gets positive DSMB recommendation for late-stage heart failure study
BioCardia (BCDA) announces that the independent Data Safety Monitoring Board ((DSMB)) has recommended that the company continue with its late-stage heart failure trial as designed.The DSMB's recommendation comes after it completed a prespecified data review for the Phase III pivotal CardiAMP cell therapy heart failure trial.The ongoing multi-center, double-blinded, randomized (3:2), controlled pivotal CardiAMP heart failure trial is expected to enroll 260 patients at up to 40 centers nationwide.The trial’s primary endpoint is 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.
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BioCardia gets positive DSMB recommendation for late-stage heart failure study