BioCardia Inc. announced it has finalized external review of interim data and evaluated interim efficacy results for the ongoing Phase III pivotal trial of CardiAMP Cell Therapy for Heart Failure (CardiAMP HF, clinicaltrials.gov Identifier: NCT02438306), for which the FDA granted Breakthrough Designation for the treatment of heart failure of reduced ejection fraction (HFrEF). The external review both confirmed the quality and appropriateness of the work by the Statistical Data Analysis Center at the University of Wisconsin and the DSMB in their review and recommendation. In order to enhance understanding of heart failure program, BioCardia has taken steps, previously reviewed by the DSMB, to unblind itself to the interim results of the study and was provided a copy of the closed session study report presented to the DSMB for review.

The interim efficacy review by the DSMB did not include the final results of the study but is an analysis of the data as part of the adaptive statistical analysis plan. This review was based on the three-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis of 12-month data, whose composite score comprises the primary efficacy endpoint of the CardiAMP HF study. There were additional prespecified outcome measures detailed in the comprehensive SDAC closed session report.

The company also have significant data for the autologous cell dosing as performed in the study procedure, enabling assessments of efficacy on a patient-by-patient basis, which the company will study. knowledge from these interim details may be incorporated in its ongoing development plans for its autologous CardiALLO cell therapy programs.