BioCardia announces CBER completed review of CardiAMP analysis

BioCardia announced that FDA Center for Biologics Evaluation and Research, or CBER, has completed review of the CardiAMP Cell Therapy System adaptive statistical analysis design supplement for the ongoing pivotal study to treat ischemic heart failure with reduced ejection fraction, or HFrEF. The adaptive statistical analysis plan is on track to be implemented at the upcoming Data Safety Monitoring Board, or DSMB, meeting, scheduled for July 12. Under the adaptive statistical analysis plan, should the CardiAMP Cell Therapy for Heart Failure study be stopped early for anticipated efficacy at this, or any future DSMB review, study sites will continue to follow all enrolled patients until all of them have reached their one-year follow-up visit, at which time the trial results would be unblinded. Enrollment would continue after any DSMB meeting that stops randomization for anticipated efficacy, with all subsequently enrolled patients receiving the study treatment. The open-label patients receiving the study treatment are intended to increase the amount of data available to address safety considerations for the pre-market application and market approval for the CardiAMP Cell Therapy System by FDA CBER. The adaptive statistical analysis plan is expected to have minimal impact on statistical power of the trial. The DSMB may stop the trial early for safety or futility at any time.