BioCardia Announces FDA Completes Review of Proposed Adaptive Statistical Analysis Design for Ongoing CardiAMP Cell Therapy in Heart Failure Pivotal Study

Jun 20, 2023

SUNNYVALE, Calif., June 20, 2023 (GLOBE NEWSWIRE) -- BioCardia^®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that FDA Center for Biologics Evaluation and Research (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 (HFrEF). The adaptive statistical analysis plan is on track to be implemented at the upcoming Data Safety Monitoring Board (DSMB) meeting, scheduled for July 12, 2023.

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