The independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for BioCardia Inc's (NASDAQ:BCDA) ongoing Phase 3 CardiAMP Cell Therapy Heart Failure Trial.
- The DSMB based its review on all available data for the 108 patients enrolled with an additional six crossover patient procedures in the trial to date.
- The monitoring board's assessment indicated no significant safety concerns and recommended that the study continue as designed.
- The ongoing CardiAMP Heart Failure Trial is expected to enroll 260 patients.
- CardiAMP Cell Therapy System received FDA Breakthrough Device status for heart failure earlier this month.
- The trial's primary endpoint is an outcomes composite score based on a hierarchical analysis of the three-tiered Finkelstein-Schoenfeld (FS).
- The FS procedure is a ranked analysis that compares the occurrence of cardiovascular and other health-related events, along with functional capacity measures, through one year in patients.
- Price Action: BCDA shares are down 4.10% at $2.34 during the market session on the last check Monday.
