Safety Board Recommends BioCardia's Heart Failure Cell Therapy To Continue Unchanged

 The independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for BioCardia Inc's 

BCDA -7.79%

 (Get Free Alerts for 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.

https://www.benzinga.com/general/biotech/22/02/25599908/safety-board-recommends-biocardias-heart-failure-cell-therapy-to-continue-unchanged