BioCardia announces DSMB to pause new enrollment in Phase III CardiAMP trial

BioCardia announces that the independent Data Safety Monitoring Board, DSMB, has completed its prespecified data review for the ongoing Phase III pivotal CardiAMP Cell Therapy Heart Failure Trial, for which FDA granted Breakthrough Designation. Pursuant to the DSMB recommendation, BioCardia is pausing the trial pending the one-year follow-up outcomes analysis for patients that have been treated and those that have been enrolled but not yet treated. The DSMB recommendation stated: “Based on an analysis of the trial data, the primary FS composite endpoint assessment and a supplemental analysis presented on 7/19/23, unrelated to any emergent safety events, the DSMB recommends pausing new patient enrollment and any potential crossover patient procedures pending an outcomes analysis of patients currently completing the one-year follow-up as well as the patients completing their imminently scheduled treatment… The DSMB recommends the blind not be broken at this time to protect the integrity of the outcomes yet to be collected and to ensure that the study may be restarted without compromise after completion of the one-year data analysis.”