BIOCARDIA ANNOUNCES POSITIVE DSMB RECOMMENDATION TO CONTINUE PHASE III PIVOTAL CARDIAMP HEART FAILURE STUDY, AS PLANNED
BioCardia, Inc. (BCDA)
US:NASDAQ Investor Relations:
biocardia.com/investors/press-releases/id/1037?pressreleaseid=41
Company Research
Source: GlobeNewswire
SAN CARLOS, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for the Phase III pivotal CardiAMP™ Heart Failure Trial, based on a review of all available safety data for all patients randomized in the trial. The DSMB indicated there were no safety concerns with the CardiAMP study results and recommended that the trial continue, as planned. To date, 74 patients have been enrolled in the trial. The ongoing multi-center, double-blinded, randomized (3:2), controlled pivotal CardiAMP Heart Failure Trial is expected to enroll 260 patients at up to 40 centers nationwide. The trial’s primary efficacy endpoint is a composite of death, major adverse cardiovascular and cerebrovascular events (MACCE), and six minute walk distance (a measure of a patient’s exercis
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