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BIOCARDIA ANNOUNCES POSITIVE DSMB RECOMMENDATION TO CONTINUE PHASE III PIVOTAL CARDIAMP HEART FAILURE STUDY, AS PLANNED
Company to Host Conference Call with National Co-Principal Investigators Today at 4:15 p.m. ET to Provide Study Updates SAN CARLOS, Calif., March 31, 2020
About this update from Biocardia, Inc.
[{"type":"text","content":"Company to Host Conference Call with National Co-Principal Investigators Today at 4:15 p.m. ET to Provide Study Updates\nSAN 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.\n 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 exercise capacity) at 12 months’ follow-up. Secondary efficacy endpoints include quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire, and superiority relative to MACCE and survival. The national principal investigators are Amish Raval, MD, of the University of Wisconsin and Carl Pepine, MD, of the University of Florida, Gainesville. BioCardia will host a conference call/webcast today at 4:15 p.m. ET featuring the principal investigators to provide updates on the CardiAMP Heart Failure Trial. To participate in the conference call, dial 1-877-270-2148. To access the live webcast of the call, please visit: www.biocardia.com/investors/events-presentations/id/1036. A replay of the webcast will be available for a limited time on the BioCardia website following the presentation. “We are pleased with the progress on the CardiAMP Heart Failure Trial that has led to a positive recommendation from the DSMB to continue the study. We are currently assessing the impact of COVID-19 on patient recruitment for the trial, as trial sites focus on patient care and delay elective procedures, in accordance with guidance from the Centers for Medicaid Services, as well as trial-related patient follow-up visits. We have seen an inc...