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BioCardia Announces Positive DSMB Recommendation to Continue Phase 3 Pivotal CardiAMP Heart Failure Study as PlannedSAN CARLOS, Calif., Sept. 16, 2019 (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, which included safety follow-up results on 35 patients and all additional data available on the 50 patients randomized in the trial as of August 31, 2019. The DSMB indicated there were no safety concerns with the CardiAMP study results and recommended that the trial continue, as planned. The ongoing multi-center, double-blinded, randomized (3:2), sham-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 Six Minute Walk distance at 12 months’ post-treatment, a measure of a patient’s exercise capacity, and incorporates the impact of MACE and other clinically meaningful events. Secondary efficacy endpoints include quality of life as measured by the Minnesota Heart Failure Quality of Life self-assessment, and superiority relative to MACE and survival. The national co-principal investigators are Amish Raval, MD, of the University of Wisconsin and Carl Pepine, MD, of the University of Florida, Gainesville. “We are pleased that the comprehensive data achieved to date has led to a positive recommendation from the DSMB to continue the CardiAMP Heart Failure Trial. We are focused on accelerating enrollment with our world class clinical partners and delivering the evidence necessary to bring CardiAMP Cell Therapy to U.S. patients,” said Eric Duckers, MD, PhD, Chief Medical Officer of BioCardia. Patients interested in learning about the study can visit www.cardiamp.com or www.clinicaltrials.gov for more information. The next prespecified DSMB review is anticipated in the first quarter 2020. About the CardiAMP Therapy Program About BioCardia® Forward Looking Statements: We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-Q filed with the Securities and Exchange Commission on August 9, 2019, including under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. INVESTOR CONTACT: MEDIA CONTACT: |