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Patient Enrollment Commenced in Pivotal Phase 3 Trial of CardiAMP Cell Therapy for the Treatment of Ischemic Heart Failure
SUNNYVALE, Calif., July 25, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the
About this update from Biocardia, Inc.
[{"type":"text","content":"SUNNYVALE, Calif., July 25, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF) has commenced enrollment in the United States. BioCardia previously confirmed alignment with the United States Food and Drug Administration (FDA) on the design of the 250-patient randomized, controlled trial and the minimum of 12-month primary composite endpoint of all cause death, reduction in major adverse cardiovascular events, and improvement in quality of life. FDA granted CardiAMP Cell Therapy a Breakthrough Device Designation for the treatment of ischemic heart failure. Breakthrough designation provides for FDA to expedite development and prioritize review of regulatory submissions intended to help patients have more timely access to these product candidates. “The CardiAMP cell therapy has the potential to be groundbreaking and life changing for patients with heart failure,” said Dr. Leslie Miller, MD, trial investigator at the CHF Heart Function Clinic at BayCare Morton Plant Hospital in Clearwater, Florida and a member of the CardiAMP Heart Failure II Study Executive Steering Committee. “As the principal investigator of the first site activated to enroll patients in this important study, I have identified many patients who may benefit from inclusion in this clinical trial, including nine patients in my clinic in active screening to participate after meeting the important NTproBNP inclusion criterion.” BioCardia Chief Executive Officer, Peter Altman, PhD said “We are looking forward to expeditious enrollment in the trial ahead working with world class clinical heart function teams with the objective of confirming the trends of enhanced survival, reduced major adverse events, and improved quality of life observed in previous studies. There is a significant need for a safe, effective, and durable treatment for patients with ischemic heart failure, in particular one that positively impacts patient survival and quality of life.” About Chronic Heart Failure of Reduced Ejection Fraction (HFrEF) Heart failure of reduced ejection fraction (HFrEF...