BioCardia announces confirmatory Phase 3 trial of CardiAMP commenced enrollment

BioCardia announced 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.