Core Insights - BioCardia, Inc. has successfully completed a consultation with Japan's PMDA regarding the registration submission for its lead therapeutic asset, BCDA-01, aimed at treating ischemic heart failure of reduced ejection fraction (HFrEF) [1][2] Group 1: Consultation Outcomes - The PMDA has invited BioCardia for a subsequent consultation after the submission of final clinical data with a two-year follow-up to assess the evidence supporting safety and efficacy claims for the BCDA-01 program [2] - PMDA is open to considering results from the CardiAMP Heart Failure Trial and previous trials as sufficient evidence for registering the CardiAMP Cell Therapy System for heart failure patients in Japan [2] Group 2: Clinical Trials and Data - BioCardia is currently working on data lock from the fully enrolled 125 patient CardiAMP Heart Failure Trial, with final data expected to be available in the first quarter of 2025 [2] - The CardiAMP Cell Therapy for HFrEF (BCDA-01) has received Breakthrough Designation from the FDA CBER, with development supported by the Maryland Stem Cell Research Fund [2] Group 3: Company Overview - BioCardia, Inc. is headquartered in Sunnyvale, California, and is recognized as a global leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [3] - The company has two biotherapeutic platforms: CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, with three clinical stage product candidates in development [3]
BioCardia Announces Positive Consultation with Japan PMDA on CardiAMP Cell Therapy for Ischemic Heart Failure