Core Insights - BioCardia, Inc. has completed source data verification and frozen primary outcomes data for the Phase 3 CardiAMP HF study, focusing on autologous cell therapy for ischemic heart failure with reduced ejection fraction (HFrEF) [1][2] - The study represents the largest cohort of ischemic HFrEF patients in a randomized trial of autologous cell therapy and employs a precision medicine approach to identify likely responders [2] - Results from the study are expected to be presented at the American College of Cardiology (ACC) 2025 Scientific Sessions on March 30, 2025 [1] Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its CardiAMP and CardiALLO cell therapies in clinical development [5] - The CardiAMP Cell Therapy has received FDA Breakthrough designation and aims to stimulate natural healing responses in patients through a minimally invasive procedure [3][5] - The clinical development of CardiAMP is supported by the Maryland Stem Cell Research Fund and is reimbursed by the Centers for Medicare and Medicaid Services (CMS) [4]
BioCardia Announces Primary Outcome Measures Data Freeze in CardiAMP Heart Failure Trial for Presentation at the American College of Cardiology 2025 Scientific Sessions