BioCardia Initiates Patient Enrollment at University of Wisconsin at Madison for Ongoing CardiAMP HF II Pivotal Study

Core Insights - BioCardia, Inc. is conducting a pivotal Phase 3 trial, CardiAMP HF II, to evaluate the CardiAMP™ cell therapy for patients with ischemic heart failure of reduced ejection fraction (HFrEF) and elevated cardiac stress markers [1][3] - The trial aims to demonstrate that the cell therapy can significantly improve survival and quality of life for heart failure patients, particularly those with elevated NTproBNP levels [2][3] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [7] - The company has two main biotherapeutic platforms: CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, and is developing three clinical stage product candidates [7] Clinical Study Details - The CardiAMP HF II study will enroll 250 patients and is a randomized, multicenter, placebo-controlled trial focusing on the safety and efficacy of the CardiAMP autologous cell therapy [3] - The primary outcome measures include all-cause death, nonfatal major adverse cardiac events, and a validated quality of life assessment [3] Therapeutic Approach - CardiAMP cell therapy utilizes a patient's own bone marrow cells delivered via a minimally invasive procedure to enhance the body's natural healing response [5] - The therapy targets mechanisms leading to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial dysfunction [5] Regulatory and Financial Support - The CardiAMP clinical development is supported by the Maryland Stem Cell Research Fund and is reimbursed by the Centers for Medicare and Medicaid Services (CMS) [6]