BioCardia Announces University of Wisconsin Enrolls Their First Patient in Phase 3 CardiAMP HF II Cell Therapy Pivotal Trial

Core Insights - BioCardia, Inc. has enrolled its first patient in the Phase 3 CardiAMP HF II clinical trial at the University of Wisconsin School of Medicine and Public Health, focusing on the treatment of ischemic heart failure [1][2] Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases, with a focus on the CardiAMP autologous cell therapy [7] - The company is headquartered in Sunnyvale, California, and has three clinical stage product candidates in development [7] Clinical Trial Details - The CardiAMP HF II study is a 250-patient randomized multicenter, placebo-controlled trial designed to evaluate the safety and efficacy of CardiAMP cell therapy in patients with ischemic heart failure with reduced ejection fraction (HFrEF) [3] - The trial aims to confirm previous safety and efficacy results observed in the earlier CardiAMP HF study, utilizing a composite primary outcome measure that includes all-cause death, nonfatal major adverse cardiac events, and a validated quality of life measure [3] Therapeutic Approach - CardiAMP cell therapy has received FDA Breakthrough designation and involves using a patient's own bone marrow cells delivered to the heart through a minimally invasive procedure [5] - The therapy aims to increase capillary density and reduce tissue fibrosis, addressing microvascular dysfunction in heart failure patients [5] Technological Advancements - The trial incorporates advancements such as cell population analysis for treatment dose definition and improvements to the Helix system, including the FDA-approved Morph DNA steerable platform [4]