BioCardia Announces Henry Ford Health Enrolls Their First Patient in Phase 3 CardiAMP HF II Cell Therapy Pivotal Trial

Core Insights - BioCardia, Inc. has initiated the enrollment of the first patient in its Phase 3 CardiAMP HF II clinical trial targeting ischemic heart failure with reduced ejection fraction (HFrEF) [1][2] - The CardiAMP HF II trial aims to confirm the safety and efficacy of the CardiAMP autologous cell therapy, which has shown promising results in previous studies despite not meeting the primary endpoint [2][3] - The trial is significant as it addresses a critical need for treatment options among the approximately 2 million patients in the U.S. and EU suffering from ischemic HFrEF [2][5] Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics, focusing on cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [7] - The company is developing two main biotherapeutic platforms: CardiAMP autologous and CardiALLO allogeneic cell therapies, with three clinical stage product candidates [7] - The CardiAMP Cell Therapy has received FDA Breakthrough designation and is designed to treat microvascular dysfunction by using a patient's own bone marrow cells [5][7] Clinical Trial Details - The CardiAMP HF II study is a randomized, multicenter, placebo-controlled trial involving 250 patients, focusing on those with elevated NTproBNP levels [3] - The primary outcome measure includes all-cause death, nonfatal major adverse cardiac events, and a validated quality of life measure, similar to the previous CardiAMP HF study [3] - Advances in the trial include improved cell population analysis for treatment dosing and enhancements to the Helix system, including the FDA-approved Morph DNA steerable platform [4][5]