BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDA

Core Insights - BioCardia, Inc. has completed a third preliminary clinical consultation with Japan's PMDA regarding its CardiAMP Cell Therapy for treating Heart Failure with Reduced Ejection Fraction (HFrEF) [1] - The PMDA has indicated that BioCardia can proceed to formal clinical consultation, which may lead to regulatory approval in Japan if the data is deemed sufficient [1] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases [5] - The company is headquartered in Sunnyvale, California, and focuses on developing autologous and allogeneic cell therapies [5] Product Development - CardiAMP Cell Therapy utilizes a patient's own bone marrow cells delivered via a minimally invasive procedure to improve heart function [3] - The therapy has received FDA Breakthrough designation and is supported by the Maryland Stem Cell Research Fund [3] Clinical Trial Highlights - Phase 1: TABMMI Heart Failure Trial involved 20 patients [4] - Phase 2: TACHFT Trial included 33 patients, with 29 randomized [4] - Phase 3: CardiAMP HF Trial had 125 patients, with 115 randomized and a 24-month follow-up [4] - Key outcomes include a 90% survival rate at three years and a 7% improvement in left ventricular ejection fraction at 24 months (p=0.001) [4] - Treated patients showed a 20% reduction in major adverse cardiovascular events compared to controls [4] Efficacy Signals - A subgroup of randomized patients with elevated NTproBNP before enrollment (n=57) demonstrated strong efficacy signals [5] - Quality of life improved by 17.4 points (p=0.039) for treated patients compared to controls [4] Future Prospects - The ongoing regulatory discussions in Japan and the United States will determine the next steps for CardiAMP Cell Therapy [2][4]