Core Insights - BioCardia, Inc. has submitted its CardiAMP autologous cell therapy for heart failure to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for clinical consultation, marking a significant step towards regulatory approval in Japan [1][4] Group 1: Regulatory Process - The PMDA consultation process is essential for new medical products in Japan, involving a detailed clinical data package that includes the full CardiAMP HF Trial data and Summary Technical Documentation (STED) [2] - The consultation will review clinical data from the CardiAMP HF trial, focusing on efficacy, safety, target patient populations, and the therapy's role in heart failure care in Japan [3] Group 2: Clinical Development - The CardiAMP therapy has received FDA Breakthrough designation and utilizes a patient's own bone marrow cells to treat microvascular dysfunction through a minimally invasive procedure [6] - The recently completed CardiAMP HF Trial demonstrated significant outcomes, including reduced all-cause death and improved quality of life in patients with elevated NTproBNP [6] Group 3: Future Prospects - Successful alignment with PMDA could lead to market entry approval for the CardiAMP system in Japan, with potential for a post-marketing study next year [4][5] - BioCardia is committed to advancing heart failure treatments and is exploring collaboration opportunities in Japan [5]

Core Insights - BioCardia, Inc. is focused on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [1] - The CEO, Dr. Peter Altman, will discuss recent developments in the company's therapeutic pipeline, particularly the CardiAMP autologous cell therapy for ischemic heart failure [2] Event Details - The fireside chat is scheduled for May 21, 2025, at 03:40 p.m. EDT, moderated by Jim Molloy from Alliance Global Partners [3] - The event will be available via webcast [3] Company Overview - BioCardia is headquartered in Sunnyvale, California, and is recognized as a leader in cellular and cell-derived therapeutics [3] - The company has two main biotherapeutic platforms: CardiAMP autologous and CardiALLO™ allogeneic cell therapies, with three cardiac clinical stage product candidates in development [3] - BioCardia's therapies utilize the Helix™ biotherapeutic delivery and Morph vascular navigation product platforms [3]

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]