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BioCardia Submits Request for Clinical Data Review Meeting with Japan PMDA To Discuss Approval Pathway for CardiAMP® Cell Therapy in Ischemic Heart Failure
Globenewswire· 2025-07-24 13:00
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]
BioCardia Announces New United States Patent for Helix Biotherapeutic Delivery System
Globenewswire· 2025-06-25 12:00
Core Insights - BioCardia, Inc. has been granted US Patent No. 12,311,127 for its "Radial and Trans-endocardial Delivery Catheter" technology, which focuses on minimally invasive interventional catheter systems for delivering biologic therapies to the heart [1][2]. Company Overview - BioCardia is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [4]. - The company is developing two main biotherapeutic platforms: CardiAMP autologous and CardiALLO™ allogeneic cell therapies, with three clinical stage product candidates currently in development [4]. Technology and Innovation - The patented helical needle-tipped catheter technology is designed to provide optimal, site-specific treatment while minimizing off-target toxicities and avoiding surgical access to the heart [2]. - The Helix catheter system is integral to the safety and efficacy of the CardiAMP Cell Therapy development program, which aims to improve outcomes for patients with ischemic cardiomyopathies and refractory angina [3]. Future Developments - BioCardia is actively pursuing separate approvals for both the CardiAMP Cell Therapy and the Helix biotherapeutic delivery system, which is expected to facilitate a smooth transition from research to commercialization [3].
Biocardia Phase 3 CardiAMP-HF Trial of Novel Cardiac Cell Therapy for Ischemic Heart Failure Shows Increased Survival, Decreased Cardiac Events, and Improved Quality of Life at Two Years
Newsfilter· 2025-03-31 12:00
Core Insights - BioCardia, Inc. announced two-year outcomes from the Phase 3 CardiAMP-HF study, demonstrating the efficacy of CardiAMP autologous cell therapy for ischemic heart failure patients with reduced ejection fraction [1][2][3] Group 1: Clinical Trial Results - The CardiAMP-HF Trial involved 115 ischemic heart failure patients across 18 centers in the U.S. and Canada, showing that patients receiving CardiAMP therapy alongside medication experienced decreased mortality and major adverse cardiac and cerebrovascular events (MACCE) [2][4] - Statistically significant improvements were observed in patients with elevated NTproBNP, indicating greater benefits for those under active heart stress [4][5] - Treated patients exhibited a 13% reduction in heart death equivalents and a 47% relative risk reduction in heart death equivalents compared to those on medication alone [5] Group 2: Quality of Life Improvements - Patients receiving CardiAMP therapy reported a clinically meaningful 10.5-point improvement in quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) [5] - Improvements in physical capacity were noted, with a 13.9-meter increase in Six Minute Walk Distance for treated patients [5] Group 3: Mechanism and Market Potential - CardiAMP Cell Therapy is designated as a Breakthrough Therapy by the FDA, utilizing a pre-procedural cell analysis, a high target dosage of cells, and a minimally invasive delivery system [3][6] - The therapy targets mechanisms leading to microvascular dysfunction, potentially benefiting around one million patients in the U.S. who currently incur $30 billion annually in healthcare costs [7][8] Group 4: Future Directions - BioCardia plans to share the two-year data with the U.S. FDA and Japan PMDA to expedite the therapy's availability for patients [7] - The company emphasizes the potential of CardiAMP therapy to reduce healthcare costs associated with heart failure by improving patient health outcomes [7]