BioCardia, Inc. announced it has submitted its CardiAMP autologous cell therapy for clinical consultation with Japan's Pharmaceuticals and Medical Devices Agency (PMDA), representing a pivotal milestone in the company's pursuit of regulatory approval in Japan's advanced heart failure therapy market.
The submission consists of a comprehensive clinical data package including complete results from the CardiAMP HF Trial, along with the principal clinical portion of the Summary Technical Documentation (STED). This extensive technical summary demonstrates to regulatory authorities that the CardiAMP System meets required safety and performance standards.
Clinical Evidence Supporting Regulatory Review
The PMDA consultation will involve a thorough review of clinical data from the recently completed CardiAMP HF trial, focusing on the efficacy and safety profile of the CardiAMP system. The agency will evaluate proposed target patient populations and assess how the investigational therapy fits into Japan's continuum of care for heart failure patients.
The 125-patient randomized procedure controlled double blind CardiAMP HF Trial (NCT02438306) demonstrated significant clinical benefits. Results presented at the American College of Cardiology's late breaking clinical trial sessions on March 29, 2025, showed reduction in all-cause death, reduced major adverse cardiac events, and improved quality of life. The composite endpoint achieved statistical significance in patients with elevated NTproBNP, a marker of active heart stress.
Breakthrough Therapy Mechanism
The proprietary CardiAMP Cell Therapy, which has received FDA Breakthrough designation, utilizes a patient's own bone marrow cells delivered to the heart through a minimally invasive, catheter-based procedure. The therapy works by increasing capillary density and reducing tissue fibrosis to treat microvascular dysfunction.
The clinical development program spans three trials, beginning with the Phase I Transendocardial Autologous Bone Marrow in Myocardial Infarction Trial (NCT 00507468) involving 20 patients, followed by the Phase II 33-patient randomized placebo controlled Transendocardial Autologous Cells in heart Failure Trial (NCT 00768066). Both earlier trials demonstrated enhanced exercise ability and heart function in patients who received therapy.
Strategic Market Expansion
"Consulting with the PMDA on the totality of clinical evidence from our three trials supporting CardiAMP cell therapy for heart failure is a pivotal step in our ongoing discussions with PMDA to bring this heart failure therapy to patients in Japan," said Peter Altman, PhD, CEO of BioCardia. "We look forward to incorporating the agency's insights into our development plans and working towards a successful regulatory submission and review. Success in these efforts could result in our being engaged in a meaningful post marketing study in Japan next year."
Successful alignment with PMDA on the acceptability of clinical data and positioning of the CardiAMP system for Japanese heart failure patients could enable BioCardia to submit for approval and market entry in Japan. The company is actively evaluating collaboration opportunities with Japanese partners to advance this innovative heart failure treatment.
Ongoing Development Program
The Phase IIIB CardiAMP HF II Trial (NCT06258447) is currently enrolling patients in the United States. The CardiAMP clinical development program for heart failure receives support from the Maryland Stem Cell Research Fund and reimbursement from the Centers for Medicare and Medicaid Services (CMS).
