SUNNYVALE, Calif. — November 10, 2025 — Leads & Copy — BioCardia, Inc. (NASDAQ: BCDA) has announced the enrollment of the first patient at Henry Ford Health in its Phase 3 CardiAMP® HF II clinical trial. This trial focuses on patients with ischemic heart failure of reduced ejection fraction (HFrEF).
Dr. Gerald Koenig, Director of the Cardiac Catheterization Laboratory at Henry Ford West Bloomfield Hospital and Director of Clinical Research in the Cardiac Catheterization Laboratory at Henry Ford Health System, emphasized the potential of the study. He noted the CardiAMP-HF trial’s groundbreaking nature, highlighting promising results from autologous cell therapy, particularly in HFrEF patients with elevated biomarkers of heart stress. The team is actively recruiting patients for this confirmatory study, which aims to improve microvascular function and patient outcomes, including quality of life.
Peter Altman, PhD, CEO of BioCardia, expressed his appreciation for the collaboration with Dr. Koenig and the Henry Ford Health team. He cited approximately 2 million ischemic HFrEF patients in the U.S. and EU with NYHA Class II and III symptoms. He noted the heavy burden on patients, families, and the healthcare system, as many of these patients face a worse prognosis than those with cancer and have limited treatment options. Altman conveyed his excitement about the CardiAMP HF results, which indicated the therapy system’s ability to reduce mortality and major adverse cardiac events, enhance quality of life, and positively influence other study endpoints in HFrEF patients, suggesting the investigational cell therapy could meet significant clinical needs.
The CardiAMP HF II study is a randomized, multi-center, procedure placebo-controlled trial involving 250 patients. It will assess the CardiAMP autologous cell therapy as a single treatment for ischemic heart failure patients with reduced ejection fraction (HFrEF) who are undergoing guideline-directed medical therapy and have elevated NTproBNP. The study seeks to confirm the safety and efficacy observed in the CardiAMP HF study. The CardiAMP HF II study employs a similar three-tier composite primary outcome measure, encompassing all-cause death, nonfatal major adverse cardiac events, and a validated quality-of-life measure. In the CardiAMP HF study, the composite efficacy endpoint was achieved with statistical significance in patients with elevated NTproBNP, who are the focus of the CardiAMP HF II study.
Advances in this therapeutic approach include using cell population analysis to define treatment doses and improvements to the Helix system utilizing the FDA approved Morph DNA steerable platform.
CardiAMP Cell Therapy has been granted FDA Breakthrough designation and uses a patient’s own bone marrow cells delivered to the heart via a minimally invasive, catheter-based procedure to increase capillary density, reduce tissue fibrosis, and treat microvascular dysfunction.
The CardiAMP Cell Therapy clinical development for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS).
CAUTION – Limited by United States law to investigational use.
BioCardia, Inc., based in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms.
Miranda Peto, Investor Relations Email: mpeto@BioCardia.com Phone: 650-226-0120 Investor Contact: David McClung, Chief Financial Officer Email: investors@BioCardia.com Phone: 650-226-0120
Source: BioCardia, Inc.
