BioCardia, Inc. has announced the completion of its Phase III CardiAMP HF trial, a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of the CardiAMP Cell Therapy System in patients with heart failure of reduced ejection fraction (HFrEF). The trial, conducted across 18 hospitals in the United States, enrolled 125 patients, with 115 being randomized in a 3:2 ratio to either the CardiAMP autologous cell therapy treatment arm or a procedure placebo control arm. This milestone marks a significant step toward potentially addressing the unmet needs of individuals suffering from ischemic heart failure. Top-line results are anticipated in the first quarter of 2025.
Trial Design and Objectives
The CardiAMP HF trial is a prospective, multi-center pivotal clinical trial evaluating the CardiAMP Cell Therapy System for HFrEF. The primary objectives include reducing all-cause mortality and future hospitalizations, enhancing functional capacity, and improving symptoms and overall quality of life for patients. The study population consisted of advanced heart failure patients on guideline-directed medical therapy (GDMT). The primary effectiveness follow-up ranged from 12 to 24 months.
CardiAMP Cell Therapy System
The CardiAMP Cell Therapy System, which has been granted Breakthrough Device Designation by the FDA, is an investigational device system involving the delivery of a patient’s own marrow cells to the heart via a minimally invasive, catheter-based procedure. This autologous cell therapy is designed to promote microvascular repair through enhanced capillary density and reduced fibrosis, mechanisms demonstrated in preclinical studies. Patients typically require only an overnight hospital stay following the procedure.
Clinical Context and Future Steps
HFrEF affects over a million patients in the United States and millions more worldwide, representing a significant end-stage manifestation of ischemic heart disease. Despite advancements in medical therapy, premature death, recurrent hospitalizations, and deteriorating quality of life remain substantial burdens. BioCardia has submitted its annual report for the CardiAMP Heart Failure Trial to the FDA, detailing plans for completing patient follow-up, and intends to request a meeting with the FDA to discuss the results concerning the approvability of the CardiAMP Cell Therapy System. Furthermore, BioCardia has completed a supplementary submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA) and requested a consultation to discuss the approvability of the CardiAMP Cell Therapy System based on U.S. data. This consultation is scheduled for late November.
Prior Clinical Data
According to Peter Altman, PhD, CEO of BioCardia, Phase I and II trial results, along with interim Phase III trial results, have indicated trends toward patient benefit across most outcome measures. These findings support the belief that the CardiAMP autologous, minimally invasive cell therapy holds promise in providing meaningful benefits for heart failure patients.
