BioCardia, Inc. has announced the completion of the last protocol-specified follow-up visit in its CardiAMP HF trial, a Phase III randomized, double-blinded, placebo-controlled clinical trial. The trial is designed to assess the safety and effectiveness of the CardiAMP Cell Therapy System for the treatment of heart failure with reduced ejection fraction (HFrEF).
The CardiAMP HF Trial enrolled 115 advanced HF patients on guideline-directed medical therapy (GDMT) across 18 hospitals in the United States. Patients were randomized in a 3:2 ratio to either the CardiAMP autologous cell therapy treatment arm or a procedure placebo control arm. An additional ten patients were enrolled in an open-label roll-in cohort, bringing the total number of patients to 125. The primary effectiveness follow-up ranged from 12 to 24 months.
Addressing a Critical Unmet Need
HFrEF, an end-stage of ischemic heart disease, affects over a million patients in the US and millions more worldwide. Despite advancements in therapy, premature death, recurrent hospitalizations, and deteriorating quality of life remain significant challenges for patients and healthcare systems.
CardiAMP Cell Therapy: A Novel Approach
The CardiAMP Cell Therapy System, which has received Breakthrough Device Designation from the FDA, involves a minimally invasive, catheter-based procedure to deliver a patient's own marrow cells to the heart. The therapy is designed to promote microvascular repair by enhancing capillary density and reducing fibrosis. Preclinical studies in animal models have demonstrated these effects.
According to Peter Altman, PhD, CEO of BioCardia, previous Phase I and II trial results, along with interim Phase III trial results, have indicated trends toward patient benefit across various outcome measures. He stated, "These results support our belief that the CardiAMP autologous, minimally invasive, cell therapy has great promise to provide a meaningful benefit for patients suffering from heart failure."
Upcoming Milestones
Close-out visits and data monitoring with source data verification are expected to be completed this quarter. Final data transfer to the independent Statistical Data Analysis Core at the University of Wisconsin is anticipated soon thereafter. Top-line results are expected to be released in the first quarter of 2025.
BioCardia has submitted the Annual Report for the CardiAMP Heart Failure Trial to the FDA, detailing plans for completing patient follow-up. The company intends to request a meeting with the FDA to discuss the results and the potential approvability of the CardiAMP Cell Therapy System.
Regulatory Strategy in Japan
BioCardia has also completed a supplementary submission to the Japan Pharmaceutical and Medical Device Agency (PMDA), providing answers to PMDA’s previous responses on the approvability of the CardiAMP Cell Therapy System based on US data. A consultation with PMDA is scheduled for late November, serving as preparation for a subsequent clinical consultation after the CardiAMP Heart Failure Trial results are available.
