CardiAMP-HF Trial Data Presented for BioCardia Cardiac Cell Therapy for HFrEF

April 7, 2025—BioCardia, Inc. recently announced 2-year outcomes from the double-blind, randomized, placebo-controlled, phase 3 CardiAMP-HF study of the company’s CardiAMP autologous minimally invasive cell therapy for the treatment of patients with ischemic heart failure with reduced ejection fraction.

The company stated that the CardiAMP-HF trial included 115 patients enrolled at 18 centers in the United States and Canada. All patients were maintained on heart failure medication, with treated patients receiving a single dose of CardiAMP cell therapy adjunctive to medication.

The trial’s Coprincipal Investigator Amish N. Raval, MD, presented the findings as a late-breaking clinical trial at ACC.25, the American College of Cardiology’s annual scientific session held March 29-31 in Chicago, Illinois.

BioCardia’s press release outlined the CardiAMP-HF 2-year results.

According to the company, the trial showed the following in patients with elevated N-terminal pro–B-type natriuretic peptide (NT-proBNP) biomarkers (50% of enrolled patients) compared to patients on optimized heart failure medication regimens alone:

• 13% fewer heart death equivalents—all-cause death, heart transplantation, left ventricular assist device implantation; 47% relative risk reduction
• 2% fewer nonfatal major adverse cardiac and cerebrovascular events (MACCE); 16% relative risk reduction
• Clinically meaningful 10.5-point improvement in quality-of-life score, as measured by Minnesota Living with Heart Failure Questionnaire
• 13.9-meter improvement in 6-minute walk distance

In all treated patients compared to patients on optimized heart failure medication regimen alone, the trial showed the following:

• 3.6% fewer heart death equivalents; 20.9% relative risk reduction
• 8.7% fewer nonfatal MACCE; 44.6% relative risk reduction
• 14% fewer nonsustained ventricular tachyarrythmias and 5.5% fewer sustained ventricular tachyarrhythmias
• Modest improvements in left ventricular ejection fraction in both treated and controlled patients; however, treated patients also showed evidence of reduced left ventricular end-diastolic and end-systolic volumes

Dr. Raval, Professor of Medicine at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin, commented on the study and its findings in the company’s press release.

“This clinical trial was conducted because there remains a large group of heart failure patients today who are insufficiently responsive to optimized heart failure medication,” stated Dr. Raval. “In this rigorous CardiAMP-HF trial, patients who received the novel cell therapy adjunctive to medication experienced decreased mortality and MACCE, with improved quality of life, when compared to those on medication alone.”

Dr. Raval continued, “These benefits appeared to be greater in patients with elevated NTproBNP—comprising fully half of treated patients—reaching statistical significance in the composite measure of these outcomes.”

He concluded, “The trial shows us that CardiAMP therapy has the potential to safely and significantly improve survival and quality of life for heart failure patients in distress, encompassing a large group of patients we see in daily practice.”

CardiAMP-HF Coprincipal Investigator Carl Pepine, MD, Professor of Medicine with the University of Florida in Gainesville, Florida, added, “It is interesting to note that the results for this therapy were durable at 2 years, suggesting the therapy may have lasting benefits for the heart that may help prevent disease progression. It is an exciting prospect to anticipate an addition to our heart failure armamentarium that can meaningfully improve patients’ lives to an extent that many don’t enjoy today.”