BioCardia’s CardiAMP Cell Therapy Evaluated at 2 Years in Data From Roll-In Cohort of Pivotal Trial

March 6, 2023—BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced the presentation of detailed echocardiography data from the roll-in cohort of the phase 3 CardiAMP Cell Therapy Heart Failure trial. The results showed that from baseline through 1 and 2 years, there was a more than doubling in the number of heart segments functioning normally, as well as restoration of function to 30% of previously nonfunctioning segments.

Peter Johnston, MD, presented the findings at ACC.23/WCC, the American College of Cardiology’s annual scientific session together with the World Congress of Cardiology held March 4-6, 2023, in New Orleans, Louisiana. Dr. Johnston is Assistant Professor of Medicine at Johns Hopkins University in Baltimore, Maryland, where he serves as the trial’s site Principal Investigator.

“The substantial improvements in segmental wall motion and overall left ventricular ejection fraction (LVEF) seen at 1 year continued to improve at 2 years,” commented Dr. Johnston in the company’s press release. “This resulted in a median LVEF of 37% at 2 years as compared to 27% at baseline.” Dr. Johnston continued, “While this is an early cohort in the phase 3 trial, it is remarkable that the benefits from improved heart function continue to be realized 2 years after a single treatment of autologous CardiAMP cell therapy.”

As previously reported, the multicenter, double-blind, randomized (3:2), controlled pivotal trial was initiated in 2017 and is expected to enroll 260 patients at up to 40 centers in the United States and Canada.

According to BioCardia, results from the 10-patient roll-in cohort of the clinical trial showed that myocardial wall motion in the 16 regions of the heart was more often characterized as normal after the study treatment at 1- and 2-year follow-up, as measured by the blinded echocardiography core lab at Yale University in New Haven, Connecticut.

The findings included the following:

• In this series, only 13% of heart segments in patients were contracting normally before treatment.
• At 1 year, 25% of heart segments were contracting normally.
• At 2 years, 29% of heart segments were contracting normally, indicating a more than doubling of the number of heart segments characterized as having normal function postprocedure.
• In completely nonfunctioning heart segments, 30% (17 of 56) of those heart segments resumed wall motion by 2 years.
• The overall wall motion score index for all 16 segments in the heart was improved, decreasing from 2.4 at baseline to 2 at 1 year and 1.9 at 2 years.
• As a result of the restoration of myocardial wall motion, patients experienced improvement in median LVEF, which increased from 27% at baseline to 34% at 1 year and 37% at 2 years.

The company noted that these findings expand on data presented at the Heart Failure Society of America annual meeting held September 20 to October 3 in National Harbor, Maryland.

In the previously presented data, patient demographics at the start of the study demonstrated characteristics typical of the target population of New York Heart Association class II and III ischemic heart failure patients with reduced ejection fraction. No serious adverse events were observed related to any of the procedures performed.

Despite severe, symptomatic ischemic heart failure with reduced ejection fraction, 2-year survival was 100%, and all patients completed 24 months of follow-up.

The company noted that changes in guideline-directed medical therapy experienced by these patients were minimal during the 2-year study period.

These outcomes are consistent with previously presented data showing improvement in functional capacity as measured by median change in 6-minute walk distance of +37.5 meters at 12 months and +31 meters at 24 months and improvement in quality of life as measured by the Minnesota Living with Heart Failure Questionnaire in seven of 10 patients at 1 year and six of 10 patients at 2 years.

BioCardia CEO Peter Altman, PhD, advised in the company’s press release, “These early results lend further support to the potential efficacy of the autologous CardiAMP cell therapy and to our mission of restoring heart health. BioCardia continues to move this clinical trial forward, with recent FDA approval of a supplement designed to add clarity to inclusion criteria for clinical sites in this trial and submission of an adaptive statistical analysis plan for the trial to the FDA for consideration.”

According to the company, CardiAMP uses autologous bone marrow cells delivered to the heart in a catheter-based procedure to potentially stimulate the body’s natural healing response.

BioCardia’s CardiAMP cell therapy incorporates proprietary features: a preprocedural diagnostic for patient selection, a high target dosage of cells, and the company’s delivery system. The trial is supported by the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services.

In February 2022, CardiAMP cell therapy received FDA Breakthrough Device designation.