BioCardia Finishes Phase III Trial of Cell Therapy for Ischemic Heart Failure

In SUNNYVALE, California, BioCardia, Inc. [Nasdaq: BCDA], a prominent entity in cellular and cell-derived therapeutics focused on cardiovascular and pulmonary diseases, has announced the conclusion of the last scheduled follow-up visit for its CardiAMP HF trial. This significant clinical trial, designed to assess the efficacy and safety of the CardiAMP® Cell Therapy System in patients with heart failure with reduced ejection fraction (HFrEF), was conducted as a prospective, randomized, double-blinded, placebo-controlled study across multiple centers.

The CardiAMP HF Trial involved 115 advanced heart failure patients on guideline-directed medical therapy (GDMT), who were randomized in a 3:2 ratio to receive either the CardiAMP autologous cell therapy or a placebo procedure. These patients were treated at eighteen hospitals across the United States. The study also included an open-label roll-in cohort of ten additional patients, bringing the total participant count to 125. The primary follow-up period for assessing the effectiveness of the therapy ranges from 12 to 24 months, with a thorough outcomes analysis of the randomized cohort forthcoming.

Heart failure with reduced ejection fraction is a severe consequence of ischemic heart disease, affecting over a million patients in the US and millions more globally. Despite advancements in treatment, patients with ischemic HFrEF still face high rates of premature death, recurrent hospitalizations, and a declining quality of life, posing a significant challenge for patients, their families, and the healthcare system at large.

The CardiAMP Cell Therapy System, which has received Breakthrough Device Designation from the FDA, is an investigational treatment that aims to promote microvascular repair by enhancing capillary density and reducing fibrosis. This therapy utilizes a patient's own marrow cells, delivered to the heart through a minimally invasive catheter-based procedure. Patients typically experience a short hospital stay following the procedure. The therapy's efficacy in promoting tissue repair has been demonstrated in various animal models.

Peter Altman, PhD, CEO of BioCardia, highlighted the promising results of Phase I and II trials, as well as interim results from Phase III, which show trends towards patient benefit across most outcome measures. He expressed optimism about the potential of CardiAMP cell therapy to offer significant benefits to heart failure patients. The study is currently in the final stages of data monitoring, with plans to unblind and analyze the data for safety and effectiveness soon.

The closure of patient visits and data monitoring, including source data verification, is expected to be completed within the quarter. Subsequently, the final data transfer to the independent Statistical Data Analysis Core at the University of Wisconsin is anticipated, with top-line results slated for release in the first quarter of 2025.

BioCardia has also submitted an Annual Report for the CardiAMP Heart Failure Trial to the FDA, outlining their plans for concluding patient follow-up. The company intends to request a meeting with the FDA to discuss the trial results and the potential approval of the CardiAMP Cell Therapy System.

In addition to their efforts with the FDA, BioCardia has submitted supplementary information to Japan’s Pharmaceutical and Medical Device Agency (PMDA) addressing previous queries regarding the CardiAMP Cell Therapy System based on US data. A consultation with PMDA is scheduled for late November to prepare for a subsequent clinical consultation once the CardiAMP Heart Failure Trial results are available.

The CardiAMP Cell Therapy System represents a novel approach to treating heart failure by using a patient's own cells to stimulate the body's natural healing processes. This therapy targets various mechanisms that lead to microvascular dysfunction, such as fibrosis, inflammation, and endothelial dysfunction, aiming to improve patient outcomes through the production of growth factors, cytokines, and other therapeutic agents.

BioCardia, headquartered in Sunnyvale, California, continues to be a leading force in developing cellular and cell-derived therapies for cardiovascular and pulmonary diseases. Their product platforms, CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, are supported by advanced delivery systems like Helix™ and Morph® vascular navigation. These innovations are paving the way for new treatments that could significantly enhance patient care and quality of life.