FDA-Approved CardiAMP HF II Pivotal Trial Launched by BioCardia

Biotechnology firm BioCardia, Inc., which is listed on the Nasdaq stock exchange, is spearheading the development of innovative cell therapy treatments for heart-related disorders. The company has recently initiated a pivotal clinical trial known as CardiAMP HF II, which will assess the efficacy of its proprietary CardiAMP autologous cell therapy in patients suffering from ischemic heart failure.

The FDA granted approval for this trial in the fourth quarter of 2023, specifically for treating heart failure with reduced ejection fraction of ischemic origin. The trial's activation has been marked by the receipt of Institutional Review Board approval and the fulfillment of numerous regulatory requirements for conducting a randomized, controlled, and multi-centered interventional study.

The CardiAMP HF II trial is designed with the interim results from an ongoing study involving 125 patients with ischemic heart failure. These interim findings are slated to be presented at an upcoming conference focused on technology and heart failure therapeutics in March 2024, with the final results anticipated by the end of the year.

The trial's primary goal is to measure the difference in outcomes between the treatment and control groups, considering heart-related deaths, major adverse cardiac and cerebrovascular events, and the patients' quality of life. The FDA-approved trial size is set at 250 patients, which is expected to provide a high statistical power for the study's success.

BioCardia's CEO, Dr. Peter Altman, has expressed optimism about the trial's potential for rapid enrollment, citing the operational advantages gained from previous experience with their network, streamlined protocol design, and the motivation of both medical professionals and patients due to promising clinical results.

The CardiAMP therapy, recognized by the FDA as a breakthrough therapy, employs a patient's own bone marrow cells, delivered via a minimally invasive catheter-based procedure, aiming to stimulate the body's innate healing mechanisms. This therapy is distinguished by its unique pre-treatment cell analysis for patient selection, a high dosage of cells, and a proprietary delivery system that has shown superior safety and effectiveness compared to other methods.

BioCardia, based in Sunnyvale, California, is dedicated to developing cell-based and cell-derived therapeutics for cardiovascular and pulmonary diseases. The company's platforms, CardiAMP and CardiALLO, are focused on treating heart disease, and BioCardia also collaborates with other entities to support the delivery of cell, gene, and protein therapies for various heart conditions.

It is important to note that the CardiAMP therapy is limited to investigational use in the United States, as per the country's regulations. The company's proprietary kits and delivery systems are manufactured at its Sunnyvale facility, supported by the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services.