BioCardia, Inc. has announced the completion of the last protocol-specified follow-up visit in its CardiAMP HF trial, a Phase III prospective, randomized, double-blinded, placebo procedure-controlled, multi-center pivotal clinical trial evaluating the CardiAMP Cell Therapy System for the treatment of heart failure with reduced ejection fraction (HFrEF). The trial aims to assess the therapy's potential to reduce all-cause mortality, future hospitalizations, enhance functional capacity, and improve symptoms and quality of life for patients with HFrEF.
The CardiAMP HF trial enrolled 115 advanced heart failure patients on guideline-directed medical therapy (GDMT) across 18 hospitals in the United States. Participants were randomized in a 3:2 ratio to receive either the CardiAMP autologous cell therapy or a placebo procedure. An additional open-label roll-in cohort included ten patients, bringing the total number of patients in the study to 125.
HFrEF, an end-stage manifestation of ischemic heart disease, affects over a million patients in the U.S. and millions more worldwide. Despite advancements in therapies, premature death, recurrent hospitalizations, and declining quality of life remain significant challenges for patients, their families, and healthcare systems. The CardiAMP Cell Therapy System, an investigational device, has been granted Breakthrough Device Designation by the FDA.
The CardiAMP autologous cell therapy is administered via a standard minimally invasive catheter-based procedure, with patients typically discharged after an overnight stay. The cell therapy is designed to promote microvascular repair by enhancing capillary density and reducing fibrosis, effects demonstrated in both small and large animal models of the disease.
Close-out visits and data monitoring, including source data verification to prepare for data lock, are expected to be completed this quarter. The 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 trial results concerning the approvability of the CardiAMP Cell Therapy System. Additionally, BioCardia has submitted supplementary information to the Japan Pharmaceutical and Medical Device Agency (PMDA), responding to previous queries regarding the approvability of the CardiAMP Cell Therapy System based on U.S. data. A consultation with the PMDA is scheduled for late November to prepare for a subsequent clinical consultation after the CardiAMP Heart Failure Trial results are available.
