BioCardia has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP cell therapy system for the treatment of heart failure.
CardiAMP cell therapy uses autologous bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure. The therapy incorporates a pre-procedural screening assay to identify patients who may be likely responders. Eligible patients receive a high dose of cells using an intramyocardial delivery system.
According to BioCardia, the technique is designed to potentially stimulate the body’s natural healing response, provoking a beneficial paracrine reaction to repair the heart. This is a different mechanism of action from other therapies that have sought to transform stem cells into new heart cells, a method that has presented patient risks, such as rhythm abnormalities and cell rejection, the company adds.
“It is exciting for the field of cardiology that the FDA has recognised the potential of a cell therapy to improve the lives of patients struggling with heart failure. Getting this therapy fast-tracked and to patients more quickly than traditional methods would give us new options and a greater armamentarium to assist our patients in need. I am enthusiastic about completing the US pivotal trial of the CardiAMP cell therapy to build the body of evidence necessary to support this accelerated FDA path,” said Carl Pepine, professor in the Division of Cardiovascular Medicine at the University of Florida, Gainesville, USA.
The CardiAMP Cell Therapy Heart Failure Trial is a US pivotal trial currently enrolling patients to evaluate the effectiveness of the CardiAMP cell therapy system in improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for patients. The trial is scheduled to have a prespecified formal Data Safety Monitoring Board Review which will assess both safety and futility of the trial on 8 February 2022. Results from this review should be available in the days following the review.
The CardiAMP cell therapy system has shown no incidence of mortality at one year in its Phase II trial or in the 10-patient roll-in cohort from the Phase III trial that is currently enrolling, BioCardia said in a press release. Earlier studies of the therapy have shown statistically significant improvement in exercise tolerance and quality of life, the company adds.
“We thank the FDA for granting Breakthrough Device Designation to the CardiAMP cell therapy system and recognising its potential to provide more effective treatment for heart failure, a major achievement for this unique therapy,” said Peter Altman, president and chief executive officer of BioCardia. “The published results from our clinical trials to date have met our high expectations in showing the therapy’s ability to address the loss of heart function in ischaemic heart failure. We look forward to completing our phase III trial and engaging with the FDA as we move closer to the prospect of benefiting patients whose lives are severely impacted by this disease.”