BioCardia announced the initiation of the CardiAMP heart failure pivotal trial, a randomized, controlled, multi-center study of up to 260 patients evaluating CardiAMP cell therapy at up to 40 clinical sites in the US.
The trial has been initiated at two world-class centers: Johns Hopkins University, under the leadership of Dr. Peter Johnston and Dr. Gary Gerstenblith, and the University of Florida at Gainesville, under the leadership of Dr. David Anderson and Dr. Carl Pepine.
“We are honored to be working with the leading clinical research teams at each of these important centers to advance a therapeutic strategy that has great promise to help patients suffering from heart failure developed after a heart attack,” said Eric Duckers, MD, BioCardia Chief Medical Officer.
The CardiAMP Therapy for heart failure integrates a biomarker panel, a cell processing system for autologous bone marrow-derived cells, and a unique transendocardial delivery system.
This therapy will be reviewed under the PMA regulations by the FDA’s Center for Biologics Evaluation and Research (CBER) division.
BioCardia is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the company’s biotherapeutic product candidates in clinical development.
The Company's current products include the Helix™ transendocardial delivery system and the Morph® steerable guide and sheath catheter portfolio.