BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S.
The pivotal trial is a part of the company’s efforts for premarket approval, as regulated by the FDA’s Center for Biologics Evaluation and Research division.
“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,” BioCardia chief medical officer Dr. Eric Duckers said in prepared remarks.
The randomized, controlled trial is slated to enroll up to 260 patients at Johns Hopkins University and the University of Florida at Gainesville.
The San Carlos, Calif.-based company’s CardiAmp cell therapy combines a biomarker panel, a cell processing system for autologous bone marrow-derived cells and a transendocardial delivery system.
BioCardia’s cell therapy system first characterizes the potency of a patient’s own bone marrow cells and determines if the patient is eligble for therapy. A small amount of marrow is collected from the patient’s iliac crest and then processed at the patient’s bedside. The cells are infused using a routine cardiac catheterization procedure with the company’s Helix delivery system.
