The San Carlos, Calif.-based company could enroll up to 343 patients in the pivotal trial, which is designed to support benefit claims for the cell therapy product without the need for a second confirmatory trial.
BioCardia is also enrolling participants in a pivotal trial evaluating its cell therapy in ischemic heart failure patients.
“FDA approval of the CardiAMP CMI Trial is another important milestone for the company,” BioCardia CEO Peter Altman said in prepared remarks. “It is a step towards developing a new treatment strategy that could have tremendous benefit for patients with refractory angina. Approval of this second pivotal trial further demonstrates BioCardia’s leadership in the treatment of heart disease.”
The 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 eligible for therapy. A small amount of marrow is then collected from the patient and processed at the patient’s bedside. The cells are infused using a routine cardiac catheterization procedure with the company’s Helix delivery system.
BCDA shares were trading at $2.53 apiece in afternoon trading activity today, down -8%.