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.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.