Bioheart’s lead product candidate is MyoCell®, a muscle stem cell therapy that is intended to improve cardiac function months or even years after a patient has suffered severe heart damage due to a heart attack. The procedure involves a physician removing a small amount of muscle from the patient's thigh. From this muscle specimen, muscle stem cells (also called myoblasts) are then isolated, expanded using Bioheart's proprietary cell-culturing process, and injected directly into the scar tissue of the patient's heart. The cells are delivered by an endoventricular needle-injection catheter during a minimally invasive procedure performed by an interventional cardiologist or vascular surgeon. The muscle stem cells populate the regions of scar tissue and are intended to improve cardiac function by helping the heart muscle beat more efficiently.
The results of our Clinical Trial Marvel Part 1 were published in the American Heart Journal, the prominent peer reviewed medical journal. When compared with placebo, myoblast therapy was associated with sustained (six months) improvements in six minute walk distance of >90 meters, a clinically meaningful improvement. For congestive heart failure patients, this translates into returning to a more active lifestyle and a better quality of life.