FDA grants IDE approval to Harvest Technologies to commence its BMAC Enhanced CABG trial

Harvest Technologies Corp. (www.harvesttech.com) announced today that the Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to commence its BMAC Enhanced CABG Trial. This is a two phase 42-patient 'feasibility' clinical trial using the company's BMAC System to concentrate autologous bone marrow cells to treat patients with congestive heart failure undergoing treatment with coronary artery bypass grafting (CABG) Surgery. The BMAC System is a point-of-care device used in the operating room to concentrate patient's own (autologous) bone marrow stem cells in approximately 15 minutes. The study's design provides for randomization of subjects into two study cohorts: Treatment Group who will have the Harvest cellular composition injected into the myocardium after CABG surgery and Control Group who will receive only the CABG surgery.

Congestive heart failure (CHF) has emerged as a major chronic disease among patients in the United States. About 400,000 new patients develop CHF each year. Morbidity and mortality rates are high; annually, approximately 900,000 patients require hospitalization for CHF, and up to 200,000 patients die from this condition. The average annual mortality rate is 40-50% in patients with severe (New York Heart Association [NYHA] class IV) heart failure. CHF accounts for over 10 million office visits, 6 million hospital days and $30 billion in direct costs each year. The initial stages of heart failure are managed with medical therapy and the end-stage heart failure is managed with surgical procedures in addition to medical therapy. The "gold standard" surgical treatment for myocardial revascularization is coronary artery bypass grafting (CABG).

Although surgical and catheter based revascularization of ischemic myocardium can treat angina, reduce the risk of myocardial infarction, and improve function of viable myocardium, these treatments can not restore the viability of severely ischemic and/or necrotic myocardium.

Autologous cell therapy has been studied as an innovative treatment option for this patient population. Recent discoveries showing that primitive, pluripotent stem/progenitor cells may differentiate into functional myocardial or vascular tissue have ignited great interest and sparked studies utilizing these cells as a treatment strategy for acute myocardial infarction and chronic ischemic heart disease. Several papers have shown that autologous bone marrow may be the most practical and safest source for these reparative cells, as pre-clinical data suggest that subsets of bone marrow derived cells may be able to generate both functional cardiomyocytes and blood vessels.

However, two major obstacles associated with autologous adult stem cell therapy have been the lack of a simple, practical method for integrating cell therapy within the clinical setting and credible scientific-based, randomized controlled studies. "Our BMAC technology is making the benefit of cellular therapy available right now for European physicians," said Gary Tureski, President of Harvest Technologies. "They are able to harvest and concentrate autologous adult stem cells easily and quickly, at the point of care -- thereby enabling them to develop cellular therapy treatments for orthopedic and vascular diseases, today. We believe that this experience will prove to be a major benefit to cellular therapy approaches for cardiac disease."

Principal Investigator Dr. Amit Patel, MD, associate professor of surgery at the University of Utah School of Medicine, will lead this U.S. clinical study. "Having a methodology for concentrating a composition of bone marrow cells in the operating room represents the next phase in the evolution of cell based therapies for cardiac disease. The Harvest rapid bedside method can do in minutes what other methodologies used in our first series of clinical trials needed hours to complete."