Clinical study to investigate Cytori's adipose-derived cell therapy in patients with heart failure

Clinical trial treats heart failure patients with their own stem cells to restore blood flow

Timothy Henry, M.D. of the Minneapolis Heart Institute Foundation treated the first patient in the ATHENA study, injecting the patient's own stem cells into the heart to restore blood flow and help regenerate heart muscle. Henry, the Foundation's Director of Research is co-principal investigator of the ATHENA study sponsored by Cytori Therapeutics. The study will investigate Cytori's adipose-derived cell therapy in patients who suffer from heart failure related to chronic myocardial ischemia.

"Patients who qualify for this study essentially have limited options beyond left ventricular assist devices and heart transplantation," said Dr. Henry, "Patients in the ATHENA study are treated using their own cells taken from fat tissue that are put back into the heart to regenerate tissue, a process that minimizes the risk of rejection. This is an exciting trial which may potentially add an attractive alternative for patients who have a critical need."

The purpose of the study is to see if cells taken from one's own fat can help restore the heart muscle function by growing new blood vessels to improve the blood supply and thereby increase the heart's ability to pump blood.The stem cells will be taken from fat tissue. The stem cells, or placebo, will then be delivered into the heart muscle. Enrollment is expected to complete in mid-2013.

""The ATHENA clinical trial gives us an opportunity to explore the potential for Cytori's cell therapy in heart failure patients," said Marc H. Hedrick, M.D., president, Cytori Therapeutics. "While this is an investigational treatment, we believe that cell therapy will someday become a new option for these heart failure patients and at the same time, lower the cost of care by delaying or preventing patients from needing a transplant or assist device."

Cytori previously reported six and 18-month safety and feasibility data from the PRECISE trial, a European clinical trial for this same indication. The PRECISE trial demonstrated a statistically significant improvement in VO2 Max in patients treated with Cytori's cell therapy compared to those treated with placebo. VO2 Max is an objective functional measurement that can be predictive of outcomes in heart disease, including mortality, and is commonly used as a primary determinant for qualifying patients for heart transplantation. The Company is also conducting the ADVANCE trial, a European pivotal trial investigating the effect of Cytori's cell therapy in heart attack patients.

In addition to the Minneapolis Heart Institute Foundation, the Texas Heart Institute (Houston, TX) is screening patients under the direction of Emerson Perin, M.D., Ph.D., co-principal investigator for ATHENA, and James T. Willerson, M.D. Four additional centers are also expected to participate in the trial including:

• University of Florida, in Gainesville, FL, Carl Pepine, M.D.
• University of South Florida, Tampa, FL, Leslie W. Miller, M.D.
• Scripps Green Hospital in San Diego, California, Richard Schatz, M.D.
• Cardiology P.C., Birmingham, AL, Farrell Mendlesohn, M.D.

Source: Minneapolis Heart Institute Foundation