Dear Friends of Aastrom,

February is American Heart Month, and it is during this time that we recognize many of the important advances in medical research that may help us prevent and treat cardiovascular disease more effectively. In recent years, breakthroughs in surgery, drug therapy and devices have expanded options for patients, making it possible to lower the risk of a cardiac event and treat the effects of peripheral artery disease (PAD). Despite these advances, cardiovascular disease remains the leading cause of death in the United States. Each year it disrupts the quality of life of millions of people and is the cause of approximately 160,000 amputations and 1.5 million heart attacks in the U.S.

Fortunately, there are reasons to be optimistic. Recent advances in regenerative medicine and cell therapy are encouraging and have shown the potential to improve the lives of patients with the most severe forms of cardiovascular disease. In preclinical and clinical studies, cell therapies have demonstrated the potential to repair damage to the heart muscle and other vascular tissue that can occur with a cardiac event. They also have the potential to help restore blood flow or repair genetic defects. If we continue to make clinical progress in this area, cell therapies may become an effective, less costly treatment option for people with advanced cardiovascular disease. For example, we know that patients living with critical limb ischemia (CLI) or dilated cardiomyopathy (DCM) are severely compromised and have few treatment options available. Currently, the only effective treatment option for DCM patients may be a heart transplant, a procedure which is hard to obtain, highly invasive and puts patients at risk of future complications. For patients with CLI, amputation may be the only treatment option, but it reduces quality of life and functionality and often leads to additional amputations if the disease progresses.

Our cell therapy shows promise in providing significant relief to these patients without the risks associated with either transplantation or amputation. We have advanced our lead product candidate, ixmyelocel-T, into Phase 3 clinical trials as a potential treatment for CLI and into Phase 2 clinical trials as a potential treatment for DCM. By repairing damaged tissue using a therapy derived from a patient’s own bone marrow cells, ixmyelocel-T could represent a major advance in the treatment of these severe and often fatal forms of cardiovascular disease in the years ahead.

We are working aggressively to advance the development of ixmyelocel-T in order to bring this potential new treatment option to patients as quickly as possible. We look forward to continuing our research in this area and identifying new areas in cardiovascular medicine where ixmyelocel-T may improve patient care.

Regards,

Daniel Orlando