Business Update

Aastrom receives orphan drug designation from U.S. FDA for dilated cardiomyopathy

Published in Medical Letter on the CDC and FDA, March 4th, 2007

Aastrom Biosciences, Inc., (ASTM), a company focused on the use of autologous cells for regenerative medicine, announced that the company's proprietary Tissue Repair Cells (TRCs) received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for use in the treatment of dilated cardiomyopathy (DCM), a severe chronic disease of the heart.

In the U.S., Orphan Drug Designation provides a variety of incentives, including 7 years of market exclusivity, should TRCs receive FDA approval for this indication.

DCM is a chronic cardiac disease that leads to enlargement of the heart and reduces pump function to a point that normal blood...

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Source: Medical Letter on the CDC and FDA (2007-03-04)

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