Aldagen Establishes Manufacturing Facility

07/02/2007 12:00am

Durham, NC – July 2, 2007 – Aldagen, Inc., a biotechnology company advancing a pipeline of

clinical-stage regenerative therapies, today announced it has established a Class 10,000 clean

room for Good Manufacturing Practice (GMP)-certified manufacture of its cellular products. The

manufacturing facility is approximately 1,000 square feet and is fully validated and supported

by environmental monitoring and quality control activities.

Aldagen’s proprietary stem cell isolation technology has been incorporated into the

manufacturing process and the products produced at this facility will be used for three ongoing

clinical studies. The facility has been designed, and operating procedures are in place, to scale

up for commercial manufacture of products upon completion of the trials and approval by the

FDA.

“The establishment of this manufacturing facility is an important step toward the advancement

of our products in clinical trials. We now have the capability to produce cellular products for

multiple clinical sites. This accomplishment supports our commercial model to manufacture our

own products after gaining FDA-approval,” said Tom Amick, Chairman and Chief Executive

Officer of Aldagen.

Photos of the Aldagen manufacturing facility highlight the clean room nature and simplicity of
design.
About Aldagen, Inc.

ALDAGEN is a biotechnology company advancing a pipeline of clinical-stage regenerative

therapies. The Company has three product candidates in clinical development for chronic heart

failure, critical limb ischemia and pediatric metabolic disorders and malignancies. ALDAGEN’s

therapeutics are produced by a proprietary technology platform that selects potent, adult stem

and progenitor cells for therapeutic use. The platform yields a broad range of therapeutic cells

that can be used rapidly, without culture or expansion. To learn more about ALDAGEN, please

visit www.aldagen.com.