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U.S. FDA Approves New THERAKOS(TM) CELLEX(TM) Photopheresis System
Date:3/23/2009

- Integrated System Treats Cutaneous T-cell Lymphoma -

EXTON, Pa., March 23 /PRNewswire/ -- Therakos, Inc., a pioneer in immune cell therapy, today announced the U.S. Food and Drug Administration (FDA) approval of the THERAKOS(TM) CELLEX(TM) Photopheresis System for the palliative (reducing the severity of symptoms) treatment of the skin manifestations (appearance) of cutaneous T-cell lymphoma (CTCL) that are unresponsive to other forms of treatment. The THERAKOS(TM) CELLEX(TM) Photopheresis System is an easy-to-use, integrated system that uses extracorporeal (outside the body) photopheresis (ECP), an innovative cellular therapy, to relieve the symptoms of CTCL. The system also has been cleared recently in Canada and Europe.

The new THERAKOS(TM) CELLEX(TM) Photopheresis System features several improvements designed to enhance the patient treatment experience, such as shorter treatment times and reduced extracorporeal blood volume. The benefits of reduced risk of infection and reinfusion errors are maintained in the THERAKOS(TM) CELLEX(TM) Photopheresis System from the current THERAKOS(TM) UVAR(TM) XTS(TM) Photopheresis System. Specific features of the new system include an automated, closed system design that provides users the ability to switch between double and single needle treatment, if necessary. The system also utilizes a new, patented separation technology to separate white blood cells from whole blood.

"Advancements in the new THERAKOS(TM) CELLEX(TM) Photopheresis System have opened up this important treatment option to patients for whom it was previously unfeasible," said Larisa J. Geskin, MD, FAAD, Director of Cutaneous Oncology and Photopheresis Unit and Dermatology Residency Program Director at the University of Pittsburgh School of Medicine. "This new system requires less extracorporeal blood volume at any one time, making it possible to treat lower weight patients and others
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SOURCE Therakos, Inc.
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