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U.S. Food and Drug Administration Clears Sickle Cell Disease Indication with New Red Blood Cell Exchange (RBCX) Protocol on the



  U.S. Food and Drug Administration Clears Sickle Cell Disease Indication with
  New Red Blood Cell Exchange (RBCX) Protocol on the Spectra Optia® Apheresis
  System in the United States

  RBCX protocol delivers ability to safely and effectively treat sickle cell
                        disease in adults and children

Business Wire

LAKEWOOD, Colo. -- December 16, 2013

Terumo BCT has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for RBCX on the Spectra Optia Apheresis System. This
option gives clinicians the flexibility to perform multiple types of RBCX
procedures on the Spectra Optia system, and tailor each procedure for the
transfusion management of sickle cell disease in adults and children.

KEY FACTS ABOUT RBCX ON SPECTRA OPTIA SYSTEM:

  * With the addition of the RBCX capability, the Spectra Optia system can now
    perform three dedicated procedures—exchange, depletion and
    depletion/exchange
  * The RBCX procedure on the Spectra Optia system delivers enhanced
    procedural flexibility as compared to the same procedure on the COBE^®
    Spectra Apheresis System
  * Results of a U.S. clinical trial concluded that RBCX on the Spectra Optia
    system enables clinicians to safely and effectively treat adults and
    children with sickle cell disease:

       * The study confirmed that the Spectra Optia system decreased the
         percentage of hemoglobin S in patients, as expected, for the amount
         of replacement red blood cells administered
       * Study results included a post-procedure patient hematocrit within
         1.03% (standard deviation of 0.065%) of that targeted by the Spectra
         Optia system
       * The clinical trial was the first RBCX FDA 510(k)-supporting study to
         include pediatric patients

  * In the U.S., the Spectra Optia system now offers RBCX, therapeutic plasma
    exchange (TPE) with single or dual-needle access and mononuclear cell
    (MNC) collection protocols
  * The RBCX protocol on the Spectra Optia system has been available in Canada
    since May 2010 and available since November 2009 in Europe, Australia, and
    in select countries in the Middle East and Africa
  * The Spectra Optia system offers nine protocols in Europe, Australia,
    Africa, the Middle East and select areas of Asia, including: RBCX, MNC,
    TPE with single or dual-needle access, TPE with a secondary plasma device,
    granulocyte collections, BMP, white blood cell depletions and platelet
    depletions

KEY FACTS ABOUT SICKLE CELL DISEASE

  * More than 100,000 people suffer from sickle cell disease in the United
    States, according to the Centers for Disease Control and Prevention
  * In patients with sickle cell disease, the abnormal hemoglobin (hemoglobin
    S) in the cells sticks together when oxygen is released to the tissues,
    causing clumping that forces red cells to become stiff and sickle shaped
  * Patients with sickle cell disease often experience pain, fatigue and
    difficulty breathing, among other symptoms
  * Sickle cell disease can lead to stroke; damage to the heart, kidneys,
    liver and lung tissue; anemia; and serious infections

KEY QUOTES:

Bob Sullivan, Vice President of Therapeutic Systems Worldwide Sales and
Marketing

“The launch of the RBC exchange protocol in the U.S. empowers our customers to
use the Spectra Optia Apheresis System, the next-generation apheresis system,
to perform RBCX procedures for the transfusion management of sickle cell
disease in adults and children.”

“Terumo BCT is thrilled to have collaborated with Dr. Haewon Kim of Children’s
Hospital in Philadelphia to develop the dedicated RBC depletion/exchange
procedure concept. This capability on the Spectra Optia system helps
clinicians make a difference in the lives of adults and children with sickle
cell disease.”

KEY RESOURCE:

  * Spectra Optia System Fact Sheet

About Terumo BCT:

Terumo BCT, a global leader in blood component, therapeutic apheresis and
cellular technologies, is the only company with the unique combination of
apheresis collections, manual and automated whole blood processing, and
pathogen reduction. We believe in the potential of blood to do even more for
patients than it does today. This belief inspires our innovation and
strengthens our collaboration with customer.

Contact:

Terumo BCT
Laura Fusco, +1-303-205-2546
Global Corporate Communications
press@terumobct.com
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