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Terumo BCT and OneBlood Partner in a Treatment Use Program of an Investigational Device to Help Improve Blood Supply Safety

10/22/2014

Pathogen reduction technology to be used in combating bloodborne infectious diseases

Lakewood, Colo., USA—22 October 2014—In response to public health concerns over chikungunya virus (CHIKV) and dengue fever, Terumo BCT will file a submission with the U.S. Food and Drug Administration (FDA) to allow expanded access use of the Mirasol® Pathogen Reduction Technology System for the treatment of platelets. FDA's Treatment Use Provision for expanded access to unapproved devices allows the use of promising new therapeutic and diagnostic devices as early in the development process as possible. This process applies to serious or life-threatening diseases or conditions for which no comparable or satisfactory alternative exists.  

The clinical protocol that Terumo BCT will submit will allow OneBlood, one of the nation's leading not-for-profit blood centers based in Florida, to participate as an approved site to treat platelets stored in plasma or platelet additive solution (PAS) with the Mirasol system. The Mirasol system is a pathogen reduction technology designed to render a broad range of disease-causing viruses, bacteria and parasites less pathogenic, and inactivates residual white blood cells found in blood components.

KEY FACTS:

  • The Mirasol system has been designed to render a broad range of disease-causing viruses, bacteria and parasites less pathogenic, and to inactivate residual white blood cells found in blood components
  • The Mirasol system is the only device that uses riboflavin (vitamin B2), a naturally occurring, non-toxic compound that is exposed to ultraviolet light, to provide effective pathogen reduction and white blood cell inactivation
  • The Mirasol system is in routine use in numerous locations throughout Africa, Asia, Europe, Latin America and the Middle East
  • The Mirasol system is designed to deliver:
    • An extra measure of safety in the face of emerging bloodborne infectious diseases
    • Reduced risk from screened and unscreened pathogens as well as white blood cells
    • An effective alternative to bacterial screening of platelets, with no delay in product release
    • Flexibility and ease of use for optimized operating efficiency
    • Accurate reporting and traceability through fully integrated data capture
  • While it is not yet approved for use in the United States, the approval granted to Terumo BCT under the Expanded Access to Unapproved Devices provision  enables this program with OneBlood to begin

About CHIKV and Dengue Fever

CHIKV and dengue fever are mosquito-borne viral infections. The viruses are transmitted from human to human by the bites of infected female mosquitoes. A mosquito carrying either virus can infect more than a dozen people in its lifetime.

To date, the Centers for Disease Control reports that more than a thousand cases of CHIKV have been diagnosed in non-Caribbean areas of the U.S. this year, all but 11 of them contracted outside the U.S. More than 2,000 cases have been confirmed in Puerto Rico, most of them locally acquired. Florida leads the way among states, with more than 200 travel-acquired cases, and 11 confirmed locally contracted cases – which are the first and only cases of locally acquired CHIKV ever reported in the continental U.S.

More than 50 cases of travel-associated dengue fever and five cases of locally acquired dengue fever have been reported this year by the Florida Department of Health.

KEY QUOTES:

Ray Goodrich, PhD, Vice President of Scientific and Clinical Affairs, Terumo BCT
"The Mirasol system is intended to help improve safety of the blood supply by reducing the infectious levels of disease-causing agents in platelets and plasma while still maintaining quality blood components. Our collaboration with the FDA and OneBlood, through this treatment program, allows us to use our technology to further promote patient safety."

Don Doddridge, Chief Executive Officer, OneBlood
"Safety of the blood supply is OneBlood's top priority. Currently there is no approved screening test for blood centers to use in detecting chikungunya virus and dengue fever. Through the pilot program with Terumo BCT we will be able to evaluate the effectiveness of the Mirasol system and provide an added layer of safety to our existing testing process."

About OneBlood:

OneBlood is a not-for-profit 501(c)(3) community asset responsible for providing safe, available and affordable blood to more than 200 hospital partners and their patients throughout most of Florida and into parts of South Georgia and Alabama.

OneBlood was established on January 27, 2012, when three of Florida's independent, not-for-profit blood centers merged. Together, OneBlood brings more than 100 years of lifesaving experience to the community. OneBlood collects nearly one million units of blood annually, employs approximately 2,000 people, operates more than 70 donor centers and deploys nearly 200 of its signature Big Red Buses throughout its service area for blood drives. To learn more about OneBlood please visit www.oneblood.org.

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 technologies. 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 customers.

Media Contact
Sherri Hughes-Smith, Terumo BCT Global Integrated Communications
Phone: 303.542.5113
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