Mirasol System identified as the Best Available Technology for Japanese Needs
LAKEWOOD, Colo.—June 16, 2010— CaridianBCT, a leading global provider of technology, products and services in the blood banking, transfusion medicine and cell therapy industries, announced that the Japanese Red Cross considers the Mirasol Pathogen Reduction Technology System for platelets stored in plasma the best available technology for Japanese needs.
In a Japan Pharmaceutical Affairs and Food Sanitation Council Blood Program Division meeting held in March 2010, the Japanese Red Cross distributed a report entitled, “Preparation for the Introduction of Infectious Pathogen Reduction Technology Implementation,” which included the endorsement of the Blood Program Steering Committee, Blood Program Division Pharmaceutical Affairs Food Sanitation Council, Ministry of Health, Labor and Welfare. The report was made on the basis of taking steps to address potential pandemic or epidemic threats, which may emerge in the future and potentially threaten both blood safety and availability in Japan.
In the report, the Japanese Red Cross compared the CaridianBCT Mirasol system to another pathogen reduction technology on the market. Based on this comparison, the Japanese Red Cross recommended the Mirasol system for its needs, subject to additional in vitro testing and in vivo clinical trials to be conducted in the future. The Mirasol system is intended to reduce the risk of transfusion transmitted diseases associated with blood products.
The report comes after approximately five years of pre-clinical evaluation of various pathogen inactivation methods on the part of the Japanese Red Cross. This evaluation included studies of platelet and plasma protein quality, functionality and performance, toxicology review, as well as logistical evaluation for routine implementation. It also included studies of efficacy against pathogens such as viruses and bacteria in blood products and the ability to inactivate donor white blood cells in comparison to gamma irradiation.
The Japanese Red Cross will undertake pre-clinical and clinical evaluations of the Mirasol system for use with platelets in Japan. The Council further conditioned the Japanese Red Cross to investigate platelet quality and the introduction status of the pathogen reduction technology in other nations prior to the in vivo clinical evaluation.
CaridianBCT’s Mirasol system has obtained the CE Mark and is currently used in various locations in the world for the reduction of infectious pathogens in platelet and plasma products.
“We are pleased with the outcome of the work undertaken by the Japanese Red Cross on behalf of blood safety in Japan,” stated David Perez, president and CEO of CaridianBCT. “We look forward to continuing our work with the Japanese Red Cross in bringing this technology forward in Japan as a means to improve both blood safety and availability.”
About the Mirasol System
The only device on the market to use a combination of riboflavin (vitamin B2), a non-toxic naturally occurring compound, and ultraviolet light, the Mirasol system delivers immediately transfusable blood products, enabling blood centers to release pathogen reduced blood products for timely patient care. CaridianBCT received a CE Mark for the Mirasol system in 2007 for treating platelets suspended in plasma, in 2008 for treating fresh frozen plasma (FFP) in addition to treating plasma-reduced platelet concentrates that are subsequently stored in Platelet Additive Solution. The Mirasol system is available for sale in countries where the CE mark is accepted. It is not currently available for sale in the United States.
CaridianBCT is the leading global provider of innovative technologies and services specializing in automated blood collections, therapeutic apheresis and cell therapy systems, whole blood processes and pathogen reduction technologies. The company serves patients through its commitment “For Better Blood and Better Lives” by developing and commercializing products that serve global customers in the blood banking, therapeutic apheresis and transfusion medicine industries. For more information, visit www.caridianbct.com.
Lisa Hayes, Vice President of Global Marketing and Corporate Communications
Phone: +1 303.231.4201