October 5, 2008
CaridianBCT Initiates Clinical Trial for Whole Blood Process With Mirasol(R) Pathogen Reduction Technology
CaridianBCT, a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies, announced today that it has initiated a clinical trial for treating whole blood with Mirasol Pathogen Reduction Technology (PRT) after receiving clearance from the U.S. Food and Drug Administration (FDA) and U.S. Department of Defense. The Mirasol PRT system is a proprietary technology that uses riboflavin and UV light to reduce the levels of infectious pathogens and inactivate white cells from collected blood, improving the safety of transfused blood.
The study, which has started enrolling subjects, will take 6 - 12 months to complete and is a feasibility study designed to support filing for regulatory approvals in the United States. The trial is sponsored by CaridianBCT Biotechnologies, LLC and is being conducted at the Hoxworth Blood Center in Cincinnati, Ohio.
CaridianBCT Biotechnologies received research funding from the U.S. Department of Defense (DOD) with the goal to develop a transportable system to treat whole blood and reduce the risks associated with blood-borne pathogens and donor white cells. This clinical study will evaluate platelet, plasma and red cell products during storage. The in vivo behavior of red cells will be evaluated in this study in healthy subjects after treatment of the products with the Mirasol PRT system. The objective of the study is to ensure that the system maintains performance of treated components.
"At CaridianBCT, our scientists are passionate about leading the development of the next generation of the Mirasol technology for whole blood and continuing their mission of improving the safety of the world's blood supply with our pathogen reduction technology," said CaridianBCT President and Chief Executive Officer David B. Perez. "We continue to be honored to work under the sponsorship of the U.S. DOD in spearheading the development and testing of the industry's first transportable pathogen reduction technology system. Patients, no matter where they are located, may clearly benefit from this simple, safe, and effective technology."
About the Mirasol PRT Process
The Mirasol PRT system has been under extensive scientific research, development and testing since 1999 and has been evaluated for its effectiveness against a broad range of disease-causing agents including viruses, bacteria, parasites and white blood cells. CaridianBCT recently received a CE Mark for the Mirasol PRT system for Plasma for transfusion. This expands the initial CE Mark approval of the Mirasol PRT System for Platelets granted in October 2007. The Mirasol PRT system is available for sale in countries where the CE mark is accepted. It is not, however, available for sale in the United States.
The Mirasol PRT system is a groundbreaking new technology based on ultraviolet (UV) light and riboflavin (vitamin B2) that has the potential to reduce infectious pathogens and inactivate white cells in all three major blood components: platelets, plasma, and red blood cells. A unique feature of Mirasol is its use of riboflavin, a compound that has been shown to be non-toxic and non-mutagenic. The residual riboflavin and any photoproducts produced during the process do not present any hazardous risks to the blood handler or patient, eliminating the need to remove it prior to transfusion.
CaridianBCT Biotechnologies, LLC is wholly owned subsidiary of CaridianBCT, Inc. CaridianBCT, Inc. improves lives through innovation, quality and services delivered by its people, products and processes in blood component technology. It is a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies--serving blood banks, hospitals and clinical and biotech research facilities. Headquartered in Lakewood, CO., the company has global operations in 32 countries and employs more than 2500 people. Learn more at www.caridianbct.com.