Successful Clinical Evaluation of Mirasol System for Treatment of Whole Blood
LAKEWOOD, Colo.—July 27, 2010— CaridianBCT, a leading global provider of technology, products and services in the blood banking, transfusion medicine and cell therapy industries, today announced it will present results from a clinical study of CaridianBCT's Mirasol® Pathogen Reduction Technology System for whole blood at the 2010 AABB Annual Meeting in Baltimore, Maryland. The study was a clinical trial for treating whole blood with the Mirasol Pathogen Reduction Technology (PRT) and was performed after receiving IDE approval from the U.S. Food and Drug Administration (FDA) and support from the U.S. Department of Defense (DoD).
The Mirasol system uses the unique properties of riboflavin (vitamin B2), a naturally occurring compound, and ultraviolet light to inactivate disease-causing agents including viruses, bacteria, parasites and white blood cells that may be present in blood components for transfusion. Initiated in October 2008, the trial was conducted at the Hoxworth Blood Center in Cincinnati, Ohio and represents the initial evaluation of red blood cells, platelets and plasma derived from whole blood treated with the Mirasol technology.
"We are pleased with the outcomes from this study and look forward to continuing our work with CaridianBCT in advancing the clinical evaluation of the Mirasol system in the United States," stated Dr. Jos e Cancelas, MD, principal investigator for the trial and division director of research at Hoxworth Blood Center. Dr. Cancelas will present the results of the trial at the 2010 AABB Annual Meeting.
CaridianBCT receives research funding from the U.S. DoD to develop the Mirasol system as a transportable way to treat whole blood and reduce the risks associated with blood-borne pathogens and donor white cells. The study evaluated the in vivo behavior of red blood cells in healthy subjects after treatment with the Mirasol system. The objectives were to ensure that the Mirasol system maintained adequate performance of the treated blood components, evaluate the safety of the system, and establish correlations between in vitro performance measures and the in vivo recovery and survival of red blood cells derived from the treated whole blood.
"This is a first step in the clinical trial program of this product and it has been a real success," said Dr. Raymond Goodrich, chief science officer for CaridianBCT. "We have reviewed the results from the study with the FDA and we are moving forward in the development program to the next phase of clinical work according to a mutually agreed upon program plan."
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 and 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 http://www.caridianbct.com/ .
Lisa Hayes, Vice President of Global Marketing and Corporate Communications
Phone: +1 303.231.4201