LAKEWOOD, Colo., USA--April 30, 2018--The first patient has enrolled in a U.S. clinical trial to evaluate the effectiveness and safety of red blood cells derived from whole blood that is treated using Terumo BCT's Mirasol® System. Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular technologies and is committed to advancing blood safety.
The pivotal study, known as PRAISE, is designed to provide the clinical evidence required to support submission of Mirasol to the U.S. Food and Drug Administration (FDA) for premarket approval (PMA). The device is designed to use riboflavin (vitamin B2) and ultraviolet light to reduce the pathogen load of various disease-causing viruses, bacteria and parasites in whole blood before it is divided into components and the red blood cells are transfused to patients. Mirasol is the only device designed to treat whole blood in this manner.
Sponsored by the Department of Defense (DOD), the PRAISE clinical study compares red blood cells derived from Mirasol-treated whole blood versus untreated red blood cells transfused to patients diagnosed with thalassemia, a genetic blood disorder caused by a lack of hemoglobin (oxygen-carrying protein). This is a prospective, multicenter, randomized, crossover trial. It is expected to take 2.5 years and involve about 100 patients. The PRAISE study, formally known as the trial to Evaluate the Efficacy and Safety of Red Blood Cells Derived From Mirasol-Treated Whole Blood in Patients Requiring Chronic Transfusion, is just one of the collaborations between Terumo BCT and the DOD. Mirasol is an Army Acquisition Program of Record.
"A safe blood supply is central to our mission of preparedness and security for the entire nation, says Army Col. Audra Taylor, Director of the Army Blood Program. "FDA approval of Mirasol will further enhance the safety of blood transfused to our Warfighters in combat as well as U.S. civilians."
There continues to be heightened awareness and need for global blood safety due to increased travel, climate change, evolving pathogens and emerging pandemics. Mirasol's pathogen reduction actions combined with its ability to inactivate residual white blood cells (which may help reduce some transfusion reactions) represent a proactive step in patient care.
Currently, pathogen-reduced red blood cells are the only blood component that does not have U.S. regulatory approval. Red blood cells are the most commonly transfused blood component, according to the National Heart, Lung, and Blood Institute.
"Terumo BCT is committed to advancing a safe global blood supply, which includes bringing Mirasol to the U.S. market", said Palani Palaniappan, Executive Vice President, Innovation and Development, Terumo BCT. "Mirasol is a proactive approach to protecting patients."
Mirasol is CE marked for platelets, plasma and whole blood and is in use in approximately 20 countries and 140 blood centers throughout Europe, the Middle East, Africa, Asia and Latin America. The system is for investigational use only in the U.S. and Canada and is available in other selected countries.
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.
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.