Gambro BCT announced today that its wholly owned subsidiary, Navigant Biotechnologies, LLC, received the CE Mark for the Mirasol Pathogen Reduction Technology (PRT) System for Platelets.
Pathogen reduction technology inactivates viruses, bacteria, parasites, and residual white blood cells found in certain donated blood components
Gambro BCT announced today that its wholly owned subsidiary, Navigant Biotechnologies, LLC, received the CE Mark for the Mirasol Pathogen Reduction Technology (PRT) System for Platelets. The company can now initiate the necessary steps to begin marketing and selling the Mirasol PRT System for Platelets in various geographies in Europe, Africa, and the Middle East.
The CE Mark is a mandatory European marking for medical devices indicating that the product has been shown to meet the essential health and safety requirements of the European Medical Device Directive.
The Mirasol PRT System uses riboflavin (vitamin B2) and a specific spectrum of ultraviolet light to alter the nucleic acids of pathogens and white blood cells found in donated blood components, rendering them inactive and unable to replicate. A unique feature of Mirasol is its use of a safe, naturally-occurring compound that has been shown to be non-toxic and non-mutagenic. The residual riboflavin or any photoproducts produced during the process do not need to be removed prior to transfusion and do not present any toxicity risks for either the blood handler or the patient. Additionally, the system is easy to use and is designed to fit into current blood bank operations.
Developed by Navigant Biotechnologies, the Mirasol PRT System has been under extensive scientific research, development, and testing since 1999. The Mirasol PRT System has been evaluated for its effectiveness against a broad range of disease-causing agents including viruses, bacteria, parasites, and white blood cells. Most recently, the safety and efficacy of the system has been established in a multi-center clinical evaluation in thrombocytopenic patients.
“We set out with the objective of delivering a product that improves the safety of all blood components without compromising their quality and performance,” says Dr. Ray Goodrich, chief science officer, Navigant Biotechnologies. “The CE Mark and initiation of commercialization of the system for platelets represents a major step toward this ultimate goal.”
The first generation Mirasol PRT System will work with standard, plasma-based platelet concentrates collected via apheresis or prepared from whole blood derived buffy-coats. Future generations of the product are in development and are designed to allow for the treatment of platelet products with reduced plasma content, for subsequent storage in commercially available Platelet Additive Solutions (PAS). Applications for treatment of plasma and whole blood are also in development.
“We are pleased to bring the Mirasol PRT System to market in Europe,” says David Perez, Gambro BCT president and chief executive officer. “This technology can provide an important safeguard against both existing and emerging pathogens. It has the potential to truly enhance the safety of the blood supply.”
The Mirasol PRT System is manufactured by Gambro BCT, Inc. in Lakewood, Colorado. The Company’s European subsidiary, Gambro BCT Europe, N.V., which is based in Brussels, Belgium, will be marketing the system in Europe, Africa, and the Middle East.
The Mirasol PRT System is an investigational device that has not been approved by the United States Food and Drug Administration for commercial use. It is not available for sale in the United States. In addition, certain European countries require additional regulatory approvals prior to the use of the Mirasol PRT System in their jurisdictions.
Gambro BCT improves lives through innovation, quality and services delivered by our people, products and processes in blood component technology. Gambro BCT is a world leader in automated blood collections, therapeutic apheresis, and cell therapy, as well as an innovative leader within automated blood component separation and purification technologies. The Company has approximately 2,000 employees and more than USD $350 million in annual revenues.
Lisa Hayes, Vice President of Global Marketing and Corporate Communications
Phone: +1 303.231.4201