CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) today announced that the INTERCEPT Blood System for platelets and plasma has been approved for commercialization in Brazil by the Agência Nacional de Vigilância Sanitária (ANVISA). The approval marks the first time that a system to inactivate pathogens in platelet and plasma components will be available in Brazil.
“With serious outbreaks of viruses such as dengue, zika, and chikungunya becoming more common in Brazil, transmission of pathogens via blood transfusion remains an ongoing threat,” commented Carol Moore, SVP, Regulatory Affairs and Quality at Cerus. “This significant approval by ANVISA represents an important step toward bringing the INTERCEPT Blood System to Brazilian blood centers as a way to proactively combat against transfusion-transmitted infections.”
Brazil represents the largest transfusion market in Latin America. Over 3.7 million whole blood and apheresis units are collected annually in public and private collection centers, generating approximately 800,000 plasma and cryoprecipitate products and 160,000 pooled random donor and apheresis platelet products for transfusion.
Cerus has partnered with the Comércio Exportação e Importação de Materiais Médicos (CEI) for the sales, deployment, and support of the INTERCEPT Blood System in Brazil. “CEI has a history of successfully implementing innovative medical technologies in Brazil, and we see INTERCEPT as the next logical step in safeguarding patients from transfusion-transmitted infections,” said Paulo Pacheco, chief executive officer of CEI.
ABOUT THE INTERCEPT BLOOD SYSTEM
The INTERCEPT Blood System for platelets and plasma, approved in Europe since 2002 and in the United States since 2014, is designed to enhance the safety of donated blood components by inactivating a broad spectrum of enveloped viruses, non-enveloped viruses, Gram-positive and Gram-negative bacteria, spirochetes, and parasites, as well as potentially harmful white blood cells present in donor blood. INTERCEPT is comprised of single-use platelet and plasma processing sets and an ultraviolet (UVA) illumination device for the ex vivo preparation and storage of pathogen-reduced whole blood-derived or apheresis plasma and apheresis platelet components. The safety and efficacy of platelets and plasma treated with the INTERCEPT Blood System has been extensively evaluated in clinical studies and has been monitored and shown to be safe in routine use through hemovigilance programs covering over 500,000 INTERCEPT-processed platelet and plasma components.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action of the INTERCEPT treatment is designed to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus, and bacteria, as well as emerging pathogens such as chikungunya, malaria, and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in the United States, Europe, the Commonwealth of Independent States, the Middle East, and selected countries in other regions around the world. The INTERCEPT red blood cell system is in clinical development. See www.cerus.com for information about Cerus.
INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.
