CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS - News) today announced that the French regulatory agency for medical products, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has granted regulatory approval in France for use of plasma treated with the INTERCEPT Blood System, subject to official journal publication. Before the plasma system can be launched broadly in France, reimbursement pricing also needs to be established.
“This approval marks a significant step towards commercializing our plasma system in France,” said Claes Glassell, president and chief executive officer, Cerus Corporation. “We are pleased that the AFSSAPS approved the plasma system so quickly.”
ABOUT THE PLASMA SYSTEM
The INTERCEPT Blood System for plasma is designed to provide increased protection to the blood supply from emerging pathogens, such as West Nile virus and Chikungunya virus, and to offer blood centers a better solution for meeting plasma production needs.
The efficacy and safety of INTERCEPT plasma system was evaluated in transfusions comprising approximately 5,000 units. The plasma system is designed to meet blood center requirements for efficiency, performance and compatibility with both whole blood and apheresis collections.
Approximately 1.5 million plasma units for transfusion are collected annually in Europe. About 70% of those units undergo pathogen inactivation treatment or quarantine to meet European standards for plasma safety.
ABOUT CERUS
Cerus Corporation is a biopharmaceutical company that develops and commercializes novel, proprietary products in the fields of blood safety and immunotherapy to provide safer, more effective medical options to patients in areas of substantial unmet medical needs. In the field of blood safety, the company is developing and commercializing the INTERCEPT Blood System, which is based on the company’s proprietary Helinx technology and is designed to enhance the safety of donated blood components by inactivating viruses, bacteria, parasites and other pathogens, as well as potentially harmful white blood cells. In the field of immunotherapy, the company is employing its proprietary attenuated Listeria vaccine platform to develop a series of novel therapies to treat cancer, and it is applying its proprietary Killed But Metabolically Active technology platform in research and development of prophylactic and therapeutic vaccines for infectious diseases.
INTERCEPT, INTERCEPT Blood System and Helinx are trademarks of Cerus Corporation.
Contact: Cerus Corporation Myesha Edwards, 925-288-6017 (Corporate Communications & Investor Relations)
Source: Cerus Corporation