The INTERCEPT Blood System for platelets and plasma is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens, such as viruses, bacteria, and parasites. The platelet and plasma systems inactivate pathogens using the same illumination device, process and active compound.
Cerus Product Pipeline*
* Not approved for sale in the US.
INTERCEPT Blood System for Platelets and Plasma: Routine Use in Europe, CIS, the Middle East and Asia
The INTERCEPT Blood System for platelets and plasma has received CE mark approvals (Class III). Kits to produce over 2 million INTERCEPT units have been shipped to date, and the technology has been used clinically in Europe, Commonwealth of Independent States (CIS), the Middle East, Asia and in selected countries in other regions around the world.
INTERCEPT Blood System for Platelets and Plasma: Progress in the United States
Cerus has made significant regulatory progress in the US market. Cerus submitted the first of three modules for its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA), for review of the INTERCEPT Blood System for platelets. In addition, as of November 2013, Cerus has submitted all four modules for its PMA application to FDA for review of the INTERCEPT Blood System for plasma. FDA agreement to proceed with INTERCEPT plasma and platelet PMA submissions was based on existing portfolio of clinical and routine use data, without the need to conduct another prospective clinical trial. In the platelet PMA, Cerus intends to include its extensive clinical and routine-use data for INTERCEPT platelets accumulated over the last 10 years, including prior US Phase III data, EU randomized trial data, and the aggregate hemovigilance data obtained by EU regulatory authorities for over 130,000 INTERCEPT platelet transfusions in both France and Switzerland. Looking ahead, 2013 and 2014 will be a pivotal years for Cerus as it completes plasma and platelet PMA submissions and continues to refine plans for US launches of both products as early as the second half of 2014.
The INTERCEPT Blood System for platelets and plasma is not approved for sale in the United States.
The INTERCEPT Blood System for Red Blood Cells
The INTERCEPT Blood System is also being developed for red blood cells, utilizing the S-303 compound which, when added to blood at neutral pH, acts to irreversibly block the replication of DNA and RNA. Phase II and Phase III trials are underway in the US and EU, respectively.
The INTERCEPT Blood System for red blood cells is in development and is not approved for sale.