Cerus Corporation (NASDAQ:CERS) announced today that it has obtained approval for a CE mark label expansion extending the time within which plasma can be treated with the INTERCEPT Blood System to 20 hours after collection. The prior approved label claim allowed INTERCEPT treatment only within 8 hours of blood collection. This new extended treatment window applies to plasma from single donor apheresis and pooled whole blood collections.
With this label expansion, blood centers using the INTERCEPT Blood System will be able to simplify their processing logistics. Whole blood from mobile donor drives, the source of most donated blood, can be collected in the afternoon, held overnight, and then processed into platelet, plasma and red blood cell components the following day. The expanded time for treatment allows processing of more plasma with INTERCEPT at lower costs due to improved collection, transportation, and storage logistics.
"This label change is especially important to blood centers that depend on mobile blood drives and then have to transport the blood back to centralized processing facilities," said Laurence Corash, Senior Vice President and Chief Medical Officer of Cerus. "We believe the increase in allowed treatment time for production of INTERCEPT-treated plasma will have very positive implications on donor recruitment, costs, resource requirements, and ultimately the supply of therapeutic plasma and other blood components with the added safety of pathogen inactivation."
Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT Blood System is designed to inactivate blood-borne pathogens in donated blood components intended for transfusion. Cerus currently markets the INTERCEPT Blood System for both platelets and plasma in Europe, Russia, the Middle East and selected countries in other regions around the world. The Company is also pursuing regulatory approvals in the United States and other countries. The INTERCEPT red blood cell system is currently in clinical development.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
Forward Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to expectations that blood centers will be able to realize cost and operational benefits. Words such as "expect" and "believe" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the company's current expectations. Forward-looking statements involve risks and uncertainties. The company's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks inherent in customer adoption of the INTERCEPT Blood System and realization of any economic or operational benefits derived from such adoption. These and other risk factors are discussed under "Risk Factors" in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2008. The company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.
William J. Dawson, 925-288-6053
Vice President, Finance & CFO