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Cerus Announces FDA Agreement On Modular Premarket Approval Application (PMA) Submission Process For INTERCEPT Plasma

ABOUT CERUS

Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT system is designed to reduce the risk of transfusion-transmitted diseases 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 enables INTERCEPT treatment to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed to inactivate emerging pathogens such as influenza, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. In the United States, Cerus is seeking regulatory approval of the INTERCEPT Blood System for plasma, and is in discussion with FDA to define the additional clinical data required for a regulatory submission for the INTERCEPT Blood System for platelets. The INTERCEPT Blood System for red blood cells is in clinical development. See http://www.cerus.com for more information.

INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

This press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements relating to the timing of the PMA review process by the FDA, the potential approval and future launch of the INTERCEPT Blood System for plasma in the U.S., and the potential benefits from applying our commercialization experience to a potential launch in the U.S. These forward-looking statements are based upon Cerus’ current expectations.  Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, the risk that the review by the FDA may take longer than expected, that the FDA could require additional data to support potential approval, or that the FDA may not approve the INTERCEPT Blood System for plasma, risks associated with successfully launching a commercial product in new territories and the related potential demand for the INTERCEPT Blood System and other risks detailed in the Cerus' filings with the Securities and Exchange Commission (SEC), including in Cerus' quarterly report on Form 10-Q for the quarter ended September 30, 2012, filed with the SEC on November 8, 2012. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Cerus does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.



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