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TMCNet:  Cerus Submits Final Module in Premarket Approval (PMA) Application Process for INTERCEPT Platelets

[July 17, 2014]

Cerus Submits Final Module in Premarket Approval (PMA) Application Process for INTERCEPT Platelets

CONCORD, Calif. --(Business Wire)--

Cerus Corporation (NASDAQ: CERS) announced today that it has submitted the third and final module for its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA), for review of the INTERCEPT Blood System for platelets. The INTERCEPT platelet submission was completed at the end of the second quarter as projected in Cerus' regulatory timeline.

"We are extremely pleased to have met major US regulatory milestones with the INTERCEPT plasma PMA currently under FDA review, and now, the initiation of the review process for INTERCEPT platelets. FDA has indicated that it has all the information needed to proceed with its PMA filing review for INTERCEPT platelets." said Carol Moore, Cerus' senior vice president of regulatory, quality and clinical affairs. "We are committed to working with FDA in completing the application reviews."

"In light of our recent regulatory progress in the US, Canada and Mexico, we are excited about the prospect of accessing the North American market," said William 'Obi' Greenman, Cerus' president and chief executive officer. "We continue to focus our efforts on launch preparation, including the expansion of our commercial team, launch material preparation, and organizing key events. When we receive these approval decisions, our commercial team plans to be ready."

ABOUT CERUS

Cerus Corporation is a biomedical products compay focused in the field of blood safety. 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 platelets. The INTERCEPT red blood cell system 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 potential approval by the FDA of the Company's PMA submissions for the INTERCEPT Blood System for plasma or for platelets and the success of the Company's launch preparedness efforts. 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, risks associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System; the uncertain and time-consuming regulatory process, including the risks that the Company may be required to complete additional clinical trials in order to obtain approval of its PMA submissions for plasma or for platelets; that the Company may otherwise encounter unanticipated difficulties complying with the regulatory requirements related to the INTERCEPT Blood System for plasma or for platelets or that the Company's PMA submissions for plasma or for platelets might not be approved by the FDA in a timely manner or at all; that the Company may not have the resources to support multiple regulatory submissions; adverse market and economic conditions; and other risks detailed in the Cerus' filings with the Securities and Exchange Commission (SEC (News - Alert)), including in Cerus' annual report on Form 10-Q for the quarter ended March 31, 2014, filed with the SEC on May 12, 2014. 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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