Cerus Submits Final Module in the Premarket Approval (PMA) Application Process for INTERCEPT Plasma Business Wire CONCORD, Calif. -- December 4, 2013 Cerus Corporation (NASDAQ: CERS) announcedtoday that it has submitted the fourth 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 plasma. As previously announced, Cerus filed the first of three modules for its INTERCEPT Platelets PMA in September 2013, with submission of the last module expected in March 2014. “We are pleased to have filed the last module for INTERCEPT plasma with FDA on schedule as planned,” said Carol Moore, Cerus’ senior vice president, regulatory affairs, quality, and clinical. “With this important milestone as well as continued progress with our regulatory submission for INTERCEPT platelets, we remain on track for a U.S. review decision and launch of both products as early as 2014.” ABOUT CERUS Cerus Corporation is a biomedical products company focused in the field of blood safety. In in vitro studies, the company’s INTERCEPT Blood System has been demonstrated to inactivate a broad range of viruses, bacteria and parasites that may be present in donated blood, including established threats such as hepatitis B and C, HIV, West Nile virus and bacteria, as well as 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 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 submission of PMA modules to the FDA, including the timing thereof, potential regulatory approval and commercial availability of the INTERCEPT Blood System in the United States, including the timing thereof. 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 Cerus may encounter unanticipated difficulties complying with the prescribed submission timing or other modular PMA requirements, or complying with the regulatory requirements for a U.S. product approval, the risk that Cerus may be required to conduct additional clinical development in support of its regulatory submissions, and that if additional clinical development is required it may require funding that Cerus does not have and that such additional clinical development could significantly delay or preclude regulatory approval, as well as 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, 2013, filed with the SEC on November 1, 2013. 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. Contact: Cerus Corporation Lainie Corten, 925-288-6319 Sr Director, Global Marketing & Investor Relations
Cerus Submits Final Module in the Premarket Approval (PMA) Application Process for INTERCEPT Plasma
Press spacebar to pause and continue. Press esc to stop.