Cerus Announces Submission of Final Module in PMA App Process for INTERCEPT Platelets

Cerus Corporation

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.”