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Cerus Corporation Provides INTERCEPT Red Blood Cell CE Mark Application Update
Cerus’ Notified Body, TÜV-SÜD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs) CONCORD,
About this update from Cerus Corporation
[{"type":"text","content":"\nCerus’ Notified Body, TÜV-SÜD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs)\n\n\n CONCORD, Calif.--(BUSINESS WIRE)--\nCerus Corporation (Nasdaq: CERS) announced today a European regulatory update on the INTERCEPT RBC program.\n\n\n“We are pleased to report that the European regulatory review for INTERCEPT RBC is advancing ahead of plan and that TÜV-SÜD, our Notified Body, has completed their review of the clinical module and transferred information to the State Institute for Drug Control (SÚKL) in the Czech Republic, for consultation. Reaching this meaningful milestone enables SÚKL to initiate its review of the active pharmaceutical ingredient (API) module. In addition, as we had anticipated, SÚKL has agreed to review our submission as the Competent Authority,” said William “Obi” Greenman, Cerus’ president and chief executive officer. “We are looking forward to working collaboratively with both TÜV-SÜD and SÚKL to facilitate the completion of the review process for our enhanced CE Mark submission for the INTERCEPT RBC system.”\n\n\nImportantly, the clinical module that has now been successfully reviewed by TÜV-SÜD included the positive results from the U.S. Phase 3 ReCePI clinical trial, expanding Cerus’ CE Mark submission to cover all patient indications for RBC transfusion. SÚKL will now review the API module in the application, before the submission goes back to TÜV-SÜD for completion of manufacturing facility audits and certification prior to CE Mark decision.\n\n\nUnder the European Medical Device Regulation (MDR), the CE Mark submission review process for Class III devices such as the INTERCEPT RBC system is rigorous and involves both Notified Bodies and Competent Authorities. The Notified Body evaluates multiple aspects including the manufacturer’s quality system and technical documentation to ensure adherence to European regulations. The Competent Authority is responsible for reviewing the active pharmaceutical ingredient manufacturing and safety.\n\n\nABOUT CERUS\n\n\nCerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood cente...