Cerus Corporation Announces FDA PMA Supplement Submission for Pathogen-Reduced Cryoprecipitated Fibrinogen Complex

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[{"type":"text","content":"\nPMA-S includes submission for pathogen-reduced cryoprecipitate-poor plasma\n\n CONCORD, Calif.--(BUSINESS WIRE)--\nCerus Corporation (Nasdaq:CERS) announced today that the Company has submitted a pre-market approval supplement (PMA-S) to the FDA for a pathogen reduced cryoprecipitated fibrinogen complex with 5-day post thaw storage. This product was previously granted FDA breakthrough device designation based on the potential to improve treatment of massive hemorrhage, a life-threatening medical condition. Trauma is the leading cause of death in the U.S. for people under 45 years of age and approximately 40% of the fatalities are the result of bleeding or its consequence1,2.\n\n\n“This is a major milestone in our corporate history,” said William ‘Obi’ Greenman, Cerus’ president and chief executive office. “Pathogen-reduced cryoprecipitated fibrinogen complex is manufactured from FDA licensed INTERCEPT plasma. If approved by the FDA, it would be our first therapeutic product candidate. It is being developed specifically to provide a source of fibrinogen and other coagulation factors to treat patients with massive bleeding.”\n\n\nSeverely bleeding patients generally do not receive conventional cryoprecipitate immediately on hospital admission in current massive transfusion protocols or during in-hospital surgical procedures with massive bleeding because it is stored frozen and requires thawing before administration. Furthermore, if unused within four to six hours of thawing, conventional cryoprecipitate must be discarded due to concern for bacterial contamination, and it is wasted3. The high wastage rates due to limited post thaw storage has impeded early use of cryoprecipitate in the treatment of massive hemorrhage, resulting in limited availability at many hospitals.\n\n\nCerus’ pathogen-reduced cryoprecipitated fibrinogen complex is designed to be stored for up to five days at room temperature after thaw and to be provided in doses enabling greater ease of use. If approved by the FDA, the room temperature storage would enable hospitals with active trauma centers, major surgical programs, and high-risk obstetric patients to maintain an inventory of thawed pathogen-reduced cryoprecipitated fibrinogen complex. This would allow for immediate availability while minimizing wastage rates due to the longer post-thaw shelf life compar...

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