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     101  0 Kommentare Cerus Corporation Announces FDA Approval of Extended Shelf Life for INTERCEPT Platelet Processing Sets – Doubling Previous Shelf Life

    Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of 12-month shelf life for INTERCEPT Platelet Processing Sets, from the date of manufacture, effective immediately. This approval extends the set shelf life by six months from the existing six-month shelf life that took effect following a set component change last year. All INTERCEPT Platelet Processing Sets in both customer and Cerus inventories are now eligible for this six-month extension. This shelf-life extension applies to all sizes of INTERCEPT Platelet Processing Sets currently available in the U.S.

    “We are pleased with this successful and timely outcome to our regulatory filing with the FDA to re-establish a longer shelf life for INTERCEPT Platelet Processing Sets in the U.S.,” said Vivek Jayaraman, Cerus’ chief operating officer. “We expect that this extension will provide relief to our customers’ and our supply chains and will give customers the flexibility to balance inventory levels with current and future demand while reducing product expiration risk.”

    The Company is continuing to generate additional data to pursue potential shelf life extension from the FDA beyond 12 months for the INTERCEPT Platelet Processing Sets.

    ABOUT CERUS

    Cerus 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 centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.

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    Cerus Corporation Announces FDA Approval of Extended Shelf Life for INTERCEPT Platelet Processing Sets – Doubling Previous Shelf Life Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of 12-month shelf life for INTERCEPT Platelet Processing Sets, from the date of manufacture, effective immediately. This approval …