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)
Cerus Corporation (NASDAQ:CERS) announced today a European regulatory update on the INTERCEPT RBC program.
"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."
Importantly, 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.
Under 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.
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. In the U.S., 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. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the U.S. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
Forward-Looking Statements
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus' INTERCEPT RBC programs and prospects, including statements relating to the anticipated completion of Cerus' CE Mark application review process for the INTERCEPT RBC system and other statements that are not historical fact. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: the uncertain and time-consuming development and regulatory process, including the risks that (a) Cerus' submission to SÚKL may not satisfactorily address the issues in its prior submission that prevented CE Mark approval for the INTERCEPT RBC system, (b) Cerus may be unable to meet the additional applicable requirements to complete the CE Mark application review process for INTERCEPT RBCs in a timely manner or at all, and that Cerus may otherwise determine to substantially delay or abandon its efforts to seek CE Mark approval of the INTERCEPT RBC system, and (c) Cerus may otherwise be unable to obtain any regulatory approvals of the INTERCEPT RBC system in a timely manner or at all; Cerus' ability to maintain an effective, secure manufacturing supply chain, including the risk that Cerus may be required to engage and validate a new supplier for key components of the INTERCEPT RBC system, which would substantially delay the CE Mark application review process for INTERCEPT RBCs and/or a review decision thereon; commercialization and market acceptance of, and customer demand for, the INTERCEPT RBC system, if approved; successfully launching a new commercial product; Cerus' ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction and the INTERCEPT Blood System, including the INTERCEPT RBC system, is safe, effective and economical; future opportunities and plans, including the uncertainty of Cerus' future capital requirements and the sufficiency of its cash resources and anticipated funding under its agreements with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Administration for Strategic Preparedness and Response; as well as other risks detailed in Cerus' filings with the Securities and Exchange Commission, including under the heading "Risk Factors" in Cerus' Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 1, 2025. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
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