{"id":866068,"date":"2025-07-02T08:33:15","date_gmt":"2025-07-02T12:33:15","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/cerus-corporation-provides-intercept-red-blood-cell-ce-mark-application-update\/"},"modified":"2025-07-02T08:33:15","modified_gmt":"2025-07-02T12:33:15","slug":"cerus-corporation-provides-intercept-red-blood-cell-ce-mark-application-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cerus-corporation-provides-intercept-red-blood-cell-ce-mark-application-update\/","title":{"rendered":"Cerus Corporation Provides INTERCEPT Red Blood Cell CE Mark Application Update"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Cerus Corporation Provides INTERCEPT Red Blood Cell CE Mark Application Update<\/b><\/p>\n<p class=\"bwalignc\"><i>Cerus\u2019 Notified Body, T\u00dcV-S\u00dcD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs)<\/i><\/p>\n<p>CONCORD, Calif.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nCerus Corporation (Nasdaq: CERS) announced today a European regulatory update on the INTERCEPT RBC program.<\/p>\n<p>\n\u201cWe are pleased to report that the European regulatory review for INTERCEPT RBC is advancing ahead of plan and that T\u00dcV-S\u00dcD, our Notified Body, has completed their review of the clinical module and transferred information to the State Institute for Drug Control (S\u00daKL) in the Czech Republic, for consultation. Reaching this meaningful milestone enables S\u00daKL to initiate its review of the active pharmaceutical ingredient (API) module. In addition, as we had anticipated, S\u00daKL has agreed to review our submission as the Competent Authority,\u201d said William \u201cObi\u201d Greenman, Cerus\u2019 president and chief executive officer. \u201cWe are looking forward to working collaboratively with both T\u00dcV-S\u00dcD and S\u00daKL to facilitate the completion of the review process for our enhanced CE Mark submission for the INTERCEPT RBC system.\u201d<\/p>\n<p>\nImportantly, the clinical module that has now been successfully reviewed by T\u00dcV-S\u00dcD included the positive results from the U.S. Phase 3 ReCePI clinical trial, expanding Cerus\u2019 CE Mark submission to cover all patient indications for RBC transfusion. S\u00daKL will now review the API module in the application, before the submission goes back to T\u00dcV-S\u00dcD for completion of manufacturing facility audits and certification prior to CE Mark decision.<\/p>\n<p>\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\u2019s 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.<\/p>\n<p><b>ABOUT CERUS<\/b><\/p>\n<p>\nCerus Corporation is dedicated solely to safeguarding the world\u2019s 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.<\/p>\n<p>\nINTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.<\/p>\n<p><b>Forward-Looking Statements<\/b><\/p>\n<p>\nExcept for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus\u2019 INTERCEPT RBC programs and prospects, including statements relating to the anticipated completion of Cerus\u2019 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\u2019 submission to S\u00daKL 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\u2019 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\u2019 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\u2019 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\u2019 Administration for Strategic Preparedness and Response; as well as other risks detailed in Cerus\u2019 filings with the Securities and Exchange Commission, including under the heading \u201cRisk Factors\u201d in Cerus\u2019 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.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20250702232469r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20250702232469\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20250702232469\/en\/<\/a><\/span><\/p>\n<p>\nInvestor Contact:<br \/>\n<br \/>Tim Lee \u2013 Head of Investor Relations<br \/>\n<br \/>Cerus Corporation<br \/>\n<br \/>ir@cerus.com<br \/>\n<br \/>925-288-6128<\/p>\n<p>\nMedia Contact:<br \/>\n<br \/>pr@cerus.com<\/p>\n<p><b>KEYWORDS:<\/b> Europe United States North America California<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Biotechnology Medical Devices Health Pharmaceutical Clinical Trials<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250702232469\/en\/724993\/3\/cerus_210x60.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Cerus Corporation Provides INTERCEPT Red Blood Cell CE Mark Application Update Cerus\u2019 Notified Body, T\u00dcV-S\u00dcD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs) CONCORD, Calif.&#8211;(BUSINESS WIRE)&#8211; Cerus Corporation (Nasdaq: CERS) announced today a European regulatory update on the INTERCEPT RBC program. \u201cWe are pleased to report that the European regulatory review for INTERCEPT RBC is advancing ahead of plan and that T\u00dcV-S\u00dcD, our Notified Body, has completed their review of the clinical module and transferred information to the State Institute for Drug Control (S\u00daKL) in the Czech Republic, for consultation. Reaching this meaningful milestone enables S\u00daKL to initiate its review of the active pharmaceutical ingredient (API) module. In addition, &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/cerus-corporation-provides-intercept-red-blood-cell-ce-mark-application-update\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Cerus Corporation Provides INTERCEPT Red Blood Cell CE Mark Application Update&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-866068","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cerus Corporation Provides INTERCEPT Red Blood Cell CE Mark Application Update - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/cerus-corporation-provides-intercept-red-blood-cell-ce-mark-application-update\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cerus Corporation Provides INTERCEPT Red Blood Cell CE Mark Application Update - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Cerus Corporation Provides INTERCEPT Red Blood Cell CE Mark Application Update Cerus\u2019 Notified Body, T\u00dcV-S\u00dcD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs) CONCORD, Calif.&#8211;(BUSINESS WIRE)&#8211; Cerus Corporation (Nasdaq: CERS) announced today a European regulatory update on the INTERCEPT RBC program. \u201cWe are pleased to report that the European regulatory review for INTERCEPT RBC is advancing ahead of plan and that T\u00dcV-S\u00dcD, our Notified Body, has completed their review of the clinical module and transferred information to the State Institute for Drug Control (S\u00daKL) in the Czech Republic, for consultation. Reaching this meaningful milestone enables S\u00daKL to initiate its review of the active pharmaceutical ingredient (API) module. 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Reaching this meaningful milestone enables S\u00daKL to initiate its review of the active pharmaceutical ingredient (API) module. 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