DRK Blood Donation Service Baden-Württemberg – Hessen Starts INITIATE Study to Evaluate Pathogen-Inactivated Platelet Concentrates Treated with Cerus' INTERCEPT™ Blood System in Routine Clinical Practice
Cerus Corporation (NASDAQ:CERS) today announced the start of the INITIATE study by the German Red Cross Blood Donation Service Baden-Württemberg – Hessen and its subsidiary organization, the German Red Cross Blood Donation Service North-East. The prospective, multicenter, non-interventional safety study, sponsored by DRK Blood Donation Service Baden-Württemberg-Hessen, is the first of its kind in Germany to evaluate the routine use of pathogen-inactivated platelet concentrates utilizing the INTERCEPT Blood System in a clinical setting.
Platelet concentrates (PC) are an important part of the blood supply in Germany. They are needed for patients with low platelet count or impaired platelet function, particularly in conditions such as leukemia, severe bleeding, after stem cell transplantation or chemotherapy, or during major surgical procedures. Pathogen Inactivation (PI) is intended to further reduce the risk of transmission of bacteria, viruses or other transfusion-associated infections.
The INITIATE study is currently being conducted in selected hospitals in several regions served by the DRK Blood Donation Services Baden-Württemberg – Hessen and North-East. The aim of the non-interventional study is to gain comprehensive insights into the integration and routine suitability of supplying pathogen-inactivated platelet concentrates to patients in Germany and to further evaluate the safety profile of platelet concentrates treated with Cerus' INTERCEPT- Blood System for platelets.
As a voluntary Post-Authorization Safety Study (PASS), the INITIATE study has three main objectives:
- Gain operational and clinical experience and confirm the safety profile of pathogen-inactivated platelet concentrates in routine transfusion practice.
- Assess the feasibility of broader or system-wide introduction of pathogen inactivation in the German healthcare system.
- Begin implementation of the current recommendations of the expert committee "Arbeitskreis Blut" at the Ministry of Health to introduce measures to further reduce the risk of transmission of infections through platelet concentrates.
"The implementation of the INITIATE study allows us to carefully examine how pathogen inactivation can best be integrated into our processes – with the clear goal of supporting the highest safety standards for patients and being able to continue to secure supply despite the short shelf life of platelets," said Prof. Dr. med. Torsten Tonn, chief medical director of the German Red Cross Blood Donation Service Baden-Württemberg-Hessen.
"We are honored that DRK-Blood Donation Service Baden-Württemberg-Hessen has chosen the INTERCEPT Blood System for this important study in Germany," said Christian Boutemy, Cerus' vice president, international commercial operations. "Our collaboration highlights our shared commitment to advancing blood safety and supporting operational excellence in transfusion medicine."
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.
Cerus, INTERCEPT and the Cerus logo are trademarks of Cerus Corporation.
About DRK Blood Donation Service Baden-Württemberg – Hessen
Nationwide, five blood donation services of the German Red Cross (DRK) ensure the long-term and sustainable patient supply with blood preparations on a non-profit basis. The DRK Blood Donation Service Baden-Württemberg – Hessen, together with its subsidiary, the DRK Blood Donation Service North-East, is the largest association of DRK blood donation services in Germany with a catchment area of over 32 million inhabitants. To care for patients, the DRK Blood Donation Service Baden-Württemberg – Hessen carries out almost 11,000 blood donation campaigns annually in its supply area. Approximately 1,000,000 whole blood donations are taken. This is achieved in cooperation with hundreds of thousands of blood donors, the many volunteers, municipalities, cities, districts, authorities and companies who take responsibility for people in their region. www.blutspende.de
About Pathogen-inactivated platelet concentrates (PI-PC)
Pathogen-inactivated platelet concentrates (PI-PC) are blood preparations consisting of platelets that have been treated with a special procedure after donation to render pathogens harmless. The aim is to reduce the risk of transfusion with platelet concentrates transmitting viruses, bacteria or parasites. The platelet concentrates used in the non-interventional INITIATE study have already been approved by the competent higher federal authority, the Paul-Ehrlich-Institut, as medicinal products for routine treatment. "Non-interventional" means that the study is exclusively observational and that the treatment of the patients is not changed by participating in the study compared to routine treatment. The observation is intended to contribute additional experience, in particular to the safety profile of pathogen-inactivated platelet concentrates.
Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the objectives, design, anticipated outcomes and insights of the INITIATE study; expectations regarding the safety profile and potential clinical utility of pathogen-inactivated platelet concentrates treated with the INTERCEPT™ Blood System; expectations with respect to the feasibility, integration and potential system-wide adoption of pathogen inactivation in Germany; anticipated implementation of current expert committee recommendations; and other statements that are not historical facts.
These forward-looking statements are based on Cerus' current expectations, estimates, projections and assumptions and involve risks and uncertainties that could cause actual results or developments to differ materially from those expressed or implied. Important factors that could cause actual results to differ materially include, without limitation, risks that the study may not yield anticipated insights or confirm expected safety outcomes; the complexity, timing and execution of clinical and operational processes; the logistical challenges associated with implementing new procedures; uncertainty surrounding acceptance and adoption by healthcare providers; regulatory and policy developments affecting pathogen inactivation practices; and other risks detailed under the heading "Risk Factors" in Cerus' Annual Report on Form 10-K for the year ended December 31, 2024 and its subsequent Quarterly Reports on Form 10-Q, including the Quarterly Report on Form 10-Q for the quarter ended September 30, 2025.
Cerus does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Lainie Corten — Corporate Communications
Cerus Corporation
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Tim Lee – Head of Investor Relations
Cerus Corporation
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