Cerus Corporation has received CE mark approval of its next-generation LED-based illumination device—the INT200—for the INTERCEPT Blood System for platelets and plasma.

INTERCEPT’s CE mark approvals for platelets and plasma completes the product’s authorization within the EU Medical Device Regulation (MDR) framework.

“We are delighted to achieve this commercial milestone. We believe the INT200 will be the foundational platform for geographic expansion and future growth of the INTERCEPT business,” Cerus President/CEO Obi Greenman said. “Today’s news also demonstrates our continued commitment to customer-centric innovation for the global transfusion medicine community.”

The CE mark is the first regulatory approval received for Cerus’ next-generation illuminator. The company continues to plan for additional regulatory submissions over the next several years, and future innovation of the INTERCEPT platelet and plasma systems will use the INT200.

“Taking into account feedback received from our customers, we designed the INT200 to provide a significantly improved user experience and operational benefits through enhanced physical design and a novel software interface while maintaining compatibility with the same disposable processing sets and pathogen inactivation process currently in use,” Cerus Chief Operating Officer Vivek Jayaraman said. “Critically, we believe the INT200 will provide blood centers with the pathogen inactivation platform they have come to expect from Cerus. We look forward to supporting our existing customers as they transition to this new device over the next few years as well as new customers as INTERCEPT is introduced in additional geographies.”

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, Calif., 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 U.S. Food and Drug Administration approval for these two blood components. In the United States, 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 treating and controlling bleeding, including massive hemorrhaging associated with fibrinogen deficiency. The INTERCEPT red blood cell system is in late-stage clinical development.

INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.