Cerus Corporation has won INT200 regulatory approvals from the French National Agency for Medicines and Health Product Safety (ANSM) and the Swiss Agency for Therapeutic Products (Swissmedic).

The INT200, a next-generation LED-based illumination device, was developed as the new foundational platform for the INTERCEPT Blood System, with input and feedback from global customers to enhance daily blood center operations. The contemporary vertical configuration is designed to improve workflow and ergonomics while freeing up bench space (three INT200 illumination devices can fit in the same footprint as a single INT100). In addition to the vertical configuration, the INT200 features touch screen navigation and intuitive software, improved tray design, intelligent scanning, and custom reporting.

These in-country regulatory approvals follow the CE Mark authorization received in March. In France and Switzerland, all platelet components have been treated with the INTERCEPT Blood System since 2018 and 2011, respectively.

“We are pleased with the important in-country approvals in France and Switzerland and view these approvals as an important validation of our technology,” Cerus Chief Operating Officer Vivek Jayaraman stated. “We have started the commercial rollout of this next generation platform and the early feedback continues to be very encouraging. France and Switzerland continue to be at the forefront of blood transfusion safety and we value their partnership toward ensuring the safety of the blood supply in their respective countries.”

The Company expects to convert its installed base of INT100s in Europe, the Middle East, and Africa to INT200s over the next three years.

The Company continues to plan for additional regulatory submissions, including a planned pre-market approval submission to the U.S. Food and Drug Administration (FDA) in 2026, as well as future innovation of the INTERCEPT platelet and plasma systems to leverage the INT200 platform.

Cerus Corporation is dedicated to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, Calif., the firm develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients. The INTERCEPT Blood System for platelets and plasma is available globally and is reportedly the only pathogen reduction system with both CE mark and FDA 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 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 United States.