Cerus has secured CE mark approval for its next-generation LED-based illumination device, INT200, under the European Union Medical Device Regulation (EU MDR).
With the CE mark approval, the company aims to commercialise the INT200 across the EU and other regions recognising the CE mark.
However, some countries may require additional regulatory approvals before commercial launch.
The CE mark approval completes the authorisation of the Intercept Blood System for both platelets and plasma within the EU MDR framework.
Cerus plans to submit further regulatory submissions in the coming years and incorporate INT200 in the future developments of the Intercept platelet and plasma systems.
Cerus chief operating officer Vivek Jayaraman said: “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.
“Critically, we believe the INT200 will provide blood centres with the robust and reliable pathogen inactivation platform that 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.”
Based in Concord, California, Cerus focuses on developing and supplying pathogen-protected blood components to blood centres and hospitals.
Its Intercept Blood System is the only pathogen reduction system to receive both the CE mark and The US Food and Drug Administration (FDA) approvals for platelets and plasma.
The system is approved in the US, for producing pathogen-reduced cryoprecipitated fibrinogen complex, which is used in treating fibrinogen deficiency-related bleeding.
The Intercept red blood cell system is currently in late-stage clinical development.
Cerus president and CEO Obi Greenman said: “We are delighted to achieve this important commercial milestone. We believe the INT200 will be the foundational platform for geographic expansion and future growth of the Intercept business.
“Today’s news also demonstrates our continued commitment to customer-centric innovation for the global transfusion medicine community.”
