Cerus Corporation Announces Multiple In-Country Regulatory Approvals for INT200 – Next-Generation INTERCEPT Illumination Device
CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) announced today two in-country regulatory approvals for INT200, one by the French National Agency for Medicines and Health Product Safety (ANSM) and the other by the Swiss Agency for Therapeutic Products (Swissmedic).
The INT200, the Company's 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,' said Vivek Jayaraman, Cerus' chief operating officer. '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 EMEA to INT200s over the next three years.
The Company continues to plan for additional regulatory submissions, including a planned PMA submission to the FDA during 2026, as well as future innovation of the INTERCEPT platelet and plasma systems to leverage the INT200 platform. Further information about the INT200 can be found at https://info.interceptbloodsystem.com/intercept-illuminator-int200.
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.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
Forward-Looking Statements
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus' products, prospects and expected results, including statements relating to: Cerus' expectations regarding the conversion of INT100s to INT200s and the timing thereof; Cerus' plans for future regulatory submissions and the timing thereof; Cerus' plans for future product innovations; 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: risks associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System, including the risks that Cerus may not (a) effectively commercialize the INT200, (b) realize meaningful revenue contribution from the INT200 in the near term or at all and/or (c) effectively expand its commercialization activities into additional geographies; risks associated with macroeconomic developments, including ongoing military conflict in Ukraine, new or increased tariffs and escalating trade tensions and the resulting global economic and financial disruptions, and the current and potential future negative impacts to Cerus' business operations; risks related to Cerus' ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction and the INTERCEPT Blood System is safe, effective and economical; risks related to the uncertain and time-consuming development and regulatory process, including the risk that Cerus may be unable to obtain and maintain the requisite in-country regulatory approvals necessary to commercialize the INT200 in a timely manner or at all; risks related to product safety; risks related to adverse market and economic conditions, including continued or more severe adverse fluctuations in foreign exchange rates and/or continued or more severe weakening in economic conditions resulting from military conflicts, rising interest rates, inflation, new or increased tariffs and escalating trade tensions or otherwise in the markets where Cerus is anticipated to commercialize the INT200; risks associated with Cerus' ability to maintain an effective, secure manufacturing supply chain, including the risks that (a) Cerus' supply chain could be negatively impacted as a result of the evolving impact of macroeconomic developments, including the ongoing military conflict in Ukraine, rising interest rates, inflation, and new or increased tariffs and escalating trade tensions, (b) Cerus' manufacturers could be unable to comply with extensive regulatory agency requirements, and (c) Cerus may be unable to maintain its supply agreements with its third party suppliers; risks associated with Cerus' need for additional funding; risks associated with the impact of legislative or regulatory healthcare reforms that may make it more difficult and costly for Cerus to produce, market and distribute the INT200; as well as other risks detailed in Cerus' filings with the Securities and Exchange Commission, including under the heading 'Risk Factors' in Cerus' 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.
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