Cerus Corporation Announces Receipt of CE Mark for Next-Generation INTERCEPT Illumination Device (INT200)

Rhea-AI Summary

Cerus (CERS) has received CE mark approval for its next-generation LED-based illumination device (INT200) for the INTERCEPT Blood System for platelets and plasma under the EU Medical Device Regulation (MDR). This approval enables Cerus to market the INT200 throughout the European Union and regions recognizing CE mark certification.

The INT200 represents a significant upgrade featuring enhanced physical design and new software interface while maintaining compatibility with existing processing sets. This approval completes the authorization of the INTERCEPT Blood System for both platelets and plasma within the EU MDR framework, following the 2023 CE mark approvals of INTERCEPT processing sets.

The CE mark represents the first regulatory approval for Cerus' next-generation illuminator, with additional regulatory submissions planned over coming years. The INT200 will serve as the foundation for geographic expansion and future growth of the INTERCEPT business.

Positive

• CE mark approval enables immediate EU market access
• Platform established for geographic expansion
• Compatibility maintained with existing processing sets
• First regulatory approval achieved for next-gen illuminator

Negative

• Additional country-specific approvals may be required
• Multi-year transition period needed for existing customers

Insights

Medical Device Analyst

Cerus 's CE Mark approval for its next-generation INTERCEPT Illumination Device (INT200) represents a significant regulatory milestone that completes the EU Medical Device Regulation (MDR) authorization pathway for the company's blood pathogen inactivation system. This regulatory achievement is particularly noteworthy as the MDR framework has presented substantial challenges for medical device manufacturers since its implementation.

The INT200 illuminator is a critical component of Cerus' INTERCEPT Blood System, serving as the hardware platform that enables the photochemical process for inactivating pathogens in blood components. With both the processing sets and now the illuminator approved under MDR, Cerus has secured a complete commercial pathway in Europe for its flagship technology.

Strategically, this approval positions Cerus to accelerate European market penetration while providing a foundation for expansion into additional regions that recognize CE marking. The improved user experience and operational benefits cited suggest the company has addressed customer feedback in ways that could strengthen adoption and retention rates among blood centers.

For Cerus, with its relatively modest market capitalization of $284 million, securing this approval helps solidify its competitive position in the blood safety market while creating new commercial opportunities. The company appears positioned to leverage this platform for future innovations while maintaining compatibility with existing processing sets, which should facilitate customer transitions to the new system.

Blood Banking Specialist

The CE Mark approval for Cerus' next-generation illuminator represents a meaningful advancement in blood safety technology designed with blood center operations in mind. The INT200's LED-based illumination system and enhanced software interface address specific operational challenges faced by transfusion centers while maintaining compatibility with existing INTERCEPT processing sets.

This technical compatibility is particularly significant as it allows blood centers to upgrade their illumination devices without disrupting established workflows or requiring retraining on new processing sets. The illuminator's improved design demonstrates Cerus' understanding of the practical constraints within blood banking operations where reliability and ease of use directly impact throughput and operational efficiency.

From a blood center perspective, having a modernized platform that maintains the same validated pathogen inactivation process while offering improved usability addresses a key adoption barrier. Blood centers operating under tight budgets and staffing constraints prioritize technologies that enhance operational efficiency without compromising safety profiles.

The INT200 appears designed to serve as Cerus' platform for future innovations in pathogen inactivation technology, which suggests the company is building a sustainable technical architecture rather than pursuing one-off improvements. This approach typically yields better long-term value for blood centers that must carefully consider the total cost of ownership when investing in blood safety technologies.

Regulatory Approval Allows Company to Initiate Commercialization of the Illumination Device throughout the European Union

CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation (Nasdaq: CERS) announced today the CE mark approval of its next-generation LED-based illumination device, or the INT200, for the INTERCEPT Blood System for platelets and plasma under the European Union (EU) Medical Device Regulation (MDR). This approval allows Cerus to market the INT200 throughout the EU and in other regions that recognize the CE mark. Some countries may require additional in-country regulatory approval prior to commercialization. With the receipt of CE mark approvals of the INTERCEPT processing sets for platelets and plasma under the MDR in 2023, today’s announced approval completes the authorization of the INTERCEPT Blood System for both platelets and plasma within the EU MDR framework.

“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,” said Obi Greenman, Cerus’ president and chief executive officer. “Today’s news also demonstrates our continued commitment to customer-centric innovation for the global transfusion medicine community.”

“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,” said Vivek Jayaraman, Cerus’ chief operating officer. “Critically, we believe the INT200 will provide blood centers 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.”

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 utilize the INT200. 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 in late-stage clinical development. 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‘ beliefs that the INT200 will be the foundational platform for geographic expansion and future growth of the INTERCEPT business, and that the INT200 will provide blood centers with a robust and reliable pathogen inactivation platform; the expected benefits of the INT200; Cerus looking forward to supporting its existing customers as they transition to the INT200 over the course of this year and next as well as new customers as INTERCEPT is introduced in additional geographies; 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’ Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 26, 2025. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250305387937/en/

Lainie Corten – Vice President, Global Marketing

Cerus Corporation

925-288-6137

Source: Cerus Corporation

FAQ

What is the significance of the CE mark approval for Cerus' INT200 device?

The CE mark allows Cerus (CERS) to market their next-generation illumination device throughout the EU and regions accepting CE mark, representing a important commercial milestone for their INTERCEPT Blood System.

How does the new INT200 device differ from previous INTERCEPT illumination systems?

The INT200 features enhanced physical design, new software interface, and improved user experience while maintaining compatibility with existing processing sets and pathogen inactivation processes.

What markets can Cerus (CERS) now access with the INT200 device?

Cerus can now market the INT200 throughout the European Union and other regions that recognize CE mark certification, though some countries may require additional regulatory approval.

What are the future plans for Cerus' INT200 illumination device?

Cerus plans additional regulatory submissions over the next several years and will use the INT200 as the platform for future INTERCEPT platelet and plasma system innovations.