Cerus gains regulatory nods for blood safety device in Europe

Published 28/05/2025, 13:38
Cerus gains regulatory nods for blood safety device in Europe

CONCORD, Calif. - Cerus Corporation (NASDAQ:CERS), a medical device company with a market capitalization of $241 million and strong revenue growth of 13% over the last twelve months, has received regulatory approval for its new blood safety device, INT200, from both the French National Agency for Medicines and Health Product Safety and the Swiss Agency for Therapeutic Products. This device is an enhancement for the INTERCEPT Blood System, which is already in use in France and Switzerland for all platelet components since 2018 and 2011, respectively.

The INT200 is a LED-based illumination device designed to improve blood center operations. It boasts a vertical configuration to optimize workflow and space, with the capability to fit three devices in the space of one previous model, the INT100. Features include touch screen navigation, intuitive software, and intelligent scanning. These approvals follow the CE Mark authorization the device received in March. According to InvestingPro analysis, Cerus maintains healthy liquidity with a current ratio of 2.32, supporting its product development initiatives. Get access to 5+ additional ProTips and comprehensive financial metrics with InvestingPro.

Cerus’ chief operating officer, Vivek Jayaraman, expressed satisfaction with the approvals, stating they validate the company’s technology and the positive early feedback from the commercial rollout. The company plans to transition its EMEA-based INT100 devices to the newer INT200 platform within the next three years.

Additionally, Cerus is preparing for further regulatory submissions, including a PMA submission to the FDA planned for 2026, and aims to continue innovating its platelet and plasma systems using the INT200 platform.

Cerus Corporation focuses on the global blood products market, developing technologies to ensure a safe blood supply. Their INTERCEPT Blood System is the only pathogen reduction system with both CE mark and FDA approval for platelet and plasma components. They are also advancing regulatory review in Europe and clinical development in the U.S. for their red blood cell system.

The company’s forward-looking statements indicate plans for commercialization and innovation, subject to the usual risks associated with new product rollouts and regulatory processes. This news is based on a press release statement from Cerus Corporation.

In other recent news, Cerus Corporation reported its Q1 2025 earnings, revealing a net loss of $7.7 million or $0.04 per share, which aligned with analyst forecasts. The company reported revenue of $48.9 million, slightly below the expected $49.61 million, despite a 13% year-over-year increase in product revenue. North American revenues surged by 22%, while EMEA experienced a slight decline. Cerus maintained its EPS forecast but revised its revenue expectations for the year. The company provided full-year 2025 product revenue guidance of $194-$200 million, with expected IFC revenue between $12 million and $15 million. Additionally, seven of the eight production partners for IFC have received biologic license application approvals, allowing them to ramp up production. The company continues to focus on expanding its geographic reach and product offerings, with the recent approval of the INT200 illumination device in Europe.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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