11:43 AM EDT, 03/19/2024 (MT Newswires) -- Cerus ( CERS ) said Tuesday that its Intercept red blood cell system achieved the main goal of non-inferiority compared with conventional red blood cells in a pivotal phase 3 study in complex cardiac surgery patients.

The company said the incidence of acute kidney injury was 29.3% for patients who received Intercept RBC, compared with 28% for those who received conventional RBC in the ReCePi pivotal trial.

Cerus ( CERS ) also said the incidence of treatment-emergent adverse events was not significantly different between the two groups.

Cerus ( CERS ) said it expects to start a modular premarket approval application for Intercept red blood cells with the US Food and Drug Administration in H2 2025, with final module submission mapped out for H2 2026.

The application is expected to include the results of an ongoing RedeS phase 3 clinical trial evaluating the safety of Intercept red blood cells transfusion, the company added.

The company's shares were up more than 13% in recent trading.

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