Cerus Corp. (CERS) Tuesday announced positive results for the phase 3 clinical trial of the pathogen-reduced INTERCEPT blood system for red blood cells in cardiovascular surgery patients.
The company said the trial met the primary efficacy endpoint demonstrating non-inferiority of the incidence of acute kidney injury compared to conventional red blood cells. Acute kidney injury is a sensitive transfusion efficacy indicator of RBC tissue oxygen delivery.
The safety endpoint is being explored in the ongoing RedeS Phase 3 clinical trial of INTERCEPT RBCs.
Cerus said it anticipates initiating a modular PMA application to FDA in the second half of 2025.
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