Cerus Corporation Announces Positive Topline Results from Phase 3 RedeS Trial of the INTERCEPT Blood System for Red Blood Cells
Business Wire•02/11/2026•16:00 ET
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Key Highlights
- ➤RedeS met non-inferiority endpoint, with adjusted hemoglobin difference of −0.054 g/dL
- ➤INTERCEPT RBCs showed no significant difference in transfusion-related treatment-emergent adverse events
- ➤INTERCEPT-specific antibodies occurred in 2.2% of treated subjects, without hemolysis or clinical impact
- ➤INTERCEPT RBC System remains investigational in the U.S. and lacks FDA approval
- ➤FDA has not reviewed the final RedeS clinical study report or Cerus’ benefit-risk assessment
Expert Statements
Ross M. Fasano, Professor of Pathology & Laboratory Medicine and Hematology at Emory University; RedeS study site investigator at Grady Memorial Hospital
“Over the past decade, pathogen reduction technology has become an integral component of the blood safety toolkit. The topline results from the RedeS study reinforce the potential to extend this established paradigm to red blood cell transfusions”
Richard Benjamin, Chief Medical Officer of Cerus Corporation
“Today, we took another important step toward extending pathogen reduction to red blood cells. The topline RedeS results provide additional evidence on the performance of INTERCEPT-treated red blood cells in patients requiring transfusion support and complement the earlier results from the STARS, SPARC, and ReCePI clinical studies.”
Cerus Corporation Announces Positive Topline Results from Phase 3 RedeS Trial of the INTERCEPT Blood System for Red Blood Cells
* Met primary efficacy endpoint demonstrating non-inferiority of INTERCEPT Red Blood Cells (RBCs) to conventional RBCs by adjusted hemoglobin increment
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