CytoSorbents is a critical care therapeutic device company using blood purification to modulate the body’s immune system. The goal of such devices is to prevent or treat multiple organ failure in life-threatening illnesses. Its unique blood purification technology is protected by 32 U.S. patents.
The company announced today the expansion of its CytoSorb dosing study to eight sites in Germany. CytoSorb is the company’s flagship product and has been approved in the European Union to treat life-threatening illnesses in intensive care units. CytoSorb is an extracorporeal cytokine filter designed to reduce the “cytokine storm” that can cause massive inflammation, organ failure, and death.
Three sites were already part of Cytosorbents’ study: the University of Goettingen, Helios Erfurt, and the University of Aichen. The five sites joining in the CytoSorb trial are: the University of Jena, the University of Oldenburg, the University of Leipzig, the University of Greifswald, and the University of Hamburg at Eppendorf.
The matched-pairs dosing study is designed to evaluate the safety and preliminary efficacy of extended CytoSorb treatment. The two treatment arms of the study include 24 hours of treatment for seven days, then six hours of treatment for up to 14 days or until planned clinical improvement occurs. This trial is expected to have at least interim data by the end of the year.
The study and its results will be key in the design of a pivotal trial protocol in the U.S. for sepsis treatment. This trial, pending FDA approval, is expected to begin sometime in 2014. For additional information about CytoSorbents and its flagship CytoSorb product, visit www.cytosorbents.com.
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