(See our Appendix for background on REFRESH studies, REMOVE study in infective endocarditis and other CytoSorb related programs and indications) REFRESH II Enrollment Accelerates Following FDA Approval of Protocol Amendment in Sept 2018 In early September CTSO announced that FDA approved the protocol amendment for their REFRESH 2-AKI trial. As a reminder, CTSO mentioned prior to that that their clinical advisors recommended the protocol amendment as it would "expand the inclusion criteria, improve operational aspects of the patient screening process, enhance the rate of enrollment, and ultimately increase the applicable market that CytoSorb could address if approved." Specifically, the amendment modified the age and weight patient eligibility criteria, removing the age cap and eliminating a weight restriction. Initial protocol restricted eligibility to only people 18 to 80 years old and of weight 100 to 382 pounds. The amendment removed the 80 year-old cap and completely eliminates any weight restriction.