EU Business News Q2 2018

16 EU BUSINESS NEWS / Q2 2018 , CytoSorb ® Adds Bilirubin and Myoglobin Reduction to European Union Approved Indications for Use Broadened indications expand the role of CytoSorb in treating liver disease and trauma. CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb ® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that it has received European Union regulatory approval to expand the use of CytoSorb to reduce elevated bilirubin and myoglobin from blood. Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, “This label expansion has the potential to significantly increase the total worldwide addressable market for CytoSorb. Critical care physicians now have a new therapy to rapidly reduce high levels of bilirubin frequently associated with chronic liver disease and liver failure, and elevated myoglobin associated with accidents and traumatic injury. These are diseases that afflict millions of people worldwide each year, where the simultaneous reduction of excessive cytokines, bilirubin, and/or myoglobin by CytoSorb can be beneficial. Interestingly, researchers continue to discover new applications for CytoSorb, many of which are being investigated among Company- sponsored and the more than 60 investigator-initiated studies in various stages occurring around the world. Where possible, we plan to continue expanding the CytoSorb label to bring our therapy to those in greatest need.” According to an article detailing the global burden of liver disease, an estimated 50 million people worldwide suffer from chronic liver disease, often caused by viral hepatitis infection, chronic alcohol use, and non-alcoholic fatty liver disease (NASH). Chronic liver disease is blamed for nearly one million deaths a year, with another one million dying of hepatic cancer and acute hepatitis. In the U.S., liver disease is the second leading cause of death from digestive disease, and the 10th leading cause of death amongst men. An article describing the global burden of injury estimates that nearly one billion patients each year suffer from injury requiring medical care, with 56 million hospitalizations, approximately five million deaths, and significant rates of complications, morbidity, and disability. One life-threatening complication in severe trauma is excessive myoglobin release, or rhabdomyolysis, due to the destruction of muscle tissue. Myoglobin is inefficiently removed by dialysis, and can lead to kidney failure, significantly increasing the risk of death. CytoSorb has been used in many cases as an adjunctive therapy in the treatment of severe trauma for this reason.