CytoSorbents Announces Approval of CytoSorb® in Korea in Collaboration with Partner Fresenius Medical Care

CytoSorbents Corporation, a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces that the Korean Ministry of Food and Drug Safety (KMFDS) has approved CytoSorb for all equivalent European Union (E.U.) approved indications, including the reduction of cytokine storm, the reduction of bilirubin in liver disease, the reduction of myoglobin in trauma, and the removal of ticagrelor and rivaroxaban during urgent or emergent cardiothoracic surgery.

Ms. Clare Kim, Managing Director of Fresenius Medical Care Korea commented, "In Korea, the sepsis mortality rate and incidence have increased steadily and remains a major problem in critical care.  Under these circumstances, we are pleased to introduce the cytokine adsorber, CytoSorb, to healthcare professionals and patients in Korea. Fresenius Medical Care Korea remains committed to having a positive impact on the care of severely ill patients with CytoSorb."

Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents, stated, "We are pleased to have successfully achieved approval of CytoSorb in Korea, in cooperation with our partner Fresenius Medical Care.  This was the culmination of a nearly 2-year process that included an on-site audit by the KMFDS and the preparation of a full technical dossier specific to Korea's regulatory requirements. With a world-class medical system serving a population of nearly 52 million people, the Republic of Korea is ranked as one of the leading healthcare systems in the world by the Legatum Institute.  Physicians in Korea will now have the opportunity to treat patients with CytoSorb as a leading therapy to fight cytokine storm in many life-threatening conditions such as sepsis, COVID-19, and many others."

Mr. Capponi continued, "We are excited to expand the global footprint of CytoSorb, now in a total of 67 countries worldwide. In addition to exclusive distribution countries of France, the Czech Republic, and Finland, we have worked with Fresenius Medical Care this year to expand to multiple additional countries, including Colombia, Ecuador, Brazil in critical care, Mexico – with approval in March 2020, and now Korea.   We believe that all of these countries have significant potential to help drive our future sales growth, and are glad to begin working with Fresenius to launch CytoSorb in this very important Asian market, with our first shipment to the country expected this month."     

About CytoSorbents Corporation

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 67 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 121,000 human treatments to date.  CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $38 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.