MONMOUTH JUNCTION, N.J., May 14, 2018 /PRNewswire/ -- 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 5 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.
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 45 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. CytoSorbents recently initiated its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb® has been used in more than 40,000 human treatments to date.
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 nearly $22 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM) and others. The Company has numerous products under development based upon this unique patented blood purification technology including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
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