MONMOUTH JUNCTION, N.J., Oct. 3, 2014 /PRNewswire/ -- CytoSorbents Corporation (CTSO), a critical care immunotherapy company using blood purification to treat life-threatening conditions, announced the launch of its International CytoSorb® Treatment Registry, established and managed by the Center of Clinical Trials at the University of Jena, Germany. The registry will collect worldwide CytoSorb® treatment and pharmacovigilance data, voluntarily submitted by treating physicians, from critically-ill patients with diseases such as sepsis, trauma, acute respiratory distress syndrome, pancreatitis, burn injury, liver failure, complications of cardiac surgery, and others. The registry follows Good Clinical Practice (GCP) guidelines and will systematically and securely collect and store de-identified patient data. These data can then be analyzed, evaluated and summarized in future publications under the auspices of an independent scientific advisory board, under Good Practice Secondary Data Analysis (GPS) and Guidelines for Good Epidemiological Practice (GEP) standards, and under quality standards outlined by such agencies as the U.S. Agency for Healthcare Research and Quality (AHRQ), and the German Memorandum Registry for Health Services Research.
Prof. Dr. med. Frank Brunkhorst, Director for the Center of Clinical Trials at the Paul Martini Research Unit of the University of Jena, stated "The International CytoSorb Registry will offer the unique opportunity to assess the effectiveness of CytoSorb® in different clinical settings. As data collection takes place on a broad scale, analyzing this huge amount of real life data will extend knowledge, show potential difficulties and thus lead to an optimized treatment with CytoSorb®. Participating centers contribute their experiences and data to the registry and get periodic analyses of their data in return. It's a win-win situation for both the registry participants and CytoSorbents."
Dr. Robert Bartlett, MD, Chief Medical Officer of CytoSorbents stated, "Capturing up-to-date CytoSorb® treatment and safety data in a registry is an extremely efficient way to see how the device is best being used globally for many different indications. These data will be used for publications and also to guide clinical trial protocols in the future to improve the likelihood of informative and useful studies. It is a pleasure to work with leaders such as Professor Brunkhorst and the team at the University of Jena on this important project."
The English version of the CytoSorb registry is expected to be available later this month.
About CytoSorbents Corporation
CytoSorbents Corporation is a critical care focused immunotherapy company using blood purification to modulate inflammation -- with the goal of preventing or treating multiple organ failure in life-threatening illnesses. Organ failure is the cause of nearly half of all deaths in the intensive care unit, with little to improve clinical outcome. CytoSorb®, the Company's flagship product, is approved in the European Union as a safe and effective extracorporeal cytokine adsorber, designed to reduce the "cytokine storm" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. 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 try to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure.
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. CytoSorbents has numerous products under development based upon this unique blood purification technology, protected by 32 issued US patents and multiple applications pending, including HemoDefend™, ContrastSorb, DrugSorb, and others. Additional information is available for download on the Company's website: http://www.cytosorbents.com/
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management's current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. Risk factors are detailed in the Company's Form 10-K filed with the SEC on March 31, 2014, which is available at http://www.sec.gov.
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