CytoSorbents, Inc. Submits IDE Application To FDA For U.S. Cytosorb® Cardiac Surgery Trial
MONMOUTH JUNCTION, N.J., Dec. 30, 2014 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ CM: CTSO), a critical care immunotherapy company commercializing its CytoSorb® extracorporeal cytokine adsorber to reduce deadly inflammation in critically-ill and cardiac surgery patients, announced today that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to conduct its proposed clinical trial using CytoSorb® intra-operatively in patients undergoing complex cardiac surgery requiring the use of a heart-lung machine. The goal of CytoSorb® treatment is to reduce inflammatory mediators and proteins such as cytokines and plasma free hemoglobin generated during surgery that can lead to serious post-operative complications.
Dr. Robert Bartlett, Chief Medical Officer of CytoSorbents, and Dr. Greg Di Russo, Senior Vice President of Clinical Development at CytoSorbents said in a joint statement, "Intra-operative use of CytoSorb® represents an innovative new strategy to improve the safety of complex cardiac surgical cases, and to reduce inflammation generated during the surgery. Currently, there are no practical alternatives approved in the U.S. or Europe to address this significant problem. We believe the proposed trial protocol, designed with significant input from our cardiac surgery advisory board, is well-designed to be effectively conducted by our clinical trial sites which include many of the leading cardiac surgery centers in the country. With approval, we will begin the clinical trial as soon as possible."
Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, "The submission of this IDE application represents a major milestone for the Company, initiating the clinical trial process needed to seek approval of CytoSorb® in the United States. With approximately half a million cardiac surgery procedures such as valve replacement and coronary artery bypass graft surgeries each year in the U.S. alone, and another one million in the rest of the world annually, we believe this represents a significant potential commercial opportunity for the Company."
All investigational medical devices require IDE approval before they can be used in U.S.-based clinical studies to evaluate safety and efficacy. This is a similar concept to the Investigational New Drug (IND) path for drug trials. CytoSorb® is currently approved in the European Union as an extra-corporeal cytokine adsorber, and installs easily and quickly into a bypass circuit in a standard heart-lung machine.
CytoSorb® has been used safely intra-operatively in well over 100 cardiac surgeries in Europe to date.
About CytoSorbents Corporation
CytoSorbents Corporation is a critical care focused immunotherapy company using blood purification to control severe 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 and marketed in 28 countries around the world, 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 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/.
Forward-Looking Statements
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SOURCE CytoSorbents Corporation