European Union Regulatory Approval for CytoSorb

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CytoSorbents Corporation (OTCBB: CTSO), a critical  care focused company using blood purification to treat life-threatening  illnesses, is pleased to announce that it has achieved European CE Mark  approval for its flagship product, CytoSorb™, as an extracorporeal  cytokine filter in situations where excessive cytokine levels exist.  This milestone certifies that CytoSorb™ has met the safety and label  efficacy claim requirements of the European Medical Devices Directive  and can now be sold in the European Union (E.U.) for human clinical use.  

The European Sepsis Trial has successfully demonstrated CytoSorb™'s  robust ability to reduce circulating plasma cytokine levels during the  extracorporeal treatment of critically-ill patients with sepsis and  respiratory failure. CytoSorb™ has achieved its primary endpoint of IL-6  (interleukin-6) reduction with statistical significance based on an  interim analysis of the trial. The data demonstrates that CytoSorb™ plus  standard of care therapy reduced IL-6 levels by an average of 49.1% (p =  0.01) during the CytoSorb™ treatment period compared to standard of  care therapy alone. The treatment was well-tolerated, with no serious  device related adverse events reported to date in more than 300  treatments in septic patients.

Dr. Phillip Chan, Chief Executive Officer, stated, "Obtaining European  regulatory approval for CytoSorb™ is the most significant accomplishment  in our company's history and we thank our employees and our  shareholders for their dedication and support. To our knowledge, we are  the only device approved in the E.U. specifically as a cytokine filter,  opening up many opportunities to not just treat patients with sepsis,  but also patients with a host of life-threatening and non-life  threatening inflammatory conditions where cytokine levels are elevated.  As we analyze the clinical data from our current trial in sepsis, we  look to continue to lead and foster additional clinical studies with a  strong focus on sepsis and other critical care illnesses such as acute  respiratory distress syndrome, severe burn injury, trauma, and  pancreatitis, where the need is great and the human and financial costs  are staggering. The goal is to drive broad usage of our technology and  generate valuable clinical data across many fields."

Dr. Chan continued, "Now that we are permitted to manufacture CytoSorb™  devices for clinical use in the E.U. under CE Mark approval and ISO  13485 certification, we will ramp manufacturing for a controlled-market  release in select territories in the second half of this year. The goal  for 2011 is to build a solid foundation for future growth and  responsibly make the transition from a development stage to a commercial  stage medical device company. Our longer term goal is to pursue trials  in the U.S. and attain FDA regulatory approval as well." Dr. Chan  concluded, "With this major milestone, we continue to advance our  mission to change the face of critical care medicine and to help save  patients' lives."