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."
Ja. Aber warum? Was war denn so schlecht an der News? Hat jemand ne Erklärung warum es nach dieser Nachricht nur nach Unten geht?
Erinnert mich irgendwie an Allos Therapeutics die haben damals nach einer Phase-II Studie schon ganz überraschend die Zulassung bekommen und seit der Nachricht ist sie jeden Tag nur runtergegangen und sich halbiert. Was ist denn so schlecht an ner Zulassung für ein Unternehmen?