Spectral signs exclusive license agreement to bring sepsis therapeutic to the U.S. market

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[{"type":"text","content":"\n\n\n\nTORONTO, March 9 /CNW/ - Spectral Diagnostics Inc. (TSX:SDI) today\nannounced that it has signed a license agreement with Toray Industries, Inc.\nof Japan granting Spectral the exclusive development and commercial rights in\nthe U.S. for Toraymyxin(TM), a therapeutic device for the treatment of sepsis\nthat removes endotoxin from the bloodstream. Under the terms of the agreement,\nSpectral will seek FDA approval for Toraymyxin(TM) and intends to\ncommercialize the product together with its Endotoxin Activity Assay\n(EAA(TM)), the only FDA cleared diagnostic for the measurement of endotoxin.\n\n\n"The finalization of this agreement, on schedule, is an important\nmilestone for Spectral and demonstrates the significant progress we have made\non our path to delivering an effective treatment for severe sepsis in the\nUnited States. Toraymyxin(TM) has been used on more than 70,000 patients to\ndate, primarily in Europe and Japan, for the treatment of severe sepsis caused\nby endotoxemia," said Dr. Paul Walker, President and CEO of Spectral.\n"Furthermore, together with our proprietary EAA(TM), the combination has\ndemonstrated a significant reduction in the mortality of patients with severe\nsepsis compared to standard of care in European clinical trials. This\ninnovative product has the potential to fulfill a severely unmet need for the\napproximately 100,000 patients that develop severe sepsis or septic shock in\nthe U.S. each year."\n\n\nSpectral plans to conduct a pre-Investigational Device Exemption\n(pre-IDE) meeting with the U.S. FDA this quarter as a first step towards\ngaining clearance for its clinical strategy, with the objective of initiating\nclinical trials in the latter half of 2009.\n\n\nAbout Toray\n\n\nToray Industries, Inc. is a leading diversified chemicals corporate group\nthat has been technology-focused since its foundation in 1926. The company's\noperations are underpinned by technological expertise in organic synthetic\nchemistry, polymer chemistry, and biochemistry. These innovative technologies\nhave yielded "advanced materials" that Toray is now exploiting to provide\ncustomers with comprehensive solutions through Fibers and Textiles, Plastics\nand Chemicals, IT-related Products, Carbon Fiber Composite Materials,\nEnvironment and Engineering, Life Science and Other Busi...

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