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Spectral granted IDE approval by U.S. FDA to conduct pivotal trial for Toraymyxin(TM)
Date:3/2/2010

TORONTO, March 2 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. (TSX:SDI), a company developing products for the treatment of sepsis, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for Toraymyxin(TM), a therapeutic hemoperfusion device that removes endotoxin from the bloodstream, allowing the Company to conduct a pivotal trial in the United States.

The EUPHRATES (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock) trial is a randomized, double-blinded control trial of standard of care versus standard of care and Toraymyxin(TM) directed by Spectral's Endotoxin Activity Assay (EAA(TM)), an FDA cleared assay for use in sepsis. The trial is expected to enroll approximately 360 patients at 15 sites throughout the U.S. and will have a primary end point of 28 day mortality.

"The FDA's approval of our IDE is a major step forward in the development of Toraymyxin(TM) for the U.S. market
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SOURCE Spectral Diagnostics Inc.
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