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

. We are on track to start the pivotal trial in the first half of 2010, using the EAA(TM) guided approach to endotoxin removal by Toraymyxin(TM) hemoperfusion in patients with septic shock. This theranostics approach, a combination of a therapeutic and diagnostic, is included in the design of our EUPHRATES trial," said Dr. Paul Walker, President and CEO of Spectral. "Also incorporated in the trial design is clinical information already available on the use of the Toraymyxin(TM) column from many previously conducted positive trials completed internationally. We look forward to confirming these findings."

Dr. Walker continued: "This theranostics strategy should address a major unmet need for more than 250,000 patients per year in the United States alone who suffer from severe sepsis and are at high risk of dying."

About Spectral Diagnostics

Spectral is a leader in the battle against sepsis. Spectral's lead product is its Endotoxin Activity Assay (EAA(TM)), the only FDA cleared assay for the measurement of endotoxin. With the growing awareness for the role of endotoxemia in sepsis and the increasing number of therapies being developed for this indication, Spectral is well-positioned to drive the adoption of the EAA(TM), which can be used to identify patients, enable therapeutics a
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SOURCE Spectral Diagnostics Inc.
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