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BioMS Medical reports Spectral receives FDA approval to initiate pivotal trial and closes financing for $19.5 million
Date:3/3/2010

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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). The use of Toraymyxin(TM) will be 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.

"Securing FDA approval to conduct this pivotal US trial is a major milestone in the advancement of Toraymyxin(TM), a product with blockbuster potential and a track record of safety and efficacy in the treatment of severe sepsis," said Kevin Giese, President and CEO of BioMS Medical Corp. "In addition, Spectral now has suitable resources in place to proceed with this pivotal trial and is on track to initiate patient enrolment in the first half of this year."

Spectral obtained exclusive rights for the Toraymyxin(TM) device in the US from Toray Industries Inc., of Japan, in March of 2009 and anticipates initiating a pivotal US clinical trial in the first half of 2010. Toraymyxin(TM) has been used in
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SOURCE BioMS Medical Corp.
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