BioMS Medical Corp. reported that Spectral Diagnostics has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for Toraymyxin(TM). Spectral Diagnostics and it have entered into a services agreement whereby BioMS will assist Spectral, as required, in its commercialization of Toraymyxin(TM), a therapeutic hemoperfusion device for the treatment of severe sepsis. This approval permits Spectral to initiate its planned pivotal trial for Toraymyxin(TM) in the United States.

BioMS Medical Corp. reported that Spectral Diagnostics has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for Toraymyxin. Spectral Diagnostics and BioMS have entered into a services agreement whereby BioMS will assist Spectral, as required, in its commercialization of Toraymyxin, a therapeutic hemoperfusion device for the treatment of severe sepsis. This approval permits Spectral to initiate its planned pivotal trial for Toraymyxin 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. The use of Toraymyxin will be directed by Spectrals Endotoxin Activity Assay (EAA), 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.

BioMS Medical Corp. Presents at 4th Annual International Partnering Conference - BIO-Europe Spring 2010, Mar-08-2010 through Mar-10-2010. Venue: AC Barcelona, Paseo Taulat, 278, 08019 Barcelona, Spain.