Spectral is seeking U.S. FDA approval for its lead product, Toraymyxin, a treatment for severe sepsis and septic shock. Toraymyxin is a therapeutic hemoperfusion device that removes endotoxin, the most important microbial trigger for sepsis, from the bloodstream. Directed by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared, CE marked diagnostic for the detection of endotoxin, Spectral’s EUPHRATES trial is the world’s first theranostics trial in the area of sepsis.

Toraymyxin was approved for therapeutic use in Japan in 1994 and Europe in 2002 and has been used safely and effectively in more than 340,000 patients worldwide. In March 2009 and November 2010 respectively, Spectral obtained the exclusive development and commercial rights in the U.S. and Canada for Toraymyxin.

More than 1.7 million patients in the United States are diagnosed with sepsis each year. Approximately one third of these patients progress to severe sepsis and septic shock, representing a significant unmet need and an approximately $1.5 billion market opportunity for Spectral.

Spectral continues to provide high quality reagents in which royalty revenue is earned from license for the Company’s proprietary Troponin I and other reagent technologies. License arrangements are held with industry leaders.