Sepsis is a life threatening condition caused by the body's response to infection. Afflicting approximately 1,000,000 Americans each year, this deadly condition costs the US healthcare system billions annually, and, with few effective therapies available, sepsis is becoming a major concern for healthcare practitioners.
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 100,000 patients to date. 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 one 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 a greater than $1 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.
Spectral is listed on the Toronto Stock Exchange under the symbol SDI and the OTCQX under the symbol DIAGF.
Sepsis affects up to 1,000,000 patients in the US alone every year
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