Sepsis affects up to 750,000 patients in the US alone every year
Sepsis is a life threatening condition caused by the body's response to infection. Afflicting approximately 750,000 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 80,000 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.
With more than 250,000 patients diagnosed with severe sepsis and septic shock in the U.S. alone each year, this product has the potential to fulfill a significant unmet need representing 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.
- December 13, 2012
ABC Action News HealthCheck
Clinical trial could help patients with sepsis
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