TORONTO, May 14 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc., (TSX: SDI), a company focused on bringing to market a diagnostic and a therapeutic targeting severe sepsis, today announced its financial results for the first quarter ended March 31, 2009.
"This quarter, we achieved an important milestone by securing the exclusive rights to develop and commercialize Toraymyxin(TM) for the US market after thorough due diligence into the product and its potential market opportunity," said Dr. Paul Walker, President and CEO of Spectral. "Toraymyxin(TM) has been used on more than 70,000 patients to date, primarily in Europe and Japan, for the treatment of severe sepsis and has demonstrated a significant reduction in the mortality of patients with severe sepsis compared to standard of care. We believe that, when used together with our proprietary Endotoxin Activity Assay (EAA(TM)), Toraymyxin(TM) represents a significant medical advance in helping doctors manage a devastating disease. Our next steps will be to obtain an Investigational Device Exemption (IDE) from the US FDA and to initiate a registration trial for Toraymyxin(TM) in 2009."
First quarter 2009 highlights: - Data on the clinical utility of EAA(TM) and Toraymyxin(TM) was featured in a key scientific symposium entitled, "The Role of Endotoxin," that included presentations from six thought leaders in the field of sepsis, at the 29th International Symposium on Intensive Care and Emergency Medicine in Brussels, Belgium in March. - New findings demonstrating the clinical utility of EAA(TM) were presented at the 13th Annual Critical Care for Endotoxemia Congress. The conference took place in Tokyo, Japan in February. - A final license and supply agreement was signed with Toray Industries, Inc. for the exclusive development and commercial rights in the U.S. for Toraymyxin(TM) in
|SOURCE Spectral Diagnostics Inc.|
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