TORONTO, March 12 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. (TSX:SDI) today announced its operational highlights and financial results for the fiscal year ended December 31, 2008.
"In 2008, we accomplished several key objectives on our path to delivering an effective treatment for severe sepsis for the U.S. market," said Dr. Paul Walker, President and CEO of Spectral. "In September, we agreed to key terms with Toray Industries, Inc. (Toray) of Japan to obtain the exclusive development and commercial rights in the U.S. for Toraymyxin(TM), a therapeutic for the treatment of sepsis that removes endotoxin from the bloodstream, and which has been used on more than 70,000 patients to date, primarily in Europe and Japan. Together with our proprietary Endotoxin Activity Assay (EAA(TM)), used for measuring endotoxin levels in the blood, the combination has demonstrated a dramatic reduction in the mortality of patients with severe sepsis compared to standard of care in European trials. Spectral's current focus is to seek FDA clearance for the therapeutic product."
Highlights from 2008: - Agreed to key terms with Toray, in September 2008, to obtain the exclusive development and commercial rights in the U.S. for Toraymyxin(TM). The Company will now seek FDA clearance for this product. The final license and supply agreement with Toray was signed subsequent to the year end on March 6, 2009. - Presented findings showing the clinical effectiveness of EAA(TM) to identify patients with elevated endotoxin levels and to guide endotoxin reducing strategies at a symposium entitled "Blood Purification in the Treatment of Sepsis," at the International Shock Congress in Cologne, Germany in June 2008. - Entered into an exclusive distribution agreement in July 2008 with BB Medical, a leading distributor of medical technologies in Russia,
|SOURCE Spectral Diagnostics Inc.|
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