TORONTO, Nov. 12 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. (TSX: SDI) today announced its financial results for the third quarter ended September 30, 2008.
"In September, Spectral took a major first step in the implementation of its strategy to align its diagnostic with a therapeutic for the treatment of severe sepsis. We agreed, with Toray Industries Inc., to key terms for 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 has been used safely and effectively in over 70,000 patients in Japan and Europe since 1994," said Dr. Paul Walker, President and CEO of Spectral. "Combined with our Endotoxin Activity Assay, EAA(TM), the only FDA cleared diagnostic for the detection of endotoxin, we believe that this treatment can fulfill a major unmet need for the approximately 100,000 patients with elevated endotoxin levels that develop severe sepsis or septic shock in the U.S. each year."
Dr. Walker added: "We are in the process of completing our due diligence and we plan to meet with the U.S. FDA early in the first quarter to determine an appropriate clinical development pathway. Following the FDA's clearance of our clinical pathway, we expect to finalize the exclusive license and material supply agreements with Toray in the first quarter of 2009."
For the three months ended September 30, 2008, Spectral reported sales
of $701,000 compared to $739,000 for the corresponding period in 2007. For
the nine months ended September 30, 2008, the Company reported sales of
$2,150,000, compared to sales of $2,318,000 for the same period last year.
Sales of the Company's EAA(TM) diagnostic increased significantly, but the
improvement was offset by lower royalty revenues. Certain pre-established
royalty plateaus were reached in 2007, resulting in a reduction of $466,000
in related revenues for the first nine mon
|SOURCE Spectral Diagnostics Inc.|
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