TORONTO, Nov. 22 /PRNewswire/ - Spectral Diagnostics Inc., (TSX:SDI), today announced that it has signed a long-term, exclusive distribution agreement with Toray Industries, Inc. and Toray Medical Co., Ltd. of Japan (collectively "Toray") to market and sell Toraymyxin™ in Canada. Toraymyxin™ is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. This product and Spectral's EAA™ diagnostic, which measures endotoxin and identifies patients for treatment, are already approved for sale by Health Canada.
"We are very pleased to have secured the Canadian distribution rights for this product. In conjunction with the U.S. license agreement signed last year, Spectral now has exclusive access to a potential North American market in excess of $1 billion," said Anthony Businskas, Executive Vice President and CFO of Spectral.
"This expansion of market jurisdictions further confirms our strong business relationship with Toray and the outstanding market opportunity for this unique treatment for severe sepsis, combining our proprietary EAA™ diagnostic with the Toraymyxin™ therapeutic. We expect to begin market development activities in Canada during 2011," added Dr. Paul Walker, President and CEO of Spectral.
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for Toraymyxin™ as a treatment for severe sepsis and septic shock. Toraymyxin™ is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the detection of endotoxin ,Spectral's EUPHRATES trial is the world's first theranostics trial in the area of sepsis.
Toraymyxin™ has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively in more than 80,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin™. More than 250,000 patients are diagnosed with severe sepsis and septic shock in the US each year, representing a potential $1 billion plus market opportunity for Spectral.
Spectral is listed on the Toronto Stock Exchange under the symbol SDI.
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
SOURCE Spectral Diagnostics Inc.