Spectral and Toray expand EAA™/ PMX Theranostic to Saudi Arabia and Turkey
TORONTO, Aug. 16, 2012 /CNW/ - Spectral Diagnostics Inc., (TSX: SDI) (OTCQX: DIAGF), a Phase III company developing the first theranostic treatment for patients with septic shock, today announced an exclusive distribution agreement with Toray International Italy S.r.l., a subsidiary of Toray Industries, Inc. (Toray), to sell the Company's Endotoxin Activity Assay (EAA™) in combination with Toraymyxin in Saudi Arabia and Turkey.
"The expansion of commercial jurisdictions with Toray further confirms the outstanding market opportunity for this unique theranostic treatment for septic shock," said Anthony Businskas, Executive Vice President and CFO of Spectral. "While our focus remains on attaining U.S. FDA approval for Toraymyxin in the United States, we are excited to develop, in collaboration with Toray, additional markets where patients with septic shock can benefit from our personalized medicine approach to treating this condition."
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of 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 risk of developing sepsis, 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 100,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin, and in November 2010, signed an exclusive distribution agreement for this product in Canada. More than 250,000 patients are diagnosed with severe sepsis and septic shock in North America each year, representing a greater than $1 billion market opportunity for Spectral. Spectral is listed on the Toronto Stock Exchange under the symbol SDI, and on the OTQ QX under the symbol DIAGF. For more information please visit www.spectraldx.com
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.
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SOURCE: Spectral Diagnostics Inc.For further information:
Executive Vice President and CFO
416-626-3233 ext. 2200
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