TORONTO, ONTARIO--(Marketwired - Oct. 21, 2015) - Spectral Medical Inc., ("Spectral" or the "Company") (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that it has entered into an exclusive agreement with Toray Medical Co., Ltd. (TMC), to distribute Spectral's rapid test for the assessment of endotoxin activity in human whole blood (EAA™) across 15 countries in the Middle and Far East: India, South Korea, Taiwan, Singapore, Thailand, Malaysia, Indonesia, Philippines, Vietnam, Cambodia, Myanmar, Brunei, Laos, the Kingdom of Saudi Arabia, and Republic of Turkey. The diagnostic will be sold in conjunction with the Toraymyxin™ ("PMX") hemoperfusion cartridge, which medical device removes endotoxin from the bloodstream, to help guide patient treatment. Spectral is now in the later stages of a Phase III registration trial as it seeks FDA approval for the PMX medical device in the United States.
"We are very pleased to expand our strategic alliance with TMC, as it is already a distributor for EAA™ in Japan. This agreement provides further evidence of the growing recognition that our diagnostic plays a key role in the identification of patients in septic shock who are most likely to benefit from the PMX treatment," said Dr. Gualtiero Guadagni, Vice President of Sales and Marketing for Spectral. "We expect that the utilization of EAA™ should continue to increase worldwide, especially after the completion of our North American EUPHRATES trial next year," added Dr. Guadagni.
About Spectral Medical Inc.
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of endotoxemic septic shock. PMX is a therapeutic hemoperfusion device that removes endotoxin, a main trigger of 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 only active and most innovative Phase III study for a medical device in the area of septic shock.
PMX has been approved for therapeutic use in Japan and Europe, and has been used on more than 100,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 350,000 patients are diagnosed with septic shock in North America each year, representing a greater than $3 billion market opportunity for Spectral.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT, and on the OTCQX under the symbol EDTXF. 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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