Spectral Medical Inc.
TSX : EDT
OTCQX : EDTXF

Spectral Medical Inc.

November 10, 2015 08:00 ET

Spectral Announces European Distribution Agreement With Fresenius Medical Care for Its Endotoxin Activity Assay (EAA™) Diagnostic

TORONTO, ONTARIO--(Marketwired - Nov. 10, 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 a non-exclusive agreement with Fresenius Medical Care Deutschland GmbH to distribute Spectral's FDA approved rapid test for the assessment of endotoxin activity in human whole blood (EAA™) in eight European countries - Germany, Denmark, Sweden, Finland, Norway, Poland, Hungary and the Czech Republic. It is expected that the EAA™ will initially be sold in conjunction with the Toraymyxin™ ("PMX") hemoperfusion cartridge, a medical device which removes endotoxin from the bloodstream, to guide patient treatment. Spectral is now in the final stages of its Phase III registration trial in anticipation of FDA approval for PMX in the United States.

"We are very pleased to have entered into this commercial relationship with Fresenius for our EAA™ diagnostic, which is key to 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. "A positive outcome of our large clinical trial would clearly demonstrate the ability to address the huge market potential we see for the combined testing (EAA™) and treatment (PMX) protocol for patients with septic shock," 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 150,000 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. Over 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

Forward-looking Statements

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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