TORONTO, ONTARIO–(Marketwired – April 26, 2017) – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX:EDT), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced the renewal and expansion of its exclusive distribution agreements with Toray Medical Co., Ltd. (TMC) and ESTOR SpA (ESTOR) for Spectral’s rapid test for the assessment of endotoxin activity in human whole blood (EAA™). The diagnostic will be sold primarily in conjunction with the Toraymyxin™ (PMX) hemoperfusion cartridge, which removes endotoxin from the bloodstream and is currently approved for use in many countries outside of the United States.
TMC will now have distribution rights for EAA™ across 17 countries in the Middle and Far East; including Japan, India, South Korea, Taiwan, Singapore, Thailand, Malaysia, Indonesia, Philippines, Vietnam, Cambodia, Myanmar, Brunei, Laos, the Kingdom of Saudi Arabia, the Republic of Turkey, and China, including Hong Kong. ESTOR distributes the product in Italy, the Republic of San Marino, Vatican City, Austria and Switzerland, and will soon begin sales in France, Benelux and Romania.
“The renewal and expansion of these distribution agreements reflects a growing body of scientific evidence and clinical experience that demonstrates endotoxin is a major cause of septic shock and that the EAA™ diagnostic plays a key role in the identification of those patients who are most likely to benefit from the PMX treatment,” stated Dr. Paul Walker, President and CEO of Spectral.
About Spectral
Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX is currently approved for therapeutic use in many jurisdictions outside of the United States and has been used safely and effectively 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. Approximately 350,000 patients are diagnosed with severe sepsis and septic shock in North America each year. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information please visit www.spectraldx.com.
Forward-looking statement
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.
Executive Vice President and CFO
Spectral Medical Inc.
416-626-3233 ext. 2200
tbusinskas@spectraldx.com
Ali Mahdavi
Capital Markets & Investor Relations
416-962-3300
am@spinnakercmi.com