- Published: 19 October 2015
- Written by Editor
Body of Evidence Supporting the Use of Toraymyxin(TM) for Treatment of Septic Shock Continues to Grow
TORONTO, ONTARIO--(Oct 19, 2015) - Spectral Medical Inc. ("Spectral" or the "Company") (EDT.TO)(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 the medical literature supporting the use of Toraymyxin™ ("PMX") for the treatment of septic shock patients continues to grow. Peer-reviewed articles, observational studies and case reports of PMX use outside of North America conclude that this medical device is safe and effective. Upon approval, this unique treatment could potentially save tens of thousands of lives in the United States and Canada annually and solve a very significant unmet medical need.
The Company has filed its annual updated Report of Previous Investigations ("ROPI") with the United States Food and Drug Administration ("FDA"). ROPI comprises all available published literature reporting use of PMX over a 22 year period (from 1993 to September, 2015). To date, published articles on the use of PMX have reported on over 140 individual studies that included approximately 4,400 patients who have received approximately 7,600 PMX perfusions. The safety profile of PMX continues to be excellent, with the number of treatment related serious events being very low. The majority of the product use has been in Japan, but utilization of PMX in Europe and other regions is now increasing.
"Taken as a whole, the papers reporting data on PMX use outside of North America report positive patient outcomes, especially for patients with similar characteristics as those of patients in our EUPHRATES trial," said Debra Foster, Vice President of Clinical Development for Spectral. "Furthermore, we are seeing more and more reports that outline how our EAA™ diagnostic has helped to effectively guide patient treatment as the concept of personalised medicine gains traction for the management of critical illness, including septic shock," added Ms. Foster.
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 commercialization of Spectral's septic shock treatment, 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.
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