TORONTO, ONTARIO--(Marketwired - April 16, 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 the Company`s unique treatment for septic shock was included as a top 10 game-changing health technology by the Canadian Network for Environmental Scanning and Health (CNESH) and a panel of clinical experts.
For the second consecutive year, CNESH has been working to identify which new and emerging health technologies hold the greatest promise to improve both the lives of patients and the delivery of health care.
"Every day, we read sensational stories about the promise of new health technologies and wonder if they will really make a difference to our health or the health care system," said Rosmin Esmail, Chair of CNESH and Director of Health Technology Assessment and Adoption at Alberta Health Services. "But CNESH cuts through the hype and creates a list of potential game-changers; a list based on evidence and one that can help decision-makers plan for the future when it comes to new and emerging technologies."
The term "health technologies" refers to medical and dental devices, diagnostic tests, and medical, surgical, or dental procedures, as well as drugs - anything that can be described as a "health intervention." Through a public call for nominations more than 50 submissions were received from across Canada and around the world. CNESH and the panel of clinical experts assessed each submission's potential impact on clinical effectiveness, patient survival, quality of life, patient safety, or costs to the health care system.
About CNESH
CNESH was established in 2011. Its primary purpose is to identify and share information on new and emerging health technologies, an activity known as horizon scanning. This information can be used to support health care decision-making and help to facilitate the appropriate adoption and use of effective and safe health technologies. The CNESH membership includes clinicians, researchers, and health technology assessment experts who work closely with senior decision-makers throughout the Canadian health care system.
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.
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 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.