TORONTO, March 12 /CNW/ - Spectral Diagnostics Inc. (TSX:SDI), a company developing products for the treatment of sepsis, today announced that the 8th Annual World Congress on Trauma, Shock, Inflammation and Sepsis in Munich, Germany from March 9-13, 2010 will feature a key scientific symposium entitled, "Endotoxin in Health and Disease - Clinical Relevance, Novel Diagnostics and Therapeutic Target: Update 2010," that will include two panel presentations from twelve thought leaders in the field of sepsis, including Dr. R. Phillip Dellinger, Principal Investigator for Spectral's US pivotal trial for Toraymyxin(TM), a therapeutic hemoperfusion device that removes endotoxin from the bloodstream.
"The importance given to the role of endotoxin at this significant international conference demonstrates the increasing recognition of its role in disease among thought leaders and clinicians," said Dr. Paul Walker, President and CEO of Spectral. "Several presentations focus specifically on our Endotoxin Activity Assay (EAA(TM)) and Toraymyxin(TM) showing the benefit they provide to patients with severe sepsis through the identification of high levels of endotoxin, and effectiveness of the Toraymyxin(TM) product to remove endotoxin and improve patient outcomes. We are on track to start our pivotal trial in the first half of 2010, using the EAA(TM) guided approach to endotoxin removal by Toraymyxin(TM) hemoperfusion in patients with endotoxemia and severe sepsis or septic shock."
Spectral was recently granted Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) for Toraymyxin(TM) allowing the Company to conduct a pivotal trial in the US, where there is a significant unmet need for the approximately 250,000 patients that develop severe sepsis or septic shock each year. Additional information on the 8th Annual World Congress on Trauma, Shock, Inflammation and Sepsis can be found at www.tsis2010.org.
About Spectral Diagnostics
Spectral is a leader in the battle against sepsis. Spectral's lead product is its Endotoxin Activity Assay (EAA(TM)), the only FDA cleared assay for the measurement of endotoxin. With the growing awareness for the role of endotoxemia in sepsis and the increasing number of therapies being developed for this indication, Spectral is well-positioned to drive the adoption of the EAA(TM), which can be used to identify patients, enable therapeutics and monitor treatment. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin(TM), a therapeutic for the treatment of sepsis that removes endotoxin from the bloodstream. Spectral will seek FDA approval for Toraymyxin(TM) and intends to commercialize the product together with EAA(TM). Spectral is listed on TSX under the symbol SDI.
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.
SOURCE Spectral Diagnostics Inc.
For further information: For further information: Dr. Paul Walker, President & CEO, (416) 626-3233 ext. 2100; Casey Gurfinkel, Investor Relations, (416) 815-0700 ext. 283, firstname.lastname@example.org