Stocks & Investing
Stocks and Investing
Stocks and Investing
Wed, August 3, 2011 
TORONTO, Aug. 3, 2011 /CNW/ - Spectral Diagnostics Inc., (TSX: SDI), a Phase III company developing the first theranostic treatment for septic shock, today provided an update on a number of corporate and clinical activities.
On June 27, 2011, the Company mailed the management proxy circulars to its shareholders for a special meeting to be held on August 26, 2011. At this meeting, shareholders will be asked to approve a plan of arrangement with Medwell Capital Corp. ("Medwell"), whereby Spectral will issue 33,333,333 common shares at a subscription price of $0.30 per share for a total financing of $10 million. As part of the arrangement, Medwell will distribute approximately 54 million shares of Spectral directly to its shareholders, thereby reducing its ownership position from approximately 45% to just over 13%. This transaction will provide the Company with sufficient funds to complete and expand its pivotal EUPHRATES trial, significantly increase its shareholder base, and provide an opportunity to increase the trading liquidity of its shares.
In addition, the Company has just received approval from the U.S. FDA to increase the total number of clinical sites in its EUPHRATES trial from the current 15, to a total of 30. International sites may now also be included in the trial.
"These two developments are very important for Spectral," said Dr. Paul Walker, President and CEO of Spectral Diagnostics. "The increased number of sites gives us the capability and flexibility to better manage patient enrolment and meet our targeted timelines. We can also now add sites in Canada, where Spectral has the exclusive distribution rights for Toraymyxin, and expand clinical activities in Europe if we choose. The $10 million financing will provide the necessary funds for this expanded clinical development program, which is key to accessing a market opportunity for Toraymyxin in North America alone that is in excess of $1 billion."
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment for severe sepsis and septic shock. Toraymyxin is a therapeutic hemoperfusion device that removes endotoxin, which can cause 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 first theranostics trial in the area of sepsis.
Toraymyxin has been approved for therapeutic use in 18 countries, and has been used safely and effectively in more than 80,000 patients to date. In March, 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin, and in November, 2010, signed an exclusive distribution agreement for this product in Canada. More than 250,000 patients are diagnosed with severe sepsis and septic shock in North America each year, representing a greater than $1 billion market opportunity for Spectral. Spectral is listed on the Toronto Stock Exchange under the symbol SDI.
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.
