Spectral Announces Fourth Quarter and Fiscal 2014 Results

TORONTO, ONTARIO--(Marketwired - March 25, 2015) - Spectral Medical Inc., (TSX:EDT)(OTCQX:EDTXQ), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced its financial results for the fourth quarter and for the year ended December 31, 2014.

Financial Review

Revenue for the three months ended December 31, 2014 was $699,000 compared to $713,000 for the same three month period last year. Revenue for the year ended December 31, 2014 was $2,964,000 compared to $2,672,000 for the prior year, representing an increase of $292,000, or 11%.

For the quarter ended December 31, 2014, the Company reported operating costs of $1,155,000 compared to $2,960,000 for the corresponding period in 2013. Operating costs for the year ended December 31, 2014 amounted to $13,125,000 compared to $14,062,000 in 2013. The $937,000 decrease is almost entirely attributable to lower costs for the EUPHRATES trial, resulting from fewer new sites being initiated into the trial and lower patient enrolment after the implementation of an additional exclusion criterion in April, 2014 that refined patient selection. Apart from clinical trial activities, the Company continues to maintain a low cost operating structure for its base business operations.

Loss for the quarter ended December 31, 2014 was $1,854,000 ($0.01 per share) compared to $3,673,000 ($0.03 per share) for the same quarter last year. For the year ended December 31, 2014, the Company reported a loss of $9,492,000, ($0.06 per share), compared to a loss of $11,307,000 ($0.09 per share), for the year ended December 31, 2013.

The Company concluded the 2014 year with cash and cash equivalents of $10,054,000 compared to $7,229,000 cash and cash equivalents on hand as of December 31, 2013.

The total number of shares outstanding for the Company was 179,737,241 as at December 31, 2014.

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. 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 in the area of septic shock.

PMX has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively 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 severe sepsis and 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 EDTXQ. 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.