TSX:EDT / OTC:EDTXF - Spectral Medical Inc.

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Spectral Announces First Quarter Results

TORONTO, ONTARIO--(Marketwired - May 12, 2016) - Spectral Medical Inc., (TSX:EDT) (OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced its unaudited financial results for the first quarter ended March 31, 2016.

Financial Review
Revenue for the three months ended March 31, 2016 was $1,062,000 compared to $877,000 for the same three month period last year. First quarter revenues were consistent with prior year levels and this trend is expected to continue for the remainder of the year.
Operating costs for the quarter ended March 31, 2016 were $4,069,000 compared to $3,223,000 in 2015. Most of the Company's expenses are incurred in its Phase III clinical trial and will vary depending on the timing and level of patient enrolment. 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 March 31, 2016 was $2,994,000 ($0.02 per share) compared to $2,322,000 ($0.01 per share) for the same quarter last year.
The Company concluded the first quarter of 2016 with cash on hand of $12,861,000 compared to $6,369,000 as of December 31, 2015.
In February, 2016, the Company closed a bought deal prospectus financing for net proceeds of $9,042,000.
The total number of shares outstanding for the Company was 206,733,209 as at March 31, 2016.

Corporate Update
The clinical trial is on track to complete enrollment by the end of June, 2016. There will be a corporate update on clinical and regulatory activities to be released prior to the Annual General Meeting.

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MANAGEMENT’S DISCUSSION & ANALYSIS
(All figures are expressed in thousands of Canadian dollars)

This Management’s Discussion & Analysis (“MD&A”) for the year ended December 31, 2015 has been prepared to help investors understand the financial performance of the Company in the broader context of the Company’s strategic direction, the risks and opportunities as understood by management, and the key success factors that are relevant to the Company’s performance. Management has prepared this document in conjunction with its broader responsibilities for the accuracy and reliability of the financial statements, as well as the development and maintenance of appropriate information systems and internal controls to ensure that the financial information is complete and reliable. The Finance and Audit Committee of the Board of Directors has reviewed this document and all other publicly reported financial information for integrity, usefulness, reliability and consistency.

This MD&A is dated March 29, 2016 and should be read in conjunction with the consolidated financial statements for the years ended December 31, 2015, and December 31, 2014.

http://www.spectraldx.com/assets/spe...4-mda-2015.pdf

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PRESS RELEASE FROM MARKETWIRE
Spectral Medical Files Expanded Access Protocol With FDA For Toraymyxin(TM) Septic Shock Treatment
Four patients remaining to enroll in the EUPHRATES clinical trial Company expects to announce trial results and submit final PMA module before end of 2016

Tuesday, May 31, 2016

Spectral Medical Files Expanded Access Protocol With FDA for Toraymyxin(TM) Septic Shock Treatment
08:00 EDT Tuesday, May 31, 2016
TORONTO, ONTARIO--(Marketwired - May 31, 2016) - Spectral Medical Inc. ("Spectral" or the "Company"), (TSX:EDT) (OTCQX:EDTXF), a Phase III Company advancing a precision treatment targeting specific patients at high risk of death from septic shock, today announced that it has filed a protocol and is in discussions with the U.S. Food and Drug Administration (FDA) for Expanded Access of Toraymyxin™, the Company's investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. The Company also announced several significant updates and milestones achieved on its path to potential regulatory approval and anticipated commercial availability of its treatment in the United States.

The Expanded Access program, sometimes referred to as Compassionate Use, if approved by the FDA, would begin upon the completion of patient enrollment - expected no later than June 30, 2016 - at most of the 29 U.S. hospitals currently participating in the Phase III EUPHRATES clinical trial. Patients who meet the clinical criteria for septic shock, are in multiple organ failure and who have elevated levels of endotoxin in the blood, as measured by the Company's FDA cleared Endotoxin Activity Assay (EAA™), would be eligible for the treatment. A similar program is planned for Canada, where there are 12 hospitals engaged in the clinical trial.

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Company remains on track and anticipates final submission in Q4 2016

FDA accepts Spectral's 510(k) filing for its standalone pump for review


TORONTO, ONTARIO--(Marketwired - June 16, 2016) - Spectral Medical Inc. ("Spectral" or the "Company"), (TSX:EDT) (OTCQX:EDTXF), a Phase III Company advancing a precision treatment targeting specific patients at high risk of death from septic shock, today announced that the U.S. Food and Drug Administration (FDA) has reviewed and accepted one of the two pre-clinical modules in its PMA application for Toraymyxin™, the Company's investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. With acceptance of this module the Company remains on track to complete its full PMA submission by the end of 2016.
"As we look toward completing our submission to the FDA this year, the Agency's acceptance of this module is a significant milestone," said Dr. Paul Walker, President and CEO of Spectral. "This particular section contains key pre-clinical data on the use of Toraymyxin™ for patients with septic shock, including the device's engineering and bench testing; sterilization and shelf life; packaging and transport details. We are encouraged that the FDA accepted this data, which is critical to our submission, as we continue to advance our regulatory filing with the goal of bringing this treatment to people in need."
A novel therapy for certain patients in septic shock, Toraymyxin™ is specifically targeted at those with elevated levels of endotoxin in the blood. Toraymyxin™ is a direct hemoperfusion adsorption column that has been shown to be highly effective in removing endotoxin. Studies have shown that this medical device can remove up to 90 percent of an endotoxemic patient's circulating endotoxin when administered twice within a 24 hour period.
As part of the modular PMA filing, Spectral will submit a total of four modules of documentation for review in stages by the FDA. Two of the modules include pre- clinical information, one describes the manufacturing process and the last module contains clinical data. Three modules have been submitted and one of the pre- clinical modules has now been fully reviewed and accepted. Spectral plans to submit its fourth and final module, comprising data from its pivotal EUPHRATES trial, by the end of 2016.
In related news, Spectral announced that the FDA has also accepted for review the Company's separate 510(k) filing for a standalone pump that could facilitate treatment delivery in the Intensive Care Unit (ICU) and increase options available to clinicians.
http://www.marketwired.com/press-rel...dt-2134898.htm (http://www.marketwired.com/press-release/spectral-medical-announces-acceptance-pre-clinical-pma-module-toraymyxin-fda-tsx-edt-2134898.htm)