Spectral Medical Inc T.EDT

Alternate Symbol(s): EDTXF

Spectral Medical Inc. is a Canada-based late-stage theragnostic company advancing therapeutic options for sepsis and septic shock. The Company develops and commercializes a treatment for septic shock utilizing its Endotoxin Activity Assay (EAA) diagnostic and the Toraymyxin therapeutic (PMX). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s EAA. PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients to date. It has pioneered the development of biochemical markers for the clinical syndrome known as septic shock. It is continuing its legacy business of manufacturing and selling certain proprietary reagents. It develops, produces and markets recombinant proteins, antibodies and calibrators. These materials are sold for use in research and development, as well as in products manufactured by other diagnostic companies.

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Spectral Medical Inc

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Post by Stocktreeon May 13, 2016 12:04pm

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Post# 24870522

I stand corrected SWYG, PMX approved in Canada, my apologies

Also note, update before end of May...

Directly from Spectral's mouth:

"The PMX treatment has been approved in Canada. But, this is a technical approval and the product is currently not being used by clinicians pending our EUPHRATES trial results.

As per our news release earlier this week, the trial is targeted to end by June 30/16, and we intend to also have a clinical and regulatory activity update announced prior to end of May, in advance of the annual general meeting of shareholders.

The 510k approval relates to the stand alone pump. This is separate from the treatment, however with the stand alone pump, our FDA approved EAA (diagnostic) and the PMX, we have a complete solution."

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