Primary Profile

Spectral Diagnostics, Inc.

Spectral Diagnostics, Inc.

Spectral Diagnostics, Inc.

2-135 The West Mall
Etobicoke, Ontario
M9C 1C2

2-135 The West Mall
Etobicoke, Ontario
M9C 1C2

(416) 626-3233

(416) 626-2739

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Spectral Diagnostics, Inc.

Spectral is a Phase III company seeking US 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 Japan and Europe, 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 US 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.

Company Details

1991

Canada

Yes

325410 - Pharmaceutical and Medicine Manufacturing

334512 - Measuring, Medical and Controlling Devices Manufacturing
339110 - Medical Equipment and Supplies Manufacturing

Manufacturer / Processor / Producer

Product / Service / Licensing

Product Name: Endotoxin Activity Assay (EAA™)
Endotoxin Activity Assay (EAA™), the only FDA cleared, CE marked rapid diagnostic for endotoxemia. Endotoxin is an early objective marker for severity of sepsis that may not be identified with traditional clinical signs.

Product Name: Toraymyxin
Toraymyxin is a Polymyxin B extracorporeal direct hemoperfusion adsorption column which is highly effective in removing endotoxin in the bloodstream. Toraymyxin has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively in more than 80,000 patients to date. Spectral holds the exclusive rights for Toraymyxin in the U.S. and Canada, and is currently conducting a Phase III clinical trial for severe sepsis and septic shock.

Product Name: Protein Reagents
Spectral provides high quality, high performance biochemicals for research and commercial products. Possessing a long onboard shelf life, Spectral's single-chain Troponin I-C polypeptides, and other reagent products, have been recognized by the market as a premier reagent for large instrument calibration and control.


Contact Information


Dianne Cairns
Title:
Telephone: (416) 626-3233
Fax: (416) 626-2739