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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.


TSX:EDT - Post by User

Bullboard Posts
Comment by scroll4factson Oct 03, 2016 11:26am
151 Views
Post# 25302169

RE:What is 18% referring to? anyone...

RE:What is 18% referring to? anyone...This 18% has to be MB in my opinion since I understand that Toraymyxin can remove up to
90% of endotoxin. So we need a lot of clarification here. Where is this 18% mortality benefit coming from? This is a very significant number that could trigger an FDA approval somewhere
down the road in my opinion.

"A novel therapy for certain patients in septic shock, Toraymyxin™ is a medical device 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 Toraymyxin™ can remove up to 90 percent of an endotoxemic patient's circulating endotoxin when administered twice within a 24 hour period."

https://www.marketwired.com/press-release/fda-accepts-spectrals-expanded-access-protocol-for-toraymyxin-tsx-edt-2137608.htm
Bullboard Posts