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 > Potential Outcomes at 76 patients - wow !

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Comment by gebremeskelon Nov 14, 2023 1:20pm

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Post# 35734813

RE:RE:Potential Outcomes at 76 patients - wow !

Excuse my ignorance, but is there a medical device equivalent of drug trial accelerated approval? Might the FDA approve commercialization before the Tigris trial is completed?