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 > BioTuesdays Feature Article on Spectral

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Comment by BlueJays9293on Nov 15, 2024 3:07pm

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Post# 36315492

RE:RE:RE:RE:BioTuesdays Feature Article on Spectral

Yes, EAA has been approved by the FDA since 2004.

This assay was approved by the US FDA and European regulatory agency in 2004 for human diagnostic use as a tool to assess the risk of septic shock on the basis of results achieved in the Measurement of Endotoxin in the Intensive Care Unit (MEDIC) trial, which enrolled more than 800 ICU patients with systemic inflammatory response syndrome and suspicion of infection [15].

https://pmc.ncbi.nlm.nih.gov/articles/PMC3672550/#:~:text=This%20assay%20was%20approved%20by,800%20ICU%20patients%20with%20systemic

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