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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

Comment by Gorf79on Jul 19, 2022 10:46am
157 Views
Post# 34834163

RE:RE:RE:With the Recent FDA Breakthrough Designation

RE:RE:RE:With the Recent FDA Breakthrough Designation MM,

I can't be bothered to apply an EBIDITA multiple to the 55 mil annual opportunity in Canada but you may want to for fun.

As Far as PMX FDA approval goes the CEO called it "near term" and seemed giddy in doing so.

Given their 3 of 4 PMA modules into the FDA, have a 100% safety profile across Europe and Japan, are using 176 patients from the previous trial, have an FDA BTD designation and the trial is greatly "exceeding expectations" I expect an approval and a Baxter takeout with 14 trading days.


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