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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

Post by Gorf79on Jul 19, 2022 1:01pm
222 Views
Post# 34834784

Expanded Access for New Investors!

Expanded Access for New Investors!In 2016 Spectral's PMX was granted an Expanded Access designation by the FDA.

This used to be called a Compassionate Approval, meaning it could be used for Sepsis patients on compassionate grounds. Yes the FDA saw the benefits and granted this approval which I am 99.9% sure is still in place as Dr. Kellum mentioned it in a recent presentation.

Combine Expanded Access, with 250,000 RWE uses, a 100% safety profile, excellent segmented Euphrates data, the Tigris trial greatly exceeding expectations, major league trial sites and the Breakthrough Designation and it demonstrates PMX is a LOCK for approval!!

Yes it is a LOCK!
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