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 > Top Line Tigris Results by April 30, 2025 ?

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Comment by mercedesmanon Sep 10, 2024 2:03pm

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Post# 36217011

RE:Top Line Tigris Results by April 30, 2025 ?

Hey G.

A good but ( IMHO) conservative timeline and expected final benefit.

If I had to guess, I'd say Top Line by Feb/March 2025

FDA final approval I expect before the end of 2025 - see Breakthrough Device designation.

Spectral went out of its way to highlight that Tigris was exceeeding expectations, even adding a few extra adjectives at times. Personally I'd be shocked if we're not at 15% AB or more.

All of the above presumes no early takeout of Spectral rendering the timeline especially moot.

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