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 > Not likely to see ANY "insider activity here" for a month +

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Comment by RevJameson Feb 11, 2021 9:26am

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Post# 32536092

RE:Not likely to see ANY "insider activity here" for a month +

So here are the three events (corrected from 2) that might be imminent and which might be contributing to the recent surge (using Spectral's numbers for potential market size):

- the FDA approval of DIMI's IDE for home use (submitted late Q4 2020), which would allow that investigation/study to proceed (anticipated FDA approval in Q1 2022) [Market size once approved: US$2.9B in 2025]

- HC licence for DIMI (Acute and chronic dialysis (HD, HDF, UF) in hospitals, health care facilities and home) [Market size: $35-70M]

- FDA & HC submission of DIMI for peritoneal dialysis. [Market size: US$400M]

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