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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 hmmmmmmmmon Nov 15, 2020 2:12pm
867 Views
Post# 31903393

Stony Brook PMX COVID 19 study- and two EAA studies

Stony Brook PMX COVID 19 study- and two EAA studies

Stony Brook University a PMX/ COVID 19 study underway, along with an study of EAA levels in COVID 19 patients, and an EAA study of all patients admitted to the ICU- which is very interesting.
Link at bottom.


Industry Sponsored Clinical Research Studies:
Polymyxin B cartridge hemoperfusion for patients with septic shock and COVID 19
PI: Dr. Sandeep Mallipattu
IRB# 2020-00267

The PMX cartridge will be utilized to treat critically ill patients with septic shock who also have the COVID 19 virus. The objective will be to observe the efficacy of the PMX cartridge with a focus on safety of use in this population.  Overall design: Prospective, interventional, clinical investigation of PMX cartridge use.

Study Objectives:
1. To observe the 28 day mortality rate for patients with COVID 19 who are treated with the PMX cartridge.
2. To observe for adverse events related to the use of the PMX cartridge, associated heparin use (if any) and of the venous access line if placed only for the purpose of this protocol.


Prevalence of Endotoxemia in Hospitalized Patients with COVID-19
PI: Dr. Sobia Khan
IRB# 2020-00474

This was a retrospective study to investigate whether the Endotoxin Activity Assay level prognosticates acute kidney injury. We also investigated if the prevalence of increased endotoxemia coincided with increased hospital stay.
 

Endotoxin Activity Assay Results and Kidney Outcomes in Intensive Care Unit
PI: Dr. Sobia Khan
IRB# 2020-00592

We would like to investigate the relationship between Endotoxin Activity Assay (EAA) results and health outcomes of diverse cohort of patients admitted to the intensive care unit in Stony Brook University Hospital in 2020.  This is a prospective study in which the EAA results will be analyzed over time.

https://renaissance.stonybrookmedicine.edu/medicine/nephrology/ongoing_clinical_research_studies


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