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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 mercedesmanon Sep 27, 2021 2:00pm
155 Views
Post# 33924782

The Golden Hour, Personalized Medicine and Seq. Therapies

The Golden Hour, Personalized Medicine and Seq. TherapiesThe Golden hour was a term coined by Ronco in this paper about PMX and the EAA and Sepsis

The golden hour of polymyxin B hemoperfusion in endotoxic shock: The basis for sequential extracorporeal therapy in sepsis

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7003912/

Not sure who ranks higher in the scholars algorithm on Sepsis? Kellum, our CMO, or Ronco the Italian hockey playing stallion?
So close that our studio audience may have to decide who ranks higher...

"Expertscape's PubMed-based algorithms place Dr. Kellum in the top 0.1% of scholars writing about Sepsis over the past 10 years"  recent NR from Spectral.

Anyway a key excerpt below from Ronco's seminal piece.


"According to our experience and clinical practice, the early phase of hemodynamic instability (vasoactive inotropic score [VIS] 10 < x < 30) during endotoxemia is usually associated with a slight decrease in renal function (kidney disease improving global outcomes [KDIGO] stages 1–2), biomarkers positivity and with an EAA level of 0.3 < x < 0.6. However, several concerns might be raised on the delayed approach of extracorporeal endotoxin removal in these situations. In particular, a rapid increase in endotoxin levels should be expected, particularly for patients with Gramnegative sustained sepsis, due to endotoxin release during bactericidal treatment. Research and clinical protocols should consider an assessment of EAA at regular intervals to identify this rapid endotoxin increase.

Based on our experience, we strongly suggest to start extracorporeal endotoxin removal within 4 hours after source control and starting antibiotic therapy (Figure (Figure1A).1A). An overtime assessment of EAA should be performed in these cases. The further and evident worsening of the renal function, as well as the increase in vasoactive support and a progressive increase in EAA, should corroborate the extracorporeal endotoxin removal initiation. However, an extracorporeal approach confined to patients with severe unresponsive shock (VIS >35 and sequential organ failure assessment score (SOFA) >15) and/or with a high level of EAA (higher than 0.9) should be carefully evaluated, particularly considering the potential futility of this expensive but efficient treatment if used improperly.

Three stages of a “golden hour” might be thus recognized in which the patient with a high risk of endotoxic shock might probably benefit most from endotoxin extracorporeal removal.

The timing becomes a crucial factor in the management of sepsis and the consequent MODS. Based on accurate monitoring and biological markers, an adjust prescription and appropriate delivery of what we defined sequential extracorporeal therapy in sepsis (SETS) might be guaranteed (Figure (Figure11B).9 In the early phase, just after source control, PMXB HP can be the treatment of choice, followed by other extracorporeal blood purification therapies. When organ failure develops, extracorporeal therapies may become a broad spectrum support replacing or supporting the function of several organs such as heart, kidney, liver, and lungs. This is the rationale of extracorporeal organ support (ECOS), a new form of therapy in MODS.11

In a comprehensive approach to the endotoxic shock treatment, the evaluation of kidney function, vasopressor requirements, and EAA levels with source control and antibiotic therapy based on the time from sepsis diagnosis, may have a role to personalize the treatment for each specific patient. The dynamic monitoring and prescription could further refine the treatment personalization adequately responding to the criteria of precision medicine. Thus, not only a specific treatment could be provided for every single patient, but even a more specific treatment shall be provided for every moment that patient has a particular need during his/her ICU stay."



ie. What better tool (PMX) can there been than one that reduces endotoxin levels (precursors to the cytokine storm) as measured by companion diagnostic (EAA), thereby respecting that every situation is different, that time is of the essence and, that the use and timing of the various therapies need to be personalized to the individual, every step of the way through the course of the days or weeks long treatment.  Oh...and it's proven to be safe.

Not also that Spectral's other product (Dialco pumps) can be used to support a key organ like the kidney as well.  Why not use the one that was put there to deliver the PMX therapy?  Are there any other combo HP and CRRT pumps out there? I don't think so.

Anyway, I'd want Ronco to be my Doc if I got Sepsis...with Kellum as a close second choice...but only becasue Ronco may be slightly less biased,  even though they are likely both top .1 % Scholars.

MM

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