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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

Comment by mercedesmanon Dec 20, 2021 9:47am
172 Views
Post# 34246453

RE:New PMX Study

RE:New PMX Study
mercedesman wrote: Dec 16, 2021

Impact of polymyxin B hemoperfusion therapy on high endotoxin activity level patients after successful infection source control: a prospective cohort study

Use of EAA and SOFA scores


Among the 31 high-risk patients (EA level ≥0.54), 16 patients (51.6%) received PMX-HP treatment and showed signifcant decreases in EA levels compared to patients who underwent conventional treatment only





Sorry  wasn't finished before accidently hitting Post

Korean Study. Advocating for use of EAA (monitoring .4 to .6), and PMX for >.54

SOFA scores also showed signifcant improvement with PMX-HP treatment (12.8–8.9, p = 0.007).....

Endotoxin, which is a major component of the outer membrane of GNB, would be a powerful causative agent of systemic infammatory response syndrome by releasing various infammatory cytokines
....
Also, endotoxin activity (EA) is regarded as a useful assessment tool in evaluating the treatment response to initial sepsis management or the detection of a newly developed infection. Terefore, changes in EA levels might be feasible to not only evaluate the efect of treatment but also help to improve clinical outcomes by the early detection of new infectious complications. ...

In the current study, a total of 14 in-hospital deaths occurred (14/31, 45.2%) in the high-risk group (EA≥0.54), and four in-hospital death occurred (4/29, 13.8%) in the low-risk group (EA<0.54). In multivariate logistic regression, PMX-HP had a protective efect on in-hospital death in the high-risk group (EA≥0.54,....

Te detection of high EA levels in septic patients may be used as a signal for initiating PMX-HP, a direct endotoxin removal treatment, which is expected to resolve and prevent multi-organ failure induced by septic shock1 . Our results showed that patients with abdominal sepsis or septic shock experienced signifcant improvements in EA levels and SOFA scores by receiving additional PMX-HP treatment afer infection source-removing surgery...

Identifying the appropriate timing for PMX-HP treatment is also important. The present study measured EA levels immediately afer ICU admission to detect septic shock. The results of this study revealed patients with high EA levels (>0.54) at acute period may experience more severe clinical conditions including septic shock and higher probability of mortality which are similar results with the other studies1,2,7 . Within these high risk patients, prompt PMX-HP treatment was performed before irreversible organ damages occurs, and showed signifcant decreasing EA levels with survival beneft. Reducing EA level at the early phase might have improved clinical outcomes which fndings are in accordance with Klein et al., that organ dysfunction was associated with the total burden of endotoxin within the frst 72-h period afer ICU admission23. Terefore, it might be useful to decide the early administration of PMX-HP treatment if EA level is high in the acute admission period.

...

Despite these shortcomings, our study has several advantages that diferentiate it from previous studies. To the best of our knowledge, this was the frst study that included a large number of data in a homogeneous subset of patients showing the serial trend in endotoxin activity afer surgery. We believe that our results can suggest detailed guidelines under which to perform PMX-HP treatment (EA≥0.54) on an infectious source-controlled patient with abdominal sepsis, which can generate survival beneft and recovery from organ dysfunction. Additionally, an EA cutof level 0.54 could facilitate decision-making on performing PMX-HP therapy in marginally ill patients with EA levels between 0.4 and 0.6, which is regarded as an intermediate-range26,27. Most previous studies were designed by enrolling the patients in PMX-HP treatment when their EA level was 0.6 or greater. Te MEDIC study, however, revealed that patients who shows intermediate EA level, in-hospital mortality might be high as in the high EA group (≥ 0.6)7 . Terefore, our cut-of value of 0.54 might be useful to consider the PMX-HP treatment in this group of patients. A large-scale randomized prospective study should be conducted to confrm the results of the current study in the near future.


https://www.nature.com/articles/s41598-021-03055-8.pdf
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