EAA™ and PMX are licensed and available for use in Canada. PMX is not approved for clinical use in the USA, and is currently undergoing the PMA (Premarket approval) process. EAA™ is FDA cleared for use in the USA. The information presented herein is region specific. Please contact Spectral Medical Inc. at info@spectraldx.com to obtain appropriate product information for your country.

Spectral Medical is committed to decreasing the unacceptably high mortality rates caused by sepsis. Spectral’s vision is to provide a personalized approach that will enable vastly improved outcomes for patients with septic shock by combining a targeted diagnostic test and therapy.

It is widely known that endotoxin is a trigger of sepsis. Spectral has conducted a Phase III clinical trial for its lead product, PMX, for the treatment of patients with septic shock and endotoxemia (measured by the Company’s Endotoxin Activity Assay (EAA™). PMX is a therapeutic hemoperfusion device that removes circulating endotoxin from the bloodstream. The EUPHRATES pivotal trial, (Evaluating Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock) showed that PMX, when applied to septic shock patients with a baseline value of EAA between 0.6 and 0.9, reduces mortality and improves organ dysfunction.

EAA™ and PMX are both Health Canada licensed and commercially available in Canada.

Spectral strives to exceed the highest ethical, financial and scientific standards in all our operations and activities. By maintaining excellent relationships within the clinical community, as well as with customers and business partners, Spectral aims to win the battle against sepsis mortality with the first ever theranostic – EAA™ and Toraymyxin.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT and the OTCQX under the symbol EDTXF.

 

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