Spectral Medical Announces Publication of EDEN Observational Study
New Study Strengthens Rationale for Spectral’s PMX Therapy by Defining Endotoxic Septic Shock (ESS) as the Highest-Risk Patient Group
TORONTO, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today highlighted newly published findings in Critical Care Explorations that define endotoxic septic shock (“ESS”) as a distinct and deadly form of septic shock.
The prospective, multicenter observational study of 90 patients demonstrated that those with ESS – defined as endotoxin activity assay (“EAA™”) = 0.6 combined with a Multiple Organ Dysfunction Score (“MODS”) > 9 or a Sequential Organ Failure Assessment (“SOFA”) > 11 – had a 28-day mortality rate of 57.1%, compared with only 15.9% in other septic shock patients. This represents a more than three-fold increase in risk of death.
“These findings underscore that endotoxin activity, when combined with measures of organ failure, identifies the sickest sepsis patients with the greatest likelihood of dying,” said Dr. John Kellum, Chief Medical Officer at Spectral Medial. “By precisely identifying this high-risk subgroup, we can better design clinical trials and target therapies, such as endotoxin removal, to the patients most likely to benefit.”
The study provides strong clinical validation of Spectral’s approach to precision medicine in septic shock. Spectral’s FDA-cleared EAA diagnostic enables rapid identification of patients with elevated endotoxin activity, while its PMX hemoadsorption device (“PMX”) is designed to remove circulating endotoxin from the blood. Importantly, the criteria used in the study to define ESS directly align with the enrollment parameters of Spectral’s recently completed Tigris trial, which tested PMX therapy in septic shock patients with high endotoxin levels and significant organ dysfunction.
By clearly defining ESS as the subgroup of septic shock patients with the highest mortality, this study underscores the medical and commercial potential for Spectral’s theranostic strategy – pairing the EAA diagnostic with PMX therapy to deliver Targeted Rapid Endotoxin Adsorption (“TREA”) Therapy. The findings strengthen the evidence base supporting Spectral’s upcoming FDA submission and potential future commercialization of PMX in the United States.
The study, “Organ Failure, Endotoxin Activity, and Mortality in Septic Shock”, can be accessed at: Critical Care Explorations.
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