Core Insights - A new study identifies endotoxic septic shock (ESS) as a distinct and high-risk form of septic shock, with a significantly higher mortality rate compared to other septic shock patients [1][2][4] - The study found that patients with ESS had a 28-day mortality rate of 57.1%, more than three times the 15.9% rate observed in other septic shock patients [2] - The findings support Spectral Medical's precision medicine approach, which combines the Endotoxin Activity Assay (EAA) diagnostic with the PMX hemoadsorption device to target high-risk patients [3][4] Company Overview - Spectral Medical Inc. is a late-stage theranostic company focused on developing therapeutic options for sepsis and septic shock, currently seeking FDA approval for its PMX device [1][6] - PMX is a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream and has been approved for use in Japan and Europe, with over 360,000 units sold globally [7] - The company has received Breakthrough Device Designation from the FDA for PMX in treating endotoxic septic shock, with approximately 330,000 patients diagnosed with septic shock annually in North America [7] Clinical Study Insights - The study titled "Organ Failure, Endotoxin Activity, and Mortality in Septic Shock" involved a multicenter observational analysis of 90 patients, establishing criteria for identifying ESS [2][5] - The criteria for ESS included an endotoxin activity assay (EAA) score of ≥ 0.6 combined with a Multiple Organ Dysfunction Score (MODS) > 9 or a Sequential Organ Failure Assessment (SOFA) > 11 [2] - The results align with the enrollment parameters of Spectral's recently completed Tigris trial, which tested PMX therapy in patients with high endotoxin levels and significant organ dysfunction [3][4][8]