Mr. Chris Seto reports

SPECTRAL MEDICAL ANNOUNCES PUBLICATION OF EDEN OBSERVATIONAL STUDY

Spectral Medical Inc. 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, multicentre observational study of 90 patients demonstrated that those with ESS -- defined as endotoxin activity assay (EAA) greater than or equal to 0.6 combined with a multiple organ dysfunction score (MODS) greater than nine or a sequential organ failure assessment (SOFA) greater than 11 -- had a 28-day mortality rate of 57.1 per cent, compared with only 15.9 per cent in other septic shock patients. This represents a more than threefold 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 Food and Drug Administration-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 on-line.

About Spectral Medical Inc.

Spectral is a phase 3 company seeking United States FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin (PMX). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the company's FDA cleared Endotoxin Activity Assay (EAA), the clinically available test for endotoxin in blood.

PMX is approved for therapeutic use in Japan and Europe, licensed by Health Canada, and has been used safely and effectively with over 360,000 units sold worldwide to date. In March, 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November, 2010, signed an exclusive distribution agreement for this product in Canada. In July, 2022, the U.S. FDA granted breakthrough device designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.

The Tigris trial is a confirmatory study of PMX in addition to standard care versus standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics.

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