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Spectral Medical Inc. focuses on the development and commercialization of products for the treatment of septic shock in the United States, Italy, Ireland, Russia, and internationally. The company markets Endotoxin Activity Assay, a rapid in-vitro diagnostic test for the detection of components of gram negative bacterial cell wall; and Polymyxin B-Hemoperfusion, a therapeutic hemoperfusion device that removes endotoxin from the bloodstream. It also develops, manufactures, and markets monoclonal and polyclonal antibodies, recombinant cardiac proteins, antibodies, and calibrators for use in the…

TORONTO, June 25, 2026 (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 announced that the U.S. Food and Drug Administration (“FDA”) has completed its filing review and formally filed the Company's Premarket Approval (“PMA”) application for PMX, the Company's endotoxin removal therapy for patients with endotoxic septic shock (“ESS”). FDA acceptance for filing of the PMA application follows completion of the Agency's filing review process and confirms that the application contains all the information needed to proceed with the substantive review.

TORONTO, June 09, 2026 (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 announced the results of its Annual and Special Meeting of shareholders (the "Shareholders") held on June 8, 2026 (the "Meeting"). The Company confirms that all resolutions put forward in the Management Information Circular dated April 27, 2026 (the "Circular") to its Shareholders were approved.

Spectral Medical Inc. (EDT:CA) Shareholder/Analyst Call Transcript

100% follow-up achieved for all 157 patients enrolled in the Tigris trial Mortality at 12 months was 52.8% with PMX vs. 66.7% with standard of care alone (absolute risk reduction of 13.9%; number needed to treat of 7.2) 95.9% probability of benefit for PMX at 12 months, independent of prior clinical studies (Tigris data alone) Additional Bayesian and non-Bayesian analyses will be performed including incorporation of prior data from EUPHRATES TORONTO and DEERFIELD, Ill.

TORONTO, May 29, 2026 (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 announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for PMX, the Company's endotoxin removal therapy for patients with endotoxic septic shock (“ESS”).