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Spectral Medical Announces U.S. FDA Filing of PMA Application for PMX

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…

GlobeNewsWire • Jun 25, 2026
Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders

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…

GlobeNewsWire • Jun 9, 2026
Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral's Tigris Trial

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…

GlobeNewsWire • Jun 4, 2026
Spectral Medical Announces PMA Submission to U.S. FDA for PMX

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…

GlobeNewsWire • May 29, 2026

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