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• Company gains further clarity on the additional information required to advance its PMA review • FDA did not request an additional clinical trial following its 100-day review of the PMA application • Company does not currently expect a material change to its overall regulatory timeline TORONTO, Sept. 11, 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 provi
TORONTO, Aug. 07, 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 its financial results for the second quarter ended June 30, 2026 and provided a corporate update. The second quarter of 2026 marked a significant milestone in the Company's evolution as Spectral completed its U.S. Food and Drug Administration ("FDA") Premarket Approval ("PMA") applica
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 th
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