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• Company gains further clarity on the additional information required to advance its PMA review
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• FDA did not request an additional clinical trial following its 100-day review of the PMA application
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• Company does not currently expect a material change to its overall regulatory timeline
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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 provided an update following its in-person 100-Day Meeting with the U.S. Food and Drug Administration (“FDA”) regarding the Company’s Premarket Approval (“PMA”) application for Toraymyxin™ (“PMX”).
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As part of its substantive review of the PMA, FDA provided Spectral with a deficiency letter several days prior to the Company’s scheduled in-person 100-Day Meeting. Deficiency letters are commonly issued as part of the 100-day PMA review process and are used by FDA to identify additional information necessary to complete its review of an application. The letter identified a number of items requiring additional information, analyses, testing and clarification and provided the Company with the opportunity to focus the 100-Day Meeting discussion on the items identified by FDA.
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The Company considered the meeting constructive. Based on the Company’s understanding of the discussion, Spectral has further clarity regarding the additional analyses, testing and information required to address the outstanding items and advance the PMA review. FDA did not request an additional clinical trial as part of the Company’s response to the deficiency letter. FDA’s official minutes of the meeting are the definitive record of the discussion and have not yet been issued.
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“We were pleased with the constructive dialogue with FDA during the in-person 100-Day Meeting,” said Chris Seto, Chief Executive Officer of Spectral Medical. “Receiving the deficiency letter in advance of the meeting allowed us to have a focused discussion with FDA regarding the outstanding items. We came away with a clearer understanding of the remaining work required to advance the review of our PMA and are actively progressing the additional analyses, testing and other activities discussed with FDA.”
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Spectral is incorporating FDA’s feedback into its ongoing regulatory activities and is finalizing the associated work plan and timing. Based on its current assessment, the Company does not currently expect the additional activities to result in a material change to its overall regulatory timeline. Spectral will provide further updates as appropriate.
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About Spectral
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Spectral is a Phase 3 company seeking U.S. 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 only FDA-cleared test for endotoxin in blood.