Press Release Archives - Spectral Medical Inc

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

TORONTO, Canada – June 25, 2026 – 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...

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...

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...

Spectral Medical Announces PMA Submission to U.S. FDA for PMX

TORONTO, Canada – May 29, 2026 – 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”)...

Spectral Medical Announces First Quarter 2026 Financial Results and Provides Corporate Update

PMA submission targeted for May 29, 2026 in alignment with FDA Vantive commits to additional funding support ahead of PMA acceptance milestone TORONTO, Canada – May 8, 2026 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage...

Spectral Medical Announces Participation in the 2026 Bloom Burton & Co. Healthcare Investor Conference

TORONTO, Canada – April 1, 2026 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, will be participating in the 2026 Bloom Burton & Co. Healthcare...

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EAA™ and PMX are licensed and available for use in Canada. PMX is not approved for clinical use in the USA, and is currently undergoing the PMA (Premarket approval) process. EAA™ is FDA cleared for use in the USA. The information presented herein is region specific. Please contact Spectral Medical Inc.to obtain appropriate product information for your country.