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Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders

Tue, 09 Jun 2026 16:18:00 -0400

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.

Results of the matters voted on at the Meeting are set out below.

Election of Directors

Spectral's seven director

Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders

Tue, 09 Jun 2026 16:18:00 -0400

Results of the matters voted on at the Meeting are set out below.

Election of Directors

Spectral's seven director

Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders

Tue, 09 Jun 2026 16:18:00 -0400

Results of the matters voted on at the Meeting are set out below.

Election of Directors

Spectral's seven director

Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders

Tue, 09 Jun 2026 16:18:00 -0400

Results of the matters voted on at the Meeting are set out below.

Election of Directors

Spectral's seven director

Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders

Tue, 09 Jun 2026 16:18:00 -0400

Results of the matters voted on at the Meeting are set out below.

Election of Directors

Spectral's seven director

Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders

Tue, 09 Jun 2026 16:18:00 -0400

Results of the matters voted on at the Meeting are set out below.

Election of Directors

Spectral's seven director

Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders

Tue, 09 Jun 2026 16:18:00 -0400

Results of the matters voted on at the Meeting are set out below.

Election of Directors

Spectral's seven director

Spectral Medical Inc. Announces Results of Annual and Special Meeting of Shareholders

Tue, 09 Jun 2026 16:18:00 -0400

Results of the matters voted on at the Meeting are set out below.

Election of Directors

Spectral's seven director

Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral’s Tigris Trial

Thu, 04 Jun 2026 07:00:00 -0400

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., June 04, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc.

Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral’s Tigris Trial

Thu, 04 Jun 2026 07:00:00 -0400

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., June 04, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc.

Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral’s Tigris Trial

Thu, 04 Jun 2026 07:00:00 -0400

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., June 04, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc.

Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral’s Tigris Trial

Thu, 04 Jun 2026 07:00:00 -0400

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., June 04, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc.

Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral’s Tigris Trial

Thu, 04 Jun 2026 07:00:00 -0400

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., June 04, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc.

Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral’s Tigris Trial

Thu, 04 Jun 2026 07:00:00 -0400

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., June 04, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc.

Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral’s Tigris Trial

Thu, 04 Jun 2026 07:00:00 -0400

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., June 04, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc.

Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral’s Tigris Trial

Thu, 04 Jun 2026 07:00:00 -0400

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., June 04, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc.

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

Fri, 29 May 2026 07:00:00 -0400

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”).

The PMA submission includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).

The submission is supported

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

Fri, 29 May 2026 07:00:00 -0400

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”).

The PMA submission includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).

The submission is supported

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

Fri, 29 May 2026 07:00:00 -0400

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”).

The PMA submission includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).

The submission is supported

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

Fri, 29 May 2026 07:00:00 -0400

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”).

The PMA submission includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).

The submission is supported

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

Fri, 29 May 2026 07:00:00 -0400

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”).

The PMA submission includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).

The submission is supported

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

Fri, 29 May 2026 07:00:00 -0400

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”).

The PMA submission includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).

The submission is supported

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

Fri, 29 May 2026 07:00:00 -0400

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”).

The PMA submission includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).

The submission is supported

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

Fri, 29 May 2026 07:00:00 -0400

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”).

The PMA submission includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).

The submission is supported

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

Fri, 08 May 2026 07:30:00 -0400

PMA submission targeted for May 29, 2026 in alignment with FDA
Vantive commits to additional funding support ahead of PMA acceptance milestone

TORONTO, May 08, 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 first quarter ended March 31, 2026 and provided a corporate update.

The first quarter of 2026 marked continued progress across regulatory, clinical and commercial readiness initiatives as the Company advances