Spectral Medical Inc EDT

• 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

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

100% follow-up achieved for all 157 patients enrolled in the Tigris trialMortality 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 NEWSW

Spectral Medical (EDT.TO) has submitted its premarket approval (PMA) application to the U.S. Food an

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

PMA submission targeted for May 29, 2026 in alignment with FDAVantive 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 pro

Toronto, Ontario--(Newsfile Corp. - April 1, 2026) - Spectral Medical Inc. (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 Investor Conference, which will take place on April 21 and 22 at the Metro Toronto Convention Centre.Dates: Tuesday April 21, 2026-Wednesday April 22, 2026Time:8:30 AM - 5:00 PM ETLocation:Metro Toronto Convention Centre, North Building255 Front St...

Spectral Medical (EDT.TO) Thursday reported a swing to a fourth-quarter loss on lower revenues and h

We feel now is a pretty good time to analyse Spectral Medical Inc.'s ( TSE:EDT ) business as it appears the company may...

TORONTO, March 26, 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 fourth quarter and for the year ended December 31, 2025 and provided a corporate update. The past year marked a significant milestone in Spectral’s clinical and regulatory progression, highlighted by the completion of enrollment of the Tigris trial, the

Tigris publication confirms positive results for primary and key secondary endpoints with 95.3% and 99.4% probability of benefit for PMX at 28-day and 90-day mortality After adjusting for baseline severity, absolute risk reduction for mortality of 10.3% at 28-days and 15.5% at 90-daysSafety profile consistent with standard of care with no significant difference in adverse eventsTigris trial results to be presented at the Society of Critical Care Medicine (“SCCM”) in Chicago, Ill. on March 24, 20

Spectral Medical (EDT.TO) Thursday said it expects to submit its premarket approval (PMA) submission

TORONTO, Feb. 26, 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 on the timing of its Premarket Approval (“PMA”) submission to the U.S. Food and Drug Administration (“FDA”) for its hemoadsorption device to treat endotoxic septic shock. Following recent interaction with the FDA, the Company now expects to submit its PMA around the end of Ap

PMA submission targeted for Q1 2026 following positive Tigris results and ongoing FDA interactionsCompany to host Corporate Update call on Wednesday, December 10, 2025 TORONTO, Nov. 07, 2025 (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 third quarter and provided a corporate update. The third quarter of 2025 marked a pivot