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 the PMA application follows completion of the Agency's filing review process and confirms that the application contains all the information needed to proceed with the substantive review. The PMA application 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 FDA’s filing of our PMA application represents a defining milestone for Spectral and reflects years of focused clinical, regulatory and operational execution,” said Chris Seto, Chief Executive Officer of Spectral. “We believe the totality of evidence supporting PMX demonstrates the potential for a targeted therapy approach in endotoxic septic shock, an area of critical unmet medical need with limited therapeutic innovation over the past several decades. We have worked closely with the FDA throughout the PMA process and have been deliberate in assembling what we believe is a complete and compliant application. We look forward to continuing our engagement with the Agency during the review process.”

John A. Kellum, Chief Medical Officer of Spectral, added, “Endotoxic septic shock remains one of the most challenging conditions encountered in critical care medicine, with persistently high mortality despite advances in supportive care. The Tigris trial further strengthens the clinical evidence supporting PMX and the importance of identifying patients with elevated endotoxin activity using EAA™. We are grateful to the investigators, research coordinators and patients who participated in the clinical development of PMX and helped advance this important work. We are encouraged to have reached this important stage of the regulatory process.”

As previously announced, the Tigris trial met its pre-specified primary endpoint, demonstrating a 95.3% probability of benefit for 28-day all-cause mortality in the adjusted analysis, as well as a greater than 99% probability of benefit at 90 days. Complete results of Tigris trial out to 90 days were published in March of this year in the journal The Lancet Respiratory Medicine. The full Bayesian analysis of Tigris revealed an absolute risk reduction for mortality of 10.3% at 28 days corresponding to a number needed to treat (NNT) to prevent one death of 9.7 and 15.5% at 90-days corresponding to a NNT of 6.5. Long-term follow-up demonstrated that the survival benefit observed at 90 days persisted through 12 months, with mortality rates of 52.8% in PMX-treated patients compared to 66.7% in the standard-of-care group, representing an absolute risk reduction of 13.9%.

The FDA's filing of the PMA application initiates the substantive review phase of the PMA process. Spectral will continue to work closely with the Agency throughout the review and will provide updates as appropriate.

About the Tigris Trial

Tigris was a confirmatory Phase 3 study evaluating PMX in addition to standard care versus standard care alone in adult patients with endotoxic septic shock and elevated endotoxin activity levels measured using EAA™. The trial was designed as a 2:1 randomized study of 150 patients utilizing a Bayesian statistical framework.

As previously reported, the adjusted analyses demonstrated:

• 95.3% probability of benefit for 28-day all-cause mortality;
• Greater than 99% probability of benefit for 90-day mortality; and
• A favorable safety profile consistent with prior PMX studies and clinical experience.
  
  

Complete results from the Tigris Trial appeared in the May 2026 issue of The Lancet Respiratory Medicine, and the trial methodology is further detailed in “Bayesian methods: a potential path forward for sepsis trials”.

About Spectral 

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 clinically available test for endotoxin in blood.

PMX is approved for therapeutic use in Japan and Europe, licensed by Health Canada, and has been used safely and effectively with over 360,000 units sold worldwide to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.

Forward-looking statement

Informationinthisnewsreleasethatisnotcurrentorhistoricalfactualinformationmayconstituteforward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior managementaswellasinformationcurrentlyavailabletoit.Whiletheseassumptionswereconsideredreasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results aresubjecttoanumberofrisksanduncertainties,includingtheavailabilityoffundsandresourcestopursueR&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

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