Mr. Chris Seto reports

SPECTRAL MEDICAL ANNOUNCES PMA SUBMISSION TO U.S. FDA FOR PMX

Spectral Medical Inc. has submitted its premarket approval (PMA) application to the United States 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 by data from the company's Tigris trial, a phase 3 follow-on study evaluating PMX in patients with ESS. As previously announced, complete results of the Tigris trial out to 90 days were published in March of this year in the journal The Lancet Respiratory Medicine and demonstrated a 95.3-per-cent posterior probability of benefit for 28-day all-cause mortality in the full adjusted Bayesian analysis, as well as a greater than 99-per-cent posterior probability of benefit at 90 days. This analysis revealed an absolute risk reduction for mortality of 10.3 per cent at 28 days corresponding to a number needed to treat (NNT) to prevent one death of 9.7 and 15.5 per cent at 90 days corresponding to a NNT of 6.5.

"This PMA submission 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 that a targeted therapy for endotoxic septic shock is beneficial. This is 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 submission package. 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 co-ordinators and patients who participated in the clinical development of PMX and helped advance this important work."

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 baseline severity-adjusted analyses demonstrated:

• 95.3-per-cent probability of benefit for 28-day all-cause mortality;
• Greater than 99-per-cent probability of benefit for 90-day mortality;
• A favourable 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 Medical Inc.

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 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.

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