Mr. Chris Seto reports

SPECTRAL MEDICAL PROVIDES UPDATE ON PMA SUBMISSION TIMING FOR PMX-20R

Spectral Medical Inc. has provided an update on the timing of its premarket approval submission to the U.S. Food and Drug Administration for its hemoadsorption device to treat endotoxic septic shock.

Following recent interaction with the FDA, the company expects to submit its PMA around the end of April to mid-May, 2026, compared with its previously disclosed target of first quarter 2026.

The updated timing reflects continuing FDA feedback to incorporate complete 12-month mortality data from the Tigris study into the PMA submission, as well as the completion of certain non-clinical module items, including human factor engineering testing, to support a complete and compliant submission.

The company believes the inclusion of complete 12-month mortality outcomes will further inform the FDA's review and contribute to the totality of clinical evidence supporting PMX for the treatment of endotoxic septic shock.

Spectral currently anticipates being in a position to report top-line 12-month mortality data in late May or early June, 2026, subject to the completion of additional data analysis.

"We continue to work constructively with the FDA to ensure a high-quality PMA submission," said Chris Seto, chief executive officer of Spectral Medical. "The inclusion of longer-term mortality data and completion of the remaining non-clinical components are intended to support a comprehensive submission, and will position PMX for an efficient review process."

Spectral continues to work closely with the FDA on the PMA submission process and will provide updates as appropriate.

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, 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 United States 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.

The Tigris trial is a confirmatory study of PMX in addition to standard care versus standard care alone, and is designed as a two-to-one randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis.

The trial methods are detailed in "Bayesian methods: a potential path forward for sepsis trials."

Spectral is listed on the Toronto Stock Exchange under the symbol EDT.

We seek Safe Harbor.