Mr. Chris Seto reports

SPECTRAL MEDICAL PROVIDES JANUARY TIGRIS TRIAL UPDATE

Spectral Medical Inc. has provided an update on the company's Tigris trial, a phase 3 follow-on study evaluating the use of polymyxin B hemoperfusion in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Tigris enrolment:

• Strong start to 2025 enrolment:
  • 146 patients enrolled to date;
  • Six patients enrolled in January;
• Closing in on full enrolment of 150 evaluable patients:
  • Project full enrolment close to the end of the first quarter of 2025.

Dr. John Kellum, chief medical officer of Spectral, stated: "It's gratifying to see that despite new year's holiday schedules, Tigris experienced a return to a more normalized enrolment rate in January. We continue to enjoy very strong activity and engagement at our Tigris sites. As such, we remain confident in finalizing full Tigris enrolment close to the end of the first quarter 2025."

About Spectral Medical Inc.

Spectral is a phase 3 company seeking U.S. Food and Drug Administration 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 endotoxin activity assay, the only Food and Drug Administration-cleared diagnostic for the risk of developing sepsis.

PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 340,000 patients 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.

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