Dr. John Kellum reports

SPECTRAL MEDICAL PROVIDES JULY TIGRIS TRIAL UPDATE

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

Enrolment:

• Robust enrolment to start the second half of 2024, which continues the pace experienced since January, 2024:
  • 125 patients enrolled at end of July, 2024:
    • Record monthly enrolment with nine patients enrolled in July, equal to monthly enrolment record set in June;
    • 44 patients enrolled in 2024 so far, representing the most robust enrolment rates since the start of the Tigris study;
• With 25 patients to full enrolment, the company has entered the final push to fully enroll and finish the Tigris trial:
  • Based on current rate of enrolment, Tigris could be completed as early as December, 2024.

Trial sites:

• Currently 23 clinical sites:
  • Spectral clinical team focused on trial site management activities to ensure that Tigris sites have the support and resources to enroll patients as efficiently as possible.

Dr. John Kellum, chief medical officer of Spectral, noted: "Tigris is gathering momentum as we enter the final months of the trial. We have a very strong group of sites and very dedicated investigators. We could not ask for a better team."

About Spectral Medical Inc.

Spectral is a phase 3 company seeking U.S. Food and Drug Administration (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 Endotoxin Activity Assay (EAA), the only FDA-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 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 2:1 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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