Mr. Chris Seto reports

SPECTRAL MEDICAL PROVIDES FEBRUARY 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 (PMX) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Enrolment:

• Robust enrolment activity continues throughout 2024:
  • 93 patients enrolled to date:
    • Six patients enrolled in the month of February -- follows the six patients enrolled in January;
    • Twelve patients enrolled in the first two months of 2024 -- represents the most robust enrolment rates since the start of the Tigris study.
• With 57 patients to full enrolment, the company is entering the final push to fully enroll and finish the Tigris trial:
  • To support sustained enrolment, Spectral to host an in-person investigator meeting on March 12 and March 13, in conjunction with the 29th International Conference on Advances in Critical Care Nephrology in San Diego.

Trial sites:

• Currently 21 Tigris trial sites, with continued progress opening an additional four new, high-quality clinical sites:
  • The Institute for Extracorporeal Life Support (San Antonio, Tex.) finalized and executed the Tigris clinical trial agreement;
  • Expect significant site onboarding activity throughout Q1 2024, with final training scheduled at three of the remaining four sites.

About Spectral

Spectral is a phase 3 company seeking United States 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 endotoxins, 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 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 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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