Mr. Chris Seto reports

SPECTRAL MEDICAL PROVIDES DECEMBER 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.

Tigris enrolment:

• Strong close to 2024 enrolment with 140 patients enrolled at end of December, 2024;
  • 59 patients enrolled in 2024 versus 31 patients enrolled in 2023.
• Experienced improved enrolment in December as issues related to the production of critical intravenous fluids started to ease
  • For more information on Hurricane Helene's impact on the supply of critical intravenous fluids, see the link available in the original version of this news release.

Dr. John Kellum, chief medical officer of Spectral, stated: "We view December as a transitional month from an enrolment perspective, as the medical supply chain issues eased. Given the continued strong engagement and enthusiasm at our Tigris sites, we anticipate a return to a more normalized enrolment rate in the new year."

"Our enrolment throughout 2024 was incredibly robust -- even when taking into account the enrolment disruptions encountered throughout the fourth quarter," said Chris Seto, chief executive officer of Spectral Medical. "We are very much in the final stretch of Tigris enrolment, and project full enrolment closer to the end of the first quarter of 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 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 to 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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