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

Enrolment:

• Robust enrolment activity continued throughout January, 2024:
  • 85 patients enrolled to date;
  • Four patients enrolled in the month of January;
• Closing in on the interim enrolment target of 90 patients; at interim enrolment, Baxter has the option to make the second milestone payment to Spectral to maintain its PMX exclusive distribution rights.

Trial sites:

• Continue to make progress opening an additional six new, high-quality clinical sites:
  • University of Texas Health Sciences Center at Houston finalized and executed the Tigris clinical trial agreement; the company anticipates another Texas-based site to execute its clinical trial agreement in the coming days;
  • Expect significant site onboarding activity in Q1 2024, with final training scheduled at four sites in February so far.

"We are very excited about our prospects for 2024. The robust enrolment activity throughout January puts Spectral within striking distance of our interim enrolment milestone of 90 patients, which is expected to play as a major catalyst for the company," said Chris Seto, chief executive officer of Spectral Medical. "Additionally, with 65 patients to go, we are entering the final push to fully enroll and finish the Tigris trial."

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 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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