Dr. John Kellum reports

SPECTRAL MEDICAL ENROLLS PATIENT 82 IN ITS PHASE 3 FDA TIGRIS SEPTIC SHOCK TRIAL

Spectral Medical Inc. has released 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

Initiated 2024 with robust site activity to start the new year:

• Enrolled patient 82 during the first week of January;

• Postholiday break, strong screening activity resumed with more than 100 patients screened per week;

• Closing in on the interim enrolment target of 90 patients; at interim enrolment, Baxter International has the option to make the second non-dilutive milestone payment to Spectral to maintain its PMX exclusive distribution rights;

• Crude mortality results at both 28 days (primary end point) and at one year, thus far, continue to exceed efficacy targets.

Trial sites:

• Near term onboarding of six new, high-quality clinical sites;

• Expect significant site onboarding activity during the first quarter of 2024.

Dr. John Kellum, chief medical officer of Spectral, commented: "We are pleased to see that our clinical sites have returned from the December holiday season and are experiencing robust enrolment activities. This resumes the strong enrolment into Tigris which we experienced since holding our investigator meeting this past May. We continue to make progress opening additional sites, which should positively impact the pace of enrolment. Over all, we are rapidly advancing our Tigris trial and remain highly encouraged by the outlook, given the fact preliminary mortality data continues to exceed our expectations."

"We are very excited about our prospects for 2024. The robust enrolment activity to start the new year 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 68 patients to go, we are entering the final push to fully enroll and finish the Tigris trial."

About Spectral

Spectral is a phase 3 company seeking U.S. 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 U.S. Food and Drug Administration 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.

Spectral is listed on the Toronto Stock Exchange under the symbol EDT.

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