Dr. John Kellum reports

SPECTRAL MEDICAL PROVIDES NOVEMBER TIGRIS TRIAL UPDATE

Spectral Medical Inc. has provided an update for the month of November 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.

Highlights:

• 79 patients enrolled to date and continuing to close in on the interim target of 90 patients, an important milestone as the company's strategic commercial partner, Baxter, will have the opportunity to view the data as well as provide a second milestone payment to Spectral.
• Currently 20 Tigris trial sites, with near-term onboarding of new, high-quality clinical sites.
• Crude mortality results at both 28-day (primary end point) and at one-year, thus far, continue to exceed efficacy targets.

Dr. John Kellum, chief medical officer of Spectral, commented: "In November, we experienced strong enrolment into Tigris despite the U.S. Thanksgiving holiday, with five patient enrolments in the last six weeks. We continue to make progress opening additional sites, which should positively impact the pace of enrolment. Additionally, the high rates of influenza that we are witnessing across the southern U.S. and California could have a positive impact on our enrolment, as influenza is often a trigger for bacterial sepsis. 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 continue to be very bullish on the outcome of the Tigris trial. We recently published a Bayesian methodology paper in a major scientific journal. The analysis clearly indicates that our trial strategy is highly likely to succeed in our goal of FDA [Food and Drug Administration] approval for PMX. The simulations involving over 2,000 potential trial results show that using the planned 75-per-cent weight on the prior Euphrates data, an observed absolute risk reduction for mortality of 7 per cent in Tigris is at approximately the 95 per cent probability threshold for declaring PMX effective. Current results from Tigris are far in excess of this threshold," said Chris Seto, chief executive officer of Spectral. "Additionally, we are making steady headway towards reaching out our interim count of 90 patients, which is expected to play as a major catalyst for the company."

The Tigris trial methods paper, entitled "Bayesian methods: a potential path forward for sepsis trials," can be accessed on-line.

About Spectral Medical Inc.

Spectral is a phase 3 company seeking United States 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. FDA granted breakthrough device designation for PMX for the treatment of endotoxemic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.

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

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