Dr. John Kellum reports

SPECTRAL MEDICAL ANNOUNCES TIGRIS CLINICAL TRIAL UPDATE

Spectral Medical Inc. has enrolled a total of 69 patients for 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.

Rutgers, The State University of New Jersey (RU) enrolled its first patient within three weeks of opening for enrolment in the Tigris trial.

University of Alabama at Birmingham (UAB) enrolled its second patient in less than a month since opening for enrolment in the Tigris trial.

Sixty-nine 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.

Based on the enrolment rate experienced over the past three months, the company remains on pace to achieve its target timeline of 90 patients enrolled around the end of 2023. On track to achieve 25 active trial sites open by the end of September, 2023, 18 sites are currently active, with four more expected by the end of August.

Crude 28-day mortality results, thus far, continue to exceed efficacy targets.

Dr. John Kellum, chief medical officer of Spectral, commented: "We are pleased with the enrolment momentum these past few months, with four new enrolments in July alone, which is particularly noteworthy as we typically experience slower enrolment in the summer months. Since we communicated our business initiatives to increase enrolment just this past April, we have already enrolled 16 new patients in the Tigris trial, of which nearly half have come from new sites opened for enrolment in 2023. 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."

While the company continues to witness the benefits of its enrolment initiatives, management believes that the company will realize increasing benefit from these and other initiatives over time. Management looks forward to reporting additional Tigris progress and milestones as material developments unfold.

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 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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