Dr. John Kellum reports

SPECTRAL MEDICAL ANNOUNCES THE OPENING OF THREE ADDITIONAL TIGRIS CLINICAL TRIAL SITES

Spectral Medical Inc. has opened three new clinical trial sites, the University of Alabama at Birmingham (UAB), Rutgers, the State University of New Jersey (RU), and a major medical centre in Wisconsin, bringing the total number of active clinical trial sites to 18 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.

• On track to have 25 active trial sites open by the end of September, 2023, with 18 current sites and two more expected in July.
• Sixty-five 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.
  • The enrolment rate experienced over the past 12 weeks maintains the target timeline of 90 patients enrolled around the end of 2023.
• Crude 28-day mortality results, thus far, continue to exceed efficacy targets.

Dr. John Kellum, chief medical officer of Spectral, commented: "We are pleased to add three additional excellent clinical trial sites for Tigris, which is expected to accelerate patient enrolment and enable us to more rapidly reach our 150 total patient target. A strong pace of enrolment now is important as July and August are traditionally slower months for clinical trials. We continue to advance our Tigris trial and remain encouraged by the outlook with preliminary mortality data that continually exceeds our expectations. With no approved or cleared treatment on the market to date, we believe, if Tigris is successful, we can swiftly move towards FDA submission and address a significant unmet medical need with a market currently estimated at $2-billion in the United States alone."

While the company continues to witness initial benefits of its business initiatives, management believes that the company will realize the full impact of these initiatives over time. Management looks forward to reporting Tigris progress as material developments unfold.

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). 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 U.S. 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.

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