Dr. John Kellum reports

SPECTRAL MEDICAL PROVIDES TIGRIS TRIAL UPDATE

Spectral Medical Inc. has enrolled a total of 76 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.

Highlights:

• Emory Healthcare newest trial site addition (Tigris site No. 20), enrolling out of two hospitals.
• University of California San Francisco (UCSF) and University of Alabama at Birmingham (UAB) continue to be strong Tigris enrollers, with the enrolment of patients 75 and 76 at the end of October.
• 76 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.
• Crude 28-day mortality results, thus far, continue to exceed efficacy targets.

Dr. John Kellum, chief medical officer of Spectral, commented: "After a somewhat sluggish September, we are pleased with October's robust screening activity, which resulted in two new enrolments at the end of October. 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 taking measured, yet rapid action to maintain and even increase momentum in patient enrolment, with a view to enrolling our interim count of 90 patients, which is expected to play as a major catalyst for the company," said Chris Seto, chief executive officer of Spectral Medical. "Based on the pace of patient enrolment in the past number of months, and our activities around site additions, we are optimistic on the prospect of reaching the 90-patient interim milestone around the end of 2023."

About Spectral Medical Inc.

Spectral is a phase 3 company seeking United States 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.

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