Mr. Chris Seto reports

SPECTRAL MEDICAL PROVIDES TIGRIS TRIAL UPDATE

Spectral Medical Inc. has provided an update on the progress of its Tigris trial, including patient enrolment and new trial site additions to further accelerate patient enrolment.

As of Oct. 2, 2023, the company had 74 patients enrolled in its phase 3 Tigris clinical trial with crude mortality data continuing to exceed expectations. To further accelerate patient enrolment, reach the interim milestone of 90 enrolled patients and subsequently complete the Tigris trial, Spectral is on schedule to add seven new vetted trial sites in the United States around the end of November, 2023. The company had previously communicated reaching a full complement of 25 sites by the end of September, however, administrative delays at new sites has resulted in a slight shift in the new site onboarding timeline.

"We are taking decisive 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."

As a reminder, under the exclusive distribution agreement between Spectral and Baxter International, following the enrolment of 90 patients, Baxter will have the opportunity to view the crude data as well as provide a second milestone payment to Spectral in order to affirm and maintain its exclusive distribution rights to PMX.

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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