Mr. Chris Seto reports

SPECTRAL MEDICAL PROVIDES TIGRIS TRIAL UPDATE

Spectral Medical Inc. has provided an update 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.

Enrolment:

• Robust enrolment activity since the end of October, with 81 patients enrolled to date:
  • Seven patients enrolled over the past eight weeks;
  • Screening activity at current sites remains strong with 100-plus patients screened per week.
• Closing in on the interim enrolment target of 90 patients -- at interim enrolment, Baxter has the option to make the second milestone payment to Spectral to maintain its PMX exclusive distribution rights.
• Crude mortality results at both 28-day (primary end point) and at one year, thus far, continue to exceed efficacy targets.

Trial sites:

• Currently 20 Tigris trial sites, with near term onboarding of new, high-quality clinical sites:
  • Clinical trial agreements (CTA) either executed or in final revision phase at six new clinical sites.

EDEN study:

• Completed the EDEN study, a parallel observational study, in which data are collected on patients with septic shock, even if ineligible for Tigris. The EDEN study is among the largest ever to examine the full range of septic shock and its relation to organ failure and endotoxin activity. These data will inform subsequent discussions with the FDA (Food and Drug Administration) on labelling for PMX and provide important data on potential expanded indications for PMX.

Dr. John Kellum, chief medical officer of Spectral, commented: "Since the end of October, we experienced strong enrolment into Tigris, despite the U.S. Thanksgiving holiday, with seven patient enrolments in the last eight 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 are pleased with the pace of enrolment activity since holding our investigator meeting this past May. The sustained enrolment activity over these past seven months has put Spectral within striking distance of our interim enrolment milestone of 90 patients, which is expected to play as a major catalyst for the company," said Chris Seto, chief executive officer of Spectral Medical.

As a reminder, under the exclusive distribution agreement between Spectral and Baxter International, following the enrolment of 90 patients, Baxter has the option to 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 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.

The Tigris trial is a confirmatory study of PMX in addition to standard care versus standard care alone, and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis.

We seek Safe Harbor.