Spectral Medical Provides Tigris Trial Update

• 76 patients enrolled

• Emory Healthcare latest clinical site addition into the Tigris Trial

TORONTO, Nov. 07, 2023 (GLOBE NEWSWIRE) --  Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that it 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.

• Emory Healthcare newest trial site addition (Tigris site #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 enrollment 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 (NYSE:BAX), 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 enrollments at the end of October. We continue to make progress opening additional sites, which should positively impact the pace of enrollment. Overall, 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 enrollment 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 enrollment 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        

Spectral is a Phase 3 company seeking U.S. 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 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 endotoxic 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. For more information please visit www.spectraldx.com.

Forward-looking statement

Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the company’s ability to raise capital and the availability of funds and resources to pursue R&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies, the success of Baxter’s commercialization efforts, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.

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