Patient mortality data continues to exceed expectations

Recent FDA approved SOFA amendment contributing to increased patient enrollment

TORONTO, Feb. 11, 2022 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly-owned subsidiary Dialco Medical Inc. (Dialco), today provided a clinical trial update on Tigris, a follow on study designed to build on knowledge gained from the earlier EUPHRATES trial, evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock. The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.

Key Tigris Trial Updates:

• Patient mortality data continues to exceed expectations
• 30 patients randomized to-date (out of the 150 total patients to be enrolled in the Tigris trial)
• Of the three patients enrolled over the past month, two were enrolled as a result of the recent FDA approved protocol amendment allowing for the use of sequential organ failure assessment (SOFA) scoring as inclusion criteria into the study
• Investigator meeting scheduled for February 17, 2022, expected to be well attended by existing and new trial sites

Chris Seto, CEO of Spectral, commented, “We are highly encouraged by both the patient mortality data thus far, as well as the recent rate of patient screening, enrollment, and randomization activity. We attribute the increased enrollment to a number of factors, including the implementation of our United States Federal Food and Drug Agency (FDA) approved SOFA amendment and new sites coming online. Notably, we recently opened enrollment at UC Health Memorial Hospital in Colorado Springs, one of the highest enrolling sites in the Euphrates trial, which has already enrolled two patients in the past month alone. We look forward to our upcoming investigator meeting later this month, which we expect will be well attended and will feature Professor Claudio Ronco, MD, and Dr. Paul Walker as keynote speakers.”

“It’s gratifying to see the commitment from our participating Tigris sites,” said Dr. John Kellum, Chief Medical Officer of Spectral. “COVID-19 has again disrupted research activities across the U.S., but the passion for sepsis care and research shown by our sites is quite remarkable. We have still managed to enroll patients even with COVID cases occupying most of the ICU beds. Now that COVID cases are falling, we expect a meaningful increase in enrollment in the coming weeks. Equally important, early efficacy signals continue to exceed targets.”

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 300,000 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. Approximately 330,000 patients are diagnosed with severe sepsis and septic shock in North America each year.

Spectral, through its wholly owned subsidiary, Dialco Medical Inc., is also commercializing a new set of proprietary platforms addressing renal replacement therapy (RRT) across the dialysis spectrum. SAMI is targeting the acute RRT market, while DIMI is targeting the chronic RRT market. Dialco is currently pursuing regulatory approval for U.S. in-home use of DIMI, which is based on the same RRT platform as SAMI, but will be intended for home hemodialysis use. DIMI recently received its FDA 510k clearance for use in hospital and clinical settings, and obtained its Health Canada license for use within Canadian hospitals, clinics and in home.

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 availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, 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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