Spectral Medical Announces the Opening of Three Additional Tigris Clinical Trial Sites

University of Alabama enrolls patient 65 after second day of opening for enrollment

TORONTO, July 05, 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 the opening of three new clinical trials sites, the University of Alabama at Birmingham (UAB), Rutgers, The State University of New Jersey (RU), and a major medical center in Wisconsin, bringing the total number of active clinical trial sites to eighteen 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.

• On track to have 25 active trial sites open by the end of September 2023, with 18 current sites and 2 more expected in July.
• 65 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.
  • The enrollment rate experienced over the past twelve weeks maintains the target timeline of 90 patients enrolled around the end of 2023.
• Crude 28-day mortality results, thus far, continue to exceed efficacy targets.

Dr. John Kellum, Chief Medical Officer of Spectral, commented, “We are pleased to add three additional excellent clinical trial sites for Tigris, which is expected to accelerate patient enrollment and enable us to more rapidly reach our 150 total patient target. A strong pace of enrollment now is important as July and August are traditionally slower months for clinical trials. We continue to advance our Tigris trial and remain encouraged by the outlook with preliminary mortality data that continually exceeds our expectations. With no approved or cleared treatment on the market to date, we believe, if Tigris is successful, we can swiftly move towards FDA submission and address a significant unmet medical need with a market currently estimated at $2 billion in the United States alone.”

While the Company continues to witness initial benefits of its business initiatives, Management believes that the Company will realize the full impact of these initiatives over time. Management looks forward to reporting Tigris progress as material developments unfold.

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 endotoxemic 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 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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