Spectral Medical Provides April Tigris Trial Update

?   105 patients enrolled

?   April represents a record breaking month for patient enrollment 

TORONTO, May 06, 2024 (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 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.

Enrollment:

• Robust enrollment activity continuing throughout 2024:
  • 105 patients enrolled at end of April 2024
    • Record monthly enrollment with seven patients enrolled in April
    • 24 patients enrolled in 2024 so far ? represents the most robust enrollment rates since the start of the Tigris study
• With 45 patients to full enrollment, the Company is entering the final push to fully enroll and finish the Tigris trial
  • To support sustained enrollment, Spectral hosted an in-person Investigator Meeting March 12^th & 13^th in conjunction with the 29^th International Conference on Advances in Critical Care Nephrology in San Diego
  • In-person meeting well attended with multiple stakeholders present, including: principal investigators and clinical research coordinators from existing and new trial sites; CRO, Beaufort; and representatives from the Company's strategic partner Baxter
    

Trial Sites:

• Continued progress opening additional high quality clinical sites
  • Recently onboarded the University of Virginia
  • Two pending sites in the pipeline finalizing contracting and training
  • Spectral clinical team focused on trial site management activities to ensure that Tigris sites have the support and resources to enroll patients as efficiently as possible  

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, Toraymyxintm ("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 (EAAtm), 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.

The Tigris Trial is a confirmatory study of PMX in addition to standard care vs 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 https://www.youtube.com/watch?v=6RANrHHi9L8.

The trial methods are detailed in  "Bayesian methods: a potential path forward for sepsis trials".

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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