Spectral Medical Provides Tigris Trial Update

• 101 patients enrolled
  

TORONTO, April 10, 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 continues throughout 2024:
  • 101 patients enrolled to-date
    • Q1 2024 record enrollment with 17 patients enrolled in the quarter
    • 20 patients enrolled in 2024 so far – represents the most robust enrollment rates since the start of the Tigris study
• With 49 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:

• Currently 22 Tigris trial sites, with continued progress opening an additional two new, high quality clinical sites
  • 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, 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.