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, 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.