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Biotech / Medical : Spectral Medical Inc.
EDTXF 0.624+0.6%11:22 AM EDT
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From: Sultan3/3/2025 12:11:32 PM
   of 504
 
Spectral Medical Provides February Tigris Trial Update

  • 152 patients enrolled

TORONTO, March 03, 2025 (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.

Tigris Enrollment:

  • Strong start to 2025 enrollment:

    • 152 patients enrolled to date

    • Six patients enrolled in February

  • Closing in on full enrollment of 150 evaluable patients:

    • Estimate a further four to seven patients (given the enrollment randomization scheme) to reach 150 evaluable patients

      • Addresses the six patients randomized into the PMX arm that did not receive the treatment

      • Enrollment of 100 patients in the PMX arm and 50 patients in the standard-of-care arm who receive the assigned treatment is important for PMX regulatory review with respect to safety analysis and secondary analyses

    • Project full enrollment closer to the end of March 2025

Dr. John Kellum, Chief Medical Officer of Spectral, stated, “We are very much in the final stretch of enrollment into Tigris, which we attribute to continued strong activity and engagement at our Tigris sites. As such, we remain confident in finalizing full Tigris enrollment closer to the end of the first quarter in 2025.”
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