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.”