Spectral Medical Announces Tigris Clinical Trial Update

Enrollment momentum continues as Tigris Trial reaches 69 patients

TORONTO, July 25, 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 that it has enrolled a total of 69 patients 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.

• Rutgers, The State University of New Jersey (RU) enrolled its first patient within three weeks of opening for enrollment in the Tigris Trial.
  
• University of Alabama at Birmingham (UAB) enrolled its second patient in less than a month since opening for enrollment in the Tigris Trial.
  
• 69 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.
  
• Based on the enrollment rate experienced over the past three months, the Company remains on pace to achieve its target timeline of 90 patients enrolled around the end of 2023.
• On track to achieve 25 active trial sites open by the end of September 2023; 18 sites are currently active with four more expected by the end of August.
  
• Crude 28-day mortality results, thus far, continue to exceed efficacy targets.
  

Dr. John Kellum, Chief Medical Officer of Spectral, commented, “We are pleased with the enrollment momentum these past few months, with four new enrollments in July alone, which is particularly noteworthy as we typically experience slower enrollment in the summer months. Since we communicated our business initiatives to increase enrollment just this past April, we have already enrolled 16 new patients in the Tigris Trial, of which, nearly half have come from new sites opened for enrollment in 2023.   We continue to make progress opening additional sites, which should positively impact the pace of enrollment. Overall, we are rapidly advancing our Tigris trial and remain highly encouraged by the outlook, given the fact preliminary mortality data continues to exceed our expectations.”