Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral's Tigris Trial

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Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral’s Tigris Trial 100% follow-up achieved for all 157 patients enrolled in the Tigris trialMortality at 12 months was 52.8% with PMX vs. 66.7% with standard of care alone (absolute risk reduction of 13.9%; number needed to treat of 7.2) 95.9% probability of benefit for PMX at 12 months, independent of prior clinical studies (Tigris data alone) Additional Bayesian and non-Bayesian analyses will be performed including incorporation of prior data from EUPHRATES TORONTO and DEERFIELD, Ill., June 04, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, and Vantive, a vital organ therapy company committed to pursuing novel diagnostic and therapeutic options for organ failure, today announced topline mortality data at 12 months for patients enrolled in the Tigris trial. The randomized-controlled trial evaluated the use of Polymyxin B Hemoadsorption (“PMX”) in adults with endotoxic septic shock. Endotoxic septic shock is a particularly deadly form of sepsis, occurring in approximately 5-7 million people annually worldwide.1 There is currently no specific therapy targeting this patient population available in the United States. Complete 28-day and 90-day results of the Tigris trial were published in March of this year in The Lancet Respiratory Medicine. The full Bayesian analysis of Tigris revealed an absolute risk reduction for mortality of 10.3% at 28 days corresponding to a number needed to treat (NNT) to prevent one death of 9.7 and 15.5% at 90 days corresponding to a NNT of 6.5. Initial 12 Month Follow-up Results: As a secondary endpoint of the trial, preplanned follow-up was conducted on all enrolled Tigris study patients to assess vital status at 12 months. Mortality differences observed earlier in the study persisted through one year, with 12-month mortality of 56/106 (52.8%) in patients treated with PMX compared to 34/51 (66.7%) in patients receiving standard of care alone, representing an absolute risk reduction of 13.9% and a number needed to treat of 7.2. Initial Bayesian statistical analyses based solely on the randomized Tigris trial data, without incorporation of the informative prior from EUPHRATES, demonstrated a 95.9% pr...

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