Spectral Medical and Vantive Announce Publication of Complete Results from Spectral's Tigris Trial in the Lancet Respiratory Medicine

Executive Summary

• The full results of the Phase 3 Tigris trial were published in The Lancet Respiratory Medicine, confirming statistically significant reductions in 28‑day and 90‑day mortality for PMX‑treated patients with endotoxic septic shock.
• Adjusted absolute risk reduction (ARR) was 10.3 % at 28 days (NNT ≈ 9.7) and 15.5 % at 90 days (NNT ≈ 6.5), with posterior probabilities of benefit of 95.3 % and 99.4 %, respectively.
• Safety was comparable to standard care; serious adverse events occurred in 30 % of PMX patients vs 22 % of control, a non‑significant difference.

Key Details

• Trial Design: U.S. multicenter, randomized, 2:1 (PMX + standard care n=106; standard care alone n=51), Phase 3, Bayesian analysis per FDA guidance.
• Population: Adults with endotoxic septic shock (EAA 0.60‑0.90) and MODS > 9 or SOFA > 11; total enrolled 157 patients.
• Primary Endpoint – 28‑day Mortality:
• Posterior probability of benefit: 95.3 % (exceeds 95 % target).
• Adjusted odds ratio: 0.67 (95 % CI 0.39‑1.08).
• Adjusted ARR: 10.3 % (CI ‑1.7 to 22.3); NNT ≈ 9.7.
• Key Secondary Endpoint – 90‑day Mortality:
• Posterior probability of benefit: 99.4 %.
• Adjusted odds ratio: 0.54 (95 % CI 0.32‑0.87).
• Adjusted ARR: 15.5 % (CI 3.6‑27.1); NNT ≈ 6.5.
• Posterior hazard ratio for survival: 0.68 (95 % CI 0.47‑0.95), probability of benefit 98.8 %.
• Survival Trends: At day 28, 46 % of survivors remained hospitalized and 16 % in ICU; by day 90, 98 % of survivors were discharged.
• Safety Profile:
• SAEs: 30 % (PMX) vs 22 % (control); difference not statistically significant.
• Device‑related SAE rate: 2 % (both resolved and patients discharged).
• Regulatory Outlook: Spectral plans to submit FDA Premarket Approval (PMA) Module 3 for PMX around Apr–May 2026; Vantive will commercialize PMX and EAA in the U.S. if approved.
• Presentation: Results will be presented at the Society of Critical Care Medicine (SCCM) Congress, Chicago, IL on 24 Mar 2026 (Late‑Breaking Studies session).

Notable Quotes

“The detailed analysis… shows that the trial not only achieved its prespecified goal of >95 % posterior probability of benefit for 28‑day mortality… but also demonstrated robust 90‑day results…” – Dr. John Kellum, Chief Medical Officer, Spectral Medical.

“Publication of the Tigris results represents a significant milestone for Spectral as we continue advancing toward our goal of improving outcomes in endotoxic septic shock.” – Chris Seto, CEO, Spectral Medical.