Spectral, Vantive release Tigris results in Lancet

Executive Summary

• Spectral Medical Inc. and Vantive announced the publication of complete results from the Phase 3 Tigris trial in The Lancet Respiratory Medicine, confirming positive primary and key secondary endpoints for Polymyxin B Hemoadsorption (PMX) in adults with endotoxic septic shock.
• The trial demonstrated a 95.3% probability of benefit for 28-day mortality and a 99.4% probability of benefit for 90-day mortality, with significant absolute risk reductions in mortality compared to standard of care.
• Spectral Medical plans to submit the final premarket approval (PMA) module (Module 3) to the FDA around the end of April to mid-May 2026, with Vantive planning to commercialize the therapy in the U.S. upon approval.

Key Details

• Publication: Complete results published in The Lancet Respiratory Medicine, a leading peer-reviewed journal in critical care medicine.
• Trial Design: U.S.-based, multicenter, Phase 3 randomized-controlled trial evaluating PMX in adults with endotoxic septic shock (ESS).
  • Population: 157 patients randomized 2:1 to receive PMX plus standard care (n=106) or standard care alone (n=51).
  • Criteria: ESS defined by endotoxin activity assay (EAA) level between 0.60 and 0.90, plus multiple organ dysfunction (MODS >9 or SOFA >11).
  • Analysis: Bayesian statistical model aligned with FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials.
• Primary Endpoint (28-day mortality):
  • Probability of benefit: 95.3%.
  • Adjusted odds ratio: 0.67 (0.39 to 1.08).
  • Absolute risk reduction: 10.3% (negative 1.7, 22.3).
  • Number Needed to Treat (NNT): 9.7 to prevent one death.
• Key Secondary Endpoint (90-day mortality):
  • Probability of benefit: 99.4%.
  • Adjusted odds ratio: 0.54 (0.32 to 0.87).
  • Absolute risk reduction: 15.5% (3.6, 27.1).
  • Number Needed to Treat (NNT): 6.5 to prevent one death.
  • Posterior hazard ratio for survival: 0.68 (0.47, 0.95); probability of benefit 98.8%.
• Safety Profile:
  • No significant difference in adverse events between PMX and standard of care.
  • Serious adverse events (SAE) occurred in 30% of PMX group vs. 22% of standard care group (not statistically significant).
  • Two subjects (2%) experienced SAEs possibly/probably/definitely related to the intervention; both recovered and were discharged.
• Clinical Outcomes:
  • At day 28, 46% of surviving patients remained hospitalized and 16% remained in the ICU.
  • By day 90, 98% of surviving patients had been discharged from the hospital.
  • Kaplan-Meier curves showed continued separation beyond day 28, indicating sustained survival benefit.
• Regulatory & Commercial Timeline:
  • FDA Submission: Final PMA module (Module 3) for PMX to be submitted to the FDA around the end of April to mid-May 2026.
  • Presentation: Results to be presented at the Society of Critical Care Medicine (SCCM) Congress in Chicago, Ill., on March 24, 2026.
  • Commercialization: Vantive plans to commercialize EAA and PMX in the U.S. upon FDA approval.
• Product Background:
  • PMX (Toraymyxin) is a single-use therapeutic hemoperfusion device that removes endotoxin from the bloodstream.
  • Approved in Japan and Europe; licensed by Health Canada.
  • Over 360,000 units sold worldwide to date.
  • FDA granted Breakthrough Device Designation for PMX in July 2022.

Notable Quotes

• "The detailed analysis in the publication shows that the trial not only achieved its prespecified goal of greater than 95 per cent posterior probability of benefit for 28-day mortality using a Bayesian analysis, but also demonstrated robust 90-day results across multiple sensitivity analyses, confirming a lasting survival benefit." — Dr. John Kellum, Chief Medical Officer, Spectral Medical
• "Publication in The Lancet Respiratory Medicine reflects the scientific rigor of the Tigris trial and the strength of the data supporting these findings... This highlights why longer-term outcomes provide a clearer view of the true impact of therapy in septic shock..." — Dr. Matthieu Legrand, Corresponding Author, Tigris Manuscript
• "The 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... We believe these findings further support our planned FDA PMA submission..." — Chris Seto, Chief Executive Officer, Spectral Medical