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

Executive Summary

• Spectral Medical announced 12-month mortality data from its Phase 3 Tigris trial, demonstrating a statistically significant and durable reduction in mortality for patients with endotoxic septic shock treated with Polymyxin B Hemoadsorption (PMX) compared to standard of care.
• The 12-month analysis showed a 52.8% mortality rate with PMX versus 66.7% with standard care alone, yielding a 13.9% absolute risk reduction and a number needed to treat (NNT) of 7.2, with a 95.9% Bayesian probability of benefit.
• Spectral submitted the final PMA Module 3 to the FDA on May 28, 2026, targeting potential approval in Q1 2027, while additional Bayesian and non-Bayesian analyses incorporating prior EUPHRATES trial data are currently underway.

Key Details

• Trial Design: Tigris is a U.S.-based, multicenter, Phase 3, 2:1 randomized controlled trial using Bayesian statistics, enrolling 150 adults with endotoxic septic shock (ESS) defined by an Endotoxin Activity Assay (EAA) level between 0.60 and 0.90.
• 12-Month Mortality Outcomes: 56/106 (52.8%) mortality in the PMX arm vs. 34/51 (66.7%) in the standard of care arm.
• Statistical Metrics: 13.9% absolute risk reduction (ARR) and a Number Needed to Treat (NNT) of 7.2 to prevent one death at 12 months.
• Bayesian Analysis: 95.9% probability of benefit for PMX at 12 months based solely on Tigris trial data, independent of prior studies.
• Prior Trial Results: 28-day ARR of 10.3% (NNT 9.7) and 90-day ARR of 15.5% (NNT 6.5), previously published in The Lancet Respiratory Medicine.
• Regulatory Status: Final PMA Module 3 submitted to the FDA on May 28, 2026. FDA approval is anticipated in Q1 2027, contingent on regulatory review.
• Commercialization & Distribution: Vantive holds exclusive U.S. and Canadian distribution rights for PMX and non-exclusive global rights for EAA. Vantive plans to commercialize both products in the U.S. under the Targeted Rapid Endotoxin Adsorption (TREA) Therapy platform.
• Product Background: PMX (Toraymyxin) is a single-use hemoperfusion device approved in Japan and Europe and licensed in Canada, with over 360,000 units sold globally. It received FDA Breakthrough Device Designation in July 2022.
• Ongoing Analyses: Additional Bayesian and non-Bayesian survival analyses will incorporate prior data from the EUPHRATES trial to further evaluate long-term efficacy.

Notable Quotes

• Dr. John Kellum, Chief Medical Officer, Spectral Medical: “Durability of benefit over the long term is the ultimate goal of any acute therapy. The results announced today clearly indicate that the benefits of PMX therapy observed in Tigris persisted over the months following hospital discharge.”
• Chris Seto, CEO, Spectral Medical: “One-year results from the Tigris trial provide continued support for PMX and EAA and mark another step forward toward our goal of improving outcomes in endotoxic septic shock... While many therapies for lethal diseases provide only short-term benefit, PMX has demonstrated a sustained effect on mortality in our phase 3 trial.”
• Dr. Peter Rutherford, Head of Worldwide Medical, Vantive: “Septic shock continues to carry a high risk of death despite advances in supportive care... These findings further support the potential role of an endotoxin-targeted therapy in a well-defined, high-risk patient population and reinforce the importance of continued innovation in this space.”