WINNING THE BATTLE AGAINST ENDOTOXIC SEPTIC SHOCK
The first theranostic: EAA™ & Toraymyxin™
Critical Care Reviews Podcast: Tigris Trial
Dr. John A. Kellum joins Professor Rob Mac Sweeney for a detailed discussion on the TIGRIS Trial, hosted by Critical Care Reviews.
In this podcast, they walk through the rationale behind the study, including the role of endotoxin in septic shock and the use of biomarker-guided patient selection. The conversation covers trial design and methodology, including the Bayesian framework and enrichment strategy.
The discussion also explores how the findings may inform clinical thinking, particularly around identifying patients most likely to benefit from targeted intervention, as well as the importance of longer-term outcomes in septic shock, and perspectives on remaining questions and areas for future research as the field continues to move toward more precise, biology-informed approaches in critical care.
🎧Listen to the full podcast
Endotoxic Septic Shock & Precision Medicine
Sepsis is a life-threatening condition caused by the body’s overwhelming response to bacterial components like endotoxin. It remains a major global health challenge, affecting millions each year. If not recognized and treated quickly, sepsis can lead to multiple organ failure, shock, and even death. Importantly, endotoxic septic shock (ESS) is the most malignant form of sepsis with a mortality rate in excess of 50%.
At Spectral Medical Inc., we are committed to fighting endotoxic septic shock with our unique theranostic approach. This strategy combines two critical components: the EAA™ Endotoxin Activity Assay, which enables rapid detection of endotoxin activity, and Toraymyxin™ PMX extracorporeal hemoadsorption therapy, designed to remove endotoxins directly from the bloodstream.
Precision Medicine in Action: The Tigris Trial
Our targeted approach to endotoxic septic shock is demonstrated through the Tigris trial, a pivotal clinical study evaluating PMX therapy for patients with ESS. Our recently announced topline results showed that PMX met its prespecified primary endpoint for 28-day mortality, with a posterior probability of benefit of 95.3%. Observed 28-day mortality in the intention-to-treat cohort was 38.7% with PMX versus 45.1% with standard of care, an absolute difference of 6.4%. The severity-adjusted posterior odds ratio was 0.67 [0.39-1.08] using the Bayesian analysis.
The key secondary endpoint, 90-day mortality, demonstrated even more substantial benefit, with a posterior probability of benefit exceeding 99%, an adjusted odds ratio of 0.54 [0.32-0.87], and a number needed to treat (NNT) of 8.1 to save one life at 90 days. These results highlight the potential of Targeted Rapid Endotoxin Adsorption (TREA) to guide precision, data-driven therapy in the ICU. By identifying patients most likely to benefit, clinicians can deliver interventions that directly address the underlying cause of septic shock, moving beyond generalized treatment protocols. Read the full press release here.
Unite for Sepsis Symposium
Spectral is proud to once again sponsor the Unite for Sepsis Symposium, hosted by Sepsis Alliance.
This important event brings together a global community of clinicians, researchers, innovators, regulators, and advocates, united by a shared goal: advancing how sepsis is understood, identified, and treated.
More than a symposium, Unite for Sepsis continues to serve as a platform for collaboration, innovation, and meaningful progress toward improving outcomes for patients worldwide.
Dates: Thursday, June 11, 2026 – Friday, June 12, 2026
Location: Kellogg Conference Hotel, Capitol Hill at Gallaudet University
Address: 800 Florida Ave NE, Washington, DC, 20002
Latest News
Spectral Medical Announces Participation in the 2026 Bloom Burton & Co. Healthcare Investor Conference
TORONTO, Canada - April 1, 2026 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, will be...
Spectral Medical Announces Fourth Quarter and Fiscal 2025 Results and Provides Corporate Update
TORONTO, Canada – March 26, 2026 - Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today...
Spectral Medical and Vantive Announce Publication of Complete Results from Spectral’s Tigris Trial in the Lancet Respiratory Medicine
Tigris publication confirms positive results for primary and key secondary endpoints with 95.3% and 99.4% probability of benefit for PMX at 28-day and 90-day mortality After adjusting for baseline...
Investor Updates
March 2026 Investor Update
Year-End 2025 Corporate Update and Year in Review Call
Events
Unite for Sepsis Symposium
Spectral Medical Sponsor Innovation Showcase
Presentation details coming soon.
June 11 | 2:30 – 2:45 PM
Kellogg Conference Hotel Capitol Hill at Gallaudet University
Washington, DC
63rd ERA Congress
AKI & Critical Care Nephrology
Session Presentation:
Polymyxin B haemoadsorption in endotoxic septic shock (Tigris): a multicentre, open-label, Bayesian, randomised, controlled, phase 3 trial.
Prof. Dr. Blaithin McMahon
June 4 | 17:15 – 18:15 BST
Scottish Event Campus
Session room: Focussed Oral Room 13
Glasgow, Scotland
ICEOS 2026
International Conference on Extracorporeal Organ Support
Session: Endotoxemia and Sepsis
Moderator: Chawla Perez
Why do we need precision medicine for sepsis?
John Kellum
Results from Tigris —what do they mean?
Javier Neyra
Endotoxin hemoadsorption ready for prime time?
Peter Pickkers
May 8 | 14:40-15:40
Hotel International
Zagreb, Croatia
REPLAYS
SCCM Podcast
Society of Critical Care Medicine:
Endotoxin Activity and Precision Medicine in Septic Shock
March 2026
In a recent Society of Critical Care Medicine podcast, host Marilyn Bulloch, PharmD, BCPS, FCCM, is joined by John A. Kellum, MD, FCCM, to discuss the role of endotoxin activity as a potential endotype in septic shock.
The episode highlights findings from Dr. Kellum’s recent Critical Care Explorations publication examining the relationship between endotoxin activity, organ failure, and mortality in septic shock.
🎧Listen to the full podcast
TIGRIS: A Clinical Trial for Septic Shock With Endotoxemia
Critical Care Canada Forum Keynote Session
Speakers: Dr. Matthieu Legrand Dr. John Kellum Editorial Commentary: Dr. Marlies Ostermann
December 1, 2025
In this session, Dr. Legrand and Dr. Kellum examined the scientific rationale, trial design, and clinical implications of TIGRIS, with a focus on biologically informed patient identification in endotoxic septic shock.
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The role of circulating endotoxin in septic shock pathophysiology
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The importance of identifying patients with endotoxemia
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Considerations in trial design within biologically heterogeneous syndromes
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The potential implications of targeted therapy for clinical practice
As septic shock remains a complex and heterogeneous condition, the TIGRIS trial reflects an ongoing effort to better characterize high-risk patient populations and support a more precise, biology-driven approach to care.
Advancing Therapeutic Options for Sepsis and Endotoxic Septic Shock
Featured on The Balancing Act on Lifetime TV.