WINNING THE BATTLE AGAINST ENDOTOXIC SEPTIC SHOCK

The first theranostic: EAA™ & Toraymyxin™

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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

Spectral team's sepsis awareness day event

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.

 

Spectral team's sepsis awareness day event

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.

Sepsis Alliance Sponsor Badge

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 

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March 2026 Investor Update

Year-End 2025 Corporate Update and Year in Review Call

December 10, 2025

Events

44th Vicenza Course

AKI-CRRT-EBPT and Critical Care Nephrology
June 16 – 18 

AKI Biomarkers and Clinical Trials
Endotoxin: a marker and a target: the TIGRIS trial
Javier Neyra

June 16 | 16:00 | Room Giotto
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Meet the Professor
Dr. Paul Walker explains the origins of the Endotoxin Activity Assay (EAA™)

June 16 | 13:45 | Room Tiziano A
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Hepatorenal Syndrome and Liver Kidney Interaction
Role of endotoxin in HRS-AKI
John Kellum

June 17 | 11:00 | Room Giotto

Vicenza Convention Centre
Vicenza, Italy

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

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.

  • The role of circulating endotoxin in septic shock pathophysiology

  • The importance of identifying patients with endotoxemia

  • Considerations in trial design within biologically heterogeneous syndromes

  • 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.

Watch the Replay

Advancing Therapeutic Options for Sepsis and Endotoxic Septic Shock

Featured on The Balancing Act on Lifetime TV.