Spectral Medical's Tigris Trial Shows Significant Mortality Reduction in Endotoxic Septic Shock, Published in The Lancet
Key Insights
Spectral Medical (search)'s Tigris trial demonstrated a 95.3% probability of benefit for 28-day mortality and 99.4% for 90-day mortality using Polymyxin B Hemoadsorption (search) (PMX (search)) in endotoxic septic shock (search) patients.
The study showed absolute risk reduction of 10.3% at 28 days and 15.5% at 90 days, with number needed to treat of 9.7 and 6.5 respectively.
Complete trial results were published in The Lancet Respiratory Medicine, confirming safety profile consistent with standard care and no significant difference in adverse events.
Spectral Medical (search) and Vantive (search) announced the publication of complete results from the Tigris trial in The Lancet Respiratory Medicine, demonstrating significant mortality benefits for patients with endotoxic septic shock (search) treated with Polymyxin B Hemoadsorption (search) (PMX (search)). The randomized controlled trial showed a 95.3% probability of benefit at 28 days and 99.4% at 90 days, meeting prespecified endpoints for this breakthrough device designation therapy.
The Tigris trial evaluated PMX (search) in 157 adults with endotoxic septic shock (search), defined by an Endotoxin (search) Activity Assay (EAA) level between 0.60 and 0.90. Patients were randomized 2:1 to receive either PMX plus standard care (n=106) or standard care alone (n=51). All patients had multiple organ dysfunction (search) with a Multiple Organ Dysfunction Score >9 or Sequential Organ Failure Assessment score >11.
Primary and Secondary Endpoints Achieved
The trial's primary endpoint demonstrated a 95.3% probability of benefit for 28-day mortality, exceeding the prespecified 95% target. After adjusting for baseline severity, the absolute risk reduction for mortality was 10.3% at 28 days, corresponding to a number needed to treat (NNT) of 9.7 to prevent one death.
The key secondary endpoint showed even stronger results at 90 days, with a 99.4% probability of benefit for patients treated with PMX (search). The adjusted absolute risk reduction in mortality was 15.5% at 90 days, corresponding to an NNT of 6.5. These 90-day results remained robust across all sensitivity analyses, showing greater than 98% probability for benefit even when analyzed independently of prior data.
"The detailed analysis in the publication shows that the trial not only achieved its prespecified goal of >95% 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," said Dr. John Kellum, Chief Medical Officer of Spectral Medical (search).
Sustained Survival Benefits Over Time
Kaplan-Meier survival curves demonstrated continued separation beyond day 28, indicating that the survival benefit observed with PMX (search) was sustained over time. At day 28, nearly half of surviving patients (46%) remained hospitalized and 16% remained in the ICU, reflecting the ongoing clinical instability typical of septic shock (search) patients. By day 90, however, nearly all surviving patients (98%) had been discharged from hospital.
Dr. Matthieu Legrand, corresponding author of the Tigris manuscript, explained the clinical significance: "The study illustrates that many patients remain clinically unstable at 28 days – nearly half of survivors were still hospitalized and a meaningful proportion remained in the ICU. By contrast, by 90 days almost all surviving patients had been discharged, and it appears organ dysfunction had largely resolved. This highlights why longer-term outcomes provide a clearer view of the true impact of therapy in septic shock (search)."
Safety Profile Consistent with Standard Care
The safety analysis showed adverse events over the treatment period did not differ between PMX (search) and standard of care. A serious adverse event occurred in 30 subjects (30%) randomized to PMX and in 11 (22%) randomized to standard care, a difference that was not statistically significant. Only two subjects (2%) experienced a serious adverse event classified as possibly, probably or definitely related to the intervention, neither was permanent, and both subjects were discharged from the hospital.
Addressing Critical Unmet Medical Need
Endotoxic septic shock (search) affects approximately 5-7 million cases worldwide annually, representing a particularly deadly form of sepsis (search). Currently, no specific therapy targeting this patient population is available in the United States. The condition remains one of the leading causes of death in intensive care units worldwide.
"Endotoxic septic shock (search) remains one of the most challenging syndromes in critical care medicine. Despite decades of research, randomized clinical trials in septic shock (search) have rarely demonstrated improvements in survival," commented Dr. Javier Neyra, first author of the Tigris publication.
Regulatory Timeline and Commercialization Plans
Following recent FDA interaction, Spectral now expects to submit its final Premarket Approval (PMA) module around the end of April to mid-May 2026, compared to its previously disclosed target of Q1 2026. The updated timing reflects ongoing FDA feedback to incorporate complete 12-month mortality data from the Tigris study into the PMA submission.
"We continue to work constructively with the FDA to ensure a high-quality PMA submission," said Chris Seto, Chief Executive Officer of Spectral Medical (search). "The inclusion of longer-term mortality data and completion of the remaining non-clinical components are intended to support a comprehensive submission and will position PMX (search) for an efficient review process."
Vantive (search) serves as Spectral's exclusive distributor of PMX (search) in the U.S. and Canada and has non-exclusive rights to distribute EAA globally. If approved by the FDA, Vantive plans to commercialize both EAA and PMX to support Targeted Rapid Endotoxin (search) Adsorption (TREA) Therapy, bringing precision medicine to sepsis (search) treatment.
PMX (search) is already approved for therapeutic use in Japan and Europe, licensed by Health Canada, with over 360,000 units sold worldwide to date. The device received FDA Breakthrough Device Designation in July 2022 for the treatment of endotoxic septic shock (search), recognizing its potential to address a significant unmet medical need affecting approximately 330,000 patients diagnosed with septic shock (search) in North America each year.