Spectral Medical and Vantive Announce Publication of Complete Results from Spectral’s Tigris Trial in The Lancet Respiratory Medicine

Spectral Medical Inc. (“Spectral”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, and Vantive, a vital organ therapy company committed to pursuing novel diagnostic and therapeutic options for organ failure, today announced the publication of the complete results from the Tigris trial in The Lancet Respiratory Medicine, a leading peer-reviewed journal in critical care medicine. The randomized-controlled trial evaluated the use of Polymyxin B Hemoadsorption (“PMX”) in adults with endotoxic septic shock, providing a more complete picture of patient outcomes, including survival and safety over time.

Each year, approximately 5-7 million cases of endotoxic septic shock, a particularly deadly form of sepsis, occur worldwide.¹ Currently, no specific therapy targeting this patient population is available in the United States. The published Tigris trial results confirm the positive primary and key secondary endpoints previously reported in August 2025 and provide additional analyses on longer term survival, safety, and treatment effect. After adjusting for baseline severity, the Tigris trial demonstrated an absolute risk reduction for mortality of 10.3% at 28 days corresponding to a number needed to treat (“NNT”) to prevent one death of 9.7 and 15.5% at 90-days corresponding to a NNT of 6.5.

“We are pleased that the complete results of our Tigris trial are to be published in The Lancet Respiratory Medicine and will be presented at the Society of Critical Care Medicine (“SCCM”) Congress,” said Dr. John Kellum, Chief Medical Officer of Spectral Medical. “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.”

Tigris Trial Overview

The Tigris trial was a U.S.-based, multicenter, Phase 3 study evaluating PMX in adults with endotoxic septic shock (“ESS”), defined by an Endotoxin Activity Assay (“EAA”) level between 0.60 and 0.90. EAA is an FDA cleared, semiquantitative diagnostic test for measurement of endotoxin activity, allowing for rapid measurements to obtain results in approximately 30 minutes. The treating physician can use these results to help inform timely therapeutic decisions.

Eligible patients also had to meet additional criteria for ESS including multiple organ dysfunction; a Multiple Organ Dysfunction Score (“MODS”) >9 or a Sequential Organ Failure Assessment (“SOFA”) score of >11. A total of 157 patients were randomized in a 2:1 ratio to receive either PMX plus standard care (n=106) or standard care alone (n=51).

The prespecified primary analysis used a Bayesian statistical model, which evaluates results in the context of prior data—in this case a subgroup of the prior EUPHRATES trial. The Tigris trial’s design and analysis plan were aligned with published FDA’s Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials.²

The Tigris trial publication appears in The Lancet Respiratory Medicine, a leading peer-reviewed journal in respiratory and critical care medicine.³ The publication includes extensive supplementary analyses, including Kaplan-Meier survival curves, subgroup analyses, and Bayesian sensitivity analyses, providing a comprehensive evaluation of treatment effect across multiple statistical assumptions.

The publication confirms the previously reported positive findings for the primary and key secondary endpoints announced in August 2025, while providing additional analyses on survival, safety, secondary and sensitivity analyses.

Primary Endpoint (28-Day Mortality): 

• Intention to treat cohort showed a probability of benefit of 95.3% at 28 days
• Adjusted odds ratio 0.67 [0.39-1.08]
  • Adjusted probability of benefit from PMX at 28 days exceeds the prespecified 95% target and thus meets the prespecified primary endpoint.
  • Adjusted absolute risk reduction for mortality was 10.3% [-1.7, 22.3] corresponding to a number needed to treat (NNT) to save one life at 28 days of 9.7.

Key Secondary Endpoint (90-Day Mortality): 

• The key secondary endpoint, mortality at 90 days, showed a 99.4% probability of benefit for patients treated with PMX.
• Adjusted odds ratio 0.54 [0.32-0.87]
  • Adjusted absolute risk reduction in mortality was 15.5% [3.6, 27.1] corresponding to a number needed to treat (NNT) to save one life at 90 days of 6.5.
  • 90-day results were robust to all sensitivity analyses and show > 98% probability for benefit at 90 days even for Tigris alone (non-informative prior).
  • Survival over 90 days was significantly greater for patients treated with PMX with a posterior hazard ratio: 0.68 [0.47, 0.95]; probability of benefit 98.8%.

At day 28, nearly half of surviving patients remained hospitalized (46%) and 16% remained in the ICU, reflecting the ongoing clinical instability typical of septic shock patients. By day 90, however, nearly all surviving patients (98%) had been discharged from hospital. Kaplan-Meier survival curves demonstrated continued separation beyond day 28, indicating that the survival benefit observed with PMX was sustained over time.

• Adverse events over the treatment period did not differ between PMX and standard of care.
• A serious adverse event (SAE) occurred in 30 subjects (30%) randomized to PMX and in 11 (22%) randomized to SOC, a difference which is not statistically significant.
• Two subjects (2%) experienced a SAE that was classified as possibly, probably or definitely related to the intervention (PMX, catheter or anticoagulation). Neither was permanent and both subjects were discharged from the hospital.

This safety profile for PMX is consistent with other forms of extracorporeal blood purification therapies commonly used in the ICU, including ICU dialysis.⁴

“Publication in The Lancet Respiratory Medicine reflects the scientific rigor of the Tigris trial and the strength of the data supporting these findings,” said Dr. Matthieu Legrand, corresponding author of the Tigris manuscript. “The manuscript includes extensive analyses beyond the primary endpoint, including adjusted models, survival analyses, and sensitivity analyses, that consistently support the observed treatment effect. Importantly, the study also 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, a condition where recovery from multiple organ failure often extends well beyond the initial ICU phase.”

The Tigris manuscript will be presented during the Late-Breaking Studies Affecting Patient Outcomes session at the Society of Critical Care Medicine (“SCCM”) Critical Care Congress, one of the most influential scientific forums for intensive care physicians worldwide.

• The presentation will take place in Skyline Ballroom, of the McCormick Place convention center in Chicago IL at 10:20AM local time.

Dr. Javier Neyra, first author of the Tigris publication and who will present the Tigris findings at SCCM, commented, “Endotoxic septic shock remains one of the most challenging syndromes in critical care medicine.  Despite decades of research, randomized clinical trials in septic shock have rarely demonstrated improvements in survival.  Septic shock remains one of the leading causes of death in intensive care units worldwide, underscoring the need for therapies that address the underlying drivers of organ failure. Presenting the Tigris results at SCCM provides an important opportunity to engage the global critical care community and discuss how precision medicine and blood purification technologies can be applied to help address this major unmet clinical need.”

“Publication of the Tigris results represents an important milestone in advancing the clinical evidence supporting endotoxin-targeted therapy in septic shock,” said Dr Peter Rutherford, MB BS, PhD., head of Worldwide Medical at Vantive. “Vantive remains committed to supporting research that advances treatment options for critically ill patients and improves outcomes from these complex conditions. Publication of the Tigris randomized trial results provides important clinical evidence to inform treatment decisions at the bedside and support a broader understanding of endotoxin-guided approaches to care.”  

“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,” said Chris Seto, Chief Executive Officer of Spectral Medical. “When considered alongside prior evidence from the EUPHRATES trial and global clinical experience, the totality of data supporting PMX continues to strengthen. Importantly, the safety profile observed in Tigris was consistent with PMX’s historical use with over 360,000 units sold worldwide. We believe these findings further support our planned FDA PMA submission and our efforts to make this therapy available to the patients who need it most.” 

Vantive is Spectral's exclusive distributor of PMX in the U.S. and Canada and has non-exclusive rights to distribute EAA globally.  Spectral Medical intends to submit the final Premarket Approval (“PMA”) module (Module 3) for PMX to the FDA around the end of April to mid-May 2026. If approved by the FDA, Vantive plans to commercialize both EAA and PMX, beginning in the United States, to support Targeted Rapid Endotoxin Adsorption (TREA) Therapy. TREA therapy brings precision medicine to sepsis, delivering rapid, decisive treatment for patients with endotoxic septic shock. 

Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a single-use therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s FDA cleared Endotoxin Activity Assay (EAA™), the clinically available test for endotoxin in blood. EAA™ is also CE marked and licensed by Health Canada. 
 
PMX is approved for therapeutic use in Japan and Europe, licensed by Health Canada, with over 360,000 units sold worldwide to date.  In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year. 
 
The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8.  
 
The trial methods are detailed in  “Bayesian methods: a potential path forward for sepsis trials”.  
 
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com. 

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams globally. For 70 years, our team has driven meaningful innovations in kidney care. Today, Vantive’s people, solutions and services deliver over 1 million touchpoints each day to patients around the world. As we build on our legacy, we are focused on elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Our goal is to provide therapies that fit more easily into providers’ practices and patients’ lives. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. To learn more, visit www.vantive.com and follow us on LinkedIn, X, Facebook, Instagram and YouTube.

Vantive is a trademark of Vantive Health LLC or its affiliates. 

Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected. 

Spectral has not yet received FDA approval for the PMX device. While Spectral believes that a potential PMA from the FDA following the completion of Tigris could be granted in the first quarter of 2027, this is subject to the regulatory approval process. If Spectral is unable to obtain FDA approval for PMX, it will be unable to commercialize the PMX device and generate revenue in the United States which would have material adverse consequences on its business.

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement. 

PMX is not approved for use in the United States. 

EAA Rx Only: For safe and proper use of devices mentioned herein, please refer to User Manual. 

To access the paper, visit https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(26)00047- 0/fulltext.