- Results exceed prespecified primary endpoint of 95% posterior probability of benefit for PMX on 28-day mortality
- Pooled absolute risk reduction of 8.3%; Relative risk reduction of 18%
- Key secondary endpoint: 90-day Mortality 17.4% lower with PMX and >99% posterior probability of benefit
- 38.7% Mortality at 28 days with PMX confirms results of prior trial subset
TORONTO, Ontario and DEERFIELD, Ill., Aug. 12, 2025 (GLOBE NEWSWIRE) -- 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 topline results from the Tigris trial. This Phase 3 follow-on study sponsored by Spectral evaluated the use of Polymyxin B Hemoadsorption ("PMX") in a randomized clinical trial of adults treated for endotoxic septic shock.
Each year, approximately 5-7 million cases of endotoxic septic shock, a particularly deadly form of sepsis, occur worldwide.1 Today, there is no specific therapy targeting this patient population currently available in the United States. The Tigris trial was a U.S.-based, multicenter, randomized, controlled Phase 3 study evaluating PMX in adults with endotoxic septic shock, defined by an Endotoxin Activity Assay ("EAA") level between 0.60 and 0.90. EAA is an FDA approved, semiquantitative 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 criteria for multiple organ dysfunction, including 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 primary endpoint-28-day all-cause mortality-was evaluated using a prespecified Bayesian statistical model, which evaluates results in the context of prior probability. The model incorporated data from 179 patients in the previously conducted EUPHRATES trial alongside the data from the Tigris trial. The EUPHRATES trial was conducted in North America and examined the impact of PMX on mortality in patients with septic shock and endotoxemia. The goal of the Tigris trial was to confirm the benefit of PMX hemoadsorption in patients with endotoxic septic shock, defined by EAA 0.60 but < 0.90. 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
Key Findings of the Tigris Trial and Bayesian Analysis:
The purpose of Bayesian analysis is to update prior evidence with new trial data, producing a 'posterior probability' that reflects the most current and complete picture of the treatment effect. Results are presented for adjusted and unadjusted analyses. Consistent with expert recommendations and the FDA's guidance on clinical trials, the adjusted analysis is used to account for baseline prognostic covariates such as severity of illness and comorbidities - which provides a more precise estimate of the true treatment effect. Unadjusted analyses do not account for these important differences.
Primary Endpoint (28-Day Mortality):
- Intention to treat cohort showed a posterior probability of benefit of 95.3% at 28 days
- Adjusted odds ratio 0.67 [0.39-1.08]
- Adjusted posterior probability of benefit from PMX at 28 days exceeds the prespecified 95% target and thus meets the prespecified primary endpoint.
- Observed 28-day mortality for Tigris was 38.7% with PMX vs 45.1% with standard of care - 6.4% absolute difference.
- Unadjusted absolute risk reduction from the posterior distribution was 8.3% [-2.1%, 19.7%] representing a 18% relative risk reduction, posterior probability 92.3%.
- Observed 28-day mortality from the modified intention to treat population (includes 100 PMX and 51 control patients receiving any assigned treatment) was 37.0% with PMX vs 45.1% with standard of care - 8.1% absolute difference.
Key Secondary Endpoint (90-Day Mortality):
- The key secondary endpoint, mortality at 90 days, showed a >99% posterior probability of benefit for PMX.
- Adjusted odds ratio 0.54 [0.32-0.87]
- Adjusted posterior probability of benefit from PMX at 90 days was 99.4%.
- Observed mortality at 90 days (Tigris alone): 43.4% with PMX vs. 60.8% with standard of care - 17.4% absolute difference.
- Unadjusted absolute risk reduction from the posterior distribution was 12.3% [0.76%, 23.7%] representing a 20.2% relative risk reduction, posterior probability 98.3%.
- Resultant number needed to treat ("NNT") to save 1 life at 90 days is 8.1.
Dr. John Kellum, Chief Medical Officer of Spectral Medical, commented, "We are pleased to announce that the fully adjusted Bayesian analysis met our prespecified goal of >95% posterior probability of benefit for 28-day mortality. As we explained in our November 14, 2023 press release, our published simulations involving over 2,000 potential trial results found an observed absolute risk reduction for mortality in the range of 6 - 7% in Tigris would meet this bar. Final results from Tigris indicate that our observed 6.4% difference yields a 95.3% posterior probability and thus exceeds this threshold. Furthermore our 90 days results provide important confirmation that benefits with PMX are persistent."
Professor Claudio Ronco, Director of the International Renal Research Institute of Vicenza IRRIV and world-renowned expert in blood purification for sepsis, commented, "The results that we see today are a clear confirmation of what we observed more than 16 years ago with the EUPHAS trial. Tigris, together with a subset of patients from EUPHRATES indicate that hemoadsorption therapy with PMX can be effective if we select the correct population. Like in EUPHAS, patients in the Tigris trial have a 28-day mortality of approximately 50% unless treated with PMX. The benefit for survival from PMX becomes even more dramatic at 90 days where it exceeds 17%. This is not unexpected as today many patients can be maintained on life support for more than 28 days - as such, longer term survival is a more accurate reflection of benefit."
Dr. Danielle Davison, Professor of Anesthesiology and Critical Care Medicine and Director of the Intensive Care Unit, George Washington University, Washington, DC, commented, "Having participated in both EUPHRATES and Tigris, it is particularly satisfying to see these final results. We look forward to having this therapy available for our patients."
"Vantive is committed to supporting clinical research to advance therapy innovation and expand access to care for critically ill patients," said Professor Peter Rutherford, Head of Worldwide Medical at Vantive. "We are encouraged by these results, and look forward to continuing to work toward addressing unmet clinical needs and improving outcomes for patients affected by endotoxic septic shock."
"The results from Tigris represent 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 real-world global 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. 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 by end of October 2025. 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.
Full results from the Tigris trial will be submitted for presentation at an upcoming major medical conference and for publication in a peer-reviewed journal later this year.
Spectral Medical Tigris Trial Topline Results Call
Chris Seto, Chief Executive Officer, and Dr. John Kellum, Chief Medical Officer, will host the call followed by a question-and-answer session. All interested parties are invited to participate.
CONFERENCE CALL DETAILS:
Date: Wednesday, August 13, 2025
Time: 8:30 a.m. ET
Dial-in: 1-877-407-0792 or 1-201-689-8263
Call me: https://callme.viavid.com/viavid/?callme=true&passcode=13744665&h=true&info=company&r=true&B=6
Participants can use Guest dial-in s above and be answered by an operator OR click the Call me link for instant telephone access to the event. *Available 15 minutes prior to scheduled start time.
Replay Dial-in: 1-844-512-2921 or 1-412-317-6671
Available 1:00 p.m. ET, Wednesday, August 13, 2025, until 11:59 p.m. ET, Wednesday, August 27, 2025
Conference ID: 13755395
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.
Vantive is a trademark of Vantive Health LLC or its affiliates.
About Spectral
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, and has been used safely and effectively 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.
About Vantive
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.
Forward-looking statement and Disclaimer
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 clearance for the PMX device. While Spectral believes that a potential PMA from the FDA following the completion of Tigris could be granted in the second half of 2026, the regulatory approval process of the FDA is lengthy, time consuming and inherently unpredictable. If Spectral is unable to obtain FDA clearance 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.
- Kellum J, Ronco C. The role of endotoxin in septic shock. Crit Care 2023;27(1):400.
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-use-bayesian-statistics-medical-device-clinical-trials
For further information, please contact:
| Spectral Medical Inc. | ||
| Ali Mahdavi | Chris Seto | |
| Capital Markets & Investor Relations | CEO | |
| Spinnaker Capital Markets Inc. | cseto@spectraldx.com | |
| 416-962-3300 | ||
| am@spinnakercmi.com | ||
Vantive Katie Villany Media@vantive.com |
