Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results from Spectral's Tigris Trial

TORONTO, Canada and DEERFIELD, Ill., USA – June 4, 2026 – 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 mortality data at 12 months for patients enrolled in the Tigris trial. The randomized-controlled trial evaluated the use of Polymyxin B Hemoadsorption (“PMX”) in adults with endotoxic septic shock. 

Endotoxic septic shock is a particularly deadly form of sepsis, occurring in approximately 5-7 million people annually worldwide.¹ There is currently no specific therapy targeting this patient population available in the United States . Complete 28-day and 90-day results of the Tigris trial were published in March of this year in The Lancet Respiratory Medicine. The full Bayesian analysis of Tigris revealed 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. 

As a secondary endpoint of the trial, preplanned follow-up was conducted on all enrolled Tigris study patients to assess vital status at 12 months. Mortality differences observed earlier in the studied persisted through one year, with 12-month mortality of 56/106 (52.8%) in patients treated with PMX compared to 34/51 (66.7%) in patients receiving standard of care alone, representing an absolute risk reduction of 13.9% and a number needed to treat of 7.2. Initial Bayesian statistical analyses based solely on the randomized Tigris trial data, without incorporation of the informative prior from EUPHRATES, demonstrated a 95.9% probability of benefit for PMX at 12 months compared to standard care alone.

Additional analyses are ongoing to include the combination of prior EUPHRATES data in Bayesian and non-Bayesian analyses and survival analyses out to one year. 

“Durability of benefit over the long term is the ultimate goal of any acute therapy. The results announced today clearly indicate that the benefits of PMX therapy observed in Tigris persisted over the months following hospital discharge,” said Dr. John Kellum, Chief Medical Officer of Spectral Medical. “These results provide further evidence of benefit for PMX when used to treat endotoxic septic shock.”  

“One-year results from the Tigris trial provide continued support for PMX and EAA and mark another step forward toward our goal of improving outcomes in endotoxic septic shock,” said Chris Seto, Chief Executive Officer of Spectral Medical. “While many therapies for lethal diseases provide only short-term benefit, PMX has demonstrated a sustained effect on mortality in our phase 3 trial.”

“Septic shock continues to carry a high risk of death despite advances in supportive care,” said Dr. Peter Rutherford, MB BS, PhD., Head of Worldwide Medical at Vantive. “These findings further support the potential role of an endotoxin-targeted therapy in a well-defined, high-risk patient population and reinforce the importance of continued innovation in this space.”  

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 submitted the final Premarket Approval (“PMA”) module (Module 3) for PMX to the FDA on-May 28, 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.

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.

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. 

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, where PMX is licensed but is not yet commercially available. 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.  

Complete results of the Tigris trial appeared in the May 2026 issue of the Lancet Respiratory Medicine²  

The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”.³  

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.