Silicon Investor - Spectral Medical Inc.

[Sultan] A major milestone Spectral Medical Announces U.S. FDA Filing of PMA Applicatio...

Sultan — 6/25/2026 12:39:44 PM

A major milestone

Spectral Medical Announces U.S. FDA Filing of PMA Application for PMX

TORONTO, June 25, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc. ("Spectral" or the "Company") (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that the U.S. Food and Drug Administration ("FDA") has completed its filing review and formally filed the Company's Premarket Approval ("PMA") application for PMX, the Company's endotoxin removal therapy for patients with endotoxic septic shock ("ESS").

FDA acceptance for filing of the PMA application follows completion of the Agency's filing review process and confirms that the application contains all the information needed to proceed with the substantive review. The PMA application includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral's FDA-cleared Endotoxin Activity Assay ("EAA™").

"The FDA's filing of our PMA application represents a defining milestone for Spectral and reflects years of focused clinical, regulatory and operational execution," said Chris Seto, Chief Executive Officer of Spectral. "We believe the totality of evidence supporting PMX demonstrates the potential for a targeted therapy approach in endotoxic septic shock, an area of critical unmet medical need with limited therapeutic innovation over the past several decades. We have worked closely with the FDA throughout the PMA process and have been deliberate in assembling what we believe is a complete and compliant application. We look forward to continuing our engagement with the Agency during the review process."

John A. Kellum, Chief Medical Officer of Spectral, added, "Endotoxic septic shock remains one of the most challenging conditions encountered in critical care medicine, with persistently high mortality despite advances in supportive care. The Tigris trial further strengthens the clinical evidence supporting PMX and the importance of identifying patients with elevated endotoxin activity using EAA™. We are grateful to the investigators, research coordinators and patients who participated in the clinical development of PMX and helped advance this important work. We are encouraged to have reached this important stage of the regulatory process."

As previously announced, the Tigris trial met its pre-specified primary endpoint, demonstrating a 95.3% probability of benefit for 28-day all-cause mortality in the adjusted analysis, as well as a greater than 99% probability of benefit at 90 days. Complete results of Tigris trial out to 90 days were published in March of this year in the journal 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. Long-term follow-up demonstrated that the survival benefit observed at 90 days persisted through 12 months, with mortality rates of 52.8% in PMX-treated patients compared to 66.7% in the standard-of-care group, representing an absolute risk reduction of 13.9%.

The FDA's filing of the PMA application initiates the substantive review phase of the PMA process. Spectral will continue to work closely with the Agency throughout the review and will provide updates as appropriate.

About the Tigris Trial

Tigris was a confirmatory Phase 3 study evaluating PMX in addition to standard care versus standard care alone in adult patients with endotoxic septic shock and elevated endotoxin activity levels measured using EAA™. The trial was designed as a 2:1 randomized study of 150 patients utilizing a Bayesian statistical framework.

As previously reported, the adjusted analyses demonstrated:

95.3% probability of benefit for 28-day all-cause mortality;
Greater than 99% probability of benefit for 90-day mortality; and
A favorable safety profile consistent with prior PMX studies and clinical experience.

Complete results from the Tigris Trial appeared in the May 2026 issue of The Lancet Respiratory Medicine, and the trial methodology is further detailed in " Bayesian methods: a potential path forward for sepsis trials"

finance.yahoo.com

[Sultan] After Three Decades of Negative Trials, Endotoxin Removal in Septic Shock Just G...

Sultan — 6/8/2026 12:35:24 PM

After Three Decades of Negative Trials, Endotoxin Removal in Septic Shock Just Got Its First Positive Phase 3 RCT

linkedin.com

[Sultan] Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Sp...

Sultan — 6/4/2026 12:00:25 PM

Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results From Spectral’s Tigris Trial

Spectral Medical Inc.

100% follow-up achieved for all 157 patients enrolled in the Tigris trial
Mortality at 12 months was 52.8% with PMX vs. 66.7% with standard of care alone (absolute risk reduction of 13.9%; number needed to treat of 7.2)
95.9% probability of benefit for PMX at 12 months, independent of prior clinical studies (Tigris data alone)
Additional Bayesian and non-Bayesian analyses will be performed including incorporation of prior data from EUPHRATES

TORONTO and DEERFIELD, Ill., June 04, 2026 (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 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.

Initial 12 Month Follow-up Results:

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 study 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.

About the Tigris Trial

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.

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, 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.

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.

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

finance.yahoo.com

[Sultan] Spectral Medical Announces PMA Submission to U.S. FDA for PMX TORONTO, May 29...

Sultan — 5/29/2026 12:26:52 PM

Spectral Medical Announces PMA Submission to U.S. FDA for PMX

TORONTO, May 29, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for PMX, the Company’s endotoxin removal therapy for patients with endotoxic septic shock (“ESS”).

The PMA submission includes clinical, non-clinical, manufacturing and quality system information supporting the use of PMX in adult patients with ESS identified using Spectral’s FDA-cleared Endotoxin Activity Assay (“EAA™”).

The submission is supported by data from the Company’s Tigris trial, a Phase 3 follow-on study evaluating PMX in patients with ESS. As previously announced, complete results of the Tigris trial out to 90 days were published in March of this year in the journal The Lancet Respiratory Medicine and demonstrated a 95.3% posterior probability of benefit for 28-day all-cause mortality in the full adjusted Bayesian analysis, as well as a greater than 99% posterior probability of benefit at 90 days. This analysis 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.

“This PMA submission represents a defining milestone for Spectral and reflects years of focused clinical, regulatory and operational execution,” said Chris Seto, Chief Executive Officer of Spectral. “We believe the totality of evidence supporting PMX demonstrates that a targeted therapy for endotoxic septic shock is beneficial. This is an area of critical unmet medical need with limited therapeutic innovation over the past several decades. We have worked closely with the FDA throughout the PMA process and have been deliberate in assembling what we believe is a complete and compliant submission package. We look forward to continuing our engagement with the Agency during the review process.”

John A. Kellum, Chief Medical Officer of Spectral, added, “Endotoxic septic shock remains one of the most challenging conditions encountered in critical care medicine, with persistently high mortality despite advances in supportive care. The Tigris trial further strengthens the clinical evidence supporting PMX and the importance of identifying patients with elevated endotoxin activity using EAA™. We are grateful to the investigators, research coordinators and patients who participated in the clinical development of PMX and helped advance this important work.”

About the Tigris Trial

Tigris was a confirmatory Phase 3 study evaluating PMX in addition to standard care versus standard care alone in adult patients with endotoxic septic shock and elevated endotoxin activity levels measured using EAA™. The trial was designed as a 2:1 randomized study of 150 patients utilizing a Bayesian statistical framework.

As previously reported, the baseline severity-adjusted analyses demonstrated:

95.3% probability of benefit for 28-day all-cause mortality;
Greater than 99% probability of benefit for 90-day mortality; and
A favorable safety profile consistent with prior PMX studies and clinical experience.

Complete results from the Tigris Trial appeared in the May 2026 issue of The Lancet Respiratory Medicine, and the trial methodology is further detailed in “ Bayesian methods: a potential path forward for sepsis trials”.

[Sultan] What most people misunderstand about sepsis health.yahoo.com

Sultan — 5/25/2026 11:52:24 AM

[Sultan] A new publication in the Journal of Anesthesia, Analgesia and Critical Care disc...

Sultan — 5/12/2026 1:03:42 PM

A new publication in the Journal of Anesthesia, Analgesia and Critical Care discusses the broader implications of the TIGRIS trial and the evolving role of precision medicine in sepsis.

The paper highlights how TIGRIS moved beyond traditional syndrome-based trial design by applying a biologically informed approach to patient selection in Endotoxic Septic Shock (ESS).

Rather than enrolling broad septic shock populations, TIGRIS integrated both endotoxin activity (EAA) and organ dysfunction severity (SOFA/MODS) to identify a population with measurable endotoxemia and significant, but potentially reversible, organ dysfunction.

The publication highlights several important considerations for precision medicine in sepsis:

• Biological heterogeneity may help explain why many previous sepsis trials failed to demonstrate benefit despite strong mechanistic rationale

• Precision approaches may require alignment between therapeutic mechanism, biological burden, disease severity, and timing of intervention

• TIGRIS was designed around the concept of a clinically meaningful therapeutic window, excluding patients with either minimal endotoxemia or overwhelming, potentially irreversible disease

• Biomarker-guided enrichment strategies may support future development of targeted interventions in septic shock and critical care

The authors also emphasize the need for continued prospective validation, assay standardization, workflow integration, and further peer-reviewed analyses as precision medicine strategies in sepsis continue to evolve.

As understanding of sepsis biology advances, TIGRIS contributes to the growing discussion around theranostic and biology-informed approaches in critically ill patients.

Read the full publication: linkedin.com

[Sultan] Early timing continues to emerge as a meaningful variable in extracorporeal ther...

Sultan — 5/6/2026 12:56:53 PM

Early timing continues to emerge as a meaningful variable in extracorporeal therapies for septic shock.

A meta-analysis examining Polymyxin B hemoperfusion highlights the potential impact of initiating treatment within the first hours of shock onset.

What the analysis showed:
• Lower mortality with earlier treatment compared to delayed initiation
• Improved oxygenation (PaO2/FiO2)
• Faster resolution of organ dysfunction, reflected by reductions in SOFA scores

These findings reinforce a broader theme in critical care: timing and patient selection may be as important as the intervention itself.

While heterogeneity and sample size remain limitations, the signal is consistent with a biology- and timing-informed approach to therapy.

SCCM 2026 Abstract: https://lnkd.in/eb_JgVfu

PMX hemoperfusion is approved for use in Japan and Europe and is available in Canada. In the United States, PMX was evaluated in the Phase 3 TIGRIS trial and is currently being prepared for PMA submission.

[Sultan] Tigris Trial Apr 30, 2026 Rob Mac Sweeney discusses the Tigris Trial with chie...

Sultan — 5/2/2026 1:20:23 PM

Tigris Trial

Apr 30, 2026

Rob Mac Sweeney discusses the Tigris Trial with chief investigator John Kellum. Tigris investigated the efficacy of polymyxin B haemoadsorption in endotoxic septic shock. It was published in Lancet Respiratory Medicine in March, 2026.

ccrpodcast.libsyn.com

[Sultan] Septic shock remains a challenge due to its immense heterogeneity, while some pa...

Sultan — 4/15/2026 12:43:07 PM

Septic shock remains a challenge due to its immense heterogeneity, while some patients stabilize with supportive care, others rapidly progress to multiorgan failure. How do we identify those at the highest risk?

In this episode of the Society of Critical Care Medicine Podcast, our CMO Dr. John Kellum joins host Marilyn Bulloch, PharmD, to discuss a potential endotype for septic shock: High Endotoxin Activity.

Drawing from his research published in Critical Care Explorations, Dr. Kellum explains how the Endotoxin Activity Assay (EAA), when combined with organ failure clinical data, can identify a specific high-risk subgroup. In his study, patients with this profile faced a mortality rate of 60%.

The Path to Precision Medicine: Though endotoxic septic shock represents roughly a quarter of cases, segmenting these patients is a vital step toward precision medicine. Identifying these treatable subgroups allows for better diagnostics and the future development of targeted therapies.

Listen to the full discussion on the SCCM Podcast: https://lnkd.in/eDWMfPHj

[Sultan] Filtering Endotoxin in Septic Shock — Is Tigris a Practice Changer? youtube...

Sultan — 4/1/2026 2:03:58 AM

Filtering Endotoxin in Septic Shock — Is Tigris a Practice Changer?

youtube.com

[Sultan] Spectral Medical (TSX: EDT) posts C$2.44m revenue as PMA submission slips to May...

Sultan — 3/26/2026 1:55:14 PM

Spectral Medical (TSX: EDT) posts C$2.44m revenue as PMA submission slips to May 2026 and derivative liabilities widen the reported loss

Spectral Medical (EDT) reports C$2.44M revenue and shifts PMX PMA submission to May 2026. Tigris trial data in The Lancet strengthens FDA case.

Read more.

business-news-today.com

[Sultan] Vantive is Spectral's exclusive distributor of PMX in the U.S. and Canada and ha...

Sultan — 3/24/2026 1:42:01 PM

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.

[Sultan] Spectral Medical and Vantive Announce Publication of Complete Results from Spect...

Sultan — 3/24/2026 1:07:41 PM

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

spectraldx.com

[Sultan] At #SCCM2026: Late-Breaking Studies Affecting Patient Outcomes II Join this im...

Sultan — 3/23/2026 1:00:12 PM

At #SCCM2026: Late-Breaking Studies Affecting Patient Outcomes II

Join this important session highlighting emerging data shaping how we understand and manage critical illness, from socioeconomic determinants of outcomes to real-time subphenotyping and targeted approaches in septic shock.

Late-Breaking Studies Affecting Patient Outcomes II
March 24 | 9:45–10:45 AM CT
Skyline Ballroom, W375D, McCormick Place, Chicago, IL

Notably, new findings will be presented on polymyxin B hemoadsorption in endotoxic septic shock, contributing to the evolving discussion around precision medicine in critical care.

A session worth attending for clinicians interested in the future of individualized therapy in sepsis.

Register: buff.ly

[Sultan] Now available: SCCM Podcast on Endotoxin Activity and Precision Medicine in Sept...

Sultan — 3/10/2026 1:18:54 PM

Now available: SCCM Podcast on Endotoxin Activity and Precision Medicine in Septic Shock

Septic shock remains one of the most biologically heterogeneous syndromes encountered in the ICU. While some patients stabilize with supportive care, others rapidly progress to multiorgan failure.

In a recent Society of Critical Care Medicine ( hashtag#SCCM) podcast, Dr. John A. Kellum joins host Marilyn Bulloch, PharmD, BCPS, FCCM, to discuss emerging insights into endotoxin activity as a potential endotype in septic shock.

The discussion highlights findings from Dr. Kellum’s recent publication in Critical Care Explorations examining the relationship between endotoxin activity, organ failure, and mortality.

Key points from the conversation:
• Septic shock outcomes vary widely, reflecting underlying biological heterogeneity
• Elevated endotoxin activity, when combined with organ dysfunction, may identify a high-risk subgroup of patients
• In the study cohort, patients meeting these criteria experienced mortality rates approaching 60%

Understanding the biological drivers of septic shock may help move critical care toward more precise patient characterization and treatment strategies.

?? Listen to the full SCCM podcast here: buff.ly

Reference:
Organ Failure, Endotoxin Activity, and Mortality in Septic Shock. Critical Care Explorations, 2025. buff.ly

[Sultan] This analyst loves Spectral Medical Research Capital analyst Andre Uddin maint...

Sultan — 3/3/2026 2:11:48 PM

This analyst loves Spectral Medical

Research Capital analyst Andre Uddin maintained his “Speculative Buy” rating and C$3.50 price target on Spectral Medical

cantechletter.com

[Sultan] The CCCF 2025 keynote session, TIGRIS: A Clinical Trial for Septic Shock with En...

Sultan — 2/24/2026 3:03:53 PM

The CCCF 2025 keynote session, TIGRIS: A Clinical Trial for Septic Shock with Endotoxemia, is now available to watch!

In this session from the Critical Care Canada Forum, Dr. Matthieu Legrand and Dr. John Kellum examine the scientific rationale, trial design, and clinical implications of the TIGRIS trial in patients with endotoxic septic shock, with editorial commentary from Dr. Marlies Ostermann.

The discussion explores:
• The role of circulating endotoxin in septic shock
• Biologic heterogeneity and patient identification
• Considerations in targeted therapy trials
• Implications for precision approaches in critical care

As septic shock remains a complex and heterogeneous syndrome, advancing biologically informed strategies may help refine how high-risk patients are characterized and studied.

Watch the full keynote replay here: buff.ly

[Sultan] TIGRIS and EUPHRATES eventually join and provide new evidence: a narrative revie...

Sultan — 1/14/2026 12:15:50 PM

TIGRIS and EUPHRATES eventually join and provide new evidence: a narrative review of the polymyxin B hemoperfusion

link.springer.com

[Sultan] Effects on mortality of blood purification techniques in severe septic shock pat...

Sultan — 12/31/2025 12:45:09 PM

Effects on mortality of blood purification techniques in severe septic shock patients. An updated Bayesian network meta-analysis of randomized controlled trials

sciencedirect.com

[Sultan] The topline results from the Tigris trial mark an important step forward in adva...

Sultan — 10/13/2025 1:11:06 PM

The topline results from the Tigris trial mark an important step forward in advancing sepsis care. As with earlier studies, the findings highlight the potential of PMX hemoadsorption in the correct patient population.

Dr. Danielle Davison, Professor of Anesthesiology and Critical Care Medicine and Director of the Intensive Care Unit at George Washington University, shared her perspective:

“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.”

Dr. Davidson’s words emphasize both the continuity of rigorous research and the anticipation of making targeted therapies accessible to the patients who need them most.

buff.ly

[Sultan] Join the Sepsis Alliance Institute for an in-depth exploration of the TIGRIS tri...

Sultan — 10/9/2025 12:38:49 PM

Join the Sepsis Alliance Institute for an in-depth exploration of the TIGRIS trial in the Vantive-sponsored webinar: TIGRIS Unlocked: Evidence to Impact

Dr. Jonathan Eaton, Critical Care Specialist at LSU Health Shreveport, will guide attendees through a patient journey, sharing real-world challenges in managing endotoxic septic shock, insights on emerging therapies, and how his involvement in the TIGRIS trial has shaped his bedside practice.

Don’t miss this timely session on one of today’s important and evolving topics in sepsis management.

Tuesday, October 14 at 12:00 PM (PDT)
Register lnkd.in

[Sultan] Looks like Vantive is going full speed ahead to be ready to launch if and when F...

Sultan — 10/3/2025 3:12:22 PM

Looks like Vantive is going full speed ahead to be ready to launch if and when FDA approves it.. We are of course talking about recently concluded TIGRIS Phase III Trial re. Sepsis

Vantive Hiring Associate Director, Sepsis – US Marketing

jobs.vantive.com

Associate Director, Sepsis – US Marketing
Req # JR - 187641
Location Deerfield, Illinois
Job Category Marketing
Date posted 09/29/2025

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your role at Vantive

Vantive is seeking an Assoc. Director of US Marketing, who will be responsible for the planning, coordination, and execution of launch for our next generation sepsis offering, ensuring that the launch strategy is customer focused and commercially impactful. The Associate Director will partner closely with global marketing, sales, medical affairs, market access, regulatory, legal, and operations teams to deliver a best in class launch that establishes Vantive as a leader in the category.

What you’ll be doing:

- Develop and execute a comprehensive launch/marketing plan, including positioning, branding, messaging, and go-to-market strategy, integrating strategies and initiatives from Medical Affairs and Market Access to accelerate therapy adoption.

- Build and refine the financial forecast, pricing strategy, and long-range plan.

- Demonstrate high caliber project management skills & drive accountability with cross-functional stakeholders through multiple project stage gates, including strategic alignment, market assessment, operational readiness, pre-launch execution, go-live, and post-launch performance tracking.

- Translate complex customer, market, and competitive insights into actionable launch strategies that drive adoption.

- Build, further develop, and leverage relationships with physicians, hospitals, and advocacy groups to validate assumptions, and to support education and awareness leading up to, and after the launch.

- Work with internal stakeholders and third-party creative agencies to plan, create, and launch campaigns / compelling stories around the value propositions and messaging that will resonate with target audiences.

- Oversee development of sales training, promotional materials, and medical education initiatives to support consistent, aligned, and on-brand promotion.

- Ensure supply chain, distribution, and customer service readiness ahead of launch.

- Define pre-launch and launch KPI’s; deliver dashboard and reporting tools to track financial and operational KPIs.

- Maintain ongoing ownership of P&L and scenario modeling through launch; validating and adjusting financial forecasts based on wins, customer feedback, and market dynamics.

- Conduct executive reviews pre and post launch to assess performance and define corrective action planning and/or growth initiatives.

[Sultan] Spectral Medical Announces Publication of EDEN Observational Study New Study St...

Sultan — 9/16/2025 9:23:36 PM

Spectral Medical Announces Publication of EDEN Observational Study

New Study Strengthens Rationale for Spectral’s PMX Therapy by Defining Endotoxic Septic Shock (ESS) as the Highest-Risk Patient Group

TORONTO, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today highlighted newly published findings in Critical Care Explorations that define endotoxic septic shock (“ESS”) as a distinct and deadly form of septic shock.

The prospective, multicenter observational study of 90 patients demonstrated that those with ESS – defined as endotoxin activity assay (“EAA™”) = 0.6 combined with a Multiple Organ Dysfunction Score (“MODS”) > 9 or a Sequential Organ Failure Assessment (“SOFA”) > 11 – had a 28-day mortality rate of 57.1%, compared with only 15.9% in other septic shock patients. This represents a more than three-fold increase in risk of death.

“These findings underscore that endotoxin activity, when combined with measures of organ failure, identifies the sickest sepsis patients with the greatest likelihood of dying,” said Dr. John Kellum, Chief Medical Officer at Spectral Medial. “By precisely identifying this high-risk subgroup, we can better design clinical trials and target therapies, such as endotoxin removal, to the patients most likely to benefit.”

The study provides strong clinical validation of Spectral’s approach to precision medicine in septic shock. Spectral’s FDA-cleared EAA diagnostic enables rapid identification of patients with elevated endotoxin activity, while its PMX hemoadsorption device (“PMX”) is designed to remove circulating endotoxin from the blood. Importantly, the criteria used in the study to define ESS directly align with the enrollment parameters of Spectral’s recently completed Tigris trial, which tested PMX therapy in septic shock patients with high endotoxin levels and significant organ dysfunction.

By clearly defining ESS as the subgroup of septic shock patients with the highest mortality, this study underscores the medical and commercial potential for Spectral’s theranostic strategy – pairing the EAA diagnostic with PMX therapy to deliver Targeted Rapid Endotoxin Adsorption (“TREA”) Therapy. The findings strengthen the evidence base supporting Spectral’s upcoming FDA submission and potential future commercialization of PMX in the United States.

The study, “Organ Failure, Endotoxin Activity, and Mortality in Septic Shock”, can be accessed at: Critical Care Explorations.

finance.yahoo.com

[Sultan] A new publication in Critical Care Explorations highlights the critical relation...

Sultan — 9/9/2025 4:35:16 PM

A new publication in Critical Care Explorations highlights the critical relationship between endotoxin activity, organ failure, and mortality in septic shock.

- Prevalence of ESS
Endotoxic septic shock (ESS), defined as EAA = 0.6 combined with SOFA > 11 or MODS > 9, was present in 21 patients (23.3%) of the cohort.

- Mortality Rates
ESS patients had a 28-day mortality rate of 57.1%, compared to 15.9% in non-ESS patients.

- Association with the d Phenotype
The high-risk d phenotype was found in 33.3% of ESS patients versus 5.8% of non-ESS patients (p = 0.001). Importantly, the majority (63.6%) of all d phenotype patients in the study also had ESS.

- Relative Risk of Death
The relative risk of death for ESS patients was 3.58 (95% CI, 1.86–6.91), meaning patients with ESS were over 3.5 times more likely to die compared with non-ESS patients.

- Read the full article here buff.ly

In summary: This study demonstrates that ESS identifies a high-risk subgroup of septic shock patients with markedly higher mortality and a strong association with the lethal d phenotype.

[Sultan] youtube.com

Sultan — 9/9/2025 12:40:31 PM

[Sultan] Canada must put together plan to tackle sepsis, researchers warn By Adrian Gh...

Sultan — 9/9/2025 11:30:07 AM

Canada must put together plan to tackle sepsis, researchers warn

By Adrian Ghobrial
Published: September 09, 2025 at 5:00AM EDT

Adrian Ghobrial has the latest on researchers calling on Ottawa to help fix a significant training and standards gap for health-care providers.
It’s a sudden, silent killer that some nurses and doctors are ill prepared to diagnose, according to a group of Canadian researchers.

“Every physician completing their training in Canada needs to know what sepsis is, and presently that’s not the case,” said Dr. Kali Barrett, a Toronto-based critical care physician.

Barrett is part of a team of researchers who’ve completed a research review that investigates sepsis policies, guidelines and standards across Canada.

They concluded that most provinces, including Ontario, don’t have any concrete guidelines for health-care providers to follow, and that accreditation and training standards are also falling short.

In short, the peer reviewed paper, which has yet to be published, is calling on “the urgent need for a coordinated sepsis national action plan.”

Sepsis can occur when the body’s immune system is attempting to fight off an infection, which then triggers a reaction that can lead to severe organ damage, or even death.

Barrett says a quick diagnosis and antibiotic treatment are critical for survival.

“Someone can go from okay to really sick in a matter of minutes,” said Barrett.

In 2020, a report estimated that 75,000 cases of sepsis occurred in Canada annually, leading to roughly 18,000 deaths on average each year.

In recent months, CTV News has sat down with two husbands who each lost their wife after they gave birth at two separate Ontario hospitals. In each case, the cause of death was linked to sepsis.

Last August, speaking from his home in Brampton, Ont., widower Gurinder Sidhu told CTV News that he and his wife begged for help, but their cries to a student nurse and a rotation of doctors weren’t taken seriously until an infection became visible on his wife’s leg.

“Sepsis is a race against time, but doctors never started the clock,” said Sidhu.

Barret is one of many now calling on the federal government to work with provinces in the race to save lives.

“My fear is that we’re going to have these stories in the media about people who have unnecessarily died from a potentially preventable sepsis death,” shared Barrett.

CTV News asked Health Canada if they’re open to standardizing sepsis detection guidelines across the country.

“The creation of, or changes to, hospital standards fall under the guise of Accreditation Canada,” a health agency spokesperson said in an emailed response. “Accreditation is a voluntary process for hospitals, which fall under the jurisdiction of provinces and territories.”

According to Barrett, however, there are national agencies that can bring about change.

“There are national bodies like Accreditation Canada or Physician Training Standards that are national in scope and we can address policy changes at those places,” she said.

Health Canada also shared that they feel that existing policies related to the prevention and control of infectious diseases have contributed to a reduction of sepsis.

But for families who’ve lost loved ones, that statement doesn’t go far enough.

“How come it’s not being taken seriously in the hospitals?” Sidhu said. “How come proper sepsis controls aren’t put in place? All of these questions need to be answered if we really want to prevent another tragedy.”

[Sultan] Spectral Medical Sponsors Unite for Sepsis Symposium, Chicago September 8 – 9, ...

Sultan — 9/8/2025 1:21:56 PM

Spectral Medical Sponsors Unite for Sepsis Symposium, Chicago September 8 – 9, 2025

Company to present at session titled “Personalizing Sepsis Treatment”

TORONTO, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced its sponsorship of the Unite for Sepsis Symposium, taking place September 8 – 9, 2025, in Chicago, Illinois. The Company also announced that Debra Foster, Clinical Consultant at Spectral Medical, will participate in a featured session during the event.

Ms. Foster will contribute to the session titled “Personalizing Sepsis Treatment”, scheduled for Day 1 at 4:15 PM CT, which will highlight how individualized approaches may support earlier intervention and improved outcomes in sepsis care.

The Unite for Sepsis Symposium is a unique, in-person event convening an extraordinary community of clinicians, researchers, regulators, investors, innovators, and advocates. More than a symposium, Unite for Sepsis is a collaborative movement dedicated to transforming the way sepsis is prevented, diagnosed, and treated.

For more information or to register, please visit UniteforSepsis.org

finance.yahoo.com

[Sultan] Spectral Medical is a stock to buy now, this analyst says Paradigm Capital ana...

Sultan — 8/27/2025 12:56:24 PM

Spectral Medical is a stock to buy now, this analyst says

Paradigm Capital analyst Scott McAuley said Spectral Medical is undergoing “a fundamental re-rating of the stock

cantechletter.com

[Sultan] TIGRIS Unlocked: Evidence to Impact Sepsis Alliance gratefully acknowledges the...

Sultan — 8/26/2025 7:30:14 PM

TIGRIS Unlocked: Evidence to Impact

Sepsis Alliance gratefully acknowledges the support provided for this webinar by Vantive

Includes a Live Web Event on 10/14/2025 3:00 – 4:00 pm ET / 12:00 pm – 1:00 pm PT

Webinar Description:

Join Vantive for an in-depth exploration of the TIGRIS trial. Jonathan Eaton, MD, will walk attendees through a patient journey, exploring the challenges of managing patients with endotoxic septic shock, emerging therapies, and how Dr. Eaton’s involvement in the TIGRIS trial has impacted his bedside practice. You do not want to miss this sponsored webinar on one of today’s hottest topics in the management of sepsis.

No CE credits are offered for this sponsored webinar. Content was determined by the sponsor.

[Sultan] Spectral Medical Receives US$3 Million From Vantive TORONTO, Aug. 25, 2025...

Sultan — 8/25/2025 12:39:47 PM

Spectral Medical Receives US$3 Million From Vantive

TORONTO, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that it has received the US$3 million Tranche B advance from Vantive US Healthcare LLC (“Vantive”) pursuant to the previously disclosed senior secured promissory note entered into in May 2025.

The Tranche B advance further strengthens Spectral’s balance sheet and will be used to support ongoing regulatory and commercialization preparations, as well as general working capital requirements. Spectral does not anticipate requiring any additional funding – beyond the fully drawn senior secured promissory note as previously disclosed – to meet its upcoming key milestones, including U.S. FDA submission, and through to PMX commercialization.

“We appreciate Vantive’s continued support and are pleased to have closed the Tranche B advance,” said Chris Seto, Chief Executive Officer of Spectral Medical. “This non-dilutive capital enhances our liquidity and provides additional flexibility as we execute on our regulatory pathway and commercialization plans. With this funding in place, we remain focused on operational priorities.”

Under the terms of the promissory note, Vantive may advance funds up to US$10 million to Spectral in up to four separate tranches to support Spectral’s continued evidence generation strategy and path to commercialization of Toraymyxin™ (“PMX”). With the US$3 million Tranche B advance, together with the initial US$4 million Tranche A advance, the current cumulative draw of the promissory note is US$7 million.

A copy of the Agreement has been filed under Spectral’s profile on SEDAR+ at www.sedarplus.ca.

finance.yahoo.com

[Sultan] Announcement of Spectral Medical’s Tigris Trial Topline Results for “TORAYMYXIN™...

Sultan — 8/21/2025 2:24:28 PM

Announcement of Spectral Medical’s Tigris Trial Topline Results for “TORAYMYXIN™”

toray.com

[Sultan] If you have been following Spectral Medical Inc. Phase III Trial Results on Seps...

Sultan — 8/18/2025 12:47:47 PM

If you have been following Spectral Medical Inc. Phase III Trial Results on Sepsis and the fact that if and when FDA approves it, Vantive is their partner in terms of Sales in US, this ad in Vantive's Career section is quite interesting.. Vantive was on Spectral's last news release when they announced the Trial Results..

We are just connecting the dots, if it were.. Remember, at this point, there is no drug or therapy approved by FDA in USA and here we have Vantive, one of the largest company recruiting a senior, director level personnel for Sepsis Management..

Just a Monday morning speculation.. :)

Medical Director, Sepsis Management

Req # JR - 150605
Location Deerfield, Illinois
Job Category Clinical
Date posted 08/08/2025

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Reporting directly to the Global Head of Worldwide Medical, the position of Medical Director, Global Medical Affairs, Sepsis Management will provide leadership in the new business area of Sepsis Management particularly within the USA. The incumbent will provide the highest level of expertise regarding sepsis management, in particular for the critically ill patient in the intensive care unit.

The Medical Director will ensure that the USA Acute business unit has high quality medical and clinical support through individual activities and expansion of the team. The Medical Director will be accountable for scientific engagement with USA thought leaders and relevant professional organizations, evidence generation and publication/communication strategies. The Medical Director will ensure the patient and healthcare provider prospective is represented when working with the business on product strategies, development and innovation

The Medical Director is responsible for the development and implementation of the Medical Affairs vision, strategy and action plan in full alignment with the business unit strategies and functional strategy. She/he will be accountable for the collaboration with the Clinical Research and Strategy and Delivery teams within Worldwide Medical to ensure excellence in clinical trial work for Sepsis Management products and solutions. The Medical Director will ensure close collaboration with key cross-functional partners including R&D, Regulatory, Marketing, Quality, Legal, and Ethics & Compliance.

The Medical Director will support interactions with regulatory agencies and will provide medical support for reimbursement activities. The Medical Director will work with Global Patient Safety around relevant post-market safety issues.

The role will be accountable to ensure that global policies and standards are implemented and will assure the highest standard of practice, ethics, scholarship and knowledge to drive the goals of the company.

The Medical Director will be a member of the Worldwide Medical Extended Leadership team and the USA business leadership team.

Key responsibilities for the position include:

- Provide scientific knowledge and expertise to support the development of innovation in therapies and products in Sepsis Management

- Create a Medical Affairs strategy for Sepsis Management that is aligned and supports USA business unit strategy and supports effective implementation and execution of the strategy

- Develop medical and scientific relationship with USA KOLs/SMEs, and support advisory boards to gain insight and strategic direction

- Work with relevant healthcare professional organizations and support evidence based guideline generation.

- Provide medical leadership in therapy and product education by creating and providing educational and training materials for internal and external use

- Accountable for the development of and execution of evidence generation strategy and publication strategy including HEOR

- Work with cross functional colleagues to deliver reimbursement body and provider units strategies

- Provide medical expertise and knowledge to assure safety of relevant Baxter products

- Collaborate with Worldwide Medical clinical research and Strategy and Delivery teams in development and design of clinical trials to support successful launch of therapies/products

- Provide medical expertise/ input and advise to R&D, clinical research, commercial, regulatory, manufacturing, legal and other functions

- For the therapeutic area, shape an innovative and results-driven culture, ensuring effective and efficient development of products/technologies that are both market-focused as well as scientifically advanced

- Accountable for the US Sepsis Management Medical Affairs budget

- Responsible for medical voice of the Customer, medical content of regulatory submissions, and medical support in launch and maintenance of products in the market.

jobs.vantive.com

[Sultan] Tigris Trial Topline Results Call Replay August 13, 2025 spectraldx.com

Sultan — 8/13/2025 1:09:35 PM

[Sultan] Spectral Medical and Vantive Announce Topline Results from Spectral’s Tigris Tri...

Sultan — 8/12/2025 8:40:00 PM

Spectral Medical and Vantive Announce Topline Results from Spectral’s Tigris Trial Evaluating PMX Hemoadsorption Therapy for Endotoxic Septic Shock

Spectral Medical Inc.

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™: globenewswire.com

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

finance.yahoo.com

[Sultan] Spectral Medical Announces Second Quarter and Provides Corporate Update finance...

Sultan — 8/8/2025 12:06:52 PM

Spectral Medical Announces Second Quarter and Provides Corporate Update

finance.yahoo.com

[Sultan] Vantive’s Transformative Impact on Renal Care Vantive has the unique distinctio...

Sultan — 6/26/2025 4:22:01 PM

Vantive’s Transformative Impact on Renal Care

Vantive has the unique distinction of being an established company with a rich legacy and a brand-new firm that’s fresh and agile. Vantive CEO Chris Toth discusses the company's renal care focus, its Baxter separation, and medtech leadership insights in this Let's Talk Medtech episode.

Here is why we are talking about Vantive, a company spunoff from Baxter and taken over by a private deep pockets investor, Carlyle Group ..

What Vantive is referring to is Spectral Medical's Inc. (EDT.TO) TIGRIS Phase III data which will be released in about 6 weeks or so.. If you own shares in Spectral, Keep your fingers crossed.. Since we are talking about Biotech, risk tends to be high etc. so Spectral Medical Inc. as an investment is not exactly for, as they say, orphans and widows..

Follwoing is an Extract from the article related to Spectral..

""...Over the next 12 months, extending into 2026, you'll see more of these tools rolling out and scaling accordingly. You'll also see more capabilities and launches in the acute care setting. We just completed, in partnership with Spectral, the accrual phase for a trial of PMX septic shock therapy. All that data is being processed for FDA filing and subsequent steps.

As we move into 2026, likely the second half, we'll see that therapy become available. This therapy is particularly exciting because sepsis or septic shock accounts for one in five deaths in the United States, with limited treatment options available. This particular therapy showed in a previous larger clinical trial that for a subset of cases within a certain infection range—identified through an endotoxin assay—we could substantially reduce the relative risk of mortality. That's what truly matters: how we extend life and expand possibilities.

This therapy represents another component of our investments. We're putting significant resources behind it to ensure that as we progress from filing to launch, we not only have compelling clinical data to present but also the right infrastructure and supply chain support to deliver for patients..."

mddionline.com

[Sultan] Overview This agreement outlines the terms between Spectral Medical Inc. and Va...

Sultan — 5/22/2025 11:16:27 PM

Overview

This agreement outlines the terms between Spectral Medical Inc. and Vantive Health Inc. concerning the distribution and commercialization of Spectral's medical products.
Key Provisions

Appointment and Exclusivity
- Vantive is appointed as the exclusive distributor for Spectral's PMX product in Canada and the United States.
- Vantive is also a non-exclusive distributor for Spectral's EAA product.
- A non-compete clause restricts Spectral from engaging in certain activities that could compete with Vantive's distribution efforts.
Governance and Oversight
- A Joint Steering Committee (JSC) will be established to oversee the partnership's operations, including regular meetings and dispute resolution procedures.
Regulatory Responsibilities
- Both parties have defined responsibilities concerning regulatory submissions, pharmacovigilance, product labeling, and the ability for Vantive to act as the marketing authorization holder for the EAA product. avantisai.com
Commercialization and Marketing
- Vantive is responsible for the promotion, training, and commercialization of the products, adhering to agreed-upon standards of care and cost structures.
Supply and Delivery
- The agreement details forecasting, purchase orders, minimum purchase requirements for PMX products, continuity of supply, shipment, delivery schedules, and product warranties.
Financial Terms
- Specifics regarding product pricing, consideration, taxes, invoicing, and payment procedures are outlined to ensure clarity in financial transactions between the parties.
Quality Assurance and Product Recall

Both parties have obligations related to maintaining product quality and managing any potential product recalls, ensuring compliance with regulatory standards.

Original Official Filing

Updated Spectral Medical / Vantive Distribution Agreement

sedarplus.ca

[Sultan] Spectral Medical Update as posted on Linkedin Today We’re pleased to share impo...

Sultan — 5/13/2025 11:00:16 AM

Spectral Medical Update as posted on Linkedin Today

We’re pleased to share important progress as we continue advancing PMX through its final clinical and regulatory stages:

Tigris Trial Milestone

• Enrollment complete: 157 patients enrolled; 151 evaluable; 100 treated with PMX
• Topline results expected in Q3 2025, approximately two weeks after data lock
• Finalizing enrollment marks a key step forward on the regulatory path

FDA PMA Submission

• Non-clinical components submitted under a modular approach
• On track to submit clinical data by end of October 2025

EDEN Study Results

• Presented at SCCM 2025 by Dr. Mark Tidswell
• Data from 84 evaluable patients show significantly higher mortality in those with endotoxic septic shock (60% vs 14.1%, p < 0.001)
• Findings support both regulatory discussions and define the U.S. addressable patient population

Focused on Commercialization & Funding

• Post-approval planning underway
• ICU system integration in focus

“Finalizing enrollment represents another key milestone and brings us a step closer on our regulatory path to potential approval of PMX,” said Chris Seto, CEO.

“We’re now heavily focused on regulatory progress and commercialization planning. The recent financing agreement provides a clear, non-dilutive path to advance PMX toward market.”

buff.ly

[Sultan] Spectral Medical is “fundamentally undervalued”, Paradigm says [graphic] Paradi...

Sultan — 5/8/2025 1:56:08 PM

Spectral Medical is “fundamentally undervalued”, Paradigm says

Paradigm Capital analyst Scott McAuley is maintaining a “Buy” rating and $2.30 target on Spectral Medical ( Spectral Medical Stock Quote, Chart, News, Analysts, Financials TSX:EDT) following the company’s announcement of a non-dilutive US$10-million financing deal with commercial partner Vantive US Healthcare LLC.

McAuley said the deal removes a major financial overhang and provides runway through the expected PMX approval and commercialization. “This sets our sights on the upcoming data readout this August,” he said in a May 7 research note.

Spectral is a clinical-stage medical device company focused on developing therapies for critical care, particularly septic shock and dialysis.

“We view EDT as fundamentally undervalued with upcoming significant clinical catalysts,” McAuley said. “It has now finished recruitment of its Phase 3b study to show that PMX is effective at reducing mortality in endotoxemic septic shock, a condition with ~50% mortality, no FDA-approved treatments and a ~$2B market in the U.S. Market skepticism is driven by the history of failed septic shock treatments, the length of time it has taken to complete this trial and negative views on post-hoc analysis.

“Our conviction that the study will be successful is driven by a positive view on the post-hoc analysis of the prior Phase 3 trial, allowance from the FDA to include that prior data in the final analysis via Bayesian analysis, use of a companion diagnostic to select patients most likely to benefit from treatment and early results that exceeded expectations. Commercialization is significantly de-risked through its agreement with Vantive, the kidney care spin-off from Baxter International (BAX-US) that was recently acquired by Carlyle Group (CG-US). This acquisition gives Vantive the resources and incentive to grow and ensure PMX is a commercial success.”

MCauley said Paradigm still believes the market is underestimating the potential of PMX. The firm is assigning a 100% chance of success to the ongoing TIGRIS trial based on strong results from earlier analysis, FDA approval to include that earlier data in the final review, using a companion diagnostic to target the right patients, and encouraging past results.

“Using this as a base, the recent $0.81 share price and our updated $2.30 NPV reflect that the market is only giving a 35% probability of success to the Phase 3b TIGRIS trial,” he said. “Published industry averages have the probability of success for an average Phase 3 trial at 63%, or 77%, for trials that use a biomarker for patient selection. Using the 77% probability would represent a per-share value of $1.77, a 119% gain on the current share price.”

cantechletter.com

[Sultan] Spectral Medical Announces Non-Dilutive Financing of Up to $10 Million with Vant...

Sultan — 5/7/2025 11:52:55 AM

Spectral Medical Announces Non-Dilutive Financing of Up to $10 Million with Vantive

Non-Dilutive Financing

• Up to US$10 Million Promissory Note Provided by Vantive

• If Fully Drawn, Promissory Note is Expected to Fully Fund Spectral to PMX Commercialization

• Company to host Corporate Update Call on May 15, 2025

TORONTO, May 07, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that it has entered into a senior secured promissory note (the “Agreement”) with Vantive US Healthcare LLC (“Vantive”), in the aggregate principal amount of up to US$10 million.

Under the terms of the Agreement, Vantive may advance funds to Spectral in up to four separate tranches to support Spectral’s continued evidence generation strategy and path to commercialization of Toraymyxin™ (“PMX”). PMX is a blood filtration therapy that removes endotoxin, associated with sepsis, from the bloodstream.

The first tranche of US$4 million payable to Spectral was triggered on May 6, 2025 upon the execution of the Agreement. The milestones for the further three tranches are outlined in the Agreement as filed on SEDAR+.

The primary terms of the Promissory Note are:

4-year maturity
Payment-in-Kind (“PIK”) interest at an annual rate of 9%
Principal balance and PIK interest to be repaid at maturity
The Promissory Note is not convertible into any securities of the Company

Spectral does not anticipate requiring any additional funding to meet its upcoming key milestones, including release of topline results, U.S. FDA submission, and through to PMX commercialization.

“We are grateful to have such a committed partner in Vantive as we continue to advance PMX through the regulatory phase and, if ultimately approved, into commercialization,” said Chris Seto, CEO of Spectral. “Not only does this promissory note provide us with non-dilutive funding on Company-friendly terms, it also highlights the strength, confidence and alignment between Spectral and Vantive.”

Paradigm Capital Inc. acted as financial advisor to Spectral in connection with this transaction.

A copy of the Agreement will be filed under Spectral’s profile on SEDAR+ at www.sedarplus.ca.

Spectral Medical Tigris Trial and Corporate Update 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: Thursday May 15, 2025

Time: 11:00 a.m. ET

Dial-in: 1-877-407-0792 or 1-201-689-8263

Call meTM: 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 May 15, 2025, 3:00 p.m. ET, until May 29, 2025, 11:59 p.m. ET

Conference ID: 13753414

[Sultan] The Tigris Trial and Corporate Update Call Join Chris Seto, Chief Executive Off...

Sultan — 5/6/2025 4:56:28 PM

The Tigris Trial and Corporate Update Call

Join Chris Seto, Chief Executive Officer, and Dr. John Kellum, Chief Medical Officer, for an exclusive update on the Tigris Trial and corporate developments.

The call will include a Q&A session following the presentation. Bring your questions and join the discussion!

Thursday May 15, 2025
11:00 a.m. ET

Dial-in: 1-877-407-0792 or 1-201-689-8263
Call me™:buff.ly

Participants can use Guest dial-in at 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.

[Sultan] The TIGRIS Trial is a confirmatory study of Toraymyxin™ PMX Hemoperfusion in add...

Sultan — 4/28/2025 2:12:40 PM

The TIGRIS Trial is a confirmatory study of Toraymyxin™ PMX Hemoperfusion in addition to standard care vs standard care alone in patients with endotoxemic septic shock.

Study Design:
The study was a 2:1 randomized trial that enrolled 150 patients, utilizing a Bayesian statistical approach. Patients in critical care units were evaluated for septic shock based on key criteria, including known or suspected infection, multiple organ failure, adequate fluid resuscitation, and hypotension requiring vasopressor support.

Eligibility for the study required an endotoxin activity level (EAA) between =0.60 and <0.90.

Enrollment Complete
• 157 patients enrolled
• 151 evaluable patients, with 100 treated using PMX
• 28-day follow-up for the final patient to be completed by May 8, 2025

Topline Results Timing
• Data lock expected approximately 90 days after the final 28-day follow-up
• Topline results anticipated about 2 weeks following data lock

PMA Submission Progress
• Utilizing a modular submission strategy, all non-clinical modules have been submitted to the FDA
• Clinical data submission on track for end of October 2025

By refining patient selection and building on insights from previous studies, TIGRIS aims to further define the role of targeted endotoxin removal in improving clinical outcomes for patients with endotoxic septic shock.

[Sultan] Spectral Medical Completes Tigris Trial Enrollment 157 patients enrolledTopli...

Sultan — 4/16/2025 12:36:50 PM

Spectral Medical Completes Tigris Trial Enrollment

157 patients enrolled
Topline results expected to be released in August 2025
Company to host Corporate Update Call on May 15, 2025

TORONTO, Canada – April 16, 2025 – Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Key Post-Tigris Enrollment Milestones

Total enrolled patients:
- 157 total patients enrolled
  - 151 evaluable patients, 100 treated with PMX
- 28-day follow-up for last patient enrolled to be completed on May 8, 2025
Release of topline results:
- Data lock to be completed approximately 90 days after final patient 28-day follow-up
  - Expected release of topline results approximately 2 weeks post-data lock
PMA submission:
- The Company’s Premarket Approval submission (“PMA”) is a modular approach, whereby non-clinical aspects are submitted separately from the clinical data
- To-date the Company has submitted all non-clinical studies and reports to the US Food & Drug Administration (“FDA”) for evaluation
- On track to submit the clinical results and reports by end of October 2025

Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We are grateful for the strong interest in the clinical development of PMX among researchers and clinicians that has helped drive us towards completing full enrollment in the Tigris trial with a total of 157 patients. On behalf of Spectral Medical, I would like to express gratitude to the patients and their families in addition to the dedicated teams at the clinical sites, as well as our clinical and regulatory staff. We remain confident in the potential of PMX, and if ultimately approved, to play a major role in reducing the tragic rates of mortality caused by endotoxic septic shock.”

“Finalizing enrollment represents another key milestone for the Company and brings us a step closer on our regulatory path to potential approval of PMX. Spectral is now heavily focused on the regulatory phase for PMX, in addition to our continued commercialization activities with our distribution partner Vantive,” said Chris Seto, CEO of Spectral. “With enrollment now complete, we expect to be in a position to share topline results in the third quarter of this year. Additionally, the Company will be hosting a corporate update call to provide a comprehensive view on Spectral’s regulatory pathway as well as a corporate funding update.”

Balance Sheet and Financing Update

The Company is in the late stages of finalizing a non-dilutive financing with a view to be fully funded to PMX commercialization.

Spectral Medical Tigris Trial and Corporate Update 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: Thursday May 15, 2025

Time: 11:00 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 May 15, 2025, 3:00 p.m. ET, until May 29, 2025, 11:59 p.m. ET

Conference ID: 13753414

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 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.

PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively over 360,000 times 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.

Forward-Looking Statement

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 company’s ability to raise capital and the availability of funds and resources to pursue R&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies, the success of Baxter’s commercialization efforts, 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.

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

For further information, please contact:

Ali Mahdavi
Capital Markets & Investor Relations
Spinnaker Capital Markets Inc.
416-962-3300
am@spinnakercmi.com

Chris Seto
CEO
Spectral Medical Inc.
cseto@spectraldx.com

spectraldx.com

[Sultan] Spectral Medical Announces Fourth Quarter and Fiscal 2024 Results and Provides C...

Sultan — 3/27/2025 3:20:02 PM

Spectral Medical Announces Fourth Quarter and Fiscal 2024 Results and Provides Corporate Update

Corporate Highlights During & Subsequent to the Fourth Quarter and Fiscal Year Ended December 31, 2024

Tigris:

Total of 154 patients randomized to date in the Tigris trial.
- Despite enrollment headwinds experienced in the fourth quarter of 2024, due to the impact of Hurricane Helene on the medical supply chain, Tigris 2024 enrollment was incredibly robust
  - 59 patients enrolled in 2024 vs. 31 patients enrolled in 2023
- Strong start to 2025 enrollment
  - 14 patients enrolled 2025 year-to-date
Timing
- Closing in on the full enrollment of 150 evaluable patients:
  - Estimate a further two to four patients (given the randomization scheme) to reach 150 evaluable patients
  - Addresses the six patients randomized into the PMX arm who did not receive the treatment
  - Enrollment of 100 patients in the PMX arm and 50 patients in the standard-of-care arm who received the assigned treatment is important for PMX regulatory review with respect to safety analysis and secondary analyses
- Based on current rate of enrollment, management believes full Tigris enrollment is impending – and should be completed in the next few weeks.
EDEN Abstract Presentation
- On February 23, 2025, an abstract of the EDEN study was presented by Dr. Mark Tidswell at the 2025 Society of Critical Care Medicine Annual Congress (see abstract: Critical Care Medicine)
- The Company completed its EDEN study in Q4 2023 with 92 patients enrolled. The ancillary observational study collected data on patients with sepsis even if ineligible for Tigris, and captured much needed data on the full range of septic shock and its relation to organ failure and endotoxin activity.
- Based on the results of 84 evaluable patients, compared to other patients with septic shock, those with endotoxic septic shock (EAA = 0.6 and SOFA >11) had significantly higher mortality (60% vs 14.1%, p < 0.001).
- These data will inform subsequent discussions with the FDA on labelling for PMX, as well as to provide the medical community and the Company a better picture of the addressable population in the U.S. for PMX.
- A manuscript describing the full results of the EDEN study is in preparation and will be submitted to a medical journal in the next few weeks.

PMX Commercialization:

On January 31, 2025, Baxter International Inc. (“Baxter”) completed the sale of its Kidney Care business, including Vantive and its affiliated entities throughout the world, to funds affiliated with The Carlyle Group, pursuant to which Spectral Medical’s PMX distribution agreement was assigned to Vantive.
Commercialization Activities
- In anticipation of a positive Tigris trial outcome, the Company has been working closely with Vantive on post-approval marketing plans for PMX commercialization.
- In February 2025, the Vantive PrisMax sub-study was completed
  - Vantive intends to submit a 510(k) application and obtain clearance for its PrisMax System
  - The PrisMax System, with its leading installed base in ICUs throughout the U.S., is anticipated to be the primary ICU device utilized for PMX treatments on commercial launch

“We are on the cusp of full Tigris enrollment, which marks a major clinical milestone for Spectral. Completion of the Tigris study represents a big step forward in the potential of bringing the PMX therapy to market, and we look forward to our continued partnership with Vantive, and the development of a robust commercialization strategy,” said Chris Seto, CEO of Spectral. “Spectral is now entering a heavily-focused regulatory phase for PMX. The Company will be providing a more comprehensive view on Spectral’s regulatory pathway in the coming weeks.”

finance.yahoo.com

[Sultan] Spectral Medical Provides February Tigris Trial Update 152 patients enrolled T...

Sultan — 3/3/2025 12:11:32 PM

Spectral Medical Provides February Tigris Trial Update

152 patients enrolled

TORONTO, March 03, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Tigris Enrollment:

Strong start to 2025 enrollment:
- 152 patients enrolled to date
- Six patients enrolled in February
Closing in on full enrollment of 150 evaluable patients:
- Estimate a further four to seven patients (given the enrollment randomization scheme) to reach 150 evaluable patients
  - Addresses the six patients randomized into the PMX arm that did not receive the treatment
  - Enrollment of 100 patients in the PMX arm and 50 patients in the standard-of-care arm who receive the assigned treatment is important for PMX regulatory review with respect to safety analysis and secondary analyses
- Project full enrollment closer to the end of March 2025

Dr. John Kellum, Chief Medical Officer of Spectral, stated, “We are very much in the final stretch of enrollment into Tigris, which we attribute to continued strong activity and engagement at our Tigris sites. As such, we remain confident in finalizing full Tigris enrollment closer to the end of the first quarter in 2025.”

[Sultan] Presented yesterday at#SCCM2025 Read the full abstract buff.ly

Sultan — 2/24/2025 12:14:55 PM

[Sultan] Is Vantive (they hold the distribution contract with Spectral) gearing up to com...

Sultan — 2/19/2025 9:27:34 PM

Is Vantive (they hold the distribution contract with Spectral) gearing up to commercialize PMX / EAA after the conclusion of the Phase III Trial (Tigris) and expected approval by FDA.. Hints of that in this anyways..

https://jobs.vantive.com/job/deerfield/emerging-therapies-specialist-northeast/47918/77251867584

Emerging Therapies Specialist - Northeast

Location
Deerfield, Illinois, United States

Additional locations
New York (remote); Connecticut (remote); Pennsylvania (remote); Massachusetts (remote); Maine (remote)

Job Category
Sales

Date Posted
02/12/2025

Your Role at Vantive

This position is responsible for providing clinical and commercial support to Vantive's customers, in multiple hospital call points including Critical Care. This position is responsible for ongoing account development, education, training and growing existing business. The product portfolio includes innovative technologies and therapies for multi-organ extracorporeal carbon dioxide removal (ECCO2R) therapy and Targeted Rapid Endotoxin Adsorption (TREA) for Sepsis.

What you'll be doing
:...................
- Prepare market for future emerging TREA therapy by collaborating with key internal stakeholders, including but not limited to, Therapy Development Specialist, Medical Liaisons, Acute Clinical Educators, Territory Business Managers

[Sultan] Vantive Sponsored Webinar: Is Your Septic Shock Toxic? Understanding Endotoxins ...

Sultan — 2/5/2025 1:53:49 PM

Vantive Sponsored Webinar: Is Your Septic Shock Toxic? Understanding Endotoxins & Potential Treatments

Webinar Description:

Endotoxin plays a prominent role in the pathogenesis of sepsis and often comes from the gut and the idea of neutralizing its detrimental capacities. All Gram-negative bacteria have a cell wall made up of endotoxins and can activate the immune system in many ways at low or toxic level. Eight out of 12 of the most dangerous bacteria cited by the World Health Organization to encourage treatment strategies are gram negative species. In addition to delving into early recognition and treatment of sepsis using the bundles, this sponsored session will explore recognition of endotoxin and innovative treatment options.

learn.sepsis.org

[Sultan] Spectral Medical Provides January Tigris Trial Update https://finance.yahoo.com...

Sultan — 2/3/2025 12:54:54 PM

Spectral Medical Provides January Tigris Trial Update

https://finance.yahoo.com/news/spectral-medical-provides-january-tigris-130000954.html

Baxter Kidney Care is Now Vantive, A New Standalone Vital Organ Therapy Company

globenewswire.com

[Sultan] A Blood Purification publication highlights endotoxin activity's role in critica...

Sultan — 1/23/2025 3:34:23 PM

A Blood Purification publication highlights endotoxin activity's role in critically ill patient outcomes. :

Higher EAA (=0.6) is linked to:

- Increased prevalence of proteinuria.
- Lower SaO2/FiO2 ratios.
- Slower recovery in serum creatinine levels, especially in patients with AKI stage 1.

Patients with persistent EAA =0.6 experienced:

- Longer hospital stays.
- Delayed ICU discharge compared to those with EAA <0.6.

** Key Takeaway: High EAA levels are associated with worse kidney function and outcomes. Patients whose EAA levels dropped, particularly those with AKI stage 1 and day 1 EAA <0.6, recovered faster.

buff.ly