Study of 603 PEDD patients and 16,210 non-PEDD patients found PEDD technology was associated with fewer post-procedure complications, reduced hospitalizations, and approximately $7,700 in per-patient charge avoidance despite greater baseline clinical complexity

TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the “Company”), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, today announced the publication of the largest real-world evidence study to date evaluating the clinical and economic impact of Pressure-Enabled Drug Delivery (PEDD^®) technology used in trans-arterial chemoembolization (TACE) and radioembolization (TARE) procedures.

The study, titled “Clinical Outcomes of Pressure-Enabled Drug Delivery (PEDD) for Trans-Arterial Chemoembolization (TACE) and Radioembolization (TARE),” was published online on April 9, 2026 in the Journal of Comparative Effectiveness Research. Using the Clarivate Real World Data Repository, researchers analyzed outcomes for 603 PEDD patients and 16,210 non-PEDD patients with hepatocellular carcinoma (HCC) or secondary liver metastases who underwent TACE or TARE between January 2020 and March 2024.

Key Study Findings

Sicker Patients, Better Outcomes: PEDD patients had significantly higher baseline disease burden, with higher Charlson Comorbidity Index scores (7.1 vs. 6.4), more frequent prior healthcare utilization, and higher rates of prior systemic therapy use (24.5% vs. 16.1%). Despite this greater clinical complexity, PEDD patients demonstrated improved post-procedure outcomes after propensity-score matching.

Reduced Complications: In matched analyses, PEDD was associated with significantly lower rates of post-procedure fatigue overall (20.9% vs. 26.4%, p<0.05). Among patients receiving TACE, PEDD was associated with a 61% relative reduction in 30-day inpatient hospital visits (8.0% vs. 20.5%, p<0.05).

Better Targeting with Higher Drug Doses: PEDD-TACE patients received significantly higher procedure units of doxorubicin compared to non-PEDD patients (13.9 vs. 9.4, p<0.01) while experiencing fewer complications, suggesting improved tumor targeting with reduced off-target toxicity.

Enhanced Outcomes at High-Experience Facilities: At facilities with the highest PEDD procedure volume, PEDD patients experienced significantly lower lymphopenia rates overall (0.6% vs. 5.2%, p<0.05). Among patients with secondary liver metastases at these facilities, fatigue was cut roughly in half (19.2% vs. 39.7%, p<0.05) and lymphopenia was nearly eliminated (0.0% vs. 8.2%, p<0.05).

Significant Cost Avoidance: PEDD use was associated with mean per-patient charge avoidance of $7,734, driven by $3,135 in reduced inpatient stays and $4,599 in fewer clinical complications.

Notably, the study found that preservation of immune function — reflected in the lower lymphopenia rates among PEDD patients — may allow patients to better tolerate subsequent lines of therapy, including immunomodulatory treatments, potentially improving long-term disease management.

“This publication represents one of the largest and most comprehensive real-world analysis ever done in the interventional radiology space and reinforces what we’ve observed across clinical practice — that PEDD can improve outcomes for patients undergoing liver-directed therapies while also reducing the economic burden on the healthcare system,” said Dr. Richard Marshall, Chief Medical Officer at TriSalus Life Sciences.

“These data underscore the clinical and economic value of PEDD, support its growing adoption across interventional oncology and demonstrates TriSalus’ commitment to advancing the science and practice of interventional oncology,” added Mary Szela, TriSalus CEO.

About Pressure-Enabled Drug Delivery (PEDD^®)

Pressure-Enabled Drug Delivery (PEDD) is designed to counteract elevated intra-tumoral pressure — a known barrier to effective drug delivery in liver tumors — by modulating intra-arterial pressure and flow dynamics during trans-arterial embolization procedures. By enhancing drug penetration into tumors while minimizing off-target delivery, PEDD technology aims to improve treatment efficacy and reduce procedure-related complications.

About TriSalus Life Sciences

TriSalus Life Sciences^® is an oncology focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s three FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav^® Infusion System and TriNav Infusion System LV for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated in phase 1 Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via the PEDD technology may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by the PEDD technology are commonly present as well. The Company is in the final stages of data compilation for several phase 1 clinical trials and will begin exploring partnership opportunities for development.

Forward Looking Statements

Statements made in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding the benefits and potential benefits of the Company’s PEDD drug delivery technology, TriNav^® system and nelitolimod investigational immunotherapy, and the Company’s ability to execute on its strategy. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company’s clinical trials, the cost and timing of all development activities and clinical trials, unexpected safety and efficacy data observed during clinical studies, the risks associated with regulatory approval of the Company’s product candidates, the risks associated with the credit facility, including the Company’s ability to remain in compliance with all its obligations thereunder to avoid an event of default, the risk that the Company will continue to raise capital through the issuance and sale of its equity securities to fund its operations, the risk that the Company will not be able to achieve the applicable revenue requirements to access additional financing under the credit facility, the risk that the Company will not become profitable on its expected timeline, if at all, changes in expected or existing competition or market conditions, changes in the regulatory environment, unexpected litigation or other disputes, unexpected expensed costs, and other risks described in the Company’s filings with the Securities and Exchange Commission under the heading “Risk Factors.” All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.

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