TriSalus Life Sciences® Announces Publication of Pre-Clinical Data Demonstrating Improved Delivery of Embospheres® to Liver Tumors using Pressure-Enabled Drug Delivery™ (PEDD™) via the TriNav® Infusion System

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DENVER, January 09, 2025--(BUSINESS WIRE)--TriSalus Life Sciences®, Inc. ("TriSalus" or the "Company") (Nasdaq: TLSI), TriSalus Life Sciences seeks to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies and our investigational immunotherapy, announced today the publication of research titled, "Pressure Enabled Drug Delivery (PEDD) Significantly Increases Intraarterial Delivery of Embolic Microspheres to Liver Tumors in a Porcine Model," in the peer-reviewed Journal of Vascular and Interventional Radiology. The study, conducted in a transgenic tumor model, highlights the superior performance of the TriNav Infusion System in delivering Embospheres® into liver tumors when compared to delivery with a traditional microcatheter.

Key Findings:

  • Improved Tumor Penetration: PEDD achieved a 227 % increase (p=0.029) in the concentration of fluorescently labeled Embospheres within tumor tissue compared to a traditional microcatheter.

  • Improved Tumor Selectivity: The tumor-to-normal (T:N) ratio rose from 2.7 for a traditional microcatheter to 4.2 when delivered by PEDD, indicating more precise tumor targeting and reduced off-target delivery.

  • Increased Peritumoral Delivery: Delivery to peritumoral regions increased by 209% (p=0.045), demonstrating PEDD's ability to overcome challenging tumor associated microenvironments.

"This study further validates the potential of TriNav using the PEDD approach to transform the treatment of liver tumors," said Bryan F. Cox, Ph.D., Chief of Research for TriSalus. "By significantly enhancing therapeutic delivery and sparing healthy tissue, PEDD offers a promising advancement for patients whose outcomes may be limited by conventional delivery methods."

The study was conducted using a transgenic porcine (Oncopig) liver tumor model, employing fluorescent imaging and advanced deep-learning algorithms to quantify therapeutic delivery with millimeter-scale resolution. Results showed the TriNav Infusion System using the PEDD approach markedly outperforms traditional microcatheters in delivering embolic microspheres into liver tumors.

These findings add to the growing body of clinical and real-world evidence supporting PEDD's ability to improve the delivery of therapeutic agents for patients with primary and metastatic liver cancers.

To read the full study, visit here.

About TriSalus Life Sciences

TriSalus Life Sciences® is an oncology focused medical technology business providing disruptive drug delivery technology with the goal of improving therapeutic delivery to solid tumors. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors as well as other solid tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD is a novel delivery approach designed to address the anatomic limitations of infusion into solid tumors. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to limit delivery to normal tissue, creating 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 during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via PEDD 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 PEDD are commonly present as well. Nelitolimod delivered by PEDD will be studied across several indications in an effort to address immune dysfunction and overcome drug delivery barriers in the liver and pancreas.