Pressure enabled drug deliver (PEDD) method significantly increased penetration of glass microspheres into porcine liver tumors (117%; p=0.004 and 39%; p=0.032) with lobar infusions and selective infusions, respectively

TriSalus Life Sciences®, Inc. (“TriSalus” or the “Company”) (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with standard of care therapies and immunotherapy to transform treatment for patients with liver and pancreatic tumors, announced today the publication of research titled, “Intra-arterial Pressure-Enabled Drug Delivery Significantly Increases Penetration of Glass Microspheres in a Porcine Liver Tumor Model,” in the peer-reviewed Journal of Vascular and Interventional Radiology. The article illustrates that the PEDD method via the TriNav Infusion System significantly improved delivery of glass microspheres (GM) with deeper penetration into liver tumors and the peritumoral tissue, when compared to delivery of GM with a conventional microcatheter in a transgenic (oncopig) model.

“This is another example of how our PEDD approach effectively tackles a significant challenge in cancer care by ensuring the selective and increased delivery of therapeutics to the tumor. This research advances and validates our understanding of the PEDD method, providing high-resolution evidence of enhanced delivery,” said Bryan F. Cox, Ph.D., Chief of Research for TriSalus. “With both proximal and distal placements of the PEDD device, we observed significantly improved delivery of glass microspheres to the tumor, quantified on a millimeter scale. The strength of the proximal infusion data suggests an opportunity to selectively target multiple tumors simultaneously in patients with heavy disease burdens.”

“These results contribute to the substantial and expanding body of pre-clinical and clinical evidence supporting the wide-ranging potential applicability of the PEDD approach,” said Mary Szela, Chief Executive Officer and President of TriSalus. “Efficient delivery of therapeutics into tumor cells without causing harm to off-target normal tissue remains a real-world challenge in cancer care, and the PEDD approach aims to overcome this obstacle. This publication strengthens our current understanding that, regardless of placement of the technology, either lobar or selective infusions, the PEDD method increased glass microspheres delivery uptake compared to conventional microcatheters. The TriNav device signifies a potential breakthrough in delivering glass microspheres and other drugs into tumors in a highly controlled and targeted manner.”

“This study shows the potential of PEDD method to address an unmet need in liver cancer therapy – achieving the same safety profile of selective Y90 treatment to those performed for more advanced diffuse disease using lobar injections. This study suggests that the use of PEDD method alters hemodynamics and the microenvironment in a manner resulting in higher concentrations of microspheres in the tumor compared to the adjacent liver parenchyma, thereby offering the ability to increase efficacy and improve safety. If further validated in human models, this may represent a significant advancement in the management of liver cancer,” said Dr. Riad Salem, Chief of Interventional Radiology, and Professor of Radiology, Surgery, and Medicine in Chicago.

The research involved transgenic pigs (oncopigs) with induced liver tumors. These tumors were intra-arterially infused with fluorescently labeled GM. The PEDD method with the TriNav device was compared to the use of conventional microcatheter delivery in both lobar and selective infusions. Near-infrared (near IR) imaging was utilized to detect the GM fluorescent signal in tumors. The results showed significant increases in GM signal intensity in and around tumors after delivery with the PEDD method, with a 117% increase in tumor penetration with lobar infusions and a 39% increase with selective infusions compared to conventional delivery. Lobar PEDD delivery of GM to the tumor was statistically equivalent to conventional selective delivery (p=0.497).

A copy of the full abstract can be accessed 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 therapeutics delivery to liver and pancreatic 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 and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD 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 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.

In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on X (formerly Twitter) and LinkedIn.

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