TriSalus Life Sciences Initiates PREDICTT Clinical Trial

TriSalus Life Sciences Inc. has begun patient enrollment for the PREDICTT clinical trial (NCT07444645), a prospective study to evaluate its Pressure-Enabled Drug Delivery (PEDD) approach in patients with primary or metastatic liver tumors.

The PREDICTT trial is an investigator-led single-arm, interventional study designed to evaluate the way(s) PEDD impacts tumor targeting and radiation dose distribution. Investigators at The University of Texas MD Anderson Cancer Center will assess the use of the TriNav Infusion System in conjunction with Y90 radioembolization therapy. Specifically, the trial will measure changes in CT-based tumor-to-normal liver ratios and assess the way these changes correlate with tumor dose and treatment outcomes.

Y90 radioembolization is a widely used treatment for unresectable liver tumors. However, optimizing delivery to maximize tumor dose while minimizing exposure to healthy liver tissue remains a critical challenge. The PREDICTT study aims to address this by evaluating the TriNav Infusion System, a Pressure-Enabled Drug Delivery device designed to improve microsphere distribution within tumors.

The PREDICTT (Prospective Evaluation of Pressure-Enabled Delivery and Alterations in CT-Based Tumor-to-Normal Liver Ratio and Tumor Dose) trial is an investigator-led study evaluating the impact of pressure-enabled delivery using the TriNav Infusion System in patients undergoing Y90 radioembolization for liver tumors. The PREDICTT trial will enroll approximately 20 adult patients with unresectable primary or metastatic liver tumors who are eligible for Y90 radioembolization. The study is led by principal investigator Peiman Habibollahi, M.D., associate professor of Interventional Radiology at UT MD Anderson.

Key objectives include:

• Evaluate changes in CT-based tumor-to-normal liver enhancement ratios using the TriNav Infusion System
• Correlate imaging-based measurements with tumor dose and microsphere distribution
• Evaluate relationships between imaging metrics and post-treatment SPECT/CT findings
• Assess safety of the TriNav Infusion System [with Y90] in liver directed therapy

The launch of PREDICTT underscores the continued collaboration between TriSalus Life Sciences and UT MD Anderson.

“This study represents an important step toward optimizing locoregional therapies through advanced delivery technologies,” TriSalus Life Sciences Chief Medical Officer Richard Marshall, M.D., stated. “We are proud to collaborate with UT MD Anderson to generate clinical evidence that could redefine how Y90 therapies are delivered.”

TriSalus Life Sciences is an oncology-focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its delivery technology with standard-of-care therapies and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for various 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 U.S. Food and Drug Administration-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 delivery approach that addresses the anatomic limitations of pancreatic arterial infusion. The PEDD approach modulates pressure and flow to deliver more therapeutic to the tumor and 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, 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 through 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 completion for several phase 1 clinical trials and will begin exploring partnership opportunities for development.