WESTMINSTER, Colo. – May 4, 2026
TriSalus Life Sciences has announced the initiation of patient enrollment for its PREDICTT clinical trial, a prospective study evaluating its proprietary Pressure-Enabled Drug Delivery™ (PEDD™) technology in patients with primary and metastatic liver tumors, marking a significant step toward improving precision drug delivery in oncology. The trial, conducted in collaboration with The University of Texas MD Anderson Cancer Center, aims to assess how PEDD enhances tumor targeting, drug distribution, and radiation dose optimization when used alongside Y90 radioembolization therapy, a widely adopted treatment for unresectable liver cancers. This development positions TriSalus at the forefront of device-driven innovation in cancer treatment, where improving delivery efficiency is as critical as the therapy itself.
Pressure-Enabled Delivery Targets Tumor Precision
The PREDICTT trial focuses on evaluating the TriNav® Infusion System, a key component of TriSalus’ platform that utilizes Pressure-Enabled Drug Delivery technology to improve how therapeutics are distributed within tumors; traditional Y90 radioembolization often struggles with uneven microsphere distribution, leading to suboptimal tumor dosing and unintended exposure to healthy liver tissue, but PEDD is designed to modulate pressure and flow dynamics, allowing for deeper and more uniform penetration of therapeutic agents into tumor tissue, which could significantly enhance treatment precision, efficacy, and safety outcomes, addressing one of the most persistent limitations in liver-directed oncology therapies.
Study Design and Clinical Objectives
The PREDICTT (Prospective Evaluation of Pressure-Enabled Delivery and Tumor Dose) study is an investigator-led, single-arm, interventional trial that plans to enroll approximately 20 adult patients with unresectable liver tumors who are eligible for Y90 therapy; led by interventional radiology experts at MD Anderson, the trial will evaluate CT-based tumor-to-normal liver enhancement ratios, correlating these imaging metrics with tumor radiation dose, microsphere distribution, and treatment response, while also incorporating SPECT/CT imaging analysis to validate post-treatment outcomes; in addition to performance metrics, the study will assess the safety profile of the TriNav Infusion System, ensuring that enhanced delivery does not compromise patient safety, which is critical for broader clinical adoption; while the sample size is relatively small, the study is designed as a proof-of-concept trial, meaning its real value lies in generating high-quality mechanistic and imaging data rather than definitive efficacy conclusions.
Advertisement
Strengthening MedTech Innovation in Oncology
With the launch of PREDICTT, TriSalus Life Sciences continues to strengthen its position as a MedTech innovator integrating device technology with oncology therapies, combining its PEDD platform with both standard treatments and investigational immunotherapy such as nelitolimod, a TLR9 agonist designed to overcome tumor-induced immunosuppression, particularly in liver and pancreatic cancers; this dual approach—enhancing drug delivery mechanics while also modulating immune response—reflects a broader industry trend toward combination strategies that address both biological and physical barriers in cancer treatment, and if successful, PEDD could become a critical enabling technology not only for Y90 therapies but also for a wide range of locoregional and systemic oncology treatments, potentially improving drug efficiency, reducing toxicity, and driving better patient outcomes across multiple tumor types.
Source: TriSalus Life Sciences press release
