DENVER, USA – March 18, 2026
TriSalus Life Sciences has announced new preclinical findings demonstrating that its Pressure-Enabled Drug Delivery (PEDD™) technology significantly enhances the delivery and immune activation of its investigational immunotherapy, nelitolimod, in liver tumor models, marking an important advancement in targeted oncology treatment strategies.
Enhanced Intratumoral Drug Delivery Demonstrated
TriSalus reported that PEDD-enabled delivery using the TriNav® Infusion System resulted in significantly improved distribution of nelitolimod within tumor tissues compared to conventional delivery methods, addressing one of the major challenges in solid tumor treatment—poor drug penetration.
This innovative approach works by modulating pressure within tumor vasculature, allowing better drug dispersion into dense tumor microenvironments. In preclinical porcine liver tumor models, the technology showed superior intratumoral and peritumoral drug localization, highlighting its potential to improve therapeutic efficacy. The findings reinforce the growing importance of drug delivery technologies in maximizing the clinical potential of immunotherapies, particularly in hard-to-treat cancers such as liver tumors.
Immune Activation and Tumor Reduction Outcomes
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The study further revealed that nelitolimod delivered via PEDD enhanced immune system engagement, with notable reductions in immunosuppressive myeloid-derived suppressor cells (MDSCs) and increased infiltration of cytotoxic CD8+ T cells within tumors.
These immune changes are critical indicators of effective anti-tumor responses. Additionally, murine liver metastasis models showed significant tumor growth reduction when treated with PEDD-delivered nelitolimod compared to systemic administration, suggesting that localized delivery can substantially improve therapeutic outcomes. This dual mechanism—enhanced delivery and immune activation—positions PEDD as a promising platform for next-generation immuno-oncology therapies.
Implications for GxP and Future Clinical Development
From a cGxP perspective, the findings highlight the critical role of delivery systems in ensuring drug performance, consistency, and safety, aligning with GMP requirements for controlled drug administration and GCP expectations for reproducible clinical outcomes. The PEDD platform is designed to overcome elevated intratumoral pressure and restore microvascular flow, enabling more predictable and targeted therapy distribution.
As TriSalus advances toward further clinical development, these results support continued investigation of combined delivery-immunotherapy strategies, which could redefine standards for solid tumor treatment. Moreover, the integration of device-based delivery systems with biologic therapies reflects a growing convergence of MedTech and biopharma innovation, an area of increasing regulatory focus.
The publication underscores a key industry shift toward precision drug delivery as a determinant of therapeutic success, particularly in oncology. By demonstrating that optimized delivery can enhance both immune activation and tumor suppression, TriSalus strengthens the case for integrated therapeutic platforms that combine advanced delivery technologies with immunotherapies. As the company prepares for further clinical validation, the PEDD approach could play a pivotal role in unlocking the full potential of cancer immunotherapy and improving patient outcomes in solid tumors.
Source: TriSalus Life Sciences press release
