TriSalus Receives FDA Clearance for TriNav Advance

TriSalus Life Sciences® is an oncology company dedicated to improving outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies and our investigational immunotherapy. The Company’s platform features FDA-cleared devices and a clinical-stage investigational immunotherapeutic, all designed to enhance treatment efficacy. Its proprietary Pressure-Enabled Drug Delivery™ (PEDD) technology optimizes therapeutic delivery to tumors while minimizing off-target exposure. TriSalus’ FDA-cleared devices include the TriNav® Infusion System, designed for hepatic arterial infusion to treat liver tumors and the Pancreatic Retrograde Venous Infusion System, specifically developed to address the unique challenges of drug delivery in pancreatic tumors. The PEDD approach overcomes anatomic barriers by modulating pressure and flow, improving therapeutic delivery directly to the tumor and reducing delivery of toxic therapeutics to healthy tissues—offering the potential to significantly enhance patient outcomes and reduce complications. Additionally, the Company’s investigational immunotherapeutic, nelitolimod, is designed to counteract the immunosuppressive environment created by many tumors, which often renders conventional treatments less effective. Data from Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials suggest that nelitolimod delivered via PEDD technology produces promising immune-modulating effects both within the liver and systemically. Nelitolimod targets TLR9, a receptor expressed across various cancer types, and its delivery leverages PEDD technology to address physical barriers that impede treatment in solid tumors. 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 Twitter and LinkedIn.