TriSalus Life Sciences Announces Real-World Data Demonstrating the Ability of TriNav to Successfully Treat Patients with Higher Disease Burden and to Improve Delivery of Therapeutics to Liver Tumors

TriSalus Life Sciences Inc. (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, today announced the publication in Current Medical Research and Opinion a manuscript detailing a real-world study of the use of the pressure-enabled drug delivery (PEDD) method with the TriNav device for trans-arterial chemoembolization (TACE) and trans-arterial radioembolization (TARE) in patients with hepatocellular carcinoma (HCC) and liver metastases.

The data presented in this study captured real-world safety and clinical outcomes data for TriNav in its launch phase (2020-2022) utilizing a large, 300 million patient dataset covering 98% of US payers. These data provide valuable insights into the important benefits of this technology that would otherwise take many years to accumulate through alternative approaches using clinical trials. Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden. The study also revealed that:

• In TACE procedures, interventional radiologists could deliver significantly more chemotherapeutic to the tumor when using TriNav vs. the amount delivered using standard catheters, a critical treatment goal.
• In a matched cohort comparison, TriNav patients had fewer 30-day inpatient visits post-procedure than non-TriNav patients.
• TriNav HCC patients were more likely to have a post-procedure liver transplant in a matched cohort comparison.
• TriNav TARE patients with liver metastases had fewer clinical complications post-procedure vs. non-TriNav patients in a matched cohort comparison.
• TriNav TARE patients with liver metastases had lower rates of post-procedure fatigue vs. non-TriNav patients.

These study data clearly demonstrate that TriNav is preferentially selected to treat patients with a higher burden of disease than patients treated with standard catheters, yet these patients show similar results post-treatment compared to patients with a lower disease burden. TriNav patients showed impressive trends toward better outcomes in matched cohort comparisons, including an increased rate of liver transplants. The results also demonstrate how real-world data complement traditional clinical trials to provide a more robust and timely understanding of the benefits realized by patients. TriSalus is committed to updating this data set continuously and affirming the benefit TriNav and the PEDD approach bring to patients, providers, and payers.