Trisalus Life Sciences (TLSI) Maxim Group’s 2024 Healthcare Virtual Summit summary

Business and technology overview

• Focused on improving outcomes for liver and pancreatic cancer using innovative pressure-enabled drug delivery technology for TACE and TARE procedures.

• Technology delivers more therapeutic to tumors, reduces complications, and has exclusive CMS reimbursement due to compelling clinical and economic data.

• Sales are growing over 50% annually, with low current market share and robust growth expected.

• Technology is also being used for multinodular goiter, targeting 50,000 additional procedures, and has an FDA-cleared pancreatic device.

• Market opportunity is concentrated in 400 hospitals performing 95% of procedures, with a $400M market and 90% margin per device.

Clinical development and pipeline

• TLR9 agonist nelatolimod acquired to stimulate tumor immune environment and eliminate immunosuppressive cells, with strong phase 1 data in liver and pancreas.

• Decision on lead indication expected by year-end, focusing on commercial opportunity and regulatory path.

• Combination strategies with standard of care and checkpoint inhibitors are being considered, with collaboration from MD Anderson.

• Data releases planned for SITC and other conferences in the first half of the year, including updates on liver and pancreatic trials.

• Multinodular goiter study to publish initial data in Q1, with six- and twelve-month updates planned, covering several hundred patients.

Market expansion and competitive landscape

• DELIVER program launched to generate data for NCCN guideline inclusion, aiming to drive adoption in complex patient populations.

• Technology adoption requires hospital value analysis committee approval, typically a six-month process; 100 new hospitals added last year.

• Commercial team consists of about 50, targeting growth to 60-70, with launch of TriNav Large for larger vessels to address 15-20% of missed cases.

• Main competition is standard microcatheters, which lack pressure modulation; TriNav offers superior drug delivery, especially in complex cases.

• TLR9 class competitors have struggled due to delivery challenges; intravascular approach enables higher local concentrations with fewer systemic effects.