Business Description

Unless the context indicates otherwise, references in this Annual Report to the “Company,” “TriSalus,” “we,” “us,” “our” and similar terms refer to TriSalus Life Sciences, Inc. (f/k/a MedTech Acquisition Corp.), a Delaware corporation and its consolidated subsidiaries. Overview We are a growing, oncology focused medical technology business seeking to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies, and with our investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 ("TRL9") agonist, for a range of different therapeutic and technology applications. Our ultimate goal is to transform the treatment paradigm for patients battling solid tumors. We have developed an innovative technology designed to overcome two of the most significant challenges that prevent optimal delivery and performance of therapeutics in these difficult-to-treat diseases: (i) high intratumoral pressure caused by tumor growth and collapsed vasculature restricting the delivery of oncology therapeutics and (ii) off target delivery. Nelitolimod, specifically, combined with our technology aims to address the immunosuppressive properties of tumor immune cells in liver, pancreas and other solid tumors. By systematically addressing these barriers, we aim to improve response to therapies and to enable improved patient outcomes. Background Many solid tumors, especially desmoplastic tumors like pancreatic ductal adenocarcinoma ("PDAC"), liver tumors and various other tumor types have high interstitial fluid pressure which creates a physical barrier preventing therapeutics from penetrating the tumor. Beyond penetration issues, the blood vessels that supply these tumors are leaky and disorganized, leading to poor distribution of the therapeutic within the tumor. We have developed a platform approach to address the unique challenges of drug delivery to solid tumors with the goal of overcoming the primary barriers described above that limit therapeutic delivery and inhibits treatment success. PEDD & TriNav- Device Business with Potential for Growth: Our delivery method, Pressure-Enabled Drug Delivery (“PEDD”), modulates pressure and flow within blood vessels to improve intravascular therapeutic delivery into tumors thereby increasing the likelihood of tumor response in comparison to conventional delivery technologies. Our on-market, 510(k) cleared device, the TriNav Infusion System (“TriNav”) using PEDD technology is currently being used for interventional radiology procedures, most commonly transarterial radioembolization (“TARE”) and transarterial chemoembolization (“TACE”) in patients with primary liver cancer or in patients with liver metastases. TriNav is a highly innovative device with a novel (PEDD) delivery method. At the core of the TriNav system is SmartValve technology , a self-expanding mechanism that: • Modulates pressure and flow of the vasculature feeding the tumor to physiologically open collapsed blood vessels, • Creates consistent turbulent flow to promote more uniform and repeatable distribution of particles or drugs, • Self-centers the catheter tip within the vessel for precise delivery. This design represents a meaningful departure from traditional end-hole catheter designs by actively controlling flow dynamics and positioning to improve therapeutic outcomes. It is U.S. Food and Drug Administration ("FDA")-cleared and has undergone peer-reviewed studies at multiple clinical sites. The PEDD method has now been used in over 31,000 procedures, primarily TACE and TARE. TriNav achieved $45.2 million in revenue in 2025 representing growth of 53.4% vs. the previous year. Additionally, our PEDD technology has proven to demonstrate improved drug delivery in a range of other non-malignant tumor embolizations such as Thyroid Artery embolization for treatment of Multi-nodular goiters, uterine artery embolization ("UAE") for treatment of fibroid tumors, prostate embolization for treatment of prostate cancer and an emerging new application for treatment of osteoarthritis and genicular artery embolization. 1 Table of Contents These tumor types share common procedural and drug delivery challenges as oncologic embolization such as tortuosity and small caliber target vessels, variable floor and collateral circulation, risk of off target embolization and the need for deeper penetration of embolic particles into the abnormal tissues.…