Here are the 10-K annual reports from TriSalus Life Sciences, Inc. Warrant (TLSIW) in our archive since June 2025, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 10-K covers the audited annual report, with the full financial statements, so if you follow TLSIW and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full TLSIW filings page.
TriSalus Life Sciences is an oncology-focused medtech company combining proprietary drug-delivery devices with an investigational immunotherapy, nelitolimod, to treat solid tumors, especially in the liver and pancreas. Its core Pressure-Enabled Drug Delivery (PEDD) platform underpins the FDA‑cleared TriNav Infusion System and a 510(k)‑cleared pancreatic device (PRVI).
TriNav, used mainly in TACE and TARE procedures, has been employed in over 31,000 procedures and generated $45.2 million in 2025 revenue, a 53.4% increase versus the prior year. Clinical and real‑world data show improved tumor targeting, higher drug deposition and reduced complications compared with standard microcatheters. Management estimates a U.S. total addressable PEDD market projected to exceed $2.3 billion annually across liver cancers, pancreatic tumors, fibroids, multinodular goiters, prostate disease and osteoarthritis‑related knee pain.
Nelitolimod, a class C TLR9 agonist acquired from Dynavax, is being tested with PEDD in three Phase 1 PERIO studies in uveal melanoma liver metastases, cholangiocarcinoma, hepatocellular carcinoma and locally advanced pancreatic cancer, with readouts expected in 2026. The company holds a broad patent portfolio extending into the 2030s, manufactures TriNav in Colorado, and benefits from permanent CMS reimbursement codes C9797 and C8004 that support outpatient and ambulatory use.