TriSalus Life Sciences, Inc.

What they do

TriSalus markets Pressure-Enabled Drug Delivery (PEDD) infusion devices, led by the 510(k)-cleared TriNav Infusion System with SmartValve technology, used by interventional radiologists mainly for transarterial chemoembolization (TACE) and transarterial radioembolization (TARE) in primary liver cancer and liver metastases. The company also holds a 510(k)-cleared Pancreatic Retrograde Venous Infusion (PRVI) device for pancreatic tumors and is developing nelitolimod, a class C TLR9 agonist immunotherapeutic administered via PEDD. The PEDD method has been used in over 31,000 procedures, and the company is generating clinical data in thyroid, uterine artery and genicular artery embolization.

Revenue drivers

• TriNav Infusion System (PEDD devices) — Substantially all revenue comes from TriNav device sales for TACE/TARE and other embolization procedures; 2025 revenue was $45.2 million, up 53.4% versus 2024.
• Reimbursement codes — A permanent New Technology HCPCS code effective January 1, 2024, a second code effective April 1, 2025 for pre-TARE mapping, and a new G-code effective July 1, 2026 for office-based labs underpin hospital and physician-office payment for TriNav.
• TriNav LV, FLX and XP expansion — Launched in 2025, these variants extend the family to more flexible tips and larger embolic particles and are eligible for the same HCPCS codes, intended to widen the addressable embolization market.
• nelitolimod — Investigational TLR9 agonist; Phase I dose escalation and Phase Ib trials completed, but no product revenue and the company says it does not intend to proceed to Phase II due to the excessive cost of capital.

Recent performance

Second quarter 2026 revenue was $11.4 million, up 1.7% year over year, following $13.2 million in Q4 2025 and $8.9 million in Q1 2026. Gross margin improved to 86.8% from 83.9%, primarily on a lower cost per TriNav unit. Operating losses widened to $9.8 million from $7.3 million, driven by higher sales and marketing spend, partly offset by lower R&D and G&A. Net loss available to common stockholders was $9.2 million, or $0.16 per basic and diluted share, versus $9.0 million and $0.27 a year earlier, and adjusted EBITDA loss was $7.1 million versus $5.3 million.

Strategy

Management is expanding the commercial organization and marketing investment to drive TriNav adoption and broader market penetration. The company is broadening the PEDD portfolio with TriNav FLX and XP and pursuing new applications including the PROTECT registry study in thyroid disease (100 patients, approximately 10 sites) and work in uterine and genicular artery embolization. It raised $46.0 million in gross proceeds from an equity offering in the first quarter of 2026 and states this provides sufficient runway to fund commercial expansion and pipeline development. On the drug side, it is supporting two investigator-initiated nelitolimod trials while not funding Phase II itself.

Risks

• Persistent losses and accumulated deficit — Net losses were $39.2 million in 2025 and $30.0 million in 2024, with an accumulated deficit of $330.6 million as of December 31, 2025.
• Thin equity cushion — At June 30, 2026, total liabilities of $55.9 million against $62.4 million of assets left shareholder equity of just $6.5 million, despite $46.3 million of cash.
• Reimbursement dependence — TriNav revenue depends on HCPCS codes and payment rates, and management said CMS is still finalizing the rate for the new G-code for office-based labs.
• Pipeline funding constraints — The company stated it does not intend to proceed to Phase II trials of nelitolimod due to the excessive cost of capital.

Outlook

Management maintained full-year 2026 revenue guidance of $54 million to $57 million, representing growth of 19% to 26% versus 2025. The CEO said the company anticipates further growth in the back half of the year as the sales team ramps and cited the new G-code extending reimbursement into the office-based lab setting. Revenue in the first half of 2026 totaled $20.3 million, implying a substantial second-half step-up to reach the guidance range.