TriSalus Life Sciences (NASDAQ:TLSI) reported fourth-quarter and full-year 2025 results that management characterized as “strong,” driven by growth in its TriNav product suite and broader adoption of its Pressure-Enabled Drug Delivery (PEDD) platform beyond liver-directed procedures.
Revenue growth and 2026 outlook
For the fourth quarter, TriSalus posted revenue of $13.2 million, up 60% from $8.3 million in the prior-year period. Full-year 2025 revenue was $45.2 million, an increase of 53% versus 2024, and management said the company achieved its 2025 revenue growth guidance.
Financing and strategic priorities
Management highlighted two recent steps intended to strengthen governance and liquidity. In February, TriSalus appointed veteran healthcare investor Michael Stansky to its board. Also in February, the company completed a public offering that raised $46 million in gross proceeds, which Szela said was more than two times oversubscribed and supported by fundamental healthcare investors.
Szela outlined three primary strategic priorities for the capital:
- Expanding the sales and commercial infrastructure, including a significant increase in commercial coverage and adding a layer of management to address an increasingly high rep-to-manager ratio.
- Investing in foundational clinical studies to further validate the clinical and economic differentiation of PEDD, with management pointing to the importance of comparative evidence versus microcatheters.
- Continuing product innovation to enhance physician adoption and utilization across liver embolization and expanding applications.
In the Q&A session, management did not provide a specific headcount target for sales representatives or clinicians, but reiterated it is “meaningfully doubling” the commercial organization. Szela described TriSalus’s model as pairing a representative with a clinical specialist who supports physicians in cases until they are comfortable using the technology independently.
Portfolio expansion and product updates
Szela said TriSalus has assembled a PEDD portfolio designed to address “virtually every vascular anatomy” encountered by interventional radiologists. The company noted that it entered 2025 with two core commercial products and expects to expand to seven differentiated offerings as it moves into 2026.
TriSalus highlighted multiple product launches during 2025, including TriNav LV, TriGuide, and TriNav FLX. Szela said TriNav FLX improves trackability and access to tortuous anatomy. During the fourth quarter, TriSalus launched the TriNav XP infusion system, which the company said was engineered for compatibility with larger embolic particles and includes a more flexible distal tip, multiple lengths, and vessel sizes. Management also cited potential use in lobar liver procedures, mapping/simulation procedures, and uterine artery embolization (UAE). Szela said early market reception for TriNav XP has been “outstanding,” based on feedback from key opinion leaders.
The next planned addition is TriNav Advance, which management anticipates launching in the first half of 2026, pending 510(k) clearance. Szela said the company plans a rapid market evaluation before a broader launch in the second half of the year. Management described TriNav Advance as designed to deliver selective therapy to small distal vessels via a standard microcatheter, while still enabling PEDD to enhance delivery and protect against off-target effects. Executives also said TriNav Advance may expand the company’s ability to capture cases not previously addressable with TriNav because it can access smaller arteries.
Szela pegged the liver embolization total addressable market at approximately $480 million and said other embolization procedures—including thyroid, UAE, and genicular artery embolization (GAE)—represent a $2.3 billion U.S. addressable market.
Reimbursement, clinical programs, and new indications
Management pointed to reimbursement expansion as a commercial tailwind. Szela said the introduction of CMS HCPCS code C8004 in 2025 expanded coverage to include simulation or mapping procedures using TriNav, effectively doubling reimbursable use within radioembolization and supporting broader adoption. In response to an analyst question about mapping growth, management said TriNav XP’s larger interior diameter and TriNav Advance could contribute meaningfully to mapping and imaging use, alongside planned study releases.
On new applications, Szela said that while liver-directed therapy will remain the majority of 2026 revenue, the company expects more meaningful progress in newer indications in the second half of 2026 as clinical data are released. She said that in uterine fibroids, TriSalus has “over 10 clinical sites” enrolling patients, with initial data expected to begin around the Society of Interventional Radiology (SIR) meeting and additional releases later in the year.
The company also discussed its PROTECT registry, which is evaluating PEDD for patients with thyroid nodules or goiters who are not candidates for surgery, radioiodine, or ablation. Szela cited preliminary results published in the Journal of the Endocrine Society showing 100% technical and clinical success, no neurovascular complications, mild and transient discomfort in 81% of patients that resolved within two weeks, a 73% reduction in thyroid size, and normalization of thyroid function in 71% of participants.
TriSalus said it initiated a pilot registry in GAE in 2025 and is preparing to launch a registry evaluating GAE as a treatment option for knee osteoarthritis.
Nelitolimod update and financial details
TriSalus also addressed its nelitolimod program. Szela said the company did not meet its previously communicated timeline to release updated clinical data in the fourth quarter of 2025. Management said it chose to consolidate data across all three PERIO Phase I studies into a comprehensive update, and that final database lock and report preparation for PERIO-3 took longer than expected. TriSalus now anticipates releasing a consolidated update in the second half of 2026. Szela said the delay was not driven by safety concerns or changes in strategic priorities, and that all three PERIO Phase I dose escalation studies are complete, with PERIO-3 enrollment concluded and clinical study reports in preparation. She added that the company has substantially reduced internal development spending related to nelitolimod following study completion while continuing partnership discussions and supporting investigator-initiated studies.
On profitability metrics, CFO David Patience reported fourth-quarter gross margin of 87%, up from 85% a year earlier, which he attributed to improving manufacturing efficiency associated with newly launched products. Fourth-quarter R&D expense declined to $2.6 million from about $3.0 million, driven largely by the completion of enrollment and closure of PERIO studies. Sales and marketing expense increased to approximately $8.0 million from $7.0 million, which Patience said reflected higher performance-based compensation. G&A expense declined to $4.2 million from $4.6 million.
Net operating loss for the quarter was $3.3 million compared to $7.6 million in the prior-year quarter, while adjusted EBITDA loss improved to approximately $950,000 from an adjusted EBITDA loss of $5.7 million.
For the full year, Patience said revenue was “all from the TriNav system” at $45.0 million. Full-year gross margin was 85% versus 86% in 2024, with Patience attributing the decline to lower manufacturing efficiencies associated with product launches in the second and third quarters, which improved in the fourth quarter. Operating losses narrowed to $26.9 million from $36.2 million. Basic and diluted loss per share was $1.84 compared to $1.31 in 2024, which Patience said was primarily due to the conversion of preferred stock to common stock.
As of December 31, 2025, cash and cash equivalents totaled $20.4 million. Patience said the company is not providing specific timing or guidance on adjusted EBITDA or cash flow breakeven, citing that it is in the early stages of investing in commercial expansion and expects to provide more visibility later in 2026.
About TriSalus Life Sciences (NASDAQ:TLSI)
TriSalus Life Sciences, Inc is a clinical-stage biotechnology company focused on the development and commercialization of non-invasive drug–device combination therapies for oncology applications. Leveraging proprietary electroporation and ultrasound platforms, the company aims to enhance the localized delivery and efficacy of established chemotherapeutic agents while reducing systemic toxicity. Its lead programs target hard-to-treat head and neck cancers, where improved tumor control and patient tolerability remain significant unmet needs.
The company’s pipeline comprises investigational product candidates in early and mid-stage clinical trials, including studies that combine its electrochemotherapy platform with radiation therapy and immuno-oncology agents.
