TriSalus Highlights Tumor-Treatment Expansion, FDA Catalyst at Growth Conference

Key Points

• Commercial expansion is underway: TriSalus substantially enlarged its sales force, with new representatives expected to reach full productivity within six to nine months. The company is also increasing physician-to-physician education to broaden adoption beyond early users.
• TriNav ADVANCE is a potential FDA catalyst: The product remains under FDA review after an unusually long process of roughly 10 months and is reportedly in its final stages. Clearance could expand TriSalus’ reach into smaller and more difficult-to-access vessels, including an estimated 20% of “super selective” procedures.
• Management sees a path to stronger economics and broader markets: TriSalus estimates that quarterly revenue of $18 million to $20 million could support cash-flow positivity, while ADVANCE may achieve gross margins near 93%. A new CMS reimbursement code expected to take effect Jan. 1 could also improve access in office-based labs, supporting the company’s estimated $2.5 billion addressable market.

TriSalus Life Sciences NASDAQ: TLSI outlined its commercial expansion, product pipeline and clinical-evidence strategy during Canaccord Genuity’s Global Growth Conference, with management emphasizing the company’s pressure-enabled delivery technology for solid-tumor treatments.

President and CEO Mary Szela said the company’s catheter technology uses a valve designed to modulate pressure and flow in vessels feeding tumors. The approach is intended to improve delivery of therapeutic agents into tumors while limiting delivery to surrounding tissue.

According to Szela, pressure within tumors can exceed the pressure generated by the heart, potentially limiting the ability of therapies to penetrate tumors. She said TriSalus’ technology can increase therapeutic delivery into solid tumors by 50% to 500%, while helping protect against off-target delivery.

Commercial Expansion and Sales Force Ramp

CFO David Patience said TriSalus substantially expanded its commercial organization during the first half of the year, with the expanded team largely in place by April. New sales representatives are about halfway through a six-to-nine-month process to become fully productive, he said.

Management said it monitors physician engagements, product use, value-analysis committee approvals and the transition to routine use as indicators of adoption. Patience said newer representatives are ramping in line with the company’s expectations, while legacy representatives continue to grow.

TriSalus has also increased its use of physician-to-physician education programs. Patience said peer-to-peer events in the second quarter were two to three times higher than the number held during all of 2025 year to date. Management said these programs can help current users provide clinical-use examples to other interventional radiologists.

Szela said the company has now been on the market for four years and has moved beyond initial adopters. In many accounts, TriSalus is seeking to broaden usage from one physician to additional physicians at the same facility.

Asked about the sales-force expansion, Szela said the company moved quickly to avoid prolonged disruption within the organization. In hindsight, she said TriSalus could have established a more robust training program before expanding the commercial team. Patience said the company could have communicated more clearly to investors that the expansion was intended to address commercial coverage rather than demand weakness.

TriNav ADVANCE Awaiting FDA Clearance

TriSalus is awaiting FDA clearance for TriNav ADVANCE, a product designed to allow physicians to use a standard microcatheter while retaining the company’s pressure-enabled delivery effect. Szela said the system is intended to help physicians reach smaller and more tortuous vessels that may be inaccessible with the company’s existing portfolio.

Szela said the company submitted the product for review in November and that the review has extended to roughly 10 months, compared with approximately 45 days for four products launched over the past 24 months. She said the application had left the assigned reviewer’s desk and was in final stages, but did not provide a timing estimate for clearance.

Management estimates TriNav ADVANCE could address approximately 20% of the current market described as “super selective” procedures. The product could also support use in smaller-vessel applications, including genicular artery, prostate artery and other procedures, Szela said.

The company is developing a smaller TriNav ADVANCE size that Szela said it hopes to introduce within 12 to 24 months. Management also said the expanded portfolio could make it easier for physicians to use TriSalus technology more consistently by providing a broader set of tools for varying vascular anatomies.

Margins, Profitability and Reimbursement

Patience said TriSalus is focused on manufacturing scale and ensuring product availability as its commercial organization expands. The company currently has a dedicated manufacturing line for ADVANCE and is considering external redundancy, he said. Szela said the product has a high-margin profile and that gross margin could potentially reach about 93%, based on testing.

On profitability, Patience said the company has not provided a timetable for becoming cash-flow positive. However, he said quarterly revenue of roughly $18 million to $20 million, or an approximately $80 million annualized run rate, could support that outcome based on the company’s gross margins and expense profile. He said TriSalus expects sales and marketing leverage to improve as commercial expenses decline relative to revenue.

Szela also discussed a new permanent G-code from the Centers for Medicare & Medicaid Services. CMS is finalizing reimbursement for the code, and TriSalus expects it to become effective Jan. 1. Management said the code could expand access in the office-based lab, or OBL, market. Szela cited Clarivate claims data indicating OBLs account for about 8% of the market, while cautioning that reporting for that setting is limited.

Clinical Evidence and Market Opportunity

Management said it is pursuing head-to-head foundational studies against standard microcatheters, along with prospective studies and registries across several applications. Szela cited company-released health economics and outcomes research based on more than 300 million claims and 1,200 patients, which she said showed higher drug delivery, a 50% reduction in hospitalizations, a 30% reduction in complications and no neutropenia.

TriSalus is also conducting studies intended to assess tumor-to-normal-tissue ratios and treatment delivery in larger hypovascular tumors. Szela said the company has surpassed 60 patients in a planned 100-patient thyroid registry and is also pursuing registries in uterine artery embolization, genicular artery embolization and prostate artery embolization.

Szela said TriSalus estimates its total addressable market at roughly $2.5 billion, including liver embolization and other vascular applications outside cerebral and coronary vasculature. She said the company’s existing clearance and reimbursement framework allows it to pursue those applications without new clearance or reimbursement codes.

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.

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