TriSalus Life Sciences Q3 2025 Earnings Report

TriSalus Life Sciences EPS Results

• Actual EPS: -$0.96
• Consensus EPS: -$0.17
• Beat/Miss: Missed by -$0.79
• One Year Ago EPS: N/A

TriSalus Life Sciences Revenue Results

• Actual Revenue: $11.57 million
• Expected Revenue: $11.76 million
• Beat/Miss: Missed by -$194.00 thousand
• YoY Revenue Growth: N/A

TriSalus Life Sciences Announcement Details

• Quarter: Q3 2025
• Date: 11/13/2025
• Time: After Market Closes
• Conference Call Date: Thursday, November 13, 2025
• Conference Call Time: 4:30PM ET

TriSalus Life Sciences (NASDAQ:TLSI) 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. TriSalus collaborates with academic medical centers and cancer research institutions across the United States to advance its candidates through regulatory and clinical milestones. By integrating novel delivery technologies with proven oncology drugs, TriSalus seeks to optimize therapeutic outcomes in both recurrent and metastatic disease settings.

Headquartered in Houston, Texas, TriSalus operates research and development facilities in strategic North American life-science hubs. Its leadership team brings together seasoned professionals with backgrounds in pharmaceutical development, medical devices, and oncology therapeutics. As the company progresses through clinical validation, it plans to expand its technology platform into additional solid tumor indications, aiming to provide safer, more effective treatment options for cancer patients worldwide.

TriSalus Life Sciences Q3 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Trisalus reported $11.6 million in Q3 revenue (up 57% YoY, +3% sequential), added 20 new ordering accounts (+30% YoY), and finished the quarter with about $22.7 million in cash, while reaffirming its 50% revenue growth target.
• Positive Sentiment: CMS HCPCS code C8004 expanded reimbursement to include mapping/simulation angiograms, effectively doubling reimbursable use in radioembolization and supporting broader TriNav adoption into 2026.
• Positive Sentiment: The company expanded its TriNav platform with launches (TriNav Flex, LV, TriGuide), early rollout of TriNav XP and an upcoming TriNav Advance, with strong early feedback and growing mix penetration (Flex ≈35%), targeting new markets like uterine fibroids, thyroid nodules, and genicular artery embolization (GAE).
• Negative Sentiment: Management increased commercial investment to fuel growth, which they say will extend the timeline to reach EBITDA positive and cash-flow breakeven; Q3 operating loss was $9.0M (adjusted EBITDA loss $5.4M) and included one-time study closeout charges.
• Neutral Sentiment: Trisalus completed Phase 1 nallotolamide studies and is seeking partners to remove most development costs by end-2025 while preserving upside, with PERIO III final data and clinical study reports expected in Q4.

Presentation

[Operator]

Afternoon and welcome to TriSalus Life Sciences' third quarter 2025 earnings conference call. Currently, all participants are on a listen-only mode. Following management's prepared remarks, we will hold a question-and-answer session. As a reminder, this call is being recorded for replay purposes. I will now turn the call over to Jeremy  Feffer, Managing Director with Life Sciences Advisors. Please go ahead, sir.

[Jeremy  Feffer, Managing Director at Life Sciences Advisors]

Thank you, Operator, and thank you all for participating in today's call. Joining me today from TriSalus Life Sciences are Mary Szela, President and Chief Executive Officer; David Patience, Chief Financial Officer; and Dr. Richard Marshall, Medical Director. Ms. Szela will provide an overview of the company's third quarter results and strategy for the balance of the year. Mr. Patience will review the financial results for the quarter in detail. Following their prepared remarks, Dr. Marshall will join the call to help address questions from covering analysts. Earlier this afternoon, TriSalus released its financial results for the quarter ended September 30TH, 2025. A copy of this press release is available on TriSalus' website.

[Jeremy  Feffer, Managing Director at Life Sciences Advisors]

Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Reform Act of 1995. Any statements contained in this call, other than the statements of historical fact, are forward-looking statements. All forward-looking statements, including without limitation, statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations, and future product development and approvals, are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties, including the impact of macroeconomic conditions and global events that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements.

[Jeremy  Feffer, Managing Director at Life Sciences Advisors]

For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our Form 10-Q on file with the SEC and available on EDGAR and our other reports filed periodically with the SEC. TriSalus disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. The conference call contains time-sensitive information and is accurate only as if this live broadcast today, November 13, 2025. With that, I'll turn the call over to Mary.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Thank you, Jeremy, and good afternoon, everyone. Thank you for joining us for a review of our third quarter 2025 results. I will begin with a high-level review of the quarter and recent weeks and provide a quick update of our longer-term strategy. David will then follow my remarks to provide a more in-depth review of our financial and operational results for the quarter. We will then be happy to open the call to questions. Let's begin. I'm pleased to report that our third quarter results were strong. Revenues were $11.6 million, representing a 57% increase over the prior year quarter and a 3% sequential gain over the second quarter of 2025. During the quarter, we also continued to expand our TriNav platform, launching our TriNav FLX infusion system and advancing new clinical applications to expand our market opportunities.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

We also simplified our capital structure through the successful completion of our exchange offer and consent solicitation for preferred stock. Operationally, we continued to manage cash efficiently, ensuring resources were allocated strategically to advance our key priorities. We increased commercial investment to maintain our strong growth, a deliberate decision that extends our timeline to reach EBITDA positive and cash flow breakeven. Our commercial momentum in the third quarter remained strong. The commercial organization continued to drive deeper penetration within the complex liver embolization market, bolstered by the Centers for Medicare & Medicaid Services, CMS, HCPCS code C8004 introduced in April. This new code expands coverage to include simulation angiogram or mapping procedures using TriNav, enabling interventional radiologists to utilize TriNav for other treatment planning and delivery using radioembolization. As a result, the reimbursable use of our technology within the radioembolization market has effectively doubled, supporting the broader adoption we're observing.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Now, interventional radiologists are able to use TriNav across the full continuum of radioembolization care. Early feedback from key accounts and users highlights the clinical and economic advantages of the expanded reimbursement, which we expect to continue driving adoption into 2026. We are reaffirming our 50% revenue growth guidance, reflecting strong confidence in our growth momentum and market opportunities. Consistent with our prior commitment, we continue to invest in long-term growth via increasing commercial resources and funding of new applications. We believe TriSalus's pressure-enabled drug delivery, or PEDD technology, represents a transformative opportunity with substantial long-term value across a wide range of solid tumors and interventional treatment approaches. We continue to execute a focused strategy to expand our platform with technologies that address the complex challenges of tumor vasculature and improved delivery. Momentum across our programs remains strong, reflecting the growing clinical and commercial impact of our PEDD technology.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

In the last year, we launched TriNav LV, TriGuide, and the TriNav FLX, each advancing our commitment to innovation and improving therapeutic delivery precision. Expanding our product suite broadens our addressable market, strengthens physician adoption due to a technological solution for all the various vascular challenges, and extends our reach beyond the liver into new therapeutic areas. Expanding our product portfolio remains a core pillar of our growth strategy. By broadening our addressable market and delivering solutions with greater versatility and precision, we're enabling more physicians to treat complex patients and extending our reach beyond the liver into new therapeutic areas. Following the quarter, we began market evaluation of our next-generation TriNav XP, which features compatibility with larger particles and a more flexible distal tip, an important advancement for low-bar liver and uterine artery embolization procedures.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Although early, feedback from over 20 initial cases with key opinion leaders has been outstanding, which highlighted exceptional trackability, enhanced visualization for precise targeting, and improved professional efficiency. These advances reinforce our confidence in TriNav, powered by PEDD, as a platform that helps interventional radiologists address their most difficult tumor drug delivery challenges. We continue to invest in the TriNav portfolio to deepen its clinical impact, to improve drug penetration, reduce complications, and expand patient eligibility. Our results this quarter demonstrate that TriNav is well-positioned to become the standard of care in liver embolization for complex patients. We remain focused on strengthening the clinical evidence base, engaging closely with key medical societies, and driving commercial expansion to fully realize TriNav's market potential. As previously discussed, beyond leveraging our PEDD technology in liver cancer, we're also expanding the clinical application through the TriNav infusion system.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Yesterday, we hosted the first in a series of key opinion leader events focused on the potential use of TriNav infusion for the treatment of uterine fibroids. The event featured Dr. Nicole Lamparello of Weill Cornell Medicine and New York Presbyterian Hospital and Dr. Francis King of Rutgers Robert Wood Johnson University Hospital and University Radiology Group. Both speakers highlighted the significant unmet need in uterine fibroid treatment and reviewed the current therapeutic landscape. In addition, enrollment continues in our Protect Registry, a multi-center initiative evaluating PEDD for patients with thyroid nodules or goiters who are not candidates for surgery, radioiodine, or ablation. This study is designed to assess disease-related quality of life, thyroid function, and outcomes following PEDD-based thyroid artery embolization.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

As previously noted, preliminary results published in the Journal of Endocrine Society were highly encouraging, showing 100% technical and clinical success, no neurovascular complications, mild and transient discomfort in 81% of all patients, all resolved within two weeks, and a 73% reduction in thyroid size, and importantly, normalization of thyroid function in 71% of participants. These findings reinforce the promise of this minimally invasive alternative to thyroidectomy. We also initiated a pilot registry in the emerging field of genicular artery embolization, or called GAE, which offers a novel, minimally invasive approach to pain management and mobility preservation for patients with knee osteoarthritis. GAE has the potential to delay or avoid total knee arthroplasty in select patients. In parallel, we're preparing to launch a clinical trial evaluating TriNav and GAE as a treatment option for knee osteoarthritis, a condition affecting more than 30 million adults in the United States.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

The study aims to determine whether TriNav and GAE can effectively reduce pain and delay the need for knee replacement surgery. In parallel with expanding the clinical utility of TriNav, we're also advancing our efforts to begin partnership discussions to maximize the long-term value of nallotolamide across several high-value oncology indications. This transition will eliminate the vast majority of development-related expenses for nallotolamide by the end of 2025 while preserving the program's potential upside. It also allows us to focus internal resources on the near-term high-impact opportunities within our PEDD platform. phase I studies of nallotolamide in multiple liver tumor types, which include metastatic uveal melanoma, hepatocellular carcinoma, or HCC, cholangiocarcinoma, are now complete. Enrollment has also concluded in PERIO III, our phase I trial in locally advanced pancreatic cancer, with final data expected by year-end.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Clinical study reports for all three perio phase I dose escalation trials are in preparation, with data releases anticipated in Q4. We're currently finalizing reports and data presentations to support future partnership discussions. Completion of enrollment and closure of these studies will drive a reduction in R&D expenditures in the second half of 2025, and we continue to support several ongoing investigator-initiated studies.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Before turning the call over to David for a review of our third quarter financials, I want to reiterate that TriSalus remains focused on executing our near-term milestones, including advancing the TriNav platform across multiple indications focused on the interventional radiology call point, advancing PEDD solutions designed to optimize therapeutic delivery and address the full spectrum of vascular access and perfusion challenges faced by the interventional radiologist, generating and publishing new clinical and HEOR data to validate the effectiveness, safety, and economic value of our technology, enhancing operational performance in our manufacturing and improving gross margins, and also building a scalable, high-growth organization. As we look ahead to the balance of 2025 and into 2026, we're energized by our long-term vision of bringing our PEDD technology platform to a broader range of patients, improving outcomes and redefining standards of care.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

TriSalus remains a science-driven organization with patients at the center of everything we do. Our progress continues to make a meaningful difference for people living with liver, pancreatic, and other solid tumors. With that, I'll turn the call over to David.

[David Patience, CFO at TriSalus Life Sciences]

Thank you, Mary. As Mary mentioned earlier, TriSalus delivered another strong quarter. For the three months ended September 30th, 2025, revenue was $11.6 million, representing 57% year-over-year growth and 3% sequential growth versus the second quarter. This continued momentum reflects the exceptional performance of our commercial team and the expanding adoption of the TriNav for liver embolization procedures across a growing customer base. In the third quarter, we increased the number of unique ordering accounts by 30% compared to the third quarter of 2024, adding 20 new accounts while also achieving higher utilization per account. Sequential growth reflected expected seasonal trends.

[David Patience, CFO at TriSalus Life Sciences]

A temporary dip in July was driven by lower procedure volumes, followed by record levels in both August and September. The gross margin for the quarter was 84% compared to 86% in the prior year period. The modest decline was primarily due to lower manufacturing efficiency associated with newly launched products, a dynamic we expect to improve in the fourth quarter as production stabilizes. Research and development expenses were $5.2 million, up from $4.2 million in the third quarter of 2024. The increase was largely attributable to a one-time charge of approximately $2.1 million related to the closure of our clinical studies for nallotolamide, partially offset by the revision of approximately $700,000 in patent-related costs to general and administrative expenses. Excluding the one-time charge and the revision, R&D spend was down about $400,000 year-over-year. Sales and marketing expenses totaled $6.8 million compared to $6.1 million in the prior year.

[David Patience, CFO at TriSalus Life Sciences]

The increase was primarily due to higher performance-based compensation reflected by our strong commercial momentum. General and administrative expenses were $6.7 million, up from $4.7 million in the third quarter of 2024, driven mainly by the acceleration of approximately $1.6 million in non-cash stock-based compensation and the revision of approximately $700,000 of patent-related expenses. Excluding the one-time accelerated stock-based compensation and revision of patents, G&A was down $300,000 year-over-year. Operating loss for the quarter was $9 million compared to $8.7 million in the prior year. The increase was primarily driven by the one-time charge related to the closure of our clinical studies for nallotolamide and the non-cash stock-based compensation acceleration in the period. Cash used in operation was $3.7 million, a substantial improvement versus $11.2 million compared to the third quarter of 2024. Adjusted EBITDA loss was $5.4 million, an improvement from $7.1 million in the prior year.

[David Patience, CFO at TriSalus Life Sciences]

This includes approximately $2.1 million in one-time charges related to the PERIO study closeout. The improvement in adjusted EBITDA reflects stronger sales performance, lower underlying R&D spend, and disciplined operating expense management. Our cash burn for the quarter was approximately $3.8 million, bringing our quarter-end cash and cash equivalence balance to $22.7 million. We believe this provides us ample liquidity to fund our operations and strategic objectives. Subsequent to the quarter, we amended our debt agreement to reduce the minimum cash covenant from $10 million to $5 million, providing additional balance sheet flexibility. As Mary highlighted earlier, the preferred conversion completed in July simplified our capital structure, eliminated the 2027 preferred stock reset provision, and better aligned our long-term investor base for future growth. With that, we're ready to open the line for questions. Thank you.

[Operator]

To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. We ask you please limit yourself to one question and one follow-up. If you have additional questions, please return to the queue. Please stand by while we compile the Q&A roster. The first question comes from Frank Takkinen with Lake Street Capital Markets. Your line is now open.

[Nelson Cox, Research Analyst at Lake Street Capital Markets]

Hey, this is Nelson Cox from Frank. Congrats on all the progress here. I want to start with 2026. I understand you guys are not guiding for that today, but just any color you feel comfortable providing there in terms of how we should be thinking about growth in 2026. When I look at kind of where the street's at, there's kind of a wide range. Just wanted to give a chance if you guys are comfortable to provide more color there.

[David Patience, CFO at TriSalus Life Sciences]

Yeah, Nelson, this is David. Thank you for the question. Right now, we're confident and very excited about our current momentum, especially in the fourth quarter. That's really our focus right now. We are maintaining our guidance thus far of the 50% growth and Adjusted EBITDA positivity in the first half of next year. Other than that, we're pretty focused on the current operations of the business, and we're excited about it.

[Nelson Cox, Research Analyst at Lake Street Capital Markets]

All right. Fair enough. Kind of curious if there's any additional color you can provide outside of liver in terms of growth you're seeing in your other indications.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Yeah, I can take that, Nelson. One of the things that we're doing right now is we're investing in some of the new applications that our technology can be used for. Yesterday, we had a webinar on uterine artery embolization, and we're right in the middle of our market evaluation for one of our new products, and we're really excited about it. I think this is a product that can be really meaningful for uterine artery embolization, help reduce procedural time, help reduce the amount of embolics that are used, which correlates to reduced pain. The other important thing is just reduce the administration of embolics into the myometrium tissue, which can cause a lot of post-procedural pain. We think this could be a major opportunity for us in 2026. We'll enter our full launch in about a week.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Already, just based on the feedback and just the utilization and the market evaluation, it's been really robust. I think we mentioned too in our earnings remarks that we are in the midst of a genicular artery embolization trial. That's something that we'll continue to invest in and move even further. We have a new product launch coming in the fourth quarter, which is TriNav Advance. And this one, we think, could be really interesting for us because this is a technology where the interventional radiologist has the potential to use any microcatheter. We think that could open up the opportunity for other different procedures. I'd like to have Dr. Richard Marshall comment on this. He's actually used this product and also used our XP, and maybe you can comment on those as well, Dr. Marshall.

[Richard Marshall, Medical Director at TriSalus Life Sciences]

Thanks, Mary. Good afternoon, everybody. I am very excited about both the XP, which is our product for uterine artery embolization, that's currently in limited market release, and the feedback has been great. This will allow physicians to use a TriNav in a part of the body where they couldn't use it, or it was very difficult to use previously. The same thing goes for our genicular artery embolization. Currently, we have a pilot trial going on to evaluate this, but in Q4, we'll be launching the advanced product, which will allow physicians to get deeper into these arteries with their favorite microcatheter. We're going to be giving them the effects of a TriNav, but they're going to still feel like they're using and be able to treat patients like they normally do with their favorite microcatheter.

[Richard Marshall, Medical Director at TriSalus Life Sciences]

I think that's going to provide a lot of opportunity, especially in really small arteries and smaller parts of the body, like genicular arteries, which is a growing area of treatment. I've been able to use these products. The Advance, I have not used in a human yet because it's not available. I can tell you my experience with it in pigs has been phenomenal. I think it's going to generate a lot of excitement and expand what we can do, the number of patients that we can treat.

[Nelson Cox, Research Analyst at Lake Street Capital Markets]

Awesome. That's helpful color. Thank you, guys.

[Operator]

Thanks, Nelson. The next question will come from William Plovanic with Canaccord. Your line is open.

[William Plovanic, Managing Director and Equity Research Analyst at Canaccord]

Hey, great. Thanks. Good evening, and thanks for taking my questions. I think as we come into the year, I mean, I just want to the revenue was a little light for the quarter. I appreciate the cadence comments regarding August, September. I think that gives you the confidence to finish out the year, which I think consensus is sitting right about that $45 million. I do think going back to the first question was asked, I mean, there are estimates out there that have over 50% growth next year and up to almost 90% year-over-year growth next year for some of the sell-side analysts. I understand you do not really want to comment, but is there any reason you think that your revenue growth could accelerate above 50% in 2026?

[Jeremy  Feffer, Managing Director at Life Sciences Advisors]

Yeah. No, I think it is a great question. We have not managed to street to the 2026 numbers. I think those that are closest to the story are pretty familiar with kind of where we see the growth of the business. We're just not ready to comment on 2026 just yet. We're very focused. We appreciate your understanding. The first quarter being 9 and then two quarters of over $11 million in a row is exactly how we forecast it. We're on target and tracking towards that 50% growth, which will be a nice step up in the fourth quarter. September was a record month for us, just to close that out, and very strong, very strong momentum for us. It was the best month ever for our company. That said, we don't want to comment on 2026 just yet. We're very focused, but confident that we'll hit our 50% growth target.

[William Plovanic, Managing Director and Equity Research Analyst at Canaccord]

Just a follow-up, as we think about the use cases for mapping, a double-T opportunity, what percentage of your case mix today is mapping? If I could squeeze in just what are you seeing in terms of the new account penetration going deeper versus new account additions as drivers for you? Thanks for taking my questions.

[Jeremy  Feffer, Managing Director at Life Sciences Advisors]

Perfect. Yeah, I'll take the last part. Our new account additions, we are adding about 20 accounts through VAC approval for the quarter. Again, our focus going into this year was opening a lot of accounts—excuse me—were already opened, and we're driving deeper penetration, as you commented. Our utilization is continuing to grow on a quarterly cadence per account. That is really driven by new physicians spreading word of mouth using TriNav, where we used to have one champion. Now we have one or two. The newer applications will play a big role as those interventional radiologists are going to be using us not just for the liver.

[Jeremy  Feffer, Managing Director at Life Sciences Advisors]

To answer your question, very focused, deep penetration within each account to improve utilization. We're seeing that in the numbers, and that's what we're excited about. I'll turn it over to Mary to talk about mapping.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Hi, Beth. Thanks so much for a good question. Yeah, mapping has actually been a very important driver for us in the back half of the year. We estimate, and this is based on our—we don't really have detailed market data or external market data. This is based on our Viva internal data from our representative. We're estimating about 30% of our growth is coming from the mapping. Remember, about half the market is radioembolization. Half the market is chemoembolization. They don't do mapping in the chemoembolization. We're really seeing kind of a two-for-one in the radioembolization.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

The other factor has just been because it's a new code and it came out in April, we're working—we have a reimbursement resource with Dr. Z. We're still having some bumps with that where people are just not familiar with this code. We've really gotten through some of the bumps along the way, and we're starting to see that accelerate. That's been very helpful for us this year.

[William Plovanic, Managing Director and Equity Research Analyst at Canaccord]

Thank you.

[Operator]

The next question will come from Ross Osborn with Cantor Fitzgerald. Your line is open.

[Matthew Park, Equity Research Analyst at Cantor Fitzgerald]

Hey, guys. This is Matthew Park on for Ross today. Thanks for taking the questions. I guess just starting off, as you initiate the genicular artery embolization study for NEOA, how do you view the broader competitive landscape developing around here, and where would you see TriNav fitting in within the potential standard of care?

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Sure. GAE is a really exciting opportunity, I think, not only for patients because it can potentially reduce the need for a knee surgery, or more fundamentally, it just addresses the immediate pain that these patients are in. We're a drug delivery device. Where we see a lot of the competition coming in this is really around what type of speed that they're administering. Are they resorbable? Is it different types of drugs that they're administering? I think the key that we believe that we offer is that we can penetrate these vessels much more deeply, and we can actually protect against off-target delivery. I'll have Dr. Marshall comment about this because he's been involved in our early cases and our pilot study. This drug delivery, we think, can be a very important one in this procedure, regardless of what's being administered into the vessels. Dr. Marshall?

[Richard Marshall, Medical Director at TriSalus Life Sciences]

Thanks, Mary. I think you highlighted some really good points. The most difficult thing about these cases is being able to deliver particles or liquid into these genicular arteries and get it to go deeply without having it go into places where we do not want it to go. Obviously, the foot is distal or downstream from the knee, and that is what we all want to protect. TriNav, with both its flow modulation and reflux protection, accomplishes both of those. This procedure is already being performed with traditional microcatheters. The interest that we have received so far and the success that we have seen is that physicians do an angiogram with the TriNav, and they say they can see vessels a lot better. Then when they deliver their microspheres or their liquid embolic, they can push it in much farther without having to worry about non-target embolization.

[Richard Marshall, Medical Director at TriSalus Life Sciences]

They feel safer, more confident. We have some other positive feedback that we are going to publish in the near future about how we can treat multiple sites from one injection. I think that is going to distinguish this catheter from the traditional way of treatment. It is going to allow physicians to do this procedure faster and better.

[Matthew Park, Equity Research Analyst at Cantor Fitzgerald]

Got it. That is super helpful color. Maybe one for David. On gross margins, you called out some headwinds in the quarter driven by these newly launched products. How should we think about the cadence of gross margin over the next couple of quarters and when you would expect these manufacturing efficiencies to come back in?

[David Patience, CFO at TriSalus Life Sciences]

Perfect. I think the short answer is the fourth quarter, we will see an uptick. We've thrown a lot at our manufacturing team with four new products and eight new SKUs in one single year. But we're proud of kind of where we've evolved our processes, our procedures, and our lot sizes to really scale efficiently. We should see normalized gross margins here in the fourth quarter and then expanding early next year as well.

[Matthew Park, Equity Research Analyst at Cantor Fitzgerald]

Got it. Super helpful. Thanks for taking the questions, guys.

[Operator]

Our next question will come from Carl Byrnes with Northland Capital Markets. Your line is open.

[Carl Byrnes, Managing Director and Senior Research Analyst at Northland Capital Markets]

Thanks for the question, and congratulations on your progress. Going back to TARE mapping, what have you experienced with respect to conversion of existing TARE users with TriNav to mapping? I know you mentioned that there's some education process around the new HCP code, the C8004 code. Can you quant that at all? I know you quanted the revenue growth of 30% for mapping, but do you have any feel there? Thanks.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Yeah. I mean, I think the data that I have is what I shared with you that comes out of Viva. I think all I could really offer you is anecdotal data. Maybe I'll have Dr. Marshall respond. Dr. Marshall, how do you think about this? Just the impression that we get from physicians now is everyone likes to map with the same technology that they treat with. You want to make sure that what you see in the initial session is what you're going to define your dose on and how you're going to treat the patient. I think that's been a big message for us as we interface with physicians.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

That's been the big conversion because they've been doing—oftentimes, they'll do it with an end hole, then they'll want to treat with an end hole. Now we're converting two catheters versus the one. That's really what's been driving the majority of the upside. To your question, I don't have that definitive data. Dr. Marshall, do you want to weigh in?

[Richard Marshall, Medical Director at TriSalus Life Sciences]

I do. I'll reinforce it. I think physicians want to—they basically want to treat apples and apples. They don't want to map with one catheter and then treat with another because when they give Y90 or this radiation, they can't take it back. It has to do what they think it's going to do.

[Richard Marshall, Medical Director at TriSalus Life Sciences]

I think physicians have been really impressed with the angiography quality that they get from TriNav because of the way that contrast goes through it and is pressurized into arteries. They can see things better. That is a lot of the feedback that I get: not only can I map with the same catheter that I am treating with, I am actually seeing things and sometimes seeing more tumors. The feedback has been very positive. We do still have some education to do for physicians who understand that they can use the catheter and it is covered by insurance or Medicare or Medicaid with a CPT code.

[Carl Byrnes, Managing Director and Senior Research Analyst at Northland Capital Markets]

Great. Thanks. Very helpful. Just one quick follow-up. What are you seeing with respect to adoption of LV and FLX, and in what procedure specifically? Thanks.

[Richard Marshall, Medical Director at TriSalus Life Sciences]

I can comment on this. We have centers that have converted completely to FLX that they love the catheter and they only want to use that. Those are centers that typically do more selective treatments. Smaller portions of the liver and smaller arteries that may be at a farther distance for the catheter to travel. They appreciate the trackability of that catheter being able to go out farther, whereas others seem to be more comfortable. I think we've had a lot of users convert to FLX. It's been very well received. LV has helped us in areas where TriNav really shines. Those are really large territory treatments. For example, half of the liver, we call it a lobar treatment, an entire lobe of the liver. That valve is larger.

[Richard Marshall, Medical Director at TriSalus Life Sciences]

Some patients, for example, with primary liver cancers have hepatocellular carcinoma or metastases that receive a lot of blood flow like neuroendocrine tumors. Those arteries are larger. This is a nice fit in both of those scenarios so that the valve can fit appropriately and they can actually inject more contrast and particles faster because it is a larger catheter. I think people really appreciate that. Outside of the liver, we've seen some use of TriNav FLX in thyroid arteries because they are tortuous. It is a nice fit in that area. The same was true in uterine artery embolization. The XP catheter, which we've just released, is going to be—I think it is going to have a lot of growth in uterine artery embolization because it is designed specifically for that. That has been well received so far. I hope that answers your question.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

That's really helpful color, Dr. Marshall. I think I would add, we thought FLX—we didn't anticipate this to be this robust, but it's already about 35% of our mix. TriNav's at 50%, and the large is at about 15%. We're seeing FLX grow every month. It's been a bit of a race to keep up with how that—from a manufacturing perspective—and how that's growing month over month. It will be interesting now then to see XP. That's been our manufacturing challenge is how to—and remember, we have a single price for all these products. It's really up to the use of the physician, the type of vessel tortuosity. That's part of the inefficiency in manufacturing is just trying to estimate how this is changing month over month. We think that's going to settle out probably over the next couple of months in 2026. Great.

[Carl Byrnes, Managing Director and Senior Research Analyst at Northland Capital Markets]

That's excellent. And congrats again.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Thank you.

[Operator]

And our next question will come from Justin Walsh with Jones Trading. Your line is open.

[Justin Walsh, Equity Research Analyst at Jones Trading]

Hi. Thanks for taking the question. It's great to see you exploring different use cases for TriNav. I'd love to hear your thoughts on the long-term mix of uses if some of these indications are more likely to be more significant than others.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Yeah. So that's a really good question. I think when we first looked at our procedural code, there's roughly about 40 different embolization procedures that we could potentially be used for. So we picked ones that we think really have the most significant near-term patient benefit and market benefit. And when we think about uterine artery embolization, kind of the estimates for those markets are probably between—we've seen the low at the $110,000, higher at kind of the $250,000.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

That could be a significant market opportunity for us. Probably the biggest one that we think that could really even rival the liver market is really GAE. Just based on the patient volume and just the enthusiasm. In fact, we met with a big group of interventional—not interventional—interventional radiologists and also some orthopods. They were even excited about potentially using this procedure for even people who have had surgery. Two days postoperatively, patients are still in enormous pain. They were thinking about how do we incorporate this procedure to help allow them to do physical therapy more appropriately and recuperate much better. That is a market that could equal the size of the liver or actually be even higher than that. Maybe I can even have Dr. Marshall talk about that. The thyroid market being very comparable, again, to the uterine artery embolization.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

There is more even beyond these. This is all the ones that we're focused on right now. We've got quite a bit on our plate. We really believe this type of embolization approach can really benefit patients in terms of minimally invasive surgery, often can take a surgical procedure and make it more cost-effective for the payer, a better outcome for the patient, and potentially be used in combination with other treatments as well. Dr. Marshall, you want to comment on that?

[Richard Marshall, Medical Director at TriSalus Life Sciences]

Yes. We're talking about delivery of embolics right now. We still have more room to grow in the liver, obviously. I think the elephant in the room is genicular artery embolization. Just the number of patients that have osteoarthritis. With a population that's aging, the number of knees that are going to need to be treated in the future is going to grow quite a bit. We have a great solution for that. That is why I think it's going to be a huge area of growth for us.

[Operator]

Our next question comes from Suraj Kalia with Oppenheimer. Your line is open.

[Shaymus Contorn, Equity Research Analyst at Oppenheimer]

Hi, Mary and David. This is Shaymus on for Suraj. Just one from our—hi. Just one from our end, but just trying to cut this, I guess, two different ways. How has kind of growth/utilization looked for accounts that launched, say, 18 months ago versus one year ago versus six months ago? How kind of has the ramp kind of been increasing over time? I guess, could you kind of quantify that?

[Shaymus Contorn, Equity Research Analyst at Oppenheimer]

On a separate note, again, on utilization, how does utilization for a physician that's added on with an existing account look over time? Thank you.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

No, that's a really good question. We segment accounts into two major buckets. Oftentimes, if an account really hasn't had any education about the tumor microenvironment or some of the challenges associated with interstitial tumoral pressure and the challenges associated with it, we call that a bit of a cold account. That's going to take a little bit longer. It really depends on the type of account. An account that's more familiar with that, that's a much faster ramp. Overall, we see accounts that we started 18 months ago just continue to improve month over month. A lot of that improvement is we get one user in an account. They're using it very consistently.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

I think one of the things that we've also seen in parallel is we've offered these new options of devices. It allows that single physician to use more and more cases because we didn't have really the best technology for that particular patient. We're seeing that current user grow in a deeper amount of use within his patient population. We're also seeing the new users kind of start down that path. If it's an account that is receptive and educated along those lines, we see a more rapid uptake. If it's an account that doesn't have that information, we're starting a little bit from ground zero and we need to do some of that education and really get them familiar with the technology and the rationale, and then they get to see the technology in use. Those take a little bit longer.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Those are the two buckets that we have. I don't know, Dr. Marshall, you can talk about it as well. What we're excited about is we continue to see the continual utilization grow pretty steadily. It seems to marry how we've launched these new products too because now we've expanded the options for them to really address any vessel size or vessel tortuosity that they see in a particular patient. We think that's going to accelerate over time. Dr. Marshall?

[Richard Marshall, Medical Director at TriSalus Life Sciences]

Yeah. I think we typically see a single user at a site become a champion for us and start to use our catheter. These older accounts where a physician has been treating patients and seen the results, and they show them to their partners, then partners can start to understand, "Okay, maybe there really is something to this if they're not educated about the tumor microenvironment." We see that growth for sure that grows from one partner who's getting better results, and then all of a sudden the other partners start to show some interest and start to try to use it in their cases. Certainly, as physicians see their own results, then they start to apply it to additional treatments, tumor types, treatment scenarios. That's what we've seen. That's what we saw with adoption in uterine artery embolization. I think that explains the general idea of how it grows within a facility. Thank you very much.

[Operator]

I show no further questions in the queue at this time. I would now like to turn the call back over to Mary for closing remarks.

[Mary Szela, CEO, President, and Director at TriSalus Life Sciences]

Thank you, everyone, for joining the call and all your active support and interest in the company. We really appreciate it. Thank you again.

[Operator]

This concludes today's conference call. Thank you for participating. You may now disconnect.

Participants

Executives

• Richard Marshall, Medical Director
• Mary Szela, CEO, President, and Director
• David Patience, CFO

Analysts

• Matthew Park, Equity Research Analyst at Cantor Fitzgerald
• Nelson Cox, Research Analyst at Lake Street Capital Markets
• Justin Walsh, Equity Research Analyst at Jones Trading
• William Plovanic, Managing Director and Equity Research Analyst at Canaccord
• Jeremy  Feffer, Managing Director at Life Sciences Advisors
• Shaymus Contorn, Equity Research Analyst at Oppenheimer
• Carl Byrnes, Managing Director and Senior Research Analyst at Northland Capital Markets