Q3 2025 TriSalus Life Sciences Inc Earnings Call
Speaker #1: As a reminder, this call is for purposes. I will now turn being recorded for replay with Life Sciences, sir. Question and answer.
Speaker #2: call. Joining me today from you all for participating in today's TriSalus Life Sciences are Mary
Speaker #2: Szela, President and Chief Executive Officer; David Patience, Chief Financial Officer; and Dr. Richard Thank you, Operator, and thank Marshall, Medical Director. Jeremy Feffer, Managing Director. Ms. Szela will provide an overview of the company’s third quarter results and strategy for the balance of the year.
Speaker #2: Then, Mr. Quarter, in detail. Following their prepared remarks, Dr. Marshall will join David Patience to review the financial results for the analysts. Earlier this afternoon, TriSalus released its financial results for the quarter ended September 30, 2025.
Speaker #2: A copy of this press release is available on TriSalus's website. Before we begin, I would like to remind you that management will make statements during this call that Federal Securities Laws, which are made include forward-looking statements within the meeting of Securities Reform Act of the call to help address questions from covering pursuant to the Safe Harbor Provisions of the Private 1995.
Speaker #2: this call, other than the statements of historical fact, are forward-looking statements. All forward-looking statements, Any statements contained in business and hiring prospects, financial including without limitation, statements relating future product development and approvals, are based upon our current estimates and various assumptions.
Speaker #2: 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.
Speaker #2: Accordingly, you should not place undue reliance on these statements. For a listen description of the risks and uncertainties associated with our factors section of our Form 10Q on file with the SEC and available filed periodically with the SEC.
Speaker #2: TriSalus disclaims any intention or obligation, except as required by law, to update or revise any financial on EDGAR and our other reports events, or otherwise.
Speaker #2: The whether because of new information, future conference call contains time-sensitive information and is accurate only as projections or forward-looking statements, business, please refer to the risk
Speaker #3: you, Jeremy, and good afternoon,
Speaker #3: for a review of our third quarter everyone. Thank you for joining us I will begin with a high-level review of the quarter and recent weeks and provide a quick update of our longer-term strategy.
Speaker #3: more in-depth review of our financial , 2025.
Speaker #3: million, representing were $11.6 3% sequential gain over the year quarter, and a And with that, I'll turn the call over to second quarter of David 2025.
Speaker #3: During the quarter, we also continued to expand 57% increase over the prior our TriNav platform, launching our TriNav Flex infusion clinical applications to expand our market opportunities.
Speaker #3: We also simplified our capital structure through the successful completion of our exchange offer and consent solicitation for preferred system and advancing new stock. Operationally, we continued to manage cash efficiently, ensuring resources were allocated strategically to advance our key priorities.
Speaker #3: We increased commercial investment to maintain our strong growth, a deliberate decision that extends our timeline to reach EBITDA positive and cash flow break-even. Our commercial momentum in the third quarter remained strong.
Speaker #3: The commercial organization continued to drive deeper penetration within the complex liver embolization market. Bolstered by the Centers for Medicare and Medicaid Services, CMS, PIXPIX code C8004 introduced in April, this new code expands angiogram or mapping procedures using TriNav, enabling interventional radiologists to utilize TriNav for other treatment planning and delivery using radio embolization.
Speaker #3: As a result, the reimbursable use of our technology within the radio embolization market the broader adoption we're observing. Now, interventional coverage to include simulation across the full continuum of radio embolization care, early feedback from key accounts and users has effectively doubled, supporting radiologists are able to use TriNav highlight the clinical and economic advantages of the expanded reimbursement, which we expect to continue driving adoption into our 50% revenue growth our growth momentum and market our prior commitment, we continue to invest in long-term growth via 2026. believe TriSalus's pressure-enabled drug opportunities.
Speaker #3: As a result, the reimbursable use of our technology within the radio embolization market the broader adoption we're observing. Now, interventional coverage to include simulation across the full continuum of radio embolization care, early feedback from key accounts and users has effectively doubled, supporting radiologists are able to use TriNav highlight the clinical and economic advantages of the expanded reimbursement, which we expect to continue driving adoption into our 50% revenue growth our growth momentum and market our prior commitment, we continue to invest in long-term growth via 2026.
Speaker #3: Expanding our product growing clinical and commercial impact of portfolio remains a core pillar of our growth strategy. Consistent with By broadening our addressable market and delivering solutions with greater versatility and precision, we're enabling patients, and extending our reach beyond more physicians to treat complex the liver into new therapeutic We are reaffirming areas.
Speaker #3: Following the quarter, we began market evaluation of XP, which features our next-generation TriNav particles, and a more flexible distal tip, an important advancement for low-bar liver and compatibility with larger uterine artery embolization procedures.
Speaker #3: from over 20 initial cases with key Although early, feedback opinion leaders has been outstanding, which highlighted exceptional visualization for precise targeting, trackability, enhanced efficiency.
Speaker #3: These advances reinforce our confidence in TriNav, powered by PEDD. As a platform that helps interventional and improved professional difficult tumor drug delivery TriNav portfolio to deepen its clinical impact, to improve drug penetration, reduce complications, and expand patient eligibility.
Speaker #3: Our results this quarter demonstrate that TriNav is well-positioned to address the most complex challenges in liver embolization for radiologists. We continue to invest in strengthening the clinical evidence base, engaging closely with key medical societies, and driving commercial efforts to become the standard of care for TriNav's PEDD technology in liver cancer. We're also expanding the clinical application of our system beyond what has been previously discussed.
Speaker #3: Yesterday, we hosted the first in a series of key opinion leader events focused on the potential use of TriNav, particularly through the TriNav infusion expansion, to fully realize its applications for uterine fibroids.
Speaker #3: The event featured Dr. Nicole Lamparello of Weill Cornell Medicine in New York Presbyterian Hospital and Dr. Francis infusion for the treatment of University Radiology Group, both Kang of Rutgers Robert Wood speakers highlighted the significant unmet need in uterine fibroid treatment and reviewed the current therapeutic landscape.
Speaker #3: continues in our Protect Registry, a multi-center initiative evaluating PEDD for patients In addition, enrollment with thyroid nodules or goiters, who are not candidates for surgery radioiodine or ablation.
Speaker #3: This study is designed to assess disease-related quality of life, thyroid function, and outcomes following PEDD-based thyroid artery embolization. As previously noted, preliminary results published in the Journal of Endocrine Society were highly encouraging, showing 100% technical and clinical success.
Speaker #3: 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.
Speaker #3: 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, also known as GAE.
Speaker #3: 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.
Speaker #3: 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 melatonin, across several high-value oncology indications.
Speaker #3: This transition will eliminate the vast majority of development-related expenses for melatonin 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.
Speaker #3: Phase one studies of melatonin in multiple liver tumor types, which include metastatic uveal melanoma, hepatocellular carcinoma, or HCC, cholangiocarcinoma, are now complete. Enrollment has also concluded in Perio 3.
Speaker #3: Our Phase One trial in locally advanced pancreatic cancer is progressing, with final data expected by year-end. Clinical study reports for all three Perio Phase One dose escalation trials are in preparation, with data releases anticipated in Q4.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: 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.
Speaker #3: 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 standard of care.
Speaker #3: TriSalus remains a science-driven organization with patients at the center of everything we do. Our progress continues to make meaningful difference for people living with liver, pancreatic, and other solid tumors.
Speaker #3: And with that, I'll turn the call over to
Speaker #3: David. Thank you, Mary.
Speaker #2: As Mary mentioned earlier, TriSalus delivered another strong quarter. For the three months ended September 30, 2025, revenue was $11.6 million, representing 57% year-over-year growth and 3% sequential growth versus the second quarter.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: Sequential growth reflected expected seasonal trends, a temporary dip in July was driven by lower procedure volumes followed by record levels in both August and September.
Speaker #2: 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 Q4 as production stabilizes.
Speaker #2: 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 melatonin, partially offset by the revision of approximately $700,000 in patent-related costs to general and administrative expenses.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: Excluding the one-time accelerated stock-based compensation and the 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.
Speaker #2: The increase was primarily driven by the one-time charge related to the closure of our clinical studies for melatonin, and the non-cash stock-based compensation acceleration in the period.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: 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.
Speaker #2: With that, we're ready to open the line for
Speaker #2: questions. Thank
Speaker #1: To ask a question, please press *11 on your telephone and wait for your name to be announced. To withdraw your question, please press *11 again.
Speaker #1: We ask that you please limit yourself to one question and one follow-up. And if you have additional questions, please return to the queue. Please stand by while we compile the Q&A roster.
Speaker #1: And the first question comes from Frank Tacken with Lake Street Capital Markets. Your line is now open.
Speaker #3: 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.
Speaker #3: When I look at kind of where the street's at, there's kind of a wide range so just wanted to give a chance if you guys are comfortable to provide more color
Speaker #3: there. Yeah, Nelson, this is David.
Speaker #4: Thank you for the question. Right now, we're confident and very excited about our current momentum, especially in the fourth quarter. So that's really our focus right now.
Speaker #4: We are maintaining our guidance thus far. Of the 50% growth and adjusted EBITDA positivity in the first half of next year, but other than that, we're pretty focused on the current operations of the business.
Speaker #4: And we're excited about it.
Speaker #3: All right. Fair enough. And then I'm 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 areas.
Speaker #5: Yeah, I can take
Speaker #5: I'm indications. 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.
Speaker #5: And 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.
Speaker #5: 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 and the other important thing is just reduced the administration of embolics into the myometrium tissue, which can cause a lot of post-procedural pain.
Speaker #5: So we think this could be a major opportunity for us in 2026. We'll enter our full launch in about a week. But already, just based on the feedback and just the utilization and the market evaluation, it's been really robust.
Speaker #5: 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 will continue to invest in and move even further.
Speaker #5: We have a new product launch coming in the fourth quarter, which is trying to have advance. We think this one could be really interesting for us because this is a technology where the interventional radiologist has the potential to use any microcatheter.
Speaker #5: And 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 he can comment on those as well.
Speaker #5: Dr. Marshall. Thanks,
Speaker #6: Mary. And good afternoon, everybody. So I am very excited about both the XP, which is the product for uterine artery embolization, that's currently in limited market release.
Speaker #6: 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.
Speaker #6: The same thing goes for our genicular artery embolization so 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.
Speaker #6: So 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.
Speaker #6: So 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.
Speaker #6: I've been able to use these products to advance; I have not used them in a human yet because they're not available. But I can tell you my experience with it in pigs has been phenomenal.
Speaker #6: And I think it's going to generate a lot of excitement. And it expands what we can do, the number of patients that we can treat.
Speaker #3: Awesome. That's helpful color. Thank you, guys.
Speaker #5: Thanks,
Speaker #5: Thanks, Nelson. And the next question will come
Speaker #1: from William Plovanic with Canaccord. Your line is
Speaker #1: open. Hey, great.
Speaker #7: Thanks. Good evening and thanks for taking my questions. I think when we come into the year, I mean, I just want to say the revenue was a little light for the quarter.
Speaker #7: I appreciate the cadence comment 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.
Speaker #7: But 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 cell site analysts.
Speaker #7: So I understand you don't really want to comment, but is there any reason you think that your revenue growth could accelerate above 50% in '26?
Speaker #4: Yeah, no, I think it's a great question. So, we have not managed the 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.
Speaker #4: ready to comment on 2026 just And we're just not yet. We're very focused. We appreciate your understanding and the first quarter being nine and then two quarters of over 11 million in a row is exactly how we forecast it.
Speaker #4: And 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 we have very strong momentum.
Speaker #4: And it was the best month ever for our company. That said, we just don't want to comment on 2026 just yet. We're very focused, but confident that we'll hit our 50% growth.
Speaker #4: target. And then just a follow-up is we think
Speaker #7: about the use case use cases for mapping it doubles the opportunity. What percentage of your case mix today is mapping? And then 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?
Speaker #7: And thanks for taking my
Speaker #7: questions. Perfect.
Speaker #4: Yeah, I'll take the last part. Our new account additions—we were 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, we were already opened.
Speaker #4: And we were driving deeper penetration, as you commented. Our utilization is continuing to grow on a quarterly cadence per account. That has really been driven by new physicians spreading word of mouth and using TriNav, where we used to have one champion.
Speaker #4: Now we have one or two, and then the newer applications will play a big role as those interventional radiologists are going to be using us not just for the liver.
Speaker #4: And so, to answer your question, very focused deep penetration within each account to improve utilization. And we're seeing that in the numbers, and that's what we're excited about.
Speaker #4: And I'll turn it over to Mary to talk about
Speaker #4: mapping. Hi, Belle.
Speaker #5: 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.
Speaker #5: I would 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.
Speaker #5: So we're estimating about 30% of our growth is coming from the mapping. Remember about half the market is radio embolization, half the market is chemo embolization.
Speaker #5: They don't do mapping in the chemo embolization. So we're really seeing kind of a two-for-one in the radio embolization. And the other factor is 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.
Speaker #5: We're still having some bumps with that where people are just not familiar with this code. So we've really gotten through some of the bumps along the way, and we're starting to see that accelerate.
Speaker #5: So that's been very helpful for us this year.
Speaker #7: Thank you.
Speaker #1: And the next question will come from Ross Osborne with Cantor Fitzgerald. Your line is open.
Speaker #8: 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, I guess how do you view the broader competitive landscape developing around here and where would you see TriNav fitting in within the potential standard of
Speaker #8: care? Sure.
Speaker #5: So TAE is a really exciting opportunity. I think not only for patients because it can potentially reduce the need for a knee or surgery or more fundamentally, it just addresses the immediate pain that these patients are in.
Speaker #5: We're a drug delivery device. So where we see a lot of the competition coming in this is really around what type of speed that they're administering.
Speaker #5: Are they resorbable? Are they is it different types of drugs that they're administering? And I think the key that we believe that we offer is that we can penetrate these vessels much more deeply.
Speaker #5: And we can actually protect against off-target delivery. I'll have Dr. Marshall comment on this because he's been involved in our early cases and our pilot study.
Speaker #5: And 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?
Speaker #7: Thanks. Thanks, Mary. I think you highlighted some really good points that 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.
Speaker #7: Without having it go into places where we don't want it to go. So obviously, the foot is distal or downstream from the knee. And so that's what we all want to protect.
Speaker #7: And TriNav, with both its flow modulation and reflux protection, accomplishes both of those. So it is this procedure is already being performed with traditional microcatheters.
Speaker #7: The interest that we've received so far and the success that we've seen is that physicians do an angiogram with the TriNav and they say they can see vessels a lot better.
Speaker #7: And then, when they deliver their microspheres or their liquid embolic, they can push it in much farther without having to worry about the non-target embolization.
Speaker #7: So they feel safer, more confident. We've got some other positive feedback that we're going to publish in the near future about how we can treat multiple sites from one injection.
Speaker #7: And I think that's going to that is going to distinguish this catheter from the traditional way of treatment. It's going to allow physicians to do this procedure faster and better.
Speaker #8: Got Got it. That's super helpful, Color. And then maybe one for David. So on gross margins, you called out some headwinds in the corridor driven by these newly launched products.
Speaker #8: I guess how should we think about the cadence of gross margin over the next couple of quarters? And when you would kind of expect these manufacturing efficiencies to come back
Speaker #8: in? Perfect.
Speaker #4: I think the short answer is the fourth quarter we'll see an uptick. We've done a we've thrown a lot at our manufacturing team with four new products.
Speaker #4: And eight new SKUs. And one single year. But we're proud of kind of where we've evolved our processes, our procedures, and our lot sizes.
Speaker #4: To really scale efficiently. So we should see normalized gross margins here in the fourth quarter and then expanding early next year as
Speaker #4: well. Got it.
Speaker #8: Super helpful. Thanks for taking the questions, guys.
Speaker #1: from Carl Burns with And our next question will come Northland Capital Markets. Your line is open.
Speaker #8: Thanks for the question. And congratulations on your progress. Going back to tear mapping, what have you experienced with respect to conversion of existing tear users with TriNav to mapping?
Speaker #8: I know you mentioned that there's some education process around the new HCTP code, the C8004 code. Are you able to quantify that at all?
Speaker #8: I know you quanted the revenue growth of 30% for mapping. But do you have any feel there?
Speaker #8: Thanks. Yeah.
Speaker #5: I mean, I think what 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.
Speaker #5: Maybe I'll have Dr. Marshall respond. Dr. Marshall, how do you think about this? With just the impression that we get from physicians now is everyone likes to map with see in the initial session is what you're going to define your patient.
Speaker #5: And I think that's been a big message for us as we the same technology that they treat dose on and how you're going to treat the that's been the big conversion because they've been doing oftentimes they'll interface with physicians.
Speaker #5: with an end hole. So now we're with. the one. And that's really what's been driving the majority of the upside. But to your data.
Speaker #7: it. I think physicians do it with an end hole, then they'll want to treat apples and apples. They don't want to map with one Because when they give
Speaker #7: wanted they basically want to treat that contrast goes through it and is in pressurized into arteries. They can And been really impressed with the
Speaker #7: see things better. Dr. Marshall, do you want to weigh get is not only can I map with the same sometimes seeing more tumors. catheter that I'm treating with, I'm actually seeing things.
Speaker #7: positive. We do physicians who understand that they can use the catheter and it's covered by insurance or Medicare or Medicaid. So the feedback has been very And so that's a lot of the feedback that I code.
Speaker #8: Great. Thanks. Very helpful. And then just one quick follow-up.
Speaker #7: So we have centers that have And
Speaker #7: to be more comfortable, but I think we've had a lot of users convert to FLEX. It's been be that are a very well received.
Speaker #7: LV has helped us in areas where TriNav really shines. And those are really What are you seeing with respect to adoption liver we call it a low bar treatment large territory of an entire lobe of the liver.
Speaker #7: We can that valve is larger and so some patients for example with primary liver cancers have had a cellular that receive a lot of blood flow like neuroendocrine tumors.
Speaker #7: We can see that the valve is larger, and so some patients, for example, with primary liver cancers, have had a cellular that receives a lot of blood flow, like neuroendocrine carcinoma or metastases. Those arteries are larger, and so this is a nice fit in both of those scenarios.
Speaker #7: So that the valve can fit appropriately and they can actually inject more contrast and particles faster because it's a larger catheter. So I think people really appreciate that.
Speaker #7: Outside of the liver, we've seen some use of TriNav FLEX in thyroid arteries because they are tortuous. So it's a nice fit in that area.
Speaker #7: And the same is true and was true in uterine artery embolization, but the XP catheter which we've just released is going to be I think it's going to have a lot of growth in uterine artery embolization because it's designed specifically for that.
Speaker #7: That's been well received so far. I hope that answers your
Speaker #5: That's really helpful, Carl. Dr. Marshall. And I think I would add we saw FLEX. We didn't anticipate this to be this robust, but it's already about 35% of our mix.
Speaker #5: TriNav's at 50 in the largest at about 15%. But we're seeing FLEX 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.
Speaker #5: So 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.
Speaker #5: So it's really up to the use of the physician, the type of vessel tortuosity, and so we're just that's part of the inefficiency and manufacturing is just trying to estimate how this is changing month over month.
Speaker #5: We think that's going to settle out probably over the next couple of months in
Speaker #5: 2026. Great.
Speaker #8: That's excellent. And congrats again.
Speaker #5: Thank you.
Speaker #1: And our next question will come from Justin Walsh with Jones Trading. Your line is open.
Speaker #1: open. Hi.
Speaker #9: 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.
Speaker #5: 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.
Speaker #5: So, we picked ones that we think provide significant near-term patient benefit and market benefit. When we think about uterine artery embolization, the estimates for those markets are probably between the low at $110 million and the high at $250 million.
Speaker #5: That could be a significant market opportunity for us, but probably the biggest one that we think that could really even rival the liver market is really GAE.
Speaker #5: And 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.
Speaker #5: And they were even excited about potentially using this procedure for even people who have had surgery. Two days post-operatively, patients are still in enormous pain.
Speaker #5: And they were thinking about how do we incorporate this procedure to help allow them to do physical therapy more appropriately and recuperate much better.
Speaker #5: So that's 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.
Speaker #5: The thyroid market being very comparable again to the uterine artery embolization, but there's more even beyond these. This is all the ones that we're focused on right now.
Speaker #5: We've got quite a bit on our plate. But 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.
Speaker #5: And potentially be used in combination with other treatments as well. So Dr. Marshall, you want to
Speaker #5: comment on that? Yes.
Speaker #2: And so we're talking about delivery of embolics right now. And we still have more room to grow in the liver, obviously. But the I think the elephant in the room is genicular artery embolization.
Speaker #2: Just the number of patients that have osteoarthritis and 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.
Speaker #2: So we have a great solution for that. And that's why I think it's going to be a huge area of growth for
Speaker #2: us. And our next question comes
Speaker #1: From Suraj Kaliya with Oppenheimer. Your line is:
Speaker #1: open.
Speaker #3: Hi, Mary
Speaker #3: and David. This is Seamus on for Suraj. Just one from our hi. Just one from our end, but just trying to cut this, I guess, two different ways.
Speaker #3: So how has kind of growth/utilization looked for accounts that launched, say, 18 months ago versus one year ago versus six months? How has the ramp kind of been increasing over time?
Speaker #3: And I guess could you kind of quantify that? And then on a separate note, again, on utilization, how does utilization for a physician that's added on with an existing account look over time?
Speaker #3: Thank you.
Speaker #5: Now that's a really good question. We segment accounts into two major buckets. And 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.
Speaker #5: That's going to take a little bit longer. So it really depends on the type of account. An account that's more familiar with that, that's a much faster ramp.
Speaker #5: But overall, we see accounts that we started 18 months ago just continue to improve month over month. And a lot of that improvement is we get one user an account.
Speaker #5: They're using it very consistently. And I think one of the things that we've also seen in parallel is we've offered these new options of devices.
Speaker #5: It allows that single physician to use more and more. Cases, because we didn't have really the best technology for that particular patient. So we're seeing that current user grow in a deeper amount of use within his patient population.
Speaker #5: And we're also seeing the new users kind of start down that path. So if it's an account that is receptive and educated along those lines, we see a more rapid uptake if it's a account that doesn't have that information that 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.
Speaker #5: And those take a little bit longer. So those are the two buckets that we have. And I don't know, Dr. Marshall, you can talk about it as well, but we're seeing I think what we're excited about is we continue to see the continual utilization grow pretty steadily.
Speaker #5: And 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.
Speaker #5: And we think that's going to accelerate over time. Dr.
Speaker #5: Marshall?
Speaker #2: Yeah. I think we typically
Speaker #2: see a single user at a site become a champion for us and start to use our catheter. And these older accounts where a physician has been treating patients and seeing 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.
Speaker #2: And so we see that growth for sure. That grows from one partner who's getting better results and then all of a sudden the other partner starts to show some interest and start to try to use it in their cases.
Speaker #2: And certainly, as physicians see their own results, then they start to apply it to additional treatments: tumor types, treatment scenarios. And that's what we've seen that's what we saw with adoption in uterine artery embolization.
Speaker #2: So I think that explains the general idea of how it grows within a
Speaker #2: facility. Thank you very
Speaker #1: Hi, show no further questions in the queue at this time. I would now like to turn the call back over to Mary for closing
Speaker #1: Hi, 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.
Speaker #5: Thank you, everyone, for joining the call and all your active support and interest in the company. We really appreciate it. Thank you again.