11/13/2025

speaker
Conference Operator
Operator

Good afternoon and welcome to Trisalis Life Science 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 Pfeffer, Managing Director with LifeSci Advisors Please go ahead, sir.

speaker
Jeremy Pfeffer
Managing Director, LifeSci Advisors

Thank you, operator, and thank you all for participating in today's call. Joining me today from Tricelis Life Sciences are Mary Zella, President and Chief Executive Officer, David Patience, Chief Financial Officer, and Dr. Richard Marshall, Medical Director. Ms. Zella will provide an overview of the company's third quarter results and strategy for the balance of the year. Then 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 covered analysts. Earlier this afternoon, Trisalis released its financial results for the quarter ended September 30th, 2025. A copy of this press release is available on Trisalis' website. Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meeting 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 statements. Accordingly, we should not place undue reliance on these statements. 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. Tricelis disclaims any intention or obligation except as required by law to update or revise any financial projections or forwarded statements, whether because of new information, future events, or otherwise. The conference call contains time sensitive information and is accurate only as of this live broadcast today, November 13th, 2025. And with that, I'll turn the call over to Mary.

speaker
Mary Zella
President and Chief Executive Officer, Trisalis 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 in 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 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 Flex infusion system and advancing new clinical applications to expand our market opportunities. 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 goals, 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. The commercial organization continued to drive deeper penetration within the complex liver embolization market. Bolstered by the Centers for Medicare and 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. Now, interventional radiologists are able to use Trinav across the full continuum of radioembolization care. Early feedback from key accounts and users highlight 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 trisalasis 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. In the last year, we launched TriNav LV TriGuide and the TriNav Flex, 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 lobar liver and uterine artery embolization procedures. Although early, feedback from over 20 initial cases with key opinion leaders have been outstanding, which highlighted exceptional trackability, enhanced visualization for precise targeting, and improve 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. 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 events featured Dr. Nicole Lamparello of Weill Cornell Medicine and New York Presbyterian Hospital and Dr. Francis Kang, 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 multicenter initiative evaluating PEDD for patients with thyroid nodules or goiters who are not candidate 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. 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 emergent 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. 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 Nelotolimod across several high-value oncology indications. This transition will eliminate the vast majority of development-related expenses for Nelotolimod 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 1 studies of melatolamide in multiple liver tumor types, which include metastatic uveal melanoma, hepatocellular carcinoma, or HCC, cholangiocarcinoma are now complete. Enrollment has also concluded in PERIO3, are phase one trial and locally advanced pancreatic cancer 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. 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. Before turning the call over to David for a review of our third quarter financials, I want to reiterate that Trisalis remains focused on executing our near-term milestones, including advancing the TriNav platform across multiple indications focused on the interventional radiology call points, advancing PEDD solutions designed to optimize therapeutic delivery and address the full spectrum of vascular access and perfusion challenges based 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. Trisalis 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. And with that, I'll turn the call over to David.

speaker
David Patience
Chief Financial Officer, Trisalis Life Sciences

Thank you, Mary. As Mary mentioned earlier, Tricelis delivered another strong quarter. For the three-month-ended September 30, 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 TRINAP 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. A temporary dip in July was driven by lower procedure volume, 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 in the total month, 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. 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 melatonin 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, This includes approximately 2.1 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.

speaker
Conference Operator
Operator

Thank you. To ask a question please press star 1 1 on your telephone and wait for your name to be announced and to withdraw your question please press star 1 1 again. We ask 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 and the first question comes from Frank with Lake Street Capital Markets. Your line is now open.

speaker
Nelson Cox
Analyst, Lake Street Capital Markets

Hey, this is Nelson Cox. I'm 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.

speaker
David Patience
Chief Financial Officer, Trisalis Life Sciences

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. So 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. But other than that, we're pretty focused on the current the current operations of the business and we're excited about it.

speaker
Nelson Cox
Analyst, Lake Street Capital Markets

Alright, fair enough and then. Kind of curious if there's any additional color you can provide outside a liver in terms of growth you're seeing in your other indications.

speaker
Mary Zella
President and Chief Executive Officer, Trisalis Life Sciences

Yeah, I can take that Nelson. You know 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. 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 reduce pain. And the other important thing is just reduce the administration of embolics into the myometrium tissue, which can cause a lot of post-procedural pain. So we think this could be a major opportunity for us in 2026. You know, 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. 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 Trinab 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 micro catheter. 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 you can comment on those as well, Dr. Marshall.

speaker
Dr. Richard Marshall
Medical Director, Trisalis Life Sciences

Thanks, Mary. And good afternoon, everybody. so i am very excited about both the xp which is the uh our product for uterine artery embolization uh that's currently in limited market release um and the feedback has been great this will allow physicians to use a tri-nav 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 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 micro catheter. 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 micro catheter. 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. I've been able to use these products. The advance I have not used in a human yet because it's not available. But I can tell you my experience with it in pigs has been phenomenal. And I think it's going to generate a lot of excitement.

speaker
Mary

and expand what we can do, the number of patients that we can treat.

speaker
spk05

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

speaker
Mary Zella
President and Chief Executive Officer, Trisalis Life Sciences

Thanks, Nelson.

speaker
Conference Operator
Operator

And the next question will come from William Plovanek with Canaccord. Your line is open.

speaker
William Plovanek
Analyst, Canaccord Genuity

Hey, great. Thanks. Good evening, and thanks for taking my questions. You know, I think as we come into the year, I mean, I just want to you know the the the revenue was a little light uh for the quarter i appreciate the cadence uh comments regarding august september i think that gives you the confidence to finish out the year which i think you know consensus is sitting right about that 45 million but i do think you know going back to the first question was asked i mean there are estimates out there that have fit you know over 50 percent growth next year and up to not almost 90 percent year-over-year growth next year for some of the sell side analysts. 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
David Patience
Chief Financial Officer, Trisalis Life Sciences

Yeah, no, I think it's a great question. So, you know, we have not managed the street to the 2026 numbers. You know, I think, you know, those that are closest to the story are pretty familiar with kind of where we see the growth of the business. And we're just not ready to comment on 2026 just yet. We're very focused. You know, we appreciate, you know, your understanding and, you know, the first quarter being nine and then two quarters of over 11 million in a row is exactly how we forecast it. 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 very strong, very strong momentum for us. 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 target.

speaker
William Plovanek
Analyst, Canaccord Genuity

And then just a follow-up, as we think about the 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? And thanks for taking my questions.

speaker
David Patience
Chief Financial Officer, Trisalis Life Sciences

Perfect. Yeah, I'll take the last part. You know, our new account additions, you know, we were adding, you know, about 20 accounts through back approval for the quarter. Again, our focus going into this year was, you know, opening a lot of accounts, a lot of accounts, excuse me, were already opened. And we're driving deeper penetration, as you commented. And so our utilization is continuing to grow on a quarterly cadence per account. And that is really driven by new physicians, you know, spreading word of mouth using Trinev, where we used to have one champion. Now we have one or two. And then the newer applications will play a big role as, you know, those interventional radiologists are going to be using us not just for the liver. And so You know, to answer your question, you know, 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. And I'll turn it over to Mary to talk about mapping.

speaker
Mary Zella
President and Chief Executive Officer, Trisalis Life Sciences

Hi, Bill. Thanks so much for a good question. Yeah, mapping has actually been a very important, you know, 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 for you know, or external market data. This is based on our VIVA internal data from our representative. So 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. So we're really seeing kind of a two for one in the radioembolization. And 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. So we've really gotten through some of the bumps along the way and we're starting to see that accelerate. So that's been very helpful for us this year.

speaker
Seamus
Analyst, Oppenheimer & Co.

Thank you.

speaker
Conference Operator
Operator

And the next question will come from Ross Osborne with Cantor Fitzgerald. Your line is open.

speaker
Matthew Park
Analyst, Cantor Fitzgerald

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

speaker
Mary Zella
President and Chief Executive Officer, Trisalis Life Sciences

Sure. So, GAE is a really exciting opportunity, you know, 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 the 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. Are they resorbable? 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, and we can actually protect against off-target delivery. And I'll have Dr. Marshall comment about this, because he's been involved in our early cases and our pilot study. 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
Dr. Richard Marshall
Medical Director, Trisalis 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 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. And Trinab, with both its flow modulation and reflux protection, accomplishes both of those. Um, so, uh, it is, this procedure is already being performed with traditional micro catheters. Um, what the interest that we've received so far and the success that we've seen is that physicians do an angiogram with the China and they say they can see vessels a lot better. Um, and then when they deliver their part, their microspheres or their liquid embolic, um, they can push it in much farther without having to worry about the about non-target embolization so they feel safer more confident um we're 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 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
Matthew Park
Analyst, Cantor Fitzgerald

Got it. That's super helpful color. And then maybe one for David. So on gross margins, you know, you called out some headwinds in the quarter driven by these newly launched products. 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 in?

speaker
David Patience
Chief Financial Officer, Trisalis Life Sciences

Perfect. I think the short answer is the fourth quarter, we'll see an uptick. You know, we've done a, 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. So we should see, you know, normalized gross margins here in the fourth quarter and then expanding early next year as well.

speaker
Matthew Park
Analyst, Cantor Fitzgerald

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

speaker
Conference Operator
Operator

And our next question will come from Carl Burns with Northland Capital Markets. Your line is open.

speaker
Carl Burns
Analyst, Northland Capital Markets

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 trying to have, you know, two mapping? I know you mentioned that there's some education process around the new HCP code, the C8004 code. Are you, you know, 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.

speaker
Mary Zella
President and Chief Executive Officer, Trisalis 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? You know, 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. And I think that's been a big message for us as we interface with physicians. And 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. So now we're converting two catheters versus the one. And that's really what's been driving the majority of the upside. But to your question, I don't have that definitive data. Dr. Marshall, do you want to weigh in on that?

speaker
Dr. Richard Marshall
Medical Director, Trisalis Life Sciences

I do. I'll reinforce it. I think physicians, they basically want to treat apples on 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. And so it has to do what they think it's going to do. And 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. And so that's a lot of the feedback that I get is not only can I map with the same catheter that I'm treating with, I'm actually seeing things and sometimes seeing more tumors. So 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's covered by insurance or Medicare or Medicaid with a CPT code.

speaker
Carl Burns
Analyst, Northland Capital Markets

Great. Thanks. Very helpful. And just one quick follow-up. you know, what are you seeing with respect to adoption of LV and FLEX and in what procedures specifically?

speaker
Dr. Richard Marshall
Medical Director, Trisalis Life Sciences

Thanks. I can comment on this. So we have centers that have converted completely to FLEX that they love the catheter and they only want to use that. Those are centers that typically do more selective treatments. So smaller portions of the liver and smaller arteries that may be uh, that are a farther distance for the catheter to travel. Um, and so they appreciate the, um, the trackability of that catheter being able to go out farther. Um, whereas others are, seem to be more comfortable, but I think we've had a lot of users convert to flex. It's been very well received. LV has helped us in areas we're trying to have really shines. And those are really large, uh, territory treatment. So for example, half of the liver, we call it a low bar treatment, an entire lobe of the liver. We can, that valve is larger. And so some patients, for example, with primary liver cancers have had a cellular carcinoma or metastases that receive a lot of blood flow, like neuroendocrine tumors, those arteries are larger. And so 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's a larger catheter so i think people really appreciate that outside of the liver we've seen some use of trying to flex in thyroid arteries because they're they are tortuous um so it's a nice fit in that area uh and the same is true and was true in uterine artery embolization but the um the xp catheter which we've just released is gonna uh is gonna be i think it's going to have a lot of growth in uterine artery embolization because it's designed specifically for that. That's been well received so far. I hope that answers your question.

speaker
Mary Zella
President and Chief Executive Officer, Trisalis Life Sciences

That's really helpful color, 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. You're trying to have that 50 and the large is 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, you know, from a manufacturing perspective and how that's growing month over month. 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, you know, for all these products. So it's really up to the use of the physician, the type of vessel torturosity. And so we're just, 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 months in, you know, in 2026.

speaker
Carl Burns
Analyst, Northland Capital Markets

Great. That's excellent. And congrats again.

speaker
Mary Zella
President and Chief Executive Officer, Trisalis Life Sciences

Thank you.

speaker
Conference Operator
Operator

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

speaker
Justin Walsh
Analyst, JonesTrading

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.

speaker
Mary Zella
President and Chief Executive Officer, Trisalis Life Sciences

Yeah, so that's a really good question. I think, you know, 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 benefits. 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, higher at kind of the 250. 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. And just based on the patient volume and just the enthusiasm, In fact, we met with a big group of interventional radiologists and also some orthopods, and they were even excited about potentially using this procedure for even people who have had surgery. You know, two days post-operatively, patients are still in enormous pain, 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. So, You know, 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. You know, 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. 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 and 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. So Dr. Marshall, you want to comment on that?

speaker
Dr. Richard Marshall
Medical Director, Trisalis Life Sciences

Yes. 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. 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. So we have a great solution for that.

speaker
spk05

And that's why I think it's going to be a huge area of growth for us.

speaker
Conference Operator
Operator

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

speaker
Seamus
Analyst, Oppenheimer & Co.

Hi, Mary and David. This is Seamus on for Suraj. Just one from our end, but just trying to cut this, I guess, two different ways. So, you know, how has kind of growth slash utilization look 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? And I guess, could you kind of quantify that? And then, you know, on a separate note, again, on utilization, how does utilization for a physician that's added on with an existing account look, you know, over time? Thank you.

speaker
Mary Zella
President and Chief Executive Officer, Trisalis Life Sciences

No, that's a really good question. You know, 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, you know, 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. So it really depends on the type of account. An account that's more familiar with that, that's a much faster ramp. 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 in account. They're using it very consistently. And I think one of the things that we've also seen in parallel is as 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. So we're seeing that current user grow in a deeper amount of use within his patient population, 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 an 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. 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, you know, I think what we're excited about is we continue to see the continual utilization grow pretty steadily. 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. And we think that's going to accelerate over time. Dr. Marshall?

speaker
Dr. Richard Marshall
Medical Director, Trisalis 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. In 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. 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 partners start to show some interest and start to try to use it in their cases. 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. So I think that explains the general idea of how it grows within a facility.

speaker
spk05

Thank you very much.

speaker
Conference Operator
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.

speaker
Mary Zella
President and Chief Executive Officer, Trisalis 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.

speaker
Conference Operator
Operator

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

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