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DATE

Thursday, November 13, 2025 at 4:30 p.m. ET

CALL PARTICIPANTS

  • President and Chief Executive Officer — Mary T. Szela
  • Chief Financial Officer — David B. Patience
  • Medical Director — Dr. Richard Marshall

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TAKEAWAYS

  • Revenue -- $11.6 million, up 57% year-over-year and 3% sequentially from Q2 2025.
  • Gross Margin -- 84%, down from 86% the prior year, attributed to lower manufacturing efficiency from new product launches.
  • Adjusted EBITDA loss -- $5.4 million, an improvement from $7.1 million in 2024, inclusive of approximately $2.1 million in one-time charges for the PERIO study close-off.
  • Cash Used in Operations -- $3.7 million, compared to $11.2 million a year prior.
  • Quarter-End Cash Balance -- $22.7 million in cash and cash equivalents.
  • Operating Loss -- $9.0 million, compared to $8.7 million in the prior year, impacted by one-time clinical study and non-cash stock-based compensation charges.
  • Unique Ordering Account Growth -- Increased 30%, with 20 new accounts added in the quarter, alongside higher utilization per account.
  • Product Mix -- TriNet FLEX represented about 35% of mix, TriNet at 50%, and large valve (LV) at 15%.
  • Guidance Reaffirmed -- Management maintained 50% revenue growth guidance and projected adjusted EBITDA positive in the first half of 2026.
  • New CMS HCPCS Code -- C8004 enabled a doubling of reimbursable use for simulation angiogram or mapping procedures, leading to approximately 30% of growth attributed to mapping cases per internal data.
  • Debt Covenant Amendment -- Minimum cash covenant reduced from $10 million to $5 million post-quarter, increasing financial flexibility.
  • Capital Structure -- Preferred stock conversion completed in July, eliminating the 2027 reset provision and simplifying the structure.
  • Clinical Portfolio Expansion -- TriNav XP launched in market evaluation; TriNet Advance set for Q4 launch, targeting deeper arterial access using any microcatheter.
  • New Indication Development -- Uterine artery embolization, genicular artery embolization (GAE), and thyroid applications advancing, supported by ongoing pilot and multicenter studies.
  • Nalotolimod Out-licensing -- Transitioning toward partnering for nalotolimod, aiming to eliminate most associated development expenses while preserving upside.

SUMMARY

Management reported a sequential revenue increase and a significant year-over-year gain, crediting strong commercial execution and expanded adoption of the TriNav platform.
Operational cash burn fell sharply, supported by improved adjusted EBITDA and disciplined cost controls, with quarter-end liquidity highlighted as sufficient for ongoing initiatives.
Platform expansion continued through new product launches and deeper market penetration, with mapping procedures and recent CMS reimbursement changes cited as key growth drivers.
Advancement in new clinical indications, and the transition of nalotolimod to out-licensing, are positioned to further reduce R&D spending while supporting the commercial focus on pressure-enabled drug delivery technology.

  • CEO Szela said, "We are reaffirming our 50% revenue growth guidance, reflecting strong confidence in our growth momentum and market opportunities."
  • Chief Financial Officer Patience described gross margin impacts from "lower manufacturing efficiency associated with newly launched products" but indicated expectations for improvement in the next quarter.
  • Management reported rapid adoption of FLEX, with Szela noting, "it's already about 35% of our mix," and Marshall describing full center conversion in some cases.
  • Direct feedback from pilot and initial real-world use of TriNav XP indicates positive clinical reception, especially for procedures requiring deeper arterial access. Feedback on TriNet Advance is positive from preclinical models, but it has not yet been used in human cases.
  • Szela emphasized that CMS code C8004 has expanded reimbursable use, explaining, "the reimbursable use of our technology within the radioembolization market has effectively doubled."
  • CFO Patience said, "we amended our debt agreement to reduce the minimum cash covenant from $10 million to $5 million, providing additional balance sheet flexibility."
  • Increased sales and marketing spending reflected "higher performance-based compensation," while research and development was affected by one-time charges related to trial closures.
  • Szela noted, "we continue to invest in long-term growth via increasing commercial resources and funding of new applications."

INDUSTRY GLOSSARY

  • PEDD (Pressure-Enabled Drug Delivery): A technology designed to improve intravascular delivery of therapeutics to tumors by increasing local penetration and reducing off-target exposure.
  • GAE (Genicular Artery Embolization): A minimally invasive procedure to treat knee osteoarthritis pain by occluding blood vessels around the knee.
  • HCPCS Code: Healthcare Common Procedure Coding System, a set of medical codes used for billing reimbursement, such as C8004 for mapping procedures described in the call.
  • TriNav FLEX: A specific TriNav catheter variant engineered for greater trackability in small or tortuous vessels.
  • Nalotolimod: An investigational immunotherapy asset previously under internal development by TriSalus Life Sciences, Inc.

Full Conference Call Transcript

Operator: Good afternoon, and welcome to TriSalus Life Sciences, Inc. 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 LifeSci Advisors. Please go ahead, sir.

Jeremy Feffer: Thank you, operator, and thank you all for participating in today's call. Joining me today from TriSalus Life Sciences, Inc. are Mary T. Szela, President and Chief Executive Officer, David B. 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. 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 covering analysts. Earlier this afternoon, TriSalus Life Sciences, Inc. released its financial results for the quarter ended September 30, 2025.

A copy of this press release is available on TriSalus Life Sciences, Inc.'s 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 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 limitations, 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 the forward-looking statements. Accordingly, you 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.

TriSalus Life Sciences, Inc. 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 of this live broadcast today, November 13, 2025. And with that, I'll turn the call over to Mary.

Mary T. Szela: 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 TriNet platform, launching our TriNet 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 continue 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 and Medicaid Services (CMS) HCPCS code C8004 introduced in April. This new code expands coverage to include simulation angiogram or mapping procedures using TriNet, enabling interventional radiologists to utilize TriNet 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 TriNet across the full continuum of the 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 TriSalus Life Sciences, Inc.'s pressure-enabled drug delivery (PEDD) technology represents a transformative opportunity with substantial long-term value across a wide range of solid tumors 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 has been outstanding, which highlighted exceptional trackability, enhanced visualization for precise targeting, and improved professional efficiency. These advances reinforce our confidence in TriNet powered by PEDD as a platform that helps interventional radiologists address their most difficult tumor drug delivery challenges. We continue to invest in the TriNet portfolio to deepen its clinical impact, 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 TriNet'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 event featured Dr. Nicole Lamporello of Weill Cornell in 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, a multicenter 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.

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, 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 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 TriNet 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 nalotolimod across several high-value oncology indications. This transition will eliminate the vast majority of development-related expenses for nalotolimod by 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 nalotolimod in multiple liver tumor types, which include metastatic uveal melanoma, hepatocellular carcinoma (HCC), and cholangiocarcinoma, are now complete. Enrollment has also concluded in PERIO-3, our phase one trial in 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 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 TriSalus Life Sciences, Inc. remains focused on executing our near-term milestones, including advancing the TriNet platform across multiple indications focused on the interventional radiology call point, advancing PEDD solutions designed to optimize therapeutic delivery, and addressing the full spectrum of vascular access and perfusion challenges faced by the interventional radiologist. Generating and publishing new clinical and HOR 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, with that, I'll turn the call over to David.

David B. Patience: Thank you, Mary. As Mary mentioned earlier, TriSalus Life Sciences, Inc. 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. 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 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 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 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 flotetuzumab, 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 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 nalotolimod and the non-cash stock-based compensation acceleration in the period. Cash used in operations was $3.7 million, a substantial improvement from $11.2 million compared to 2024. Adjusted EBITDA loss was $5.4 million, an improvement from $7.1 million in the prior year. This includes approximately $2.1 million in one-time charges related to the PERIO study close-off. 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 equivalents 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 11 on your telephone, and wait for your name to be announced. And to withdraw your question, please press 11 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 Takkinen with Lake Street Capital Markets. Your line is now open.

Nelson Cox: Hey. This is Nelson Cox on for Frank. Congrats on all the progress here. Wanna 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 some kind of a wide range. So just wanted to give a chance if you guys are comfortable to provide more color there.

David B. Patience: Hey, Nelson. This is David. Thank you for the question. Right now, we're confident and, you know, very excited about our current momentum, especially in the fourth quarter. So that's really our focus right now. You know, we are, you know, 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, you know, the current operations of the business, and we're excited about it.

Nelson Cox: Alright. Fair enough. And then, kinda 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 T. Szela: 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. Yesterday we had a webinar on uterine artery embolization and we were 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 embolic that are used, which correlates to reduce pain. The other important thing is just reduce administration of 2026. You know, we'll enter our full launch in about a week.

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 earnings remarks that we are in the midst of genicular artery embolization trial, that's something that will continue to invest in and move even further. We have a new product launch coming in the fourth quarter, which is TriNet 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. And, we think that could open up the opportunity for other, you know, different procedures. I'd like to have Dr. Richard Marshall comment on this.

He's actually used this product and also used RXP and maybe you can comment on those as well, Dr. Marshall.

Dr. Richard Marshall: Thanks, Mary, and good afternoon, everybody. So I am very excited about both the ex which is the, 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 TriNet 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 microcatheter.

So we're going to be giving them the effects of a TriNav but they're gonna still feel like they're using and be able to treat patients like they normally do with their favorite microcatheter. So I think that's gonna 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 advanced 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 gonna generate a lot of excitement.

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

Nelson Cox: Awesome. That's helpful color. Thank you, guys.

Operator: Thanks, Nelson. And the next question will come from William Plovanic with Canaccord. Your line is open.

William John Plovanic: 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 wanna you know, the revenue was a little light for the quarter. I appreciate the cadence comments regarding August, September, 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, going back to the first question was asked, I mean, there are estimates out there that have over 50% growth next year in up to almost 90% year-over-year growth next year for some of the sell-side analysts.

So I understand you don't really wanna comment, but is there any you think that your revenue growth could accelerate above 50% in '26?

David B. Patience: 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 kinda 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 forecasted, 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 for our you know, company. You know, that said, we just don't we don't wanna comment on 2026 just yet. We're very focused but confident that we'll hit our 50% growth target.

William John Plovanic: And then just a follow-up. As we think about the use case use cases for mapping, know, 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 is drivers for you. And thanks for taking my questions.

David B. Patience: Perfect. Yeah. I'll take the last part. You know, our new account additions, you know, we are adding you know, about 20 accounts through VAC approval for the quarter. Again, our focus going into this year was, you know, opening 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 spreading word-of-mouth using TriNet, where we used to have one champion now we have one or two. And then the newer applications will play a big role as those interventional radiologists are gonna be using us not just for the liver.

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. And I'll turn it over to Mary to talk about mapping.

Mary T. Szela: Hi, Belle. 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. 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 Veeva internal data from our representatives. 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. We're really seeing kind of a two for one in the radioembolization.

And the other factor has just been it's a new code and it came out in April, we have a reimbursement resource with Dr. Z 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.

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

Matthew Park: 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 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 TriNet fitting in within the potential standard of care?

Mary T. Szela: Sure. So GAE is a really exciting opportunity. You know, I think not only for patients because it can potentially know, reduce the need for a knee or, you know, 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 feed that they're administering. Are they resorbable? Are they you know, 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?

Dr. Richard Marshall: 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. You got 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 wanted to protect. And TriNav, with both its flow modulation and reflux protection, accomplishes both of those. So this procedure is already being performed with traditional microcatheters.

What the interest that we've received so far and the success that we've seen is that physicians do an angiogram with the TriNet, and they say, they can see vessels a lot better. And then when they deliver their microspheres or their liquid embolic, they can push it in much farther without having to worry about the about nontarget embolization. So they feel safer and more confident. We've got some other positive feedback that we're gonna publish in the near future. About how we can treat multiple sites from one injection. And I think that's gonna that is going to distinguish this catheter from the traditional way of treatment. It's gonna allow physicians to do this procedure faster and better.

Matthew Park: Got it. The 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? When you would kind of expect these manufacturing efficiencies to come back in?

David B. Patience: Perfect. 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 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 normalized gross margins here in the fourth quarter. And then expanding early next year as well.

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

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

Carl Burns: 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 TriNet to mapping? Is it I know you mentioned that there's some education process around the new HCPCS code, the C8004 code. Are you know, can you quant that at all? I know you quanted the revenue growth of 30% for mapping. But do have any feel there? Thanks.

Mary T. Szela: Yeah. That's I mean, I think what the data that I have is what I shared with you that comes out of Veeva. 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, with 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 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 wanna treat with an end hole. So now we're converting two catheters versus the one, and that's really what's been driving majority of the upside. But to your question, don't have that definitive data. Dr. Marshall, do you want to weigh in?

Dr. Richard Marshall: I do. I'll reinforce it. I think physicians wanted they basically wanna treat apples and apples. They don't wanna map 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 gonna do. And I think physicians have been really impressed with the angiography quality that they get from TriNet because of the way that contrast goes through it and isn't 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.

Carl Burns: Great. Thanks. Very helpful. And then just one quick follow-up. What are you seeing with respect to adoption of LV and FLEX? And then what procedure specifically? Thanks.

Dr. Richard Marshall: I can comment on this. So we have centers that have converted completely to FLEX that they love the catheter, and they only wanna use that. Those are centers that typically do more selective treatments. So smaller portions of the liver and smaller arteries that may be that are a farther distance for the catheter to travel. And so they appreciate the trackability of that catheter being able to go out farther. 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 where TriNet really shines. And those are really large, territory treatments.

So, for example, half of the liver, we call it a lobar 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 TriNet FLEX in thyroid arteries because they are tortuous.

So it's a nice fit in that area. And the same is true in uterine artery embolization, but the XP catheter, which we've just released, is gonna, is gonna be, I think, it's gonna have a lot of growth in uterine artery embolization because it's designed specifically for that. But that's been well received so far. I hope that answers your question.

Mary T. Szela: 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 know, TriNet is at 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 how to and remember, we have a single price for all these products, so it's really up to the use of the physician, the vessel tortuosity, 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 gonna settle out probably over the next couple months. In, you know, in 2026.

Carl Burns: Great. That's excellent. And congrats again.

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

Justin Walsh: Hi. Thanks for taking the question. It's great to see you exploring different use cases for TriNav. 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 T. Szela: 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, the estimates for those markets are probably between, we've seen the low at the one and ten, higher at kind of you know, the two fifty. 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. Two days post-operatively, 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. 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. 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 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, and potentially be used in combination with other treatments as well. So Dr. Marshall, you want to comment on that?

Dr. Richard Marshall: Yes. And so we're talking about delivery of embolic right now, and I 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 gonna need to be treated, the future is gonna grow quite a bit. So we have a great solution for that. And that's why I think it's gonna be a huge area of growth for us.

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

Seamus: Hi, Mary and David. This is Seamus on for Suraj. Just one from our end, but just trying cut this, I guess, two different ways. So know, how has kinda growth slash utilization look for accounts that launched, say, eighteen months ago versus one year ago versus six months you know, how kind of has the ramp kind of been over time? And I guess, you kinda quantify that? And then, you know, on a separate note, again, on utilization, how does utilization for a physician that's added on within an existing account look? In overtime? Thank you.

Mary T. Szela: 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 interstitial tumor pressure and the challenges associated with it. We call that a bit of a cold account. That's gonna 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 eighteen 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 we 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 within patient population, we're also seeing the new user 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 you know, from ground zero and we need to do some of that education and really get them familiar with the technology and the rationale. Then they get to see the technology and use. 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 launch 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?

Dr. Richard Marshall: Yep. I think, we typically see a single user at a site become a champion for us and start to use our catheter. In any older accounts where a physician has been treating patients and seeing their 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.

Seamus: 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 T. Szela: Thank you everyone for joining the call and all your active support and interest in the company. We really appreciate it.

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