All right, good morning everyone. My name is Ross Osborne, MedTech, Life Science Tools, and Diagnostics Analyst at Gantt. This morning we have TriSalus Life Sciences, and with us is the CEO and President, Mary Szela, and newly appointed CFO, David Patience. Would you guys provide a brief background on yourselves? Sure. I grew up in big pharma. I was at Abbott Laboratories for 26 years. I ran the U.S. pharma business, spent the majority of my career on Humira, and then Global. When I left, I was a CEO of a small anti-infective company out of Yale. I didn't realize that no one wanted to invest in anti-infectious or escape pathogens. I left that company and then went to a small public company in Boston and then ended up at this company. I'm really very passionate. I'm a cancer survivor, and this technology really solves a key problem that I feel can unlock better outcomes for patients with solid tumors. David Patience, been with the company for a little over two months. Spent my first 10 years in financial services, and then most recently, the last eight years I was with a diagnostics company in the AMR space. With that, learned a ton about commercializing innovation, the good, the bad, and the ugly. Two things that I realized very quickly is when you're going to commercialize, you better have pretty good, and darn compelling clinical outcomes, as well as very favorable reimbursement, for the institutions itself. That was a huge factor in me joining the company because Mary has built a very good, strong competitive moat. Great. To level set the room, who is TriSalus Life Sciences? How are you guys started? Yeah, so I came to the company in 2018. The company was started actually in 2011. The whole kind of origin of the technology was to prevent off-target delivery. When I came to the company, one of the things I really noticed about the technology was its ability to deliver more therapeutic to the tumor. What the technology is, it's a microcatheter technology, but on the end is a small, tiny little valve. It solves an important problem because in solid tumors, oftentimes the pressure inside the tumor is higher than what the heart can overcome. Less than 1% of drugs can get into solid tumors. We believe this is some of the reasons why we have such poor results in pancreatic cancer, poor results in liver cancer, and other tumors throughout the body. What our technology does is modulate the pressure and flow. Think of it like a tiny little auxiliary pump in the vessels feeding the tumors. It works in sync with your heart. With diastole and systole, it's opening and closing and creating enough of a pressure gradient to open up those collapsed vessels and infuse therapeutic into the tumor. Based on all of our testing and the different modalities, it can be anywhere from 30% - 500% more therapy in the tumor. We know that if you get more drug into the tumor, it correlates with improved overall survival. What is the current standard of care? The current standard of care is just a microcatheter, and that's the challenge with it. Today, you know, it's dependent on where blood flows. It can't modulate pressure or flow. You can get a lot of off-target delivery, which creates a lot of complications. The other issue is you don't get enough drug into the tumor, so it's really a suboptimal approach in terms of that type of procedure. Great. Before going to the quarter, maybe just walk through what types of solid tumors you're targeting. Primarily, the majority of our business is in the liver. We target liver metastases as well as primary liver cancer, hepatocellular carcinoma. We've also seen physicians starting to use our technology in a wide array of other applications, which is the reason why we expanded our market opportunity from about a $400 million market opportunity now to almost a $2.5 billion market opportunity. Great. Looking at the quarter, your guidance implies a decent acceleration back half the year. What gives you confidence you can hit it? Yeah, I think we're very proud of the quarter. We came out with that guidance back in November of last year. After the first half of the year, we're very excited to see the acceleration, you know, first half of 2025 compared to the first half of 2024, right at about 50%. We're very proud of the 22% sequential growth from the second quarter to the first quarter. Really, where we're going is, and we'll probably talk about it a little bit too, is how we're segmenting the market and attacking the market too. We are very cognizant that we got a good target in the back half of the year, but we're very excited about the momentum and we're confident we can get there. are a couple of factors that are really driving it. We've launched several new products. One is a more trackable version called the TriNaflex. That inhibited us from getting into procedures where the vessel anatomy was very tortuous. That's been a good, big growth driver, and that's been adopted very rapidly. We're also going to be launching a new product that's dedicated for uterine fibroid solutions. We also received mapping earlier this year. This is a new code that was, there was a lot of uncertainty on it. We've just generated a lot more awareness around reimbursement with a new support back office that is really the guru of reimbursement in the interventional radiology space. All of those factors are really driving our growth in the second half of the year. Great. While we're here, maybe just touch on reimbursement. What's unique about us is that we have, you know, most medtech reimbursement, you know, they get a technology or a device reimbursement. What we've created, and we think this is very unique, and why this is going to play forward for us in all our future applications, is we have our own embolization procedural code. The actual reimbursement is for Pressure-Enabled Drug Delivery. Anywhere that you do Pressure-Enabled Drug Delivery, you're eligible to use this code. Our indications for use is that we can use our technology anywhere in the body for embolization procedures other than in the brain and the heart. It's very favorable and cash positive to hospitals. The reason why CMS gave us such a favorable code is that we're actually cost savings. Every time you use our technology, we're saving over $8,000 per patient for CMS. Great. Sticking with growth, how should we think about utilization within existing accounts versus bringing on new users? No, that's a great question. It's the focal point of every commercial conversation we have with leadership, the board, and most importantly with each Territory Manager. Over the past few years, we've really focused on the opportunity set and getting a ton of accounts through what's called back approval. Think about that as kind of a hunting license within an institution. Over the past nine months, we've really focused on utilization in existing accounts. What we have noticed is right now within our growth for the year, we're seeing that predominantly in our existing accounts. That has been very methodical and deliberate as we're building around essentially what was a core user or one champion and building physicians around that to be more of standard of care in the institution. It's not just one user, it's three to four users. With that, we're looking at different ways of the existing accounts to grow at what we'll call, you know, a strong growth rate. The next leg of growth will come from taking those core accounts and having newer accounts follow them thereafter. How are you feeling about your sales reps? Yeah, I can give you some flavor. I think we've gone through a lot of learning. When we first started in 2020, we hired kind of the typical medtech rep. What we learned is we're selling a new therapy, which is very different than what, you know, we're not selling a device with feature and benefits. We're really talking about how they do their procedure differently. I think we've really honed in on the phenotype. Now we have a very high-performing sales organization. We went through a lot of churn in terms of figuring out who's the right rep for our technology and who can help develop that with physicians. I'd say now across the country, they're really performing at a high level. Yeah. I would say we're really proud of kind of what our reps have achieved and the process that we've undergone over the past two years. We're getting to the structure and the scale where we're getting a process in place. This is a sales process that we're institutionalizing within all of the areas and the regions. We've taken what we've developed in that early stage market development part of the curve. Where we are going now, the next leg is building process structure and institutionalizing what has led us here to create one single focal point that is very measurable for us on a go-forward. Great. Maybe talk about the accounts you're targeting. How do you define a high-value account? Maybe what their volumes look like? Yeah, that's pretty easy because we buy the data. We can actually see where the volume is. The interventional radiology, you know, they do a lot of different things in their daily manner. Usually in a department, you can find out people who are doing the majority of the liver cases. Some of the big academic institutions have some specialization. We just target the high-volume users. Out of, you know, there's 1,100 hospitals in the United States, about 400 really are 90% of all the volume of these types of procedures. You can cut that down to even about 100 through the top volume. It's a fairly focused market for us. We don't need a massive sales organization. Like David said, we got into hospitals. Our first remit was let's get through the approval process. Let's find an adopter. Now it's about expanding it to new physicians and multiple physicians within a particular hospital, not only in the liver, but across a broader set of different applications. That's really key for us within our kind of high-value accounts as you put it. I think that's a great way to look at it because their interventional radiologists are doing so many different procedures in a day or a week. If we have uterine artery or genicular artery or thyroid embolization going alongside the liver, we're going to have more of the mind share of that interventional radiologist. Every single time they're going to do an embolization procedure, they're thinking, hey, is this a TriNav case or not? The more utility we have for them, I think the more wallet share we'll have. Honestly, it's about mind share for us. We just want to be their choice of technology when they're doing their embolization. Great. Looking at those 100 accounts, market penetration. We have 57 of the 100 that we would call thriving accounts that are doing really well. Our goal is to get into all 400 and have them thrive. I think we've done a nice job in that first year and a half of really getting into our language. We're pretty pleased with our progress so far. Great. If and when you receive pushback, what do your docs question about your device? I think the pushback is they've never really been taught. I mean, no one talks about intratumoral pressure and the tumor microenvironment for an interventional radiologist, even in the oncology community, that's just starting to emerge. This is the right time because people are learning about it. That's the biggest barrier, just lack of education or underappreciation for it. Right. You alluded to this, but maybe walk through your recent product launches, what that means for you guys in terms of targeting patients. Yeah, one of the things that we were inhibited by when we first launched is we only had one technology, one vessel size. When a rep went into a procedure room with a physician, depending on the vascular anatomy, we wouldn't be able to be used just because we didn't have the right product. Now we have our base product, a larger version, a more flexible version. We'll have one for uterine fibroid that can handle much larger size beads. Later at the end of the year, we'll have a technology that they can use any type of microcatheter they want. We'll have a complete portfolio for any type of vessel anatomy that the doctor has or, with the patient, we have a technology that can cover it. A full portfolio is really going to make a big difference for us in terms of penetration. You have a full bag, good reimbursement, and a solid sales force at this point. You know, what's the hurdle to adoption? It's just education and awareness, like you said. Part of what we need to do is just educate physicians about why this is so meaningful. I come from a big family of physicians. Physicians have done this this way for 20 years or 15 years or however they were trained. Now we're coming up with a new methodology of how they do that. That just takes time and education. Is there an opportunity for you guys to be included in guidelines? That's what our whole focus is on virtually every area that we're doing. We're doing registry studies in a very large scale, almost like a definitive comparative clinical trial, but it's easier to do this because we don't have to spend a year and a half to get through IRB. We'll use that data to submit into guidelines, in the liver guidelines, in the endocrine guidelines, the ACOG guidelines, all of them. That's what the intention of all of that registry study and clinical evidence is. Great. Maybe switching thyroid, walk through your recent data. Yeah, we just had a press release on Dr. Juan Camacho. This is what's so exciting about this technology. We didn't have anything to do with it. Dr. Juan Camacho out of Sarasota Hospital in Florida innovated a whole new procedure that avoids access to the carotid artery. Embolizations were done for the thyroid previously with the standard microcatheter, but you had to access the carotid artery and there was risk of stroke. Here's a healthy patient. Most interventional radiologists weren't really comfortable doing it, so they were at a lower level. What he innovated was that you can go through the inferior thyroid artery, avoid the carotid artery altogether. Because our technology can retrograde fill the nodule with pressure, you can now do that, which you couldn't do with a microcatheter. Now you have a non-invasive procedure. It's about 30 to 40 minutes. The nodule necroses in about a week and a half. It's much less costly than surgery. Probably the biggest benefit to the patient is you don't damage the thyroid. Often in surgery, we remove part of the thyroid. Patients are on lifelong thyroid replacement therapy, which is very challenging to manage a hormone. This is something that patients, he has a waiting list of months of patients wanting to get in. We now have 10 sites that are doing the thyroid embolization registry. We just finished all the training. We really see this rolling out much more aggressively and getting that registry started. We'll start training other physicians on how to do the procedure. How should we think about that training timeline? Is it a 2026 story expanding out? I think so. You know what? This is something that we want to do the right way. In the thyroid, some of the natural tendencies that an interventional radiologist will do in the liver, you don't do in this procedure. We really want them to be certified just very much like Y90. When Boston Scientific and Surtech rolled out Y90, they had a proctoring of you do three cases. That's exactly what we're doing here. It's the same type of formula that we're employing. What about on the reimbursement side of things? This was covered under our current embolization procedural code. It is very favorable for the hospital, so this really makes sense. It is also favorable for the payer. I mean, this type of procedure is much less expensive with better outcomes than the surgical options that are available. Good. Maybe switching to nelitolimod? Yeah, so nelitolimod, we're getting to the end. I think all of our spend and investment in the phase one will really essentially end this quarter. We're going to see that come out of the P&L. We hope to launch the data publicly and launch a whole process of finding a partner. We're really pleased with the data that we see through uveal melanoma as well as pancreas, and we hope to find the right partner that can help us advance this further. What would that partnership look like? We're targeting a partner that has a strategic interest in those liver indications or pancreatic indications, that has the capability that you can easily advance this. We don't want to go to a partner that has to build the infrastructure or anything like that, and that could help us do this more rapidly. That has a disease knowledge of that area that helps craft this in the right way for real success. Great. I guess post nelitolimod spend, what does the cash profile of the company look like? Yeah, that's a great question. Where we are right now is, you know, we had a little bit higher OpEx than we would have liked in the second quarter. I think normalized, and when we called out a few one-time expenses, both R&D as well as non-recurring G&A expenses. Round numbers, GAAP OpEx is about $60 million, cash OpEx is closer to $50 million. For us, we think, you know, that has, you know, opportunity to, you know, grind out another $3 million - $5 million in savings just by getting more efficient with our auditors, more efficient with our legal entities, as well as getting nelitolimod kind of out of our, you know, our spend profile. We're pretty excited about where we can go. You know, we're really focused on, you know, near-term cash flow breakeven. We're kind of right there. The only real, you know, opportunity for further investment is scaling sales and marketing, as well as, you know, kind of these registry studies that we're talking about. The beauty about the registry studies is you're leading with clinical evidence to be a very strong value proposition. We're already reimbursed, so it's essentially cash flow positive. It is cash flow positive. It's creating a lot of awareness for the product in the marketplace to help kind of be the tip of the spear for the sale of the marketing organization. We're very excited with where we are, and we're just very focused on continuing on how we're going to continue this momentum commercially. Looking at 2026, key milestones or catalysts we should be watching out for? It’s going to be data on the fibroid, data on genicular artery, and data on uterine fibroid. It’s going to be the launch of our next gen advance. Just a lot of clinical milestones and product milestones. Perfect. Anything else you guys like to highlight? No, thank you. This was a delight. Thank you. Thank you very much. Thank you, everyone. Okay. Thank you. Yeah, it should be me in person. Yeah. Thank you for being here.