First of all, thank you so much for the opportunity to be here. I am delighted to share the TriSalus story with you. We are a mission-driven company. Our goal is to infuse more therapy into solid tumors. If you look at oncology outcomes, solid tumors have really struggled with improvement in overall outcomes for patients. What we are starting to see in the oncology arena is incorporation of a lot of different combinatorial therapies, where delivery to the tumor, in addition to systemic therapy, is happening more and more. Five years ago, that was in the nascent delivery. They are now recognizing that the challenge of the reason why we are not getting those outcomes is oftentimes the drug does not get into the tumor. What led me to the company was my own personal experience. I am a cancer survivor. My sister and I were both diagnosed with breast cancer. We lost my sister to breast cancer liver mets. When she was dying, we had put her on a systemic tyrosine kinase inhibitor, and Roche asked us could we do a rapid autopsy. We wanted to see what the concentration of the drug in her tumors were, and it was zero. What we saw was none of the therapy systemically was getting into the tumor. Why is that? What TriSalus is solving is often these tumors have very high pressure inside them. Cells are rapidly dividing. There are very leaky new vessels that fluid leaks into the area of the tumor. There is not a good lymphatic system. What happens is the pressure in the tumor is much higher than the heart can pump at, and so you do not get any therapy into the tumor. We developed a technology that we think is quite unique. Balloon catheters were used in the early approach to try to modulate pressure and overcome that, but they did not really do it in the way that we needed to. Because these vessels are so new and fragile, oftentimes you could rupture them, or you really did not get the penetration of the therapy into the tumor because it stops flow. You use the balloon catheter, actually stop the therapy and the flow. What ours does is it is a valve-like structure that modulates pressure and flow, and it is very physiologic. When you place it in a vessel, it beats in synchrony with diastole and systole. So it gently opens up these collapsed vessels, and it allows forward flow. So it keeps the blood flowing, moving, so you can get deep into the tumor. But it also prevents off-target delivery because it has anti-reflux capability. We have been using it primarily today, and where we are selling it is for liver-directed therapy. In 2020, when we got it cleared by the FDA, we got a designation called Transitional Pass-Through Payment. It was the first interventional radiology product in a long time to actually get that type of designation, demonstrating that it was statistically better, that we got more therapy into the drug other than a normal catheter. When you think about a normal catheter, think of it just like your garden hose. It is hard to kind of direct where flow is, particularly if there is a stricture or whatever. Sometimes when you undo that, you know what? It can get very wild. That is kind of how a catheter is. It really does not have a lot of control. It does not have the ability to influence pressure. It doesn't have the ability to overcome any type of significant back pressure. We're very excited about this because we've demonstrated not only clinical outcomes, but Health Economics and Outcomes Research outcomes that are quite persuasive, and we've been growing very rapidly, about 50% a year since we launched the product. We made a decision this year because of the growth and the significant potential of the company to expand the sales organization quite significantly, so we doubled that in size, and to set us up for the future growth in the coming years. Perfect. Mary, you have said that currently you have a market share of over 10% in the liver embolization procedures, and the other 90% is using the- the old standard catheters. What are the two or three catalysts that need to happen so that that percentage market share can increase? I think there's a couple things. One of the things that we as a company feel very proud of is that we want to be an evidence-driven company. So we want to produce comparative clinical trials to really demonstrate the value of the product. We want to show Health Economics and Outcomes Research. We just completed the largest one ever for our technology in over 1,200 patients. We also do registries. So we want to collect the right evidence. Part of that moving that market share and with our goal to be standard of care, and we define that as over 50%, is how do we create the right cadre of evidence in each of the areas that we participate in that give physicians the confidence to do that? Right now, with the 10% market share, we get all those early adopters, people who can see that very clearly. One of the challenges that we have is interventional radiologists really weren't educated about the tumor microenvironment, some of the challenges with delivery and flow and treatment outcomes. They do know that if they get more drug into the tumor, just based on extensive data in multiple different studies, not TriSalus data, but other data, if you get more drug into the tumor, you tend to get an overall response that is substantially better, that can correlate with overall survival. So that concept is well-known by the interventional radiologist, but they weren't really taught about some of the physiological challenges in getting drug to tumor and how to think about it and why our device could be a better solution. So that's really about education. It's really about teaching those physicians, and that takes some time. Okay. Talking about education, so you have done this reset of the commercial structure itself, right? So roughly 40% of the territories are both rep to physician and rep to manager relationships have changed at one instance. Right. And that obviously led to having a flat first half 2026. Disruption in sales. Revenues. At the same time, the second quarter revenues, it was a big, with $11.5 million reported. Also you are reiterating your guidance of $54 million-$57 million. So what are the factors that are giving you that confidence? Also, at what point do you think you will share those metrics with us so that we can model it out better for the future years? Yeah. We are unlikely to share the metrics because that's proprietary. We've developed them ourselves. We actually have a very robust model that we use that we've followed very closely since the day we launched. We have some very hard metrics that we look at literally every day, and that's a very clear predictor of our performance. We continue to manage that very tightly, and that helps us guide us of how we feel about how the business is performing and why we have confidence in terms of moving forward. Okay. The guidance implies the second half is going to do much better than the first half. Yeah. Since you just started this, 40% of the sales force roughly just in April, I think they came on board completely. Yep. Do you think they'll be able to deliver in time so that your second half looks as good as what you want it to look? I think right now we're performing right on track. You're right that when we looked historically when a new rep came into a territory or they had a new manager, typically it was a six- to nine-month ramp, and you saw it heavily weighted to the back four months. We're early in the cycle. Based on what we see so far, we're pretty pleased. I think over time that will reveal itself, but if it performs like it did in the past, we're very comfortable with that. Okay. Going back to the education question, the other way to educate is peer to peer, right? You said you're trying to increase that number. Yeah, we've substantially increased. We found that peer to peer was probably one of the most impactful and immediately responsive type of approaches, because this is, again, interventional radiology is still a very apprentice type. Correct. They are taught in the procedural room what to do, and so that type of education just lends, this product lends it towards that approach. David, on the gross margin, it was approximately 87% in the second quarter versus 84% a year ago. You have pointed to roughly 93% as a ceiling. What is the remaining? How should we think about it to get to that point from here? Yeah. As we scale the operation, we have a near-term focus on bringing out new products. We have the formula with having the right durable reimbursement, as Mary outlined, and also having the right product set that is going to be anatomically able to deliver the therapeutics, but most importantly, give physicians their preference as well. With our new TriNav Advance, which we are waiting for clearance any day, that is a new SKU, a different catheter body, and so that is dragging on our current yields. We see 85%-93% is where we should be, and then as we get more maturity into the manufacturing line, we will see towards that 90. As a reminder, we had FLX launched similar time last year. That dragged on our margins for about a quarter, and we recovered quite nicely in the subsequent quarters. We are confident we can do that with the same team. Okay. Yeah, anytime you introduce a new product, it just takes a little bit of learning. Correct. Then we can ramp, snap right back up to our productivity. Okay. One more question for you, David. On trying to turn the business cash flow positive. You said you need to get about $80 million in annual run rate. So what needs to happen for you to get there? And then also, do you think you'll need not only additional skills, but also additional investment, in terms of either organically or inorganically to grow the pipeline? Of course. the portfolio? Just taking a step back, if you are new to this story, with the Salesforce expansion, we moved our annual GAAP operating expenses from below $60 million to probably about $70 million on a GAAP perspective on an annual basis. You just do the math at an 85% to about a 90% gross margin. We can be cash flow positive essentially between $19 million and $21 million on a quarterly basis. That is not too far off of where we expect this Salesforce team to be Yeah. in the coming quarters, exiting the year with a very strong run rate. For us, we are very focused on getting this team productive, capable of what they are able to achieve in the procedural volumes that are in each of their territories. With the durability of our gross margins, we should be able to turn the corner and turn the corner quite quickly. For us, we are confident we can get there. We are not going to give timing on that just now until we see the Salesforce ramp. Our operating structure is very durable right now. We had an increase in sales and marketing in the second quarter as we onboarded these reps. Other than that, we see each of our line items pretty durable without significant growth. David mentioned we're waiting for clearance for TriNav Advance. There is a group of physicians, they get very comfortable with their own catheter technology. It's what they trained on. Advance allows them to use that, their own microcatheter, but still get the Pressure-Enabled Drug Delivery effect. That I think is a big benefit and will open up a lot of users who just didn't want to move because they're comfortable. Then the second one is, the G-code is- Yeah. the OBL environment where a lot of our other applications, TriNav is not covered today. That now can open a lot of utilization in that side of care as well. On the OBL itself, let's say once it becomes effective on January 1, 2027, I understand you're going to expand that, but do you need to expand your sales force again to manage that properly? No. You know what's really interesting about it is, and I'll give you an example. For example, one hospital in the New York Metro area, they do mappings in their OBL, and the hospital set these OBLs up with physicians because there was so much congestion in the hospital. Then they do treatments in the hospital. They're the same physicians. Often these are physicians who go to their OBL and then they come back to the hospital. This is a real opportunity. There's going to be a lot more fluidity of care that we think that will open up the opportunity for us. Okay. Now trying to grow the portfolio in terms of adjacent indications. You have talked about two or three different indications that you could expand the business into. What's the low-hanging fruit and what's the one which you really want to get? Today about 5% of our business is in uterine artery embolization, and you'll start to see us really scale that up. We wanted to collect some data and that we really wanted to prove to ourselves this is something that's value driven and that we could add value to that procedure. In the OBL, that's where it's predominantly done, so I think that could spur a lot of growth. We saw a pretty dramatic impact with our technology in uterine fibroid, where you could actually use less embolic material, you can do the procedure much more quickly, and you can actually get up to 95%-100% coverage of the tumor. Today with the end-hole catheter, it's about 50%-60%, so pretty dramatic impact. The second one is thyroid artery embolization. We're doing a registry. Okay. We think this is game changing because it could actually eliminate the need for surgery. Today, if you wanted multinodular goiter, which are big thyroid nodules that grow into your chest or are very large, you have to have surgery. They remove a portion of your thyroid. The risk of stroke is more significant. You have a big scar on your neck and you are often on replacement levothyroxine therapy for the rest of your life. This is a 25-minute procedure that can shrink the nodule and avoid all of the cost and complications of that. We are really excited about that. We think TriNav Advance could also open the door for prostate artery embolization. This is another procedure that is really in unmet need of off-target delivery of treatment. We think we could add value there. Genicular artery embolization is one that we are very excited about. It is growing, and this is ironically, a lot of patients are coming directly to interventional radiologists on this. I have been to a couple OBLs where I was astonished by the level of volume in that. That is just a few of the procedures. There are 38 embolization codes where our technology could have application in. We are just prosecuting them, but we are doing them in a way where back to our mission, we want to have the right type of clinical data, we want to have the right technology, and we want to do it in a way where really offer value to the procedure. The other thing that you have talked about is nelitolimod and Therio. Nelitolimod, yeah. Yes, we actually invested in a therapeutic, and we did this purposely because we wanted to demonstrate to people that we could take a drug that cannot be administered systemically. Nelitolimod is essentially 31 snippets of bacterial DNA, and if you infused it, you would go into COVID cytokine storm, because it would just engage your overall immune system and elevate it to a point where it would be very dangerous. We can infuse that drug into the tumor and treat the dysfunctional immune system in the tumor, but not have any systemic circulation. We are very excited about releasing that data in the second half. We would like to find a partner for that. We think it demonstrates another avenue of how this technology could deliver these type of agents intratumorally, very safely. Okay. Last question. You closed the second quarter with $46.3 million in cash. What sort of a runway can you get from that? What are the two or three major catalysts that investors should be on the lookout for? David, you want to answer this? I'll jump in. Sure. In terms of runway, we like where our cash burn is today, given our OpEx, we think is very durable where it is. With that, we think that's more than sufficient to not only just turn the corner, but to turn the corner and sustain us independently from capital markets. When it comes to catalysts, it's the market share growth that we'll see. That's the main metric we want to focus on. What is our market share today in not just the liver and growing that, but also in the newer applications such as uterine artery, thyroid, and then with that genicular and prostate. For us, we think it's a very exciting opportunity for us. What you will see is the market share gain on the quarterly update, but also Advance, launching Advance and getting that as the final tool we really need to deeply penetrate the liver market. Then rolling out that clinical data prospectively against the end-hole catheter in the liver, as well as in our newer applications. I will comment on that because we think that evidence is doing comparative studies that would be sufficient to be included in the NCCN guidelines. We believe that is really the pivotal time where you actually see this become standard of care. It is unequivocal of why you should use this technology. So we think that is the ultimate driver of really ensuring that this business is highly durable and has high growth. Perfect. Thank you very much. Thank you. Mary and David. Thank you For coming down. Thank you. Thank you. Thank you.
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