Thanks, everyone, for joining us today. I'm Jason Bednar. I cover med tech here at Piper. Next presentation this afternoon is from TriSalus Life Sciences . Pleasure to have with us today President and CEO Mary Szela, and also CFO David Patience. I'll turn it over to you for your presentation, and then if we have some time at the end, we can take some Q&A from the room.
Great. Well, first of all, thank you so much for the opportunity to present. This is our first time at Piper, so we're really delighted to be here, and I'm delighted to introduce you to TriSalus. So let me give you a quick overview of the company. We're a high-margin, high-growth oncology-focused company that has a drug technology that delivers more to the tumor and less to the normal tissue. And by doing that, we can improve patient outcomes. We have a very large market. Today, we currently market in the liver for embolization procedures, either radioembolization or chemoembolization. But what we're finding with our technology is that it can be used in many other applications. So this is a $2.5 billion market opportunity for us. We currently are growing in excess of 50% per year. We have a very multi-layered IP portfolio.
What we've done is actually patented the pressure range to optimally perfuse the tumor. We have over about 100 patents today, 100 patents applied for. We do about 20-25 patents per year. So we've really done a nice job of creating intellectual property value on our portfolio and quite a number of catalysts that are coming. So let me start with just the problem that we solve. So the reason why I came to the company, I'm actually a cancer survivor, a two-time cancer survivor. My sister and I, we're both diagnosed with breast cancer three days apart, unbeknownst to each other. Come from a big family of physicians. And we were both going through treatment together. About five years later, my sister developed breast cancer liver metastasis. So we decided to put her on a Roche experimental tyrosine kinase inhibitor, very potent.
Tyrosine kinase inhibitors were the standard of care for liver cancer. And we thought this was the best treatment for her. She was on it for nine months. When she died, Roche said, "Can we do a rapid autopsy? We just wanted to see what the PK and PD was in her tumors." And when we did the autopsy, it was zero. She had 11 tumors, and there was no drug concentration in her tumors. I went down this rabbit hole of, "How could this be? We're infusing it right into the liver tissue. How could it not get into tumors?" And this is the issue. In a tumor, it's this little ecosystem of cancer cells rapidly expanding. You have edematous tissue that's not working properly, so it's not draining away the fluids. You've got immune cells that are just sitting there not recognizing the cancer in a confined space.
If you dropped a pressure gauge into a solid tumor, it's going to be about 110 millimeters of mercury. All of you are really healthy. Your blood pressure, your mean arterial pressure of what your heart can pump at, is between 70 and 90. You don't have to have a PhD in physics to know that the heart can't pump enough into the tumor. So this is where we come in. So what we've created is a technology. It's a catheter-based system. It has a small little valve on the end that works in sync with the heart. So it opens and closes with systole and diastole. And so here's how it works. So here's an interventional radiologist. What he's trying to do, he wants to image the vascular bed of a tumor to calculate how much dose he wants to put into it.
This is the same patient imaged a couple of minutes later. This is just a traditional catheter, a tube with two holes. Can't modulate pressure, can't modulate flow well unless it has a pump or a syringe. And you can see that he can't get into the tumor. If he didn't have our technology, he wouldn't treat this patient. What you also see it backing up and see this like blush here, if he infused radiation beads or chemo beads, he would be infusing into normal liver tissue and destroying normal liver tissue. Now, with our technology, you can actually see it just perfuse the whole tumor. And what we're doing is modulating pressure and flow so it opens up those collapsed vessels. How it works is when our device is placed in this vessel, it vasoconstricts all the healthy vessels around it.
Blood flows in, creates a higher blood volume, and with that pressure of our valve, think of it like a tiny little auxiliary pump in the vessel, so it just creates a pressure gain, and you just perfuse the whole tumor. We've actually measured this. Depending on the modality, it can be anywhere from 50%-500% more drug into the tumor. We know this is just one study, but there's hundreds of them. If you get more drug into the tumor, you get better overall survival. We know that. If you get more drug into the tumor and less into the normal tissue, you get less complications, so this is what the technology looks like. This is really the secret sauce. This flexible Nitinol braided technology allows flow to go through it, but it also has anti-reflux protection, so nothing can go backwards.
And as it's flowing through this valve, it's also flowing at a higher pressure, and it's swirling it so it mixes the therapy in the blood in a very homogeneous way. So you get really good perfusion of the tissue, and you have very high homogeneity of the drug into the tumor. I'll talk about the HEOR data. We have very favorable reimbursement. So we got transitional pass-through payment in 2020 when we first got the technology cleared. It was right at the time of COVID, so we didn't have the opportunity to really get the type of adoption that we wanted. And what happened when we wanted to get a permanent code, we went to CMS and said, "Hey, could we have another year?" And CMS said, "No, we'd have to do that for everybody." So little baby TriSalus, we went to Congress.
In 2023, we got our own bill in that 2023 omnibus bill. I have it framed, where we went to the doctor caucus on Congress and we said, "Every American deserves more drug in the tumor." And what we also presented was very favorable data, and I'll show you what that data was, is we followed, since the time we launched, and matched a cohort like-for-like in 300 million patient claim database, highly sophisticated HEOR analysis. And what we showed is that we statistically, highly statistically significant, deliver more drug to the tumor. What they really liked about this also, a 50% reduction in patients coming back into the hospital in 30 days. Now, remember, a hospital has to pay for that readmission because that's part of a 30-day procedure. But this cost savings was that CMS saves $8,000 every single time our technology is used in that database.
So that's hence why we charge $8,000 for our catheter. We saw a big reduction in fatigue. When you think about fatigue, I don't know if you guys feel fatigued. I feel fatigued every morning. This is fatigue when your liver enzymes are elevated. It's debilitating fatigue. You have to be hospitalized. So this was also a big factor, 48% increase in liver transplantation and just overall complications. So very, very influential data for CMS. Now, this year, one of the things that we think is going to really propel our growth is we launched in 2020 with TriNav. We launched LV last year, so we only had two devices. We just are going to launch two more sizes. We now have a full portfolio of devices that can handle any different type of vascular anatomy that the physician needs.
So if they need something more flexible, if they need something larger, if they need something that they want to use their own catheter on, and I'll talk about that in a minute. So now we have a portfolio to pursue every single imaginable patient presentation that a physician may have. Now, this portfolio also enables all these other different applications. Physicians started using our technology for other applications we didn't even know about. And I'm going to talk a little bit about that. So let me get to now. Let me first, before I jump there, [talk about] when we got our reimbursement code from CMS. This is quite unique. We have our own proprietary embolization code. It is written for; it's an HCPCS code. It is written for pressure-enabled drug delivery. So no one else can use this. We have one for simulation, one for treatment.
We're going to be talking with CMS on getting reimbursement approval for the office-based labs. Highly favorable in terms of reimbursement. Hospitals make money on Medicare, about $1,000 per procedure. For the commercial payer, it can be anywhere from $20,000-$40,000. So very favorable to the hospital. It's a big win for them because they save money, and it's also revenue-enhancing for them. So kind of a win for everybody. The patient gets more drug to their tumor. The clinician wins because they do a better job. The hospital wins because they don't have readmissions, and they also make money. And CMS wins because they save money. So this is really a win across the board. We also have a highly concentrated market. We target about 400 hospitals, 1,000 doctors that do these procedures. We only have to call on one.
Those doctors do many of the same applications that I'm going to talk about. So it's a very targeted approach. And we have about a field force of about 50 people, both clinicians and reps. And as we move into other applications, we may add a few, but we pretty much have what we need to actually grow this business quite substantially. So today, we have about a 9% share in the liver. Significant growth opportunity for us moving ahead. Now we have a full portfolio, so we're going to spend a lot of time on driving that market penetration. What we're also doing is promoting and developing data in these other indications so we can grow the market opportunity even more substantially. And I'll talk a little bit about them. So this is the market opportunity by patients.
There's about 20 other codes that we could pursue that we haven't even started yet. But these are the ones that physicians have started to use on, and we're starting to develop some data on. So let me talk a little bit about uterine fibroid. We just launched this technology. And I'll show you just how profound it is. This, again, is the same patient a couple of minutes apart. This is with a standard microcatheter. We actually calculated this on the screen. We only could visibly see about 22% of the tumor. Now look at this. This is the whole uterine fibroid. So you can't treat what you can't see. And this is why we think there's such profound outcomes. Now, we were able to modify our technology and address the physician needs. They wanted something that they could perfuse at very high flow rates.
They needed a very flexible tip. They needed a bigger inner luminal diameter so they could get to this highly vascular tumor. We started talking to doctors in February. We developed the product, and we launched it in June. So this is the type of modifications we can make our technology to really hone in and give the physician and the patient a highly impactful result. And in these Uterine Fibroids, the beauty of this, I have a brother who's an OBGYN. I was telling the team this morning, he was in Ghana. He does missions, and he took out a 42-pound fibroid. And he said it was the scariest moment of his life because these tumors, while not cancerous, are incredibly vascular. So as you're disrupting this type of vascular flow to these tumors, you could actually kill a patient.
So he said the beauty of embolization is you can shrink the tumor too and then do the procedure afterwards. It makes it safer and doesn't have the patient have any type of blood loss. Also, it's just minimally invasive. If you want to preserve fertility, this is a great option for patients. Multinodular Goiter. You know when you go to the doctor, they're feeling your trachea? What they're feeling for is nodules. 5% of the population have this. If you have a hyperactive thyroid, it actually can be quite devastating for you. You could have sudden death and a whole host of other things. So that's why they want to treat this. Today, some of these thyroid nodules can look a nodule like here can grow into the chest. They can grow around the trachea and actually compress the trachea.
Sometimes people are treated for asthma when really what they have is a very large nodule. Today, you have to have surgery, so have you ever seen people with a big scar on their neck? They've typically had thyroid surgery. You can have a high risk of stroke because you're manipulating the carotid artery, and you're also on thyroid replacement therapy for the rest of your life. This procedure, because of the way our technology and the valve works, we avoid the carotid artery completely. We go through an inferior thyroid artery, and we can fill up the nodule with bland beads. In about a week and a half, the nodule's gone. We can also fill them up if they're deep into the chest. Some of these I've seen are very, very large. Within six months, it's all gone, and there's no surgery.
The biggest thing is we've preserved their thyroid, and they don't have to have lifelong replacement therapy. The next one is which I think could be the crown jewel of the company. We have a pancreatic technology. This is really unique because what we do here is we go into the venous vasculature. If you looked at the pancreatic arterial bed, it's incredibly tortuous. Now, the pancreas is an incredibly sensitive organ. Very hard to navigate with devices. That's why today you don't see many people going into the pancreas at all with devices. But in the venous anatomy, they're bigger. We have a technology that can go into that. We also have a sensor embedded in our technology.
And the reason why that's so important is if you manipulate the pancreatic tissue in an improper way where you elevate pancreatic enzyme elevation, you can cause pancreatitis and death. So we have a sensor that keeps the perfusion at a very, very tight range. And by keeping it at such a tight range, we have no administration of drug outside the tumor, only inside the tumor. And we infuse nelitolimod. This is a drug that we had licensed. We're going to be releasing some data on that in the early part of the year that we're quite excited about. We also have a collaboration with Boston Scientific to actually advance the administration of Y90. The reason why I think this could be a crown jewel is we want to start marketing this to other drug companies on market drugs where anything can go into this.
There's liposomal irinotecan that's on the market today with Ipsen. We believe by putting more into the tumor as well as systemic, potentially could really improve outcomes. But there's a range of other drugs. And then the last one that I wanted to talk about is genicular artery embolization. Have you guys heard of this? So this is a new procedure, really exciting. Came out of Japan. Everybody thinks of osteoarthritis as the wear and tear on the joint if you're overweight or you're the super athlete, weekend warrior. You put a lot of harsh conditions on your joint. Well, what this physician theorized is if you looked at the joint, you can actually see it on fluoroscopy. It's like this milky tissue. He theorized this is smoldering inflammation around the joint. If I embolize those arteries, can I improve the condition?
And what you do is embolize all that smoldering inflammatory tissue. It dies. And what in the Japan data is they didn't follow it beyond five years. You can delay knee replacement for five years, and you eliminate the pain. I actually met with CMS, and it was really shocking. I thought they'd be so excited about reducing total knee. We can delay these procedures. What do you think they were most excited about? Any idea? No one knows. I mean, the majority of all the opioid prescriptions in the United States come from osteoarthritis. They were most excited about the reduction in opioid prescriptions. If we could reduce pain in these types of procedures or eliminate them, the amount of opioid prescriptions. So we want to do a demo project with them. We think this could be really exciting.
Now, this type of procedure, this inflammatory tissue can be done on elbows, shoulders, plantar fasciitis. They can do it on ankles. I believe in the next five years, these types of embolization procedures really could change the whole orthopedic environment. We met with a big group in Illinois. What they wanted to do is they wanted to do an embolization procedure right after surgery because they said there's a big cohort of their patients who don't do physical therapy, who don't have good outcomes. If we could eliminate the pain and get them more mobile, we could really improve outcomes. We have a technology called Advance. This is where the physician could use their own microcatheter but still get the pressure-enabled drug delivery because they have a guiding catheter with our valve in it. They use their own catheter.
So we have a portfolio of products, very high growth, very high margin. We're 85% to 90% margin, growing at 50%. So significant growth for the foreseeable future. And I would call this as a significant upside for us, kind of a big call option. We licensed a drug called nelitolimod. It's a TLR9 agonist. We took it through several phase one trials. All it is is 31 snippets of bacterial DNA. And what we wanted to do is infuse it into the tumor. The tumor thinks it's getting invaded by bacteria. It turns on the immune system. And now it's much more receptive to the systemic drugs that doctors are treating. We're going to be releasing data on this. And we also have a very interesting investigator-initiated study in combination with cryoablation that we'll read out that we think could have very transformative results.
So I'll stop here and then turn it over to David to cover the corporate. I don't know where we are in time. I probably went over the time. Oh, I ran out. So sorry, guys.
I said, do you want to open it up to questions?
Yep.
What's the breaking source status of?
It's an embolization procedure. You can use our technology anywhere in the body other than in the coronary vasculature or the neurovasculature. It's cleared. We can do any type of embolization procedure anywhere other than those two areas. Now, we could do it in the brain and in the heart if we went and got another 510(k) approval. But we just have too much opportunity right now. There's so much growth. We just focused on this.
Catheter moves over a guidewire?
Yep.
Is it a guidewire?
Yep. Yeah. So it can be used anywhere.
Why haven't you gone into the brain?
We can go into the brain. We just have to do the work. I mean, right now, we have people that are already using it, and we want to create the clinical data. So if I had more money, I'd go into the brain right away. One of the procedures that physicians really want to do is middle meningeal artery embolizations. What we know about them is if you can embolize the arteries around it, it prevents about a 40% recurrence. And it's really a capital issue. We just have so much to do. I mean, right now, we've got all these new applications. One of the things that we're doing is we want to create the data. So we're doing registry studies in each of the applications so we get it in the guidelines.
Once you get it into the guidelines, then it almost forces the hospital and the physician to use it because it's the most appropriate treatment. So it's not that we don't want to do it because I'd like to. It's just right now, we have so many other growth opportunities. It's just higher priority.
Finance questions?
Yep.
you look at next year. You've got tremendous growth this year. How do you think about growth for 2026? And that growth. I know you've talked about growth, but.
Yeah. We've guided this year to 50% growth. We have not given guidance for next year for growth. We're working through that with our LRP and where next year launches off from. We're very focused on hitting our guidance this quarter. But that said, we are looking at our analysts where they are today, and we feel like that's an accurate representation.
But do we need to talk positive?
Yeah. We continue to maintain our Adjusted EBITDA positivity by mid-year. If you look at kind of our operating expense run rate, we are reducing R&D spend and G&A spend. R&D spend is primarily driven by the reduction of nelitolimod-related clinical trial studies. G&A is just cleaning up a very messy cap table that we've been in process since we did the dSPAC two years ago. We're confident that we'll get cost savings there, and then sales and marketing will ramp. But right now, where we are is about between $55 and $60 million of a gap OpEx. About $8 million is non-cash. And then with 85% gross margins, and last quarter, we did $12 million, just under $12 million in revenue. We're pretty close to cash flow break-even now. We burned $3.8 million last quarter. We did have Adjusted EBITDA of about $2 million more than that.
And that related to a non-cash accounting adjustment for some prepaid clinical trials. But that said, we're very focused on maintaining our ability to drive that profitability and really highlight our operating leverage, not just at a gross margin level, which is about 85% now, and we can grow it from there, but also from a sales and marketing leverage. We're very confident that we've got the right team in place, and we can make the appropriate investments to improve productivity both from a marketing perspective and also supplement that with clinical trials that we can bill for along the way, but also drive customer adoption.
Yeah. One of the big changes is with having a full portfolio. Before, we grew really rapidly, but oftentimes, we didn't have the technology while in the cases that really fit the anatomy. Now that we have everything we need, we think that's really going to help us grow much more rapidly and not miss those cases.