Good afternoon, everyone, and I'd like to welcome EBR Systems to the J.P. Morgan Healthcare Conference for 2026. Presenting today, we have John McCutcheon, who is the President and CEO. I'll hand over to John to run through his presentation.
Thanks, Kira. Pleasure to be here. Thanks to J.P. Morgan for inviting us and giving us this opportunity to speak about EBR Systems. EBR has the world's first and only leadless pacemaker for left ventricular pacing. That's an important part of the cardiac rhythm management market, and we'll talk about why that is a game changer for patients and for industry, and how we have no competition in this space. We have a unique opportunity that's complementary to the other products that are out there. We did receive FDA approval this year and have just begun our limited market release, and I'm happy to go into more detail about that in a few minutes. EBR is an ASX-listed company. We went public on the ASX in 2021. We're also an SEC registrant, so we follow the SEC reporting requirements.
As I mentioned, we have a unique solution, no competition, complementary to the devices that are marketed and sold by the large incumbents. That includes Medtronic, Boston Scientific, Abbott Labs, and again, we are very synergistic with everything they're doing. It's a very large market opportunity. I'll get into the TAM buildup and our selling price. As I mentioned, we do have FDA approval. We've got reimbursement in place, clear commercial strategy, and we're growing out our manufacturing facility, preparing for scale and our future success. 2025 was a big year for EBR. EBR was founded in 2003, so there's a long history, but in the last few years, we've made incredible progress, starting with FDA approval, several reimbursement approvals, NTAP, and TPT. I am going to get into more detail on that in subsequent slides, and then we started our limited market release in the fourth quarter of 2025.
We released our early revenue results there, and I'll talk about those when we get to that slide. So the cardiac rhythm management space is the pacemaker space, and there's three large buckets. One is pacemakers, and that's the one that's most mature, been around the longest. It's the largest in terms of units, but the lowest in terms of ASPs. So, and these are roughly three buckets, three equal buckets in terms of revenue between pacing, defibrillation, and cardiac resynchronization therapy. So the cartoon that you see here with those two leads going into the right side of the heart, that depicts the configuration of a dual-chamber pacemaker conventional system, where these leads go from a battery generator through the venous system into the heart. And this is, again, the classic way that this is done. Similarly, there's a piece of the pie called defibrillation ICDs.
They look the same as this in terms of wire or lead configuration. The difference is that there's a high-voltage coil on the ventricular lead, and that's for patients that are at risk of sudden cardiac arrest, and they need to be jolted or defibrillated back into sinus rhythm, and then the third bucket is cardiac resynchronization therapy. That's for patients that suffer from heart failure, and it's a specific type of heart failure whereby the left and right side of the heart aren't beating together in synchrony, and this is a downward spiral for the patient. The right side will activate first. There's a delay for the left side, and then that's a very inefficient way for the heart to pump blood, and it starts pooling in the left ventricle, and that ventricle gets larger and larger and less and less efficient.
This leads to debilitating heart failure for the patient. NYHA Class 2, 3, 4, these patients have very difficult quality of life, high mortality, and need to be treated acutely. The cure for that is cardiac resynchronization therapy. This is the only part of the three systems that we mentioned where you're actually pacing the left side of the heart at the same time as the right side of the heart. Now, I'll point out in this cartoon, the lead on the left side, it's actually the right of your screen, but on the left side for the patient, that lead goes on the outside of the heart. They do that because the left side of the heart is the arterial circulation, and it's also more thrombogenic.
So if you put a lead inside the left ventricle, and it's been tried before in the past, that leads to higher incidence or higher rates of stroke. So nobody does that. They always put the lead on the outside of the heart. So that's safer for the patient, but it's a less efficient way to pace the heart. And notice on the right side, the leads go inside where you prefer to do that. So endocardial pacing is a superior way to do it. If there was a way to do that, that would be fantastic. And that's where EBR comes in. We have a way of doing leadless left-sided pacing inside the ventricle without that wire going to the outside of the heart. In general, the leads have always been the Achilles heel of these systems. So pacemakers, ICDs, CRT systems, again, they're life-changing, life-saving.
They've been great technologies, but whenever there's been a problem with them chronically, it's almost always attributable to the lead. These leads can fracture, migrate, they can get infected. If you have a lead infection, it really puts the patient at mortal risk because those leads can be a conduit for those pathogens into the heart, and so the cure there is they have to pull the lead, treat the patient with antibiotics, and then attempt to get the leads back in after that infection is cured, so there's a lot of problems there. It's led to many recalls, so for years now, industry and clinicians have thought there might be ways to do this without leads, and that day is now, so this table shows the leadless state, the leadless technologies that are on the market or coming on the market by the various players.
I mentioned earlier, the large incumbents are Medtronic, Abbott, and Boston Scientific, and you can see their portfolio products in the leadless space. So starting on the far right there, Boston Scientific, they have not yet launched the Empower leadless pacemaker, but that should be on the market this year. They have a leadless defibrillator system called the Emblem S-ICD. Abbott has a dual-chamber pacemaker system, leadless pacemaker system called the Aveir, and it's comprised of two different components. One goes in the right ventricle and the other goes in the right atrium. And Medtronic has both a leadless pacemaker called the Micra and an ICD-like component called the Aurora. Now, the CRM market was very mature about 10 years ago, became almost a commodity. There wasn't a lot of share change. Price points were coming down.
And then Medtronic introduced the Micra roughly six years ago, and that changed this whole market, really reignited it, reinvigorated it. And one of the reasons is, well, there's multiple. One is that it's a much higher price point. So suddenly, the prices and the market started going up with that introduction. And what we've seen is that the clinicians and patients prefer leadless systems. So they're also starting to get share changes and share gain. And that all happened with the launch of the Micra. I think years before that, when they're doing their quarterly reports, you wouldn't see any mention of CRM anymore in these big companies' reports because it just wasn't very dynamic and wasn't growing. And that's now changed. So that was when Micra came out.
Two years ago, Abbott launched their dual-chamber system, and now they're starting to report very high growth in their quarterly reports. We heard recently from, I think, Abbott. They believe that the U.S. pacemaker market is now 50% leadless. So in less than five years, five years or so, that's gone from 100% lead-based to 50% leadless, and that's still growing at a very aggressive rate. And then in the dual-chamber market, Abbott estimates that they now have 10% share in the U.S. on the dual-chamber market, leadless versus lead-based. And the asymptote of these, these are going to 100%. Everybody's projecting that leads will be obsolete in this space in the coming years. Now, what I've just talked about with those three incumbents, they address defibrillation, they address pacing, but not that CRT component. And WiSE is the only system that's able to treat the left ventricle.
What I didn't mention earlier is how we're complementary with these systems. Our device has a transmitter that's underneath the skin and a very tiny implant that goes inside the left ventricle. That implant's energized by ultrasound energy, so we don't have to have everything in that implant, so it can be miniaturized. And it's about a 20th the size of these other leadless pacemakers. So when it's in the left ventricle, it gets completely endothelialized or covered in heart tissue, and therefore it's not thrombogenic and poses no risk of stroke. And so then we read, or our transmitter waits for the pacing pulse on the right side, and as soon as it hears that, then it activates a focus beam of ultrasound energy on our electrode and gets you synchronous pacing. So that's how these things work together.
And our system is agnostic, or it doesn't matter whether it's a lead or one of these leadless pacemakers. It can still read that pacing pulse and activate the left ventricle to get that synchronous rhythm. When we look at our TAM, we recently revved this up. We initially started quoting a selling price of $45,000. We recently updated the TAM to $55,000 per system. And then the other thing that's changed in this TAM is that the upper left quadrant there, the leadless upgrades, has gotten bigger and bigger since we first did our TAM. And that's evident, or that's based on the growth of these leadless pacemakers that I talked about. So a leadless upgrade is when a patient has a leadless pacemaker in place. There's a phenomenon called pacing-induced heart failure. And the act of pacing the right ventricle in some patients actually induces this desynchrony.
And so the fact that they've been paced will then require them to get converted to CRT or biventricular pacing. The only way to upgrade a leadless pacemaker to CRT is with the WISE system. And so that's probably the fastest growing segment here. The other on-label indications are high-risk upgrades for lead-based systems. So if they have a standard pacemaker in and they need to have a, otherwise would have had to have a CS lead put in place for the left ventricle, instead they would use our system in patients that might have an active infection or some other relative contraindication that would be not advisable to put a conventional CRT system in. And then the last two buckets are acute and chronic lead failures.
If you go back to that image I showed with the lead going into the left side of the heart, those leads are sometimes difficult to place, or they're not able to place them. Or once they're in place, they can fracture, or as I mentioned earlier, they might need to be removed for an infection. And then those would be chronic lead failures that's also part of our TAM. So when you roll that up, it's a $5.8 billion opportunity. And these are U.S. numbers alone. This is not even the global market. This is just us focusing on the U.S. market. I mentioned we have approval. We did our early limited release starting in the fourth quarter. That coincided with the advent, the initiation of our breakthrough payments, TPT and NTAP. I'll talk a little bit more about that on the next slide.
But we're taking a very disciplined approach to the rollout. So rather than shotgunning and trying to run and start up a bunch of sites all over the country, we're trying to qualify physicians that are high volume, that have the right early adopters, large centers, and places that we can really go deep and establish early clinical success, early commercial success, and then start ramping out more sequentially from there. We have eight territories in place as of the end of 2025. Each territory consists of two salespeople, a field clinical associate, and a salesperson. And then we'll be scaling that slowly over the next year as we gain more traction. In terms of reimbursement, we did get the TPT for outpatient payments because we were a breakthrough device by FDA designation, and then the NTAP for inpatients.
Both of those will pay up to $63,300 for our device per procedure. So that's in addition to the procedure cost. This is just the part that reimburses our system. So that's what gives us that very high ASP. And I'll talk in a second about our contracting, but all of our contracts are now being written at this price level. We're also the first company to be, or the first technology to be invited to participate in Medicare's TCET program, Transitional Coverage for Emerging Technologies. And that's a fast path to getting a national coverage decision, which is often very difficult for new devices. And so this is a new program initiated in 2025. They've announced that they'll have five new technologies annually up to that number. We believe on very strong information that EBR WISE was actually the only technology invited to participate last year.
We're negotiating a coverage with evidence study with CMS, and once that study is agreed upon and we start that, we'll then have a national coverage decision very early on in our launch, and this often takes companies, new technologies, five years or more to get a national coverage decision, and we have the benefit of having access to that in the very, very near future. Just looking at a few KPIs on the couple of quarters that we have been on the market. In Q2, we had just gotten approval. We did not have reimbursement, but there were some physicians that were very anxious to get started. So we did several cases then. Similarly, in the third quarter, we still did not have reimbursement, but we were getting enough pull from clinicians that wanted to use the product. They had specific patients they wanted treated.
And then finally, in the fourth quarter, was where we called the limited market release once we had those add-on payments in position. And what I think is most exciting for me in looking at this, we already have 22 contracts signed in the U.S. at the end of the year. And contracting is, of course, the leading indicator for ultimately doing cases because the way the sales cycle works is we engage a physician, they're interested, we vet them and make sure that they've got the right phenotype, the right profile. And then we partner with them to get the device onto the shelf or part of the contracting with the site. And many times with new devices, that can be a really onerous process. And so we're getting through that very, very quickly, largely because it's a breakthrough device. We don't have competition.
We're not trying to displace something that's already on the shelf, so that system's going very smoothly, so as you see those contracts go up quarter over quarter, that's a leading indicator for sales growth to follow. We're also investing in our future, future growth, so we're moving into a new facility this year. We're based in Sunnyvale, California, just down the peninsula here in Silicon Valley. We'll be moving just a mile away to Santa Clara, and this will triple the space we have, give us room for growing both manufacturing, R&D, and we have a number of contract manufacturers right now. We do some of the assembly ourselves, but we're going to be wanting to bring more and more of those capabilities in-house, and this facility will enable us to do that and control our supply chain and cost of goods in the future. Few summary financials.
We did an early announcement on revenue, so we wanted to be able to talk about our Q4 traction at this meeting. You can see that we doubled our cases from Q3 to Q4. We're going to exit the year with roughly $1.5 million in revenue for the year. But again, this is the very nascent part of our journey. We're being very selective and cautious in our launch. And we're very excited that this is meeting our internal goals and exceeding them, and that this bodes really well for a great launch and a great ramp next year. Got a fantastic team. I won't go name by name, but there's a lot of folks on this list that are very accomplished, are seasoned, have done these startups before, are very accomplished, and we really work well together. So I'm happy to have everybody on the team.
Looking forward for the next six to 12 months, I think the most important thing is going to be traction, revenue growth, clinical cases, clinical outcomes, and so really going into that commercial mindset, we'll still have to be educating the U.S. hospitals on NTAP and TPT. It's not very common, so some of them aren't familiar with it. So we have a team that sort of provides concierge reimbursement service for these sites to make sure that they know how to code for that and get the payment that will cover the system. We'll do more sales hires, but in a very cautious manner. We're not going to run too fast, and so you'll see some expansion over the coming year.
We want to really focus on growth within sites and try to drive penetration and really get good quality outcomes and good patient outcomes that will make and delight the customers. So in summary, we're the developer of the world's first and only leadless system for the left side of the heart. That's a whole therapeutic area called cardiac resynchronization therapy. Leadless is the future. You can see that by what's happening with the other incumbents. Everybody's moving in that direction. And it really does make sense that in the next five to 10 years, all these systems will be leadless. And EBR is the only one that can interface with all of the other systems in order to provide left-sided pacing. FDA approved, attractive reimbursement in place, significant TAM. And we're really poised for success with our commercialization strategy and the commercial team that we have in place.
So with that, Kira, I think I'm finished and open for questions.
Great. Thank you. Are there any questions from the floor? I might kick off with one, John. So 2025 was a big year for EBR. You got your FDA approval. You've started commercialization. Maybe you can just give us or touch on some of the early use cases on some of the implants that have come to date.
Yeah. At the meeting here at J.P. Morgan, some investors have asked, well, how does our early experience reflect the TAM? And so if you go back and remember the slide where we had the leadless upgrades and high-risk upgrades and lead failures, we're seeing a mix of that. It essentially reflects that TAM. But also really exciting is there's been some use cases where they've been doing the combination of leadless systems. So for example, a few weeks ago, there was a case where the patient presented with one of the leadless pacemakers already in place, but they needed defibrillation and they needed CRT. So the physician upgraded them. I think it was a Medtronic Micra leadless pacemaker. They put in a Boston Scientific Emblem and an EBR WISE for the left side.
And so this is the modularity of what they can now do with our devices and never could be done before. And the patient outcome is fantastic. These patients are very, very sick. And so when you can do this for somebody that couldn't get that therapy before, it's really meaningful for them and for their families and the clinicians.
Great. Just one more before we wrap up. So you talked a little bit around the commercialization strategy and the limited release and how you're penetrating. Maybe if you could touch on a little bit more the impact you're having in the hospitals, the take-up rate. Is it on track? Are you comfortable? And how are you seeing that coming into 2026?
Yeah. The adoption rate is exactly where we want to be and where we expect it to be, and I think we're going to be hopefully beating the expectations from our analysts in Australia. We're very bullish on that, and the early key indicators are showing that, and it's important early on. What you really want to show is success, clinical success, patient success, and that the hospitals get reimbursed for it. All that's happening and that bodes really well for continued growth and penetration as we go forward.
Great. If there's no further questions, thank you very much, John, and good luck for the year ahead.
Thanks, Kira. Appreciate it. Thank you.