Thanks, Gabby, and hi, everyone. I just want to introduce a few of our team members before we get started.

I'm John McCutcheon, the President and CEO, and joining me today is Gary Doherty, our CFO; Andrew Shute, who looks like he may have dropped off temporarily, will be dialing back in, Andrew is our Chief Corporate Development Officer; and we have Erik Strandberg, our Chief Commercial Officer. There's Andrew joining us again.

Andrew, I just gave you a glowing introduction.

I'm indebted to you. Thanks, John.

Thank you. Okay.

With that, folks, we'll get started. Welcome and thanks for joining us today to hear about our 10-K and the early releases as well from the first quarter early results, which are looking very promising and show further growth from the 10-K and year-end results.

Many of you have seen this slide before, but I'll just go through our investment thesis once again. Essentially, we're in cardiac rhythm management, a subset called cardiac resynchronization therapy.

CRT is the state of the art, the standard of care for patients suffering from a certain type of heart failure. The physiology is well understood.

There's no debate from clinicians on whether this is a useful technology or therapy for their patients. EBR had a pivotal study called SOLVE that was completed and actually stopped early for success.

In that study, we showed that we were able to deliver left ventricular pacing for cardiac resynchronization therapy leadlessly. Now when Eric's team is out selling this and interacting with physicians, there's really no pushback and no clinical sell involved.

It's more of a clinical pull because the physicians accept the basic premise here. They've seen our data.

They know how CRT works, it's a very smooth selling process. Fortunately for us, there's no direct competitors in what we're doing.

There are a number of large incumbents, or three: Boston Scientific, Abbott Labs, and Medtronic. All of them are big players in the cardiac rhythm management space.

They all have CRT systems. They all have leadless devices for right-sided pacing, but none of them have leadless left ventricular endocardial pacing.

That is a key differentiator and a really key part of our business strategy is that we're complementary with theirs, not competitive, not trying to displace them. Given that background, we also have a very large market TAM, and that's based on a high ASP, which is bolstered by our reimbursement.

We do have FDA approval. That approval was almost coming up on a year now, in April of last year.

We've got strong reimbursement, as I said. We've got a great commercial strategy, a great team led by Erik, our CCO, and we also have the manufacturing capacity and capabilities to scale the business.

The 10-K looks back at 2025, and so here's a summary of some of the major events, some of the major milestones. We did first have to pass our pre-approval inspection, our facility inspection by FDA.

That's one of the final hurdles before getting FDA approval. Before, in the same month in January, we were notified that we were able to participate in the CMS TCET program for getting an expedited national coverage decision, big reimbursement win for us there.

Of course, the biggest news of the year was getting the FDA approval in April. That was very quickly followed by our first commercial implant in June, and at this point, we still did not have the add-on payments, these early cases in the second and third quarter '25, these were commercial cases that we charged for them and the sites did those at a loss, largely wanting to be early adopters, but also having high-need patients that they felt they needed to treat, and so they got started early.

The NTAP and TPT, which are the add-on payments for inpatient and outpatient procedures, were approved. The approval was staggered.

We had the NTAP in July and the TPT in September, but they both went into effect October 1, so that's when we started our limited market release. All of the contracts that we'll talk about that Eric's team and along with Gary's help have driven getting hospitals and sites on contract, after October 1, they've all been at list price of $63,300 U.S.

Prior to that, they were in the $58,000, $59,000 range before we had the NTAP and TPT in place. Those ASPs are holding and all the contracts are going out at that, so that's another great foundational moment from 2025 that's now reaping rewards here in 2026.

We started our WiSE-Up implant study, which is the post-approval registry, and we also had our first implant in the Totally Leadless CRT study that is being conducted in Australia in Queensland. These early KPIs are very exciting for us.

This shows not just through the fourth quarter, but some pre-release data that we shared as of the end of February. I think the most exciting one, I'll go to the far right, are the number of commercial patients.

We did 18 patients commercially in the fourth quarter. We were quite happy with that because that doubled the quarter before.

Now we've reported so far this year, we've already done 25 patients through February, in the first 2 months of this quarter, we've already exceeded the total number that we did in Q4, and we've got a very robust March underway. We're very excited about those results and really grateful to Erik and the team he's put together.

I think I might put Erik on the spot and just ask him to comment on some of the clinical outcomes, perhaps, Erik, or physician feedback, any color that you might want to add to sort of anecdotal information to the early reception that you've seen.

Happy to. Thanks, John.

I think what's really exciting is obviously the 25 that John just talked about with quarter still to go, but even beyond that, the cases, the acceleration, and I can't share a specific number for the quarter, but we have many physicians beyond who they've already treated where they accumulate this list of patients that they've already screened for WiSE. There are many in the double digits of patient lists that are waiting in the physician practices, and that leads to a really strong pipeline as we continue to go forward and build out the team so we can manage the demand.

You said anecdotes, John, it's interesting. We've started tracking each implant with a case study.

There's really an anecdote with every patient, but some recent examples maybe I can share. There was a patient that was bound to a wheelchair prior to receiving their WiSE implant, and now he's walking into his follow-up clinic appointment.

We've literally helped this patient move beyond heart failure to the extent that he's walking again. Another patient was on five different heart failure medications, now they're down to two, one of those was IV-administered and that's been discontinued.

Patients are losing weight, 20 to 30 pounds in some cases within 45 days, and that's reverse remodeling, we've reversed the disease state with WiSE. Then maybe a final example, we are interviewing a candidate for a director of training role right now and she's at one of the largest CRM companies in the world, I won't name the company, but she was at an industry-sponsored EP conference last week, and she shared with me just yesterday when I spoke to her that she overheard an EP who doesn't have a WiSE program yet asking another EP there who does questions about how the patients respond.

The direct quote that she overheard was, "My patients are unrecognizable after they receive WiSE and we can't schedule them fast enough." Really, really exciting, and I think all that speaks to the opportunity we have on a go-forward basis.

Hey, thanks, Erik. One thing I want to clarify, I'm not sure everybody is familiar with heart failure and how you get water retention.

Patients put on a lot of weight because their kidneys aren't working or functioning well, and a sign of success is when that starts reversing, they start shedding that water weight. What Eric's talking about is remarkable how fast that happens, how fast that turns around.

The weight loss in these patients is a sign of reversing the heart failure, like he said. Really, really good stuff.

Thank you. We've got, let's see, one slide of financials just to go through the 10-K results, and again, these don't have anything from the first quarter of this year.

Gary, if you don't mind just doing a quick walk-through on what we achieved in the fourth quarter and for the year?

Sure. Consistent with the results that we preliminarily released in early January, the 18 implants that we concluded in the fourth quarter, which John spoke about a moment ago.

Revenue coming in a little over $900,000 U.S. with the gross profit figures you see there.

OpEx at $13.5 million U.S., and our net loss coming in a little over $14 million. Our ending cash, including all marketable securities, was about $54 million U.S.

I would note, and this is disclosed in our 10-K, we have been using some previously expensed inventory that we had accumulated over the course of our early days in clinical trials, and we've been using that to the benefit of our current cost of sales. You'll see those sorts of things both percolating through the third and the second quarter results, and we're sort of consistently on that track at this time.

In summary, there you go.

Thanks, Gary. Appreciate it.

Then looking forward, I think that this year is about sales execution, ramp, and I was using the metaphor of a ship. I think I was talking about steering the ship, but maybe a better way is getting a ship out of the harbor.

It doesn't start rolling right away, there's no wake, it takes time. Once it's rolling, get out of the way.

I think the limited market release is getting this big cruise ship underway, and Eric's team and the operations team, manufacturing team that supports it, that machine is cranking. Again, we're very pleased with these early KPIs and everything that we're seeing.

A very short presentation, but we wanted to give you guys all an update, and I think we have plenty of time for questions if anybody wants to pose them. Are they coming in on the chat line?

How's that working?

Yeah. You should see a Q&A tab at the bottom of the webinar.

If not, click on the More, and then the Q&A tab should open up. Aha.

I see. Thank you.

It was so clear there's no questions. Is that --

Okay. We have one question for Erik here, and the question is, can you add any color to the enthusiasm for new sites coming on?

Happy to. The hospital pays for the device, but our primary customer really is the physician, I'll try to answer that by speaking to physician engagement.

Physician engagement is very high, and it's maybe the highest I've ever seen in my career in the space over the past 25 years or so. As a frame of reference, I launched CRT as a therapy in the U.S.

back in the early 2000s. I was a CRM sales rep for Guidant back then when we first brought BiV ICDs to the market.

I launched WATCHMAN commercially over a decade ago at Boston Scientific as a part of the leadership team. Interest and engagement with WiSE outpaces both of those at the stage where we are right now.

We know both of those are the gold standard with their respective patient populations, both WATCHMAN as well as CRT as a therapy. I think what's driving that really is the acute response from patients.

We have indicators right on the table at implant with data points, QRS duration and others, that are directionally specific relative to how a patient is going to respond to the implanted device. That's a big deal.

When a physician can see almost instant response from their patients, that's incredibly motivating. Then the patients beyond that continue to improve in the near term and then chronically as they go forward.

The excitement and enthusiasm really is tethered to the implanting physicians, and again, it's at the highest level that I've seen relative to the gold standard categories.

Great.

Thanks, Erik.

We have

a few questions here. John, a question for you: Are you comfortable with patent life?

We had a recent announcement regarding some of the patents have a short life.

Yeah. That was one particular patent.

We continue to add patents. We've got some that we've filing very recently, and the way med technology works is that you're constantly innovating and adding new features, and the best practice is current and you file new IP.

We're always refreshing the IP. Unlike if you think of a pharmaceutical drug, they've got a molecule and it's patented, and there's nothing that changes from that, and they'll sell that drug until the end of the patent and then it goes to generics.

Medical devices are very different. We continue to innovate, which is why we still have R&D expenditures, and we always want to refresh our patents and never let them get stale.

The old ones expire, but we've got fresh ones and we're always renewing those as we advance the technology.

Great. Thanks.

Gary, a question for you, I think. Why do we not include restricted cash in the full-year '25 results?

We do. We don't report it as part of our cash and marketable securities.

It's actually the security deposit on the new building. It's ours, it belongs to us, it's in one of our bank accounts, but it's not really free for us to spend at this point.

The proper place to report it is as a non-current asset. Sorry for the accounting geeky answer.

John, I think you've seen a question on when will we be cash flow positive?

I was just typing an answer. We're not permitted to answer that based on ASX rules.

Things that we haven't disclosed publicly in prior settings, we're not permitted to do that. That will come out in public at some point, but it's not at the moment.

We have a question on can we provide an update on the new manufacturing facility?

Starting the move. We'll have to be specific.

It's a phased move, we anticipate that we'll start moving in early April. We're just waiting for the final occupancy permits from the city and the county, and that's very close.

Gary and I were over there recently and everything's built out and it looks great, and we're anxious to get started. Then we'll start moving over equipment, manufacturing equipment.

We'll actually start a manufacturing line there. There's an FDA review process.

We submitted that in March and we anticipate we'll have FDA approval to ship devices by the end of the year. We'll gradually move personnel over.

There'll be some manufacturing people that go back and forth working at both locations. We're only about 2 km away.

It's not very far. Then we anticipate that we'll be completely out of this facility by the end of the year.

Great. We have a question also on the timeline from a physician completing their training to completing their first procedure, and maybe talk about the pathway?

I'll take that. Right now it's 30 to 45 days on average, somewhere in that window.

We expect that window to shrink as we have a little bit more specificity in what we're asking of physicians before they go to training. The demand from physicians requesting training has been outpacing our ability to train, we're expanding our training team, we're adding offerings to new cities and new dates to accommodate.

The training program is very straightforward. We really kind of mirrored it after other launches.

Again, WATCHMAN, it's a 1-day training, they don't have to take a lot of time out of their practice to come get trained. The feedback we've gotten on the training is incredibly positive.

Now we've trained -- I guess I won't give the number, but we've trained a lot of EPs now -- early returns were so positive that they were comparing us to a Medtronic training program. We've now integrated a very well-known electrophysiologist into our training to add peer-to-peer activity and engagement during the training.

It's been very positive, and it's basically 30 to 45 days right now.

Hey, Andrew, can we take Shane's question on CSP?

Thanks. We have a question on conduction system pacing.

Seems to be a background issue we've addressed before, but there's still some noise about it more being competing procedures rather than competing technology.

Shane, we continue to hear the noise and we see it, but it still is not mainline therapy for patients with heart failure. That's one part of the answer.

We think there's a place for CSP, we don't think it's going away, but we do not believe it's going to displace the need for biventricular pacing and our technology. A couple of anecdotes there.

We actually can be a bailout for failed conduction system pacing. There's been a recent case, probably off-label, but that's okay, doctors can use our system in an off-label way, where they were synchronizing off of a conduction system pacing lead or a left bundle branch lead.

We're going to be complementary with that just like we're complementary with other lead-based systems. We're the only technology that can do leadless conduction system pacing from within the left ventricle.

We hear about it, we hear all the noise, we talk to the doctors, and we still remain very bullish, and our key advisors remain very bullish on our technology and do not see any sort of sunsetting or obsolescence because of conduction system pacing. It's just not a real threat to what we're doing.

Just to add to what John has said. I think it's uncontroversial that conduction system pacing may find a stronghold as an alternative for a patient that's having bradycardia or pacing for slow heart rate.

At the ESC or European Society of Cardiology meeting last year, there was one of the very first multicenter randomized trials that came out looking at conduction system pacing versus CRT for heart failure indications, and it was a non-inferiority trial, and conduction system pacing actually showed it was inferior to CRT. I think that there's still not widespread acceptance of CSP or conduction system pacing for CRT applications.

If it is kind of exactly what John was saying, we're perfectly primed with what we've learned from using WiSE on the septum to put ourselves in a strong foothold for that.

Hey, Andrew, I see a number of questions that are sort of in the spirit of our future financings and our strategy for financing, and I think we just have to keep generically responding that we cannot discuss future financings. ASX does not allow us to do that until we're actually engaged in a financing, and so we're not going to speculate that or project.

I'm sorry for those questions.

Okay.

Similarly, I guess on the cash runway and expenses evolving question, we don't give forward-looking projections, but there are a number of analysts that follow us and four really strong analysts that have models, and we would just refer you to those and look at the consensus there to get better guidance on how we should perform in those domains. Andrew, I can answer the manufacturing one, too, if that's all right?

Yep. Yeah.

The question is: Once the manufacturing facility is operating, could we provide some detail on the number of third-party providers that will be required to produce the device? I don't have specific numbers, but we want to go to substantially fully integrated or vertically integration.

We'll never get to 100%. We will require some sub-vendors and outside manufacturers, but well, I won't speculate, it'll be a fraction of where it is today, though.

For a number of reasons: It's better supply chain control for us, it's more efficient, which ultimately reduces costs, and also is very synergistic to be manufacturing side by side by R&D. I mentioned ongoing IP, patent protection, we get that by manufacturing and R&D, and when we're manufacturing side by side, the R&D engineers come up with ideas on how to do it better and make improvements and design for manufacturing.

We are highly motivated to bring everything we can into this new facility. It has to happen in phases, but it'll get to the vast majority of everything will be done in our new facility over the coming years.

Okay.

Go ahead, Andrew.

Just another question is coming in: Are there any direct competitors on the radar?

This is a fun question because the answer is no. We have a pretty good line of sight to what's in the pipeline of the other major companies, and because they have to forecast or project early, they do their early pre-human, animal, bench studies and they publish those and they let their KOLs present that at society meetings.

In our business, it takes a minimum, I think 5 years from the first time you hear it to being commercial would be unprecedented. It's probably closer to 10 years by the time, if we first hear early rumblings about something being in development, to getting through all those early stages and then getting through a pivotal study, getting FDA approval.

It's 5 to a good 10 years, and so we don't see anything today. Again, we'll continue to innovate and try to outpace any future competitors that might crop up in the next decade beyond, but we don't see anything that is at all a threat to us at this point.

Thanks. Maybe a question for Erik: You have a high selling price of $63,000.

Are there any barriers to signing purchasing agreements?

Great question. We do have a very high selling price.

We're proud of that we've been able to generate that and sustain it. What makes that price work for us is we have a very comprehensive reimbursement system through our add-on payments, which supports the price of our device.

With the add-on payments, when billed correctly, hospitals are making money on our procedure even though it's priced at $63,300. The way the add-on payments work, particularly for outpatient, is it doesn't matter what the price of the device is.

If the price is $25,000 or $75,000, it still covers the cost of the system. We feel really good about the price.

Then from a contracting standpoint, again, I'll stay away from numbers here, specifics, but we continue to open new hospitals where we have the bandwidth, but that demand from physicians, similar to our training offerings, really outpaces our ability near-term. We're growing the sales team at a fast rate so we can capitalize on that.

We're taking a big step forward this month in signed contracts, and that includes some of the largest GPOs and IDNs in the U.S. Those are the major hospital buying groups, some are 200 hospitals plus, and those contracts give us access, I'll just say, to many, many more hospitals very quickly.

Contracting is going exceptionally well and the price has not been a barrier.

Thanks, Erik. We have a question on revenue guidance for '26 to '28.

I think John's already covered that we're not giving revenue guidance. However, we have four analysts from E&P, Canaccord, Bell Potter, and Morgans, and I'd suggest you refer to those for their projections.

Gary, can I put you on the spot? Can you answer generically when a company like us gets to the point where they might give forward-looking projections?

To me it's a maturation of the business. Is that fair?

Very very much so. Predictability within reasonable ranges of how effective and accurate we are would be a big piece of that.

We're a ways away from that as we've been referring to here all along. We're standing this up.

It's a small business, and we're learning a lot. To go out there right now would be a little counterproductive, it'll be sometime in the future.

That makes sense. I think we want to have predictability, be able to model the business with as much precision as possible.

Bigger companies have more momentum and they can do that more reliably, and so we don't want to be doing that to all of you. We do rely on the analysts to give some guidance, and I'm sorry that's the best we can do for now.

We look forward to the day when we're bigger and have a lot more history where we could do that.

Yeah. Thanks, everybody, and again, we always appreciate your support, your attending these and getting to know more about the story.

We frequently visit Australia and attend investor meetings, we always are happy to meet folks face-to-face, one-on-one, answer your questions there. Again, much appreciate your time here, and thanks as always for your support.