Thanks, Simon. Hello everyone, and thanks for joining us today to discuss Imricor 's results for the first half of 2025. We'll keep today's webinar short and sharp. As we know, it's a busy week of results for many of you, and we've already released the course of the two quarterlies that make up the half. Instead of covering the background of what we're building at Imricor , I'll spend just a few minutes on the vision and then cover some of the highlights so far this year before handing it over to John to run through the financials. I'll then provide some commentary on the outlook for the remainder of the year before turning the call back to Simon for questions. Starting on slide four, I love this picture. This was taken by the team at Semmelweis University in Hungary as they performed the very first cardiac ablations performed inside an MRI anywhere in Hungary. This is also the picture that the hospital chose for their media release to announce that they had climbed from 79 places. They climbed 79 places to 181st in the most recent U.S. News Best Global University rankings for clinical medicine. Out of 2,250 institutions from 105 countries, their cardiac department ranked 35th. Again, our technology is the technology they chose to represent and exemplify this climb. Our vision, as it says at the top of the page, is to bring ICMR to every cardiac center in the world. This picture reminds me that we're well on our way to fulfilling that mission. Beyond Hungary, Imricor has hospitals performing MRI-guided ablations in Germany, France, the Netherlands, Switzerland, Croatia, the United States, and very soon Qatar and Saudi Arabia. The pipeline includes sites from not just these countries, but also Italy, Denmark, Norway, Poland, Lithuania, Sweden, and on and on. It's taken some time to get here, but that should not be seen as a lack of demand or interest from the medical community. It speaks to the sheer scale of the platform we've had to put together first from a development point of view and then steward through the regulatory approvals, which make that dream a reality. We didn't do all of this over the past 19 years just to be a niche technology. The growing interest from all over Europe, the Middle East, and even the United States, where we're working toward FDA approval, has us all highly energized as we continue to work toward changing how interventional medicine is performed globally. There is a lot happening across the business, so we've grouped these highlights into three categories: regulatory, commercial, and financial. There is clearly a lot happening on the regulatory front, and this, in time, paves the way to more commercialization activity. For instance, in Europe, we now have CE Mark approval under the new, more stringent Medical Device Regulation, or MDR, for our second-generation ablation catheters, our diagnostic catheters, capital equipment, and as very recently, Northstar. This, I hope, should give you confidence that these same devices will gain approval in the U.S. market. On that note, I thought it might be helpful to outline the path to approval for the entire platform as it stands today. Until we have an approved product by the FDA, we're not permitted to be in the field talking to hospitals in the U.S. As you will recall, we pulled forward the submission of Northstar, which we expect will be our first approved product in the U.S. We expect Northstar to be approved by the end of the year, and which then will follow our U.S. sales team starting their activity to engage with potential customer sites. In the meantime, we're also actively recruiting U.S. sites who may be interested in joining our visible AFL trial, and this has uncovered significantly more hospitals than we expected that already have an MRI scanner in cardiology, which we call a CMR, or a cardiac magnetic resonance system, and they're interested in joining the trial. This bodes very well for a more rapid launch in the U.S. than we had even expected. Beyond Northstar, the Vision-MR diagnostic catheter will be submitted under 510(k), that 510(k) process this week, and the Advantage-MR EP Recorder/Stimulator system will be submitted in September. Various other disposables will continue to be submitted throughout the balance of the year as well, with approvals expected throughout Q4 of this year and into early Q1 of next year. The pre-market approval, or PMA, process is where we have faced the delay that we communicated in July. Despite this, the first three modules were submitted, and the first of the three modules was submitted and approved earlier this year. The second module is currently under review, and the third module will be submitted in September. The final module, which is the clinical module, will be submitted following completion of the clinical trial. As we've noted before, the trial is very similar to the highly successful European trial that showed 100% chronic effectiveness for our procedures and no significant safety events. The message here is, despite the delay, significant progress has been made, and every day we are one step closer to establishing the entire platform on the market in the U.S. During the first half, we also commenced our visible VT trial. This is our European trial to expand the indications of our ablation catheter and the RF generator for VT ablations. VT ablations currently can take up to nine hours to complete and have a low success rate of around 50%. We believe this is where MRI will add significant value in terms of reducing procedure times and improving success rates. As we generate this data over the next 12 months, it's our strong belief that this will catalyze an acceleration in adoption, not just in Europe, but also in the United States. The trial calls for 64 patients to be treated, and the Amsterdam University Medical Center has already started the trial. We have several other top hospitals progressing toward joining the trial. These are high-volume sites that will help accelerate enrollment. On the commercial front, we have rebuilt the European sales team with very senior sales staff who each have over a decade of experience in cardiac ablation. The pipeline of interested hospitals has rebuilt as a result of this investment, and we expect these sites to move toward closing over the balance of the year and into 2026. We've also established Imricor BV in the Netherlands. Our former Vice President of R&D, Dan Sunnarborg , has relocated to Amsterdam, where he will lead a team of researchers in our research program to accelerate the capabilities of Northstar, not only to facilitate cardiac ablation developments, but also to expand cases in both cardiology and other disciplines. John will touch on the financials shortly, but the key highlight for me is the strength of our balance sheet, which helps support all of our activities and the opportunities in front of us all over the coming years.
Thank you, Steve, and hello everyone. As a reminder, all numbers are unaudited and in U.S. dollars. As set out on slide eight, we generated total revenues of $197,000 for the half year, which was down 52% compared with the prior corresponding period. Sales of consumable devices, which totaled $135,000 in the first half of the year, were flat compared to the prior corresponding period. It is worth noting that some of our European sites continue to exclusively enroll patients in the visible AFL trial to support FDA approval, and these have not been revenue-generating procedures, as previously communicated. The decrease in total revenue was primarily the result of higher equipment revenues in the prior corresponding period. Equipment sales tend to be a lagging indicator, and the production of our rebuilt European sales team, many of whom joined in the first half of this year, is not reflected in the period's results. Costs and non-R&D expenses increased by $877,000 compared to the prior corresponding period. This reflects our renewed investment in the European sales team and our commercial support functions to drive revenue growth in existing markets and prepare for the launch of our products in the United States. R&D spend increased by $1.97 million during the first half in comparison to the prior corresponding period, primarily due to investments in the staffing and costs related to the FDA approval process, including the visible AFL clinical trial that was commenced enrollment at the end of the prior corresponding period. These FDA-related costs continue to be supported by grant funding during the period, which is reflected in the increase of $501,000 in other income compared to the prior corresponding period. The fair value change recognized in the current period is primarily related to the convertible notes and warrants issued in 2022 and 2023. The change in the fair value of these liabilities correlates with the movement in our stock price, and the larger charge recorded in the first half parallels the increase in our stock price that occurred during the first half of the year. This accounting adjustment does not have a direct impact on future cash flow. The net loss for the period was $13.1 million, an increase of 92% from the prior corresponding period, which is driven by the fair value change recognized in the first half and partially offset by favorable foreign exchange rates. Adjusted for these, our underlying net loss for the period was $9.99 million, an increase of 27% compared to the prior period's adjusted net loss of $7.89 million. Our balance sheet is provided on slide nine. We continue to maintain a strong balance sheet with over 11 quarters of funding based on the quarterly cash outflow reported for the second quarter. The increase in our cash balance reflects the proceeds from the capital raise completed in March. Contract liabilities represent deferred revenue where Imricor has at least one future obligation to be met before the revenue can be recognized. The installation of the system and cutter, for example, will trigger the recognition of some of this deferred revenue. The outstanding convertible notes at the end of the period are recorded at their estimated fair value of approximately $23.7 million. It is important to note that this valuation does not represent the amount to be paid if the notes were settled in cash on the maturity dates. The outstanding principal and accrued interest at June 30 totaled $6.3 million. The option and warrant liabilities relate to securities issued as part of the financing activities completed in 2023 and are also recorded at their estimated fair value in accordance with U.S. GAAP. Moving to cash flow on slide 10, our operating cash outflow for the half year amounted to approximately $9.1 million, showing an increase of $1.1 million compared to the prior corresponding period. This increase is primarily driven by the increased investment in our commercial team and costs related to the ongoing regulatory approval processes. During the half year, we completed an equity raise which resulted in gross proceeds of approximately $42.8 million. At the conclusion of the period, our cash balance stood at $50.3 million. Now I'll turn it over to Steve to continue with the rest of the presentation.
All right, thanks, John. Let's look ahead into the second half of the year and beyond. We are fortunate to work in a large and growing market. Today, the electrophysiology device market stands at $12 billion annually, and it's forecast to grow at a CAGR of 15% until 2032. The growth is driven by both an aging population with more people developing arrhythmias, but also by improvements in technology that are bringing more patients in for an ablation instead of managing the condition with lifelong medication or implantable devices. We expect that Imricor's technology, as it's approved for VT ablations, could stimulate further growth by making the procedures more efficient and more effective. Slide 13. I've touched on the pipeline already, and we have a number of Siemens hospitals progressing towards closing this number. Simon, the next slide from this one. One more forward. There we go, we have a number of these Siemens hospitals that are progressing towards closing, and this number will increase as we finalize the integration work on the Philips platform to allow for Northstar connectivity for Philips hospitals. The work with GE is ongoing at the same time, and once complete, we'll effectively open the entire market for us in terms of the dominant MRI vendors across the whole field. As you know, Imricor's story is not as simple as getting a single device approved by the FDA or an EU-notified body and then just launching. We have had to build an entirely new ecosystem that is globally unique in its compatibility with MRI. This has been no small feat, and whilst we communicated a delay for the PMA submission, many parts of the ecosystem remain right on track. These devices have all been approved in Europe, which already has happened, so I hope it gives you some confidence that the ultimate outcome will be no different in the United States. It's also worth highlighting that all the 510(k) devices with the green ticks on this slide next to them, once they receive approval, the approval is for all ablations, including VT and atrial fibrillation. The subsequent slide and studies that we talked about, like to expand the indications to VT and atrial fibrillation in the U.S., are only for the ablation catheter and the RF generator. The volume of work and timeframes for approval will not be as burdensome as the initial submission and the approval processes that we've been going through now. Northstar was submitted for FDA approval in July of this year. We expect this to be our first commercial product. This will allow our sales team to get out into the field with a commercially approved product, and we expect the initial interest for Northstar to be the strongest amongst pediatric hospitals where radiation avoidance for children is a very high priority. Feedback from early adopters will help inform the pipeline and the priorities in terms of where we focus the investment to continue adding new functionality and clinical utility to the system. On slide 16, we outline some of the upcoming milestones, and there's a bunch of them. We have significant focus internally on the regulatory process with FDA, and you can expect to see steady progress in terms of the submissions and approvals over the coming six months. We're fortunate in the sense that we're also commercializing across Europe and in the Middle East, where we'll show good progress over the next six months and into 2026 as this pipeline matures and continues to grow. With that, I turn it back to you, Simon, and I'm happy to field any questions.
Right, thanks, that's Steve. Just a reminder, if you did have a question, please either raise your hand to ask a question audibly or submit it through the Q&A button at the bottom of your screen, and we'll just pause there for any questions to come through. Right, we have a question from Madeline Williams at Canaccord Genuity. Madeline, please go ahead.
Hi James, thanks for taking my question. You mentioned that you're sort of looking to add additional sites to the visible AFL trial in the U.S. Can you just sort of talk through some of the timelines associated with that and how many additional sites you're looking to bring on?
It's a good question, Maddie. I'd say the timelines are a little bit different. What we did is we sent the team out to ask around to see who's got the appropriate MRI facilities now that could join a trial very quickly. Once we found, and we found a bunch of those, once we find them, we have a process to get started. We're running that process with several sites now, and certainly in the fourth quarter, we expect that a couple of those will come on. They should be pretty high volume sites for an atrial flutter trial. That's our mitigation to slow enrollment if that were to continue across Europe. At the same time, what we're finding is the European sites are ramping up their enrollment just like they said they would as people have come back now from holiday breaks. It's all looking quite good, both from a primary plan and from a backup plan to make sure that this trial gets completed in a timely fashion and we can move on to that PMA submission of the clinical data.
Madeline, if you just unmute your line again, you can ask a question.
I think I should be unmuted now. Thanks for that, Steve. Just thinking about the European pipeline and how that converts, can you maybe speak to a little bit more detail about what that looks like and the timing expectations that we should have going forward for the geographies where there is commercial opportunity already?
Yeah, so now that starting in July, we've got the fully formed European team. I was just in Europe with that team last week across the Netherlands and Germany, and I can say that they've got many sites. It's not just about sites that they've called and said, yeah, we're interested, and so now they're in the pipeline, but they're progressing those through the several steps of our sales process, and some of them are getting very close to popping out the end, and that's what should happen, right? It may take a while to get from step one to step five and complete the whole sales process. What's important is that we're putting them into that process in a very regular fashion so that when they start popping out the end, they pop out in a pretty regular fashion as well. Each site's a little bit different in the capabilities or I should say the infrastructure they have in place right now, so it happens at a variable rate, but we are looking forward to really some good news throughout the rest of this year on new sites starting up and getting going.
I think I'm still.
You're still.
Just a final one for me. I mean, going forward, do you sort of expect that you'll be able to give an indication of what the pipeline looks like and the conversion rate of that pipeline?
I think, I mean, I hope by next year at this time, for instance, we can look back and say, look, we've got a good sample size of data to say it takes this many months from beginning to end on average, or even, you know, how many sites we expect each of our capital sales reps to be able to close in a year. Right now, what we're saying is, you know, three to four is what we're targeting for each of those individuals. That seems to be a pretty reasonable assumption at this point. The timing is something we don't have great data. I know from industry that they can close quickly. Sometimes, you know, it's a matter of a new hospital that's being built, and then it could take over a year too. We'll have better information next year for sure. As long as that question's up there, I want to reiterate something that we said, that I said earlier, which is, as we've looked for these clinical sites in the U.S., really sites that could join the trial, that means that they already have to have a CMR, a cardiac magnetic resonance system. They have to have an MRI owned by cardiology, close enough to their existing cath labs and EP labs, in order for it to be appropriate to do these procedures. I am very surprised. We're all very surprised at how many of those there are. In some sites, it's the thing that will prevent them from joining the AFL trial, just that their IRB process takes longer than we'd want. We'll be done with the trial before they finish that process. There are many more that are ready to go. That really bodes well for an easier rollout of this technology in the U.S. compared to Europe. At the same time, when I was in Europe last week, the places I'm talking to are all getting new MR equipment, new labs, new cardiology wings. It's restarted in Europe, and that was really great news for me and for the rest of the team coming out of last week as well. I think the headwinds associated with the aftermath of 2020 through 2022 and 2023 seem to be behind us.
Right, thanks Steve, and thanks Madeline for the questions. We've just got a few submitted questions. The first one, will the consumables such as the catheter and cable be submitted as one 510(k) application and confirming 510(k)s are submitted sequentially, i.e., one after the other?
Yeah, so of the 510(k), Simon, if you can back up to that slide with the check marks and so forth, I can probably talk to that a bit more easily. If you look at the 510(k) devices here at the bottom of this slide, it's Northstar, it's Advantage-MR EP Recorder/Stimulator system, and then it's the diagnostic catheter and its cable, the Dispersive Electrode, steerable sheaths, and introducers. These are all 510(k) products that get approved for use in cardiac ablations. When it comes to a therapy delivery device like the Ablation Catheter, even its cable, and the RF generator, those are the things that deliver therapy, so they require the clinical trial. The diagnostic catheter is, actually, I should start in chronological order. The Northstar system has already been submitted for 510(k). We've been informed that our reviewer has been assigned, and we know that review is under process. We even had a conversation with FDA about it last week. The diagnostic catheter and the rest of the diagnostic catheter things there, the cable, that will be submitted this week. The Dispersive Electrode, I actually don't remember, that will go through the process at some point too, but I'd have to ask Jen exactly when that's getting submitted. Meanwhile, the EP Recorder system will be submitted in September, and all of that will start to pop out of the other end, meaning get approval under a 510(k) process, around the end of the year. Some of it this year, we expect, and some of it shortly after the new year starts. We will finish that clinical trial, we'll submit that data, and we expect PMA approval for the Ablation Catheter to work with all of this together second half of next year.
Right, thanks Steve. You said the MRI labs in the Middle East are under construction. Can you provide an approximate timeframe on when these will be finalized, and also what approximately construction timeframes are for construction?
Yeah, they've been under construction for a while. One of the things that's been holding us back in the Middle East is that the sites that are being constructed are on the Philips platform, and we are just at the very final days of finalizing our testing with Philips to integrate Northstar with their new R12 software set. We actually hope to have that done a little bit sooner, but with European vacations, it was hard to get in. We have to go to BEST in the Netherlands to do that testing, and their labs just weren't available for us through the last couple of months. We have some minor testing. It's just integration confirmation types of testing that we'll do in the coming weeks. We're on track for getting that Philips system released. Once that Philips system release, meaning Northstar on Philips, is the same as Northstar is on Siemens, that will open up European sites, and it will start to open up the Middle East sites as well. They're at various stages of construction and completion, I mean.
Right, thanks Steve. A question from Scott Power at Morgan's. Can you comment on any feedback you were getting in relation to using the technology in a pediatric setting?
We haven't used it in a pediatric setting. What we're getting is, and so it's not feedback about those procedures. What we're getting is strong interest from pediatric physicians and interventionalists to use especially Northstar. The reason why is because Northstar offers a user interface. You've seen the picture of it, right, with the 3D image planes and the shells associated with the various chambers of the heart. This can allow a physician to do things, not ablations even necessarily. Ablations, yes, when everything's approved. In the short term, they have the potential to use Northstar to guide things like right heart catheterizations, which is a diagnostic that they use with pediatric patients as they undergo multiple surgeries through their young lives for congenital heart defects. These things, they're procedures that need to happen pretty routinely, and radiation for these young kids is just really bad. They'd like to do these under MRI, but it's a bit more tedious, it's a bit cumbersome, and Northstar can help make that procedure something that is easier and faster for them to do. What we're hoping is that as we engage with them post approval of Northstar, we'll start to get ideas from those doctors about what features we can put into Northstar in the next release, for instance, that help support those particular procedures as well. It's a great opportunity for us to help the pediatric patient population. Truth is, many, many cool things and new things start in pediatrics for great reasons and then bloom into adults. I feel really great about the opportunity for Northstar to be able to help these kids and provide, you know, some evidence to everyone in the market that this is technology that is not just super sought after. It has application outside of ablation, and we will continue to grow those applications year after year for as far as I can see.
Right, thanks Steve. Just one last question. Can you add any more color to how many EP labs with a closely located CMR have crossed your team, and if there are any indications they're interested in partaking in the trial or future commercial use of your technology?
I think what I should say now is that there are many that have those, and many that want to start the trial, and many that want to actually not only become customers, but then they're looking ahead at saying they recognize, which is of course something we've talked about here as well, that after we get FDA approval in the U.S., we're going to want to quickly turn the switch and start a VT trial here for the ablation catheter and the RF generator as well. Even those ones who have a process that's too long for the flutter trial still want to move the process forward and get prepared as best they can for the VT trial. We haven't said how many numbers of sites there are, but I will say, and we've said this before as well, it surprised me how many are not only that they're interested, but they're sort of ready to go. It's a pretty cool spot.
Good answer. Thanks for that, Steve. That concludes the Q&A segment. I might just hand it back to you for closing remarks before we finish up.
I want to thank everyone for joining us again. It's a process for us to get through these, and what we're focused on right now are these approval processes. At the same time, we're looking forward to what's growing in Europe, and we look forward to telling you all about those things throughout the next quarter and the next half of this year. Thanks so much for joining us, and have a great day.
All right, thanks all for attending.