Thanks, Simon. Hello, everyone. Thanks for joining us today to discuss Imricor's full year results for FY 2025. For those newer to the Imricor story, we're the global leader in MRI-compatible interventional tools and equipment, built to enable physicians to perform procedures with patients inside an MRI, using MRI's soft tissue imaging capabilities during the intervention itself. Our initial and most advanced focus is electrophysiology and cardiac ablation. Today, I'll cover the milestones we delivered in 2025, remind everyone what problem we're solving and why it matters, give an update on regulatory momentum and commercialization readiness. Jon will take you through the financials. After that, I'll come back to talk about the 2026 value drivers, like VT, NorthStar, pipeline expansion, and the U.S. path. Here's our disclaimer, which I invite you all to read at your leisure.
On slide three, this is a scoreboard for the fiscal year 2025, when you step back, 2025 was a year when the platform moved from proven to ready across three dimensions: regulatory and clinical process, commercial readiness, and balance sheet strength. Let me call out a few of the most important milestones. First, regulatory process or progress across Europe. We received CE mark approval under EU's Medical Device Regulation, or MDR, for our second-generation ablation catheter and capital equipment, and we received CE mark approval for NorthStar, which is the world's only 3D mapping and guidance system designed specifically for MRI, and we often say it's MRI native. That's a major validation point, because MDR is perhaps the most challenging regulatory framework in the world today.
Second, clinical leadership in Europe, where we succeeded in achieving a clinical milestone that no one else has ever been able, or even close to achieving, one that doubters actually thought was impossible. With our tools, doctors at the Amsterdam University Medical Centers successfully performed the first-in-human ischemic VT ablation under real-time MRI guidance. I'll say that again, first in human, meaning no one else on the planet has ever done it. In fact, there were several first-in-human achievements contained in that single procedure, and each was a proof point for Imricor's technology and for this new field of MR-guided interventions that we have pioneered.
The first MRI-guided VT ablation procedure is one of those moments that becomes a reference point for the field, because VT is where outcomes and efficiencies are still very disappointing with conventional X-ray guidance, and it's one where MRI can make a significant positive difference. With U.S. momentum, we completed an enormous human factor study involving all of our products and physician-led teams from roughly 20 hospitals across the United States, all to support FDA approval. We also submitted Northstar and our Vision-MR diagnostic catheter for 510(k) clearance, and you'll have recently seen that they have both now been cleared by the FDA in January of this year. We've further continued to build our U.S. clinical foundation, adding the University of Virginia as the second site to join the VISABL-AFL trial, our clinical trial that supports FDA approval of our ablation catheter and generator.
We've since welcomed the Virginia Commonwealth University and Oklahoma Heart Institute to the trial as well. Everything is progressing nicely towards first procedures at each of these sites, and we look forward to sharing those milestones with you soon. Fourth, commercial readiness. We completed integration and testing of NorthStar on the Philips MRI platform, which unlocks Philips sites, and we completed hiring and training of the European sales team in July. This has resulted in the European customer pipeline growing from 7 to 40 by year end. Finally, Middle East preparations. Construction of 2 ICMR labs commenced in Saudi Arabia, and we supported an accredited ICMR summit in Riyadh, with close to 100 doctors in attendance, alongside a key opinion leader from Amsterdam.
It's that kind of physician interest that and attention, that gives us the confidence in our Middle East rollout. On the financial side, revenue has been temporarily impacted because of some customer sites, that they are performing clinical trial cases, so those procedures are not revenue-generating in the short term. We expect consumable revenues to accelerate through the year, and as the pipeline begins to convert, capital sales will also contribute significantly to revenue. Importantly, we strengthened the balance sheet with roughly $44 million institutional placement, managed costs well with approximately $19 million operating cash flow flow for the year, and we ended the year with $40.8 million of cash in marketable securities. Altogether, FY 25 was about building a global platform, proving it clinically, clearing the regulatory hurdles, and setting up the commercial engine.
On this slide, we have the essence of Imricor, moving cardiac ablations from X-ray cath labs to MRI labs. X-ray labs have driven the field forward for decades. They have facilitated tremendous advancements in cardiac care by allowing minimally invasive interventions. They have a core limitation. With X-ray imaging, you can't see the soft tissue well. For many of the most complex procedures, doctors are still forced to infer what's happening, mapping point by point, using surrogate signals, adding workflow steps and extra tools. MRI changes that. MRI is the gold standard for soft tissue visualization. It can show you the anatomy, it can show you the scar, the tissue characteristics. Critically, it can show the quality and durability of the ablation itself. That's why we believe MRI-guided ablation is not an incremental improvement. It is a step change.
Here, we summarize why the shift matters to the four stakeholders, really, the patients, the doctors, hospitals and the payers. For patients, we have already demonstrated strong single procedure success rates in atrial flutter clinical trials, faster procedure times, and the complete elimination of radiation exposure. For doctors and staff, eliminating radiation also means eliminating lead garments and reducing occupational injury risk. It also means moving from imagining what they're trying to look at, to seeing what they're looking at. For hospitals and payers, the biggest economic lever is that higher single procedure success means reduced repeat procedures, reduced admissions, and ongoing therapy burden. Faster procedures have a throughput effect, so more cases per day in the same infrastructure.
The key point I want investors to hold on to is this: We're not asking the world to pay more per procedure to get these benefits. We expect lower per procedure costs and meaningfully better outcomes and efficiencies, which is exactly what drives adoption in healthcare. This is where the hard work becomes visible. In Europe, we now have a full technology platform approved under MDR. Again, a tough row. To commercialize real-time ICMR-guided ablations for Flutter, including NorthStar. That's not one device, it's an ecosystem. In the United States, multiple 510(k) reviews are cleared or under review, additional 510(k) submissions are progressing, our PMA modules are advancing, with modules one and two submitted and module three nearing submission.
Meanwhile, the clinical trial site expansion work is now substantially complete, and these sites it will increase our enrollment, provide additional U.S. data for the FDA, and help us drive this trial to completion so we can submit our fourth and final PMA module. I want to acknowledge for a second our R&D, manufacturing, regulatory, and quality teams here, because the volume of work and the rigor required for this process is enormous. Each clearance results from thousands of pages of documentation around the design, test, build, validation, and manufacturing of new medical devices, lots of them, with extensive and demanding quality systems. It's a lot. This slide highlights something that is very important as we shift from a development company into a commercial company, the bolstering of our governance and leadership around the company.
I won't reread the quote in full, but the message from Aldo Denti after his 30-year career as a leader in some of the world's most iconic med tech companies, is that what Imricor has built is a paradigm shift, not an incremental change. As we move into the next phase with things like U.S. commercialization, broader clinical indications such as VT, and expansion beyond electrophysiology over time, having that kind of experience around the table is extremely valuable. With that, I'll now hand it over to Jon to walk through the financial performance for FY 2025. Jon, over to you.
Thank you, Steve, and hello, everyone. As a reminder, all numbers are in US dollars. As said on in slide nine, we generated total revenues of $292,000 for the year, compared with $959,000 recognized in the prior year. Sales of consumable devices, which totaled $171,000 in the year, were down 63% compared to the prior year. The decline was driven by the prior year result, including the first sale of consumable devices to a distribution partner in the Middle East, combined with ongoing enrollment in our VISABL-AFL trials at sites in Europe. As Steve mentioned earlier, it's important to remember that some of our European sites continue to exclusively enroll patients in the VISABL-AFL trial to support FDA approval, and these have not been revenue-generating procedures.
Equipment revenues were down to the prior corresponding period, including the sales of third-party equipment to new clinical and commercial sites in Europe. Costs and non-R&D expenses increased by $2.8 million compared to the prior year. This increase reflects our renewed investment in the European sales team and our commercial support functions to drive revenue growth in the existing markets and prepare for the launch of our products in the United States. R&D spend increased by $3 million in comparison to the prior year, primarily due to investments in staffing to fully support multiple concurrent development programs and regulatory approval initiatives. The current year included additional investments related to the VISABL-AFL and VISABL-VT clinical trials, the latter of which commenced enrollment during the year. Finance income primarily represents interest earned on our cash equivalents, and marketable securities.
Foreign exchange gains in the current year primarily reflect the effect of changes in the Australian dollar, US dollar exchange rate on our cash balances that are denominated in Australian dollars. The fair value change recognized in the current period is primarily related to the convertible notes, options, 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 it's worth remembering that this accounting adjustment does not have a direct impact on future cash flow. Net loss for the period was $25.3 million, a decrease of 15% from the prior year, which was primarily driven by the lower fair value change recognized in the current year.
Adjusted for this and the foreign exchange gains, our underlying net loss for the year was $20.99 million, an increase of 33% compared to the prior year's adjusted net loss of $15.75 million. Our balance sheet is on slide 10. We continue to maintain a strong balance sheet with nearly $41 million of funding on hand, reflected by our cash and cash equivalents, plus the marketable securities held at the end of the year. The outstanding convertible notes at the end of the period are recorded at their estimated fair values, which total approximately $25 million. The first note is now classified as a current liability due to its maturity date in December 2026. It is important to note the valuations do not represent the amount to be paid if the notes were settled in cash on their maturity dates.
The outstanding principal and accrued interest at December 31 totaled $6.6 million for both notes, including $3.1 million related to the first note that matures in December of this year. The option and warrant liabilities relate to securities issued as part of financing activities completed in a prior year, and are also recorded at their estimated fair value in accordance with US GAAP. A portion of these options expire in July 2026, and have therefore been classified as a current liability, as their expiration dates fall within 12 months of year-end. Moving to cash flow on slide 11. Our operating cash outflow for the year amounted to approximately $19 million, showing an increase of $3.5 million compared to the prior year.
This increase is primarily driven by the increased investment in our commercial development, clinical research, and regulatory affairs teams, along with costs related to the ongoing regulatory approval processes. Purchases of marketable securities represent U.S. Treasury bills purchased as part of our ongoing treasury management efforts. All treasuries are short-term in duration and will convert to cash in the first half of 2026. At the end of the year, our cash and marketable securities balance stood at $40.8 million. Now I'll turn it over to Steve to continue with the rest of the presentation.
Thanks, Jon. Look, folks, the headline for the outlook is this: FY 2025 positioned us to convert almost 2 decades of platform development into commercial scale, first in Europe and the Middle East, and then in the United States as approvals land. Importantly, the value drivers from here are not insignificant. They're measurable. Regulatory clearances, trial enrollment and data, new site activations, pipeline conversion, and NorthStar-driven commercialization. On this slide, you see a cardiac ablation. Nope, back to the last one. The cardiac ablation is, as many of you know, a large and growing market, supported by structural drivers such as higher incidence of cardiac disease, continued shift to minimally invasive therapies, and cost-effective ablation, cost effectiveness, I should say, of ablation versus chronic management in many patients. What's important for Imricor is that we're not trying to create a new market.
We are entering a market that already exists at scale, and one that is growing tremendously with a technology that can materially improve outcomes and efficiencies. This slide reflects why we invested in rebuilding our commercial capabilities. Our products are approved in 31 countries today, and we have customer sites, active or moving through the pipeline across multiple geographies. Combined procedure volume opportunity across these geographies that we are currently targeting is estimated at over 1.5 million procedures annually, and it's growing. What I want to emphasize is pipeline dynamics. We've built a commercial team. We've broadened our vendor compatibility with Philips, who will now join Siemens as market-ready, and GE integration progress continues, which will become more significant as we enter the U.S. market.
I'm delighted with the quality of the team we're putting together on the commercial front, we will invest further in US sales resourcing during the year as we prepare to launch NorthStar initially, and the full platform following approval. The VISABL-AFL clinical trial matters, of course, because it's the clinical foundation for US approval and adoption. You can see the quality of the clinical voices here, from Johns Hopkins University to UVA, VCU, and Oklahoma Heart, as well as leading European centers. These physicians understand the clinical promise of MR, visualizing fibrosis, seeing the impact of ablation, and ultimately reducing repeat procedures and improving patient care.
I'll just add that as we've expanded conversations in the U.S., we've found more hospitals than we expected already have cardiac MRI infrastructure in cardiology, and they're motivated to avoid radiation, particularly in pediatric, complex, in complex cases. That's an important demand signal. Let's talk about VT, because VT is where MR-guided ablation stops being interesting and becomes, we believe, inevitable. VT and AF ablations frequently require left-sided access, which means crossing the interatrial septum, which is the wall between the right side of the heart and the left side of the heart. Crossing the septum involves, remarkably, poking a hole in it and advancing catheters through that hole safely and precisely. Imagine doing that with X-ray guidance. You're trying to do it while you can't even see the septum itself.
That's what we're showing here, by the way, in the middle picture. That is a needle about ready to cross the septum, nothing about the septum is visible. Many centers add Intracardiac echo, which is essentially an ultrasound probe on the end of a catheter, to show them where the septum is from within the heart, that adds workflow complexity and adds disposable cost per case. Using the gold standard imaging provided by MRI eliminates the approximately $2,000 cost of using an ICE catheter and any additional risks and complications associated with introducing yet another imaging, in this case, ICE catheter, into the patient. Second burden in VT is mapping. VT substrate can be extremely difficult to identify. Scar channels within regions of dead and viable tissue, that's what sustains VT, finding and targeting those channels can take hours.
Under conventional guidance, operators build electroanatomical maps point by point, often hundreds of points per case. The dedicated mapping catheters they use add additional cost. In addition, these channels don't just exist on the endocardial, or the inside surface of the heart muscle, where you can map. They also exist within the thickness of that ventricular muscle, where they are undetectable by that endocardial mapping. When you combine access complexity, limited visualization of those tissues and of those channels, and long mapping workflows, you get VT procedures that run for many hours and outcomes that are still disappointing. This slide is the end-state vision. Targets identified, ablated, verified for chronic success, ideally all in one procedure. MRI can eliminate steps and tools. It can eliminate the reliance on ICE, that ultrasound catheter I mentioned. It can eliminate reliance on separate high-density mapping catheters.
It can allow shell creation and scar identification from actual heart images, including finding channels throughout the full three-dimensional thickness of that heart muscle. That's the promise of real-time MRI guidance for these procedures. This is why the first-in-human ischemic VT ablation under real-time MRI guidance is so important. It's not just a milestone for Imricor, it's a milestone for the entire EP field. Let's spend a moment on economics. The ICMR lab economics bring all this together to show how we win. Not only are we enabling more precise medicine and better patient outcomes in a safer, radiation-free lab, the hospital is also a big winner economically. In this table, you can see at the bottom line is the cost of savings for the top 50 hospitals in the U.S. if they were to switch to an ICMR lab.
The top 50 hospitals can save close to $5 million per year. It's worth noting that these savings do not account for the efficiency gains. A cath lab can cost over $2,000 an hour when you include nurses, anesthesia, and general lab costs. With VT ablations often taking over six hours, we have the potential to deliver even more value to the hospital, as well as unlocking additional capacity, which avoids future CapEx to cope with the growth in arrhythmia incidents. Before I wrap up, let me take a minute just to talk about NorthStar. NorthStar is a key pie- piece of infrastructure, and we intend it to become the central hub of every interventional MR lab over time. It's MRI native. I mentioned that earlier. It enables mapping and guidance designed for the MR environment, not adapted from X-ray workflows.
It also opens the door to software economics, licensing, upgrades, and AI-powered applications that further support ablation, as well as extend beyond it. Importantly, we're seeing strong early inbound interest, particularly from pediatric hospitals, where radiation minimization is very high priority. From a regulatory perspective, NorthStar is now cleared and ready for commercialization. That's a major catalyst because it enables our commercial team to engage sites and build our U.S. pipeline. Finally, these are just some of the exciting milestones we have right in front of us this year. In the U.S., FDA approvals for commercial release of the platform, continuing 510 progress, PMA modules, clinical milestones, and VISABL-AF trial completion. In Europe, VISABL-VT expansion to high-volume sites with strong, very strong KOLs, which accelerates enrollment and data generation and will keep updating the market as those sites come online.
Commercially, new site activations, installed base growth globally, and Middle East first procedures and expansion. In parallel, continued progress in pulsed field ablation research and development because we intend to deliver pulsed field ablation in the ICMR lab as well. With that, thank you again for your time and support. I'd like to thank our team at Imricor for their incredible work, because the scope of what we're bringing to market is huge, and it's unique. I also wanna thank our hospital partners and physicians who are leading this new medical field, and I wanna thank you, our investors, who share and support in our vision of a future marked by better patient care and lower healthcare costs. Simon, I'll hand it back to you then for Q&A.
Thanks so much, Steve, and thank you, Jon. Just a reminder, if you did want to ask a question, the Q&A button at the bottom of your screen. We have Madeleine Williams at Canaccord. Madeleine, please go ahead.
Thanks, Simon, and good morning or good afternoon, Steve. Thanks for taking my question. I just wanted to ask in regards to NorthStar, and just thinking about the fact that that's received approval, capabilities with that technology, you know, sort of what emphasis are you gonna put on getting that into the U.S. hospitals over the next sort of 6 and 6 months before you know, get approval for the catheter? Just thinking about the capability there and the fact that a lot of the pediatric hospitals already have the MRI installed within the cardiology departments.
Yeah, Mad, it's a great question. We With approval now, our marketing and sales teams are preparing a proper launch across the U.S. Even while they're doing that, our sales team has already gotten inbound interest from some of the sites that you just mentioned, this is ongoing. It is, it's something we look forward to talking about as those sales start to commence.
If I could just a follow-up, just, I'm not sure if you've sort of worked out what sort of the pricing looks like for NorthStar on its own, particularly given I assume it'll be sort of a software license?
One of the things that you get to do in the beginning of commercializing something like this with early adopter sites is help you hone in on what that pricing structure ought to look like. Yes, we have established it. It will be then market-tested, we'll have a better idea that we can talk about what our expected ASP is across that. What's really cool about NorthStar is that it's not just a single device of capital equipment. It's a platform that we are already talking about what I call frameworks, licenses that you can get to do electrophysiology. There's a framework for electrophysiology. There can be a framework for right heart catheterization or left heart catheterization, a framework for structural heart. That's the beauty.
When I talk about NorthStar being the central hub of every interventional MR, I'm not talking about just ICMR or just electrophysiology, but across any interventional magnetic resonance procedure. yeah, it's there's a lot of potential for additional revenues beyond the initial sale of NorthStar, and that's, I think that's one of the things that makes it a really exciting product.
Thanks. I'll let others ask questions.
Maddie, just a question from Sarah Mann at Moelis. Sarah, please go ahead.
Hi, Steve. Hi, Jonathan. Thanks for taking my questions. The first question I just had was on the U.S. Flutter trial. You made good progress in adding additional sites. Can you just confirm, I guess, the target number of sites that you are looking for there and the timeline around reaching that?
Yeah. 92 site, or 92 procedures is the goal. We had started initially with 4 sites, 'cause those were the sites that were available to us and could start quickly. 3 of those sites are in Europe, and 1 of those sites, Johns Hopkins University, was in the United States. With this expansion, we do 2 things. We get to accelerate enrollment if because actually some of the enrollment rates in Europe were a bit disappointing. There's also some protocol changes that happened to allow more patients to qualify for the trial, which is important. Sometimes clinical trial specifics, what's required by the regulator, can be counter to what is common medical practice, that's always a balancing act because patients cannot be used as experiments.
You're always gonna follow medical protocols while you're doing a trial. If those two things conflict, it can be hard on enrollment. In this case, we've been able to mitigate that with some minor modifications to the enrollment criteria. Also important is we wanna make sure that the FDA receives a fair amount of data from U.S. sites. By enrolling now or enlisting these three new U.S. sites, we both increase our enrollment to drive the completion, the trial to completion, and also that will provide additional U.S. data to the FDA. Both those things are really positive. All of this lands to what we've been saying, we expect to do, which is get the entire platform approved in this calendar year.
Great. Thank you for that. Just on the European hospital base as well, you mentioned obviously your pipeline's growing pretty strongly there. Just curious how Philips compatibility might now allow, I guess, some of those sites in your pipeline and some of those existing sites to get activated and move to more kind of routine volumes?
Yeah, it makes a huge difference, Sarah. There's, you know, it's pretty hard to change a hospital from being a Philips site to a Siemens site, or from a Siemens site to a Philips site. It can happen. We see a couple of sites in our pipeline are changing from GE sites to one of either Siemens or Philips, because GE just doesn't have an answer just yet. They're still working through the process with us. It's coming, I look forward to it, but it's not quite ready yet. For the most part, that every new platform that we have available to us, increases the number of sites that can easily adopt our technology. Gosh, I lost track of what you were asking. I'm sorry.
I guess I was just curious about how, you know, having that compatibility is gonna help speed up some of those sites in Europe moving to doing Flutter on a more routine basis.
It's definitely happening. It's not just happening in Europe either. Our Middle East expansion is pretty heavily weighted toward the Philips platform, so that will help in the Middle East as well, which is one of the reasons why we're just getting back to the relaunch of the platform across the Middle East, because we had to wait for the Philips compatibility.
Okay.
That work's done. There are a couple of paperwork items on the Philips side that need to be filed, yet, and, that's coming also very soon. We'll be off and running on that platform.
Fair to say, we should really see volumes start to step up quite nicely, in Flutter across the rest of this calendar year?
Yeah. Yeah, I think that's fair. Also, the number of installed sites. It takes a while. This pipeline, we call it a pipeline for a reason. It is not a, "Hey, how you doing? You wanna start doing procedures tomorrow?" There's real work and planning and budgeting involved in getting one of these sites up and running, and that's the thing that takes time. You know, six months ago, when we were talking to the sales team, the narrative goes like this: "Look, if you can put something into the pipeline at a regular basis, it might be a while before they come out, but when they come out of the pipeline, they're also coming out at a regular basis." That's where we're nearing now.
I'm looking forward to getting some of those new sites, what we call converted, coming out of that pipeline. One of the things that really helps in that whole thing is, as we've been re-spreading the word around Europe that we're back post-pandemic with launching this technology, and by the way, it's not just about atrial flutter for the next several years, it's about flutter today and VT. Not just that we expect to do VT, but we've done VT, and the very first patient ever performed was non-inducible, meaning properly treated and cured at the end of that procedure.
Mm-hmm.
That's a powerful message, and what we've added to that message is: "Hey, by the way, Gerhard Hindricks is doing this at the Charité. Oh, who else is doing it? Petr Neuzil is doing it in Prague. With Petr Neuzil is Vivek Reddy, one of the biggest names in electrophysiology worldwide." That helps the whole team, you know, build that pipeline and convert that pipeline, which is what we're seeing happening now.
Great. Thank you. Can I squeeze in one last question? Just on NorthStar and AI, just curious how you see that either impacting the competitive landscape or on your end, how you can use that to kind of further accelerate product development faster and kind of build a mode versus you and your peers?
... Yeah, there's actually two parts of that. I think you touched on both of them. One. I'll start in reverse order. We use AI regularly around the business to help accelerate our process. We use it for code development. We have a whole program to use it logistically to help us be more efficient as the whole operations become progress and take place.
At the same time, what I'm super excited about, 'cause, you know, I'm just trying to make a brand new field that does things no one's ever seen before, is the kind of AI that we can build into our Advantage-MR system for electrogram filtering, but more importantly, into NorthStar for things like automatic segmentation, better scar identification. Even the screening of patients for VT or non-VT, which is really difficult to do today. Today, it's simply about ejection fraction. This is how you decide whether a patient is at risk for ventricular tachycardia or ventricular fibrillation. and on and on and on.
We see one of the fun things we're doing with NorthStar now as we approach some of these pediatric sites who want to do right heart catheterizations, a pretty simple diagnostic procedure they do, but they want to do it in a radiation-free setting. We're talking about the way they've done these interventional MRI right heart catheterizations with the MRI system itself, and what we can provide with NorthStar now and in the future, based on their not long-term future, I mean, near future, based on their feedback. It's an entirely different new way of looking at devices in these patients, streaming efficiency and getting these kids in and out of this anesthetized procedure as quickly as possible.
We could follow that with the therapy that gets delivered on the back end of that, and on and on and on. AI is an important aspect of all of these advancements, both from the speed of development and from being built into the product itself.
Great. Thanks so much, Steve.
Thank you. Steve, just a last question that Scott Power and Melissa Benson of Morgans and Barrenjoey have asked, just with regards to the VISABL-VT trial, and expectations on how quickly enrollment can occur and what will drive enrollment.
It's not a linear process for us. What I mean by that is, we started the trial, we proved it's possible. We did the first in-human case at the Amsterdam University Medical Centers. The next step is to bring on new sites, and we targeted sites that are high volume sites, do lots and lots of VTs, and sites that have key opinion leaders that are known worldwide. We are now three sites deep, but we have identified already the other three, and that'll be the six sites that we'll execute through the trial. It is a pretty small trial. It's much, it's smaller than the flutter trial even.
We wanna make sure there's enough patients for everybody, and then we'll rip through that pretty quickly. It'll be a bit more time of setup, and then we'll see the execution. You know, our expectation is that it won't take very long for us to complete that trial.
Steve and Maddie at Canaccord. Maddie, please go ahead.
Sorry, Steve. Just on VT, last year, you completed the first patient with VT caused by ICM, ischemic cardiomyopathy. Just given the complexities with that procedure, I just wondered if there was sort of any feedback from the clinicians that you're speaking to as it relates to that being sort of a de-risking event, and kind of how they see, you know, performing VT, you know, sort of going forward?
Well, you know, mostly, Maddie, I've talked to doctors who have believed in this for 30 years, for longer than Imricor has been in existence, I don't get a lot of pushback. People, they don't see it as much as a de-risking for themselves. In the market, I have also talked to people, I'm talking about the clinical market, I've also talked to people who thought it would never be possible. I've talked to people who said, "This ICMR-guided," even hospitals where we're doing these procedures. I talked to a cardiologist out to the side who said, "Okay, this is great that you're doing atrial flutter ablations, but if you're gonna go to VT, you're gonna run into patients that have ICDs implanted.
Steve, listen to me, no one will ever do this procedure with an ICD on board a patient. That's nonsense. I thought it was nonsense then, and it's nonsense now, and we proved it because the first case we ever did, that patient had an ICD, worked perfectly. Crossing the septum has never been done before under MR guidance. You can do these things in animal studies, but those hearts are different, and everything, it's a big deal to do something the very first time like that. Perfect, worked perfectly. We go into the ventricle, we map, we ablate. The second channel is identified, we mapped, ablated, and the patient was not inducible. We proved so many things in that one case. It's really, really remarkable. I think, yeah, it's absolutely for the doubters.
It's, it has allowed our sales team to say, "Look, we're not planning to do VT, we're doing it. If you wanna do it, you can too, you better get started now because this trial is gonna be over, and you're already behind." That's a much better place, a much more powerful place for us to be. It allows those doctors who are proponents to go to their hospitals and say, "Hey, it's happening now. Not theory, but in reality." It helps those who maybe have been doubters to say, "Okay, when can I go see one of those cases?" We start setting that stuff up for them.
Maybe this is me just extrapolating, in, you know, the conversations that you'll start to have in the U.S., obviously, you're getting formal approval for atrial flutter, seeing these sorts of VT cases done, I guess the conversations that will be had is that they can kind of see that VT is possible in all types of VT cases. Is that fair?
It's not even that passive. They all say, "Yeah, we'd love to do this Flutter trial. Can we also be part of your VT trial when you do that?" you know.
Yeah
... everybody wants to be part of this. In fact, we are planning our VT trial in the U.S. right now. The documentation's being written, the planning's underway, and as soon as we can... I mean, what you wanna do is get FDA approval for all the rest of the devices, so that when we could do a VT trial today, for instance, in the U.S., but everything there is investigational. That's got the same burdens as we're doing now with VISABL-AFL. By doing VISABL-AFL and getting everything, the whole platform approved, then when we do it, we turn around and immediately do a VT trial in the U.S., it's very simple and straightforward from a documentation standpoint compared to getting everything being investigational.
We're following the same path we followed in Europe. Flutter establishes the platform, VT expands the indications for the therapy devices, but we're doing it much more quickly in the United States.
Just one last question. Those FDA approvals are expected as for the capital, and consumables, are expected still over the next sort of 3-6 months?
Yes, that's right. I mean, process, what I mean by that, it doesn't all happen at once at the same time. Just like you saw on the slide I showed earlier, you know, that slide starts with everything, white, and then we slowly get yellow starting from the top, going down, then they get light green as we get submissions in, and then they go dark green when there's approval. The dark green's just working its way down the slide, and that's exactly how it's supposed to work. Everyone should. It's important that everybody understands this. This is not like drug therapy, where if you make an investment in a drug therapy, that has to get approval from, say, the FDA.
It's sort of a, you know, wait and see, and then what's the output? Is it yes or is it no? It's not like that with medical devices. It's a much different process. It's iterative, and it's stepwise. We are showing that we know what we're doing, and it's working. We're step by step, we've been submitting. I know there's a lot of pressure to get this all done. We just work the process as it has, as it is presented to us and as we have to work it, and now we're starting to see those results. I hope that everyone starts to gain more and more comfort with the idea that, yeah, this is happening. It's going to happen.
We're not waiting until, you know, the end of the final submission to see if there's a thumbs up or thumbs down on the whole thing. It's thumbs up now, and it's already going on.
Steve, that concludes the Q&A segment. I might just hand it back to you for closing remarks.
Oh, thanks. Just thanks everyone for the questions and for joining us today. We sure do appreciate your continued support, and we look forward to updating you as we deliver these next set of milestones across approvals, trials, and global commercialization. Have a great day. Thanks.
Thanks, guys.