Imricor Medical Systems, Inc. (IMR) Earnings Call Transcript & Summary
August 9, 2026
Earnings Call Speaker Segments
Operator
operatorGood morning, and welcome to Imricor Medical Systems First Half of Financial Year 2026 Investor Presentation. From the company today, we have the Executive Chairman, CEO and Founder, Steve Wedan; and the company's CFO Jonathon Gut. [Operator Instructions] With that, Steve, I might just hand it over to you. Thanks for that.
Steve Wedan
executiveThanks, Simon. Hello, everyone. Thanks for joining us today to discuss Imricor's results for the first half of 2026. I want to open with a simple statement because it frames everything you're going to hear today. The second quarter of 2026 is the quarter Imricor arrived in the U.S. For close to 2 decades, we've been building towards this moment, developing the world's only complete platform of MR-compatible devices for cardiac interventions, providing it clinically, proving it clinically, carrying it through the most demanding regulatory frameworks on the planet. In May, we told you that the capital raise would give us the strength to move decisively from momentum to scale. Today, I can tell you that's exactly what's happening. Our U.S. commercial launch is no longer a plan, it's underway. We have our first U.S. customers, more hospitals in the final stage of purchasing, a new business vertical that opens a market of more than 2,000 American hospitals, and a balance sheet that funds us into 2028. So today, I will walk through the highlights of the half, remind everyone what the problems are that we're solving, and why the world is now demanding them to be solved. We will cover extraordinary regulatory ground that we've covered, introduce you properly to Imricor Cardiovascular, our newest growth engine. John will take you through the financials. I will come back to talk about the value drivers for the second half and beyond. We will leave plenty of time for your questions. Here is our disclaimer, which I invite you all read at your leisure. Here is a roadmap for today. We will start with a quick overview of Imricor and some key highlights. I want to talk about radiation for a moment. After that, I will discuss our regulatory momentum and U.S. commercial launch. Next, John will go through the financial results. I will wrap up with that look ahead. For those newer to the Imricor story, this is the company in 60 seconds. We're the only company in the world supplying the toolset required to perform cardiac ablations and other cardiac catheterizations inside an interventional MR lab, what the field calls an IMR lab. In an IMR lab, real-time MR imaging replaces X-ray fluoroscopy for guiding interventions. What do we make? We make capital equipment, software, and single-use consumables, all engineered from the ground up to function safely and effectively inside a magnetic resonance field. This is a category that Imricor pioneered and technology we invented. Many companies, large and small, have tried to do this over the years, yet only Imricor has succeeded. Why does it matter? Because MR shows soft tissue and X-ray does not. Soft tissue means the heart. When you can see the heart, you can see what you're operating on. When you can see the heart, you can see the things that are wrong with the heart and fix them. With our IMR technology, operators can even see the results of the therapy they're delivering, all with no radiation and no heavy lead garments to wear. How do we earn? A capital sale of USD 500,000 to USD 700,000 per lab installation, followed by a high-margin consumable and software license annuity that recurs every year and scales with utilization. I'll come back to those economics in detail because they're central to the investment case. Where are we? We're commercial in Europe. We're expanding indications into ventricular tachycardia there. As of this half, we have substantially cleared U.S. platform and U.S. commercial launch in motion today. This slide is the scoreboard for the half. I have to say it's one of the strongest scoreboards in our history. On the regulatory front, 4 FDA clearances secured in 6 months. The Vision-MR Diagnostic Catheter is cleared, NorthStar is cleared. Then we've cleared pediatric label expansions for both of them, meaning our cleared U.S. products can be used in patients of any age. On top of that, we submitted the Advantage-MR System as well as our third PMA module. Every single remaining 510(k) device shortly after the quarter ended. Everyone. I'll show you what that looks like in a moment because I cannot think of another company in my 35-year career that has successfully pushed an entire platform of this scale from development through approval, all at the same time. On the clinical front, we added Virginia Commonwealth University and the Oklahoma Heart Institute to the VISABL-AFL trial. The first-in-human IMR-guided VT ablation was published in Circulation, which is the flagship cardiovascular journal of the American Heart Association, placing it at the top 1% of cardiac and cardiovascular journals. That's our pioneering work, peer-reviewed and on the permanent scientific record. On the balance sheet, net cash of USD 70 million, around AUD 100 million on a pro forma basis, funds the company into calendar year 2028. That means we are executing this launch from a position of financial strength. On the corporate front, Imricor became a U.S. SEC registered. We launched Imricor Finance, a vendor financing program backed by DLL Group, one of the world's largest medical equipment financiers. Hospitals can now spread payments over one to seven years, while Imricor is paid in full upfront with the credit exposure carried by DLL. That helps remove friction from hospital purchasing decisions. Let me step back for a moment and remind everyone what this is all for, because the essence of Imricor fits into 4 words: from inferring to visualizing. X-ray cath labs have carried this field for decades. They've enabled tremendous advances in cardiac care, but they have a core limitation that no amount of engineering can fix. X-ray cannot see soft tissue. For the most complex procedures, doctors are forced to infer what's happening, mapping point by point, relying on surrogate signals, adding extra devices, and extra costs. MR changes everything on this slide. Radiation exposure becomes no radiation. Lead garments become no lead garments. Invisible soft tissue becomes visible soft tissue in exquisite detail. Point-by-point mapping becomes arrhythmia substrate visualized in minutes using NorthStar. Additional catheters like intracardiac echo become unnecessary, and the one that matters the most for patients is outcome. For the first time, lesion quality and durability can be assessed in real-time during the procedure itself. This is not an incremental improvement to the X-ray cath lab. It's a step change, a reset of what's possible in an interventional lab and a new era for image-guided therapy. I want to pause on this slide because something happened in July that I believe people will look back on as a turning point for our field. On July 14, not long ago, 6 of the world's leading medical societies issued a joint statement calling for, in their words, "mandatory and urgent action on radiation protection in cath labs." Think about that. The professional bodies representing the very physicians who perform these procedures are now saying publicly and collectively that the status quo is not acceptable. The numbers explain why. Over a 30-year career, an operator absorbs scatter radiation equivalent to somewhere between 2,500 and 10,000 chest X-rays. 85% of brain tumors for these operators occur on the left side of the head, the side that's always facing the radiation source. Nearly 60% of the operators now report orthopedic injury from wearing lead garments, up 10 points in the last decade. For a child, a single fluoroscopy-guided ablation can add measurably to their cancer risk over their lifetime. Here's the point I want you all to take away. The industry's answer to this problem has always been heavier shielding, which doesn't fix the orthopedic problems, thicker aprons, more barriers, more weight on the spines of the people doing the work. The shielding the operator, it's not the same as removing the radiation. Imricor doesn't shield the hazard, we just remove it. An IMR ablation delivers zero ionizing radiation to the patient, to the operator, and to all the medical staff. Just as the medical establishment itself is calling for urgent action, we are providing the solution. We're not pushing against the tide of radiation denial anymore. This tide is with us. Let's talk about regulatory momentum. As we put it internally, earning the right to treat patients, because in this industry, vision means nothing without approvals, and approvals are earned the hard way, as they should be. This slide might be my favorite in the entire deck. It shows our U.S. regulatory position at the fiscal year '25 results in February, and just 6 months ago against where we stand now. 15 FDA submissions make up our complete U.S. platform, 11 510s, and 4 PMAs. In 6 months, we went from a handful of clearances to 4 clearances secured and every remaining 510 device submitted, with the final device lodged just after the period. 14 of 15 submissions for the entire platform are now complete or under review. The only one outstanding is the fourth and final PMA module, which is triggered by the completion of the VISABL-AFL trial. That trial is now enrolling its final remaining patients. Keep in mind that securing regulatory clearance for a single medical device is a major milestone for any company. Consider what this table represents. An entire platform, consumables, capital equipment, and the world's only MR-native mapping system all move through the FDA process at once. I don't know of another company that has ever pushed a platform of this scale through the FDA all in parallel. Each of those rows represents thousands of pages of rigorous documentation. I want to take a moment actually to thank Jen Weisz, our Vice President of Regulatory and Quality, and her regulatory team. What they delivered in this half was truly exceptional. It enabled us to launch in the U.S. this past quarter. Before I introduce our newest growth engine and our recent U.S. launch, I want to show you a trend on this slide that I recognize clearly because I've lived through this once before. When I was designing ultrasound imaging systems 30 years ago, we sold those machines to radiologists. At that time, however, there was a growing trend of cardiologists using ultrasound in their practices, calling it echocardiography. The American Society of Echocardiography, which started in 1975, was starting at that time to grow significantly. Nowadays, you can't go to your cardiologist's office without tripping over a few echo machines. They're all over the place, and this is the result of cardiologists organizing themselves and demanding control of ultrasound technology for their medical practices. Take a look at this chart. The very same migration is underway with MR, what cardiologists call CMR, or cardiovascular magnetic resonance. Attendance at the Society for Cardiovascular Magnetic Resonance's annual scientific sessions has grown tremendously from less than 300 delegates to more than 1,700. Notice the line at the bottom of the slide. Interventional CMR now has its own standing pre-conference track, which Imricor has been a part of since it started, alongside the physician and pediatric streams. Our field has a permanent seat at the table, and the table is growing. Cardiology is pulling MR imaging modality away from radiology and into its own hands, exactly as it did with echo a generation ago and X-ray before that. Here's why that matters so much for Imricor. Every hospital that stands up a CMR program is building the infrastructure, the physician skill base, and the referral pathways that interventional MR plugs directly into. A cardiology-controlled CMR suite is the easiest thing for us to adapt to an interventional MR lab. We are not waiting to build our infrastructure footprint. The cardiologists are building it for us, and they're doing so at a structural compounding rate. That brings me to the announcement I'm most excited to talk about today, Imricor Cardiovascular, a brand-new business vertical launched in July. Imricor Cardiovascular extends real-time MR guidance beyond electrophysiology into interventional cardiology or IC. Starting with cardiac catheterizations like right and left heart cath procedures, and eventually expanding into things like angioplasty, valvioplasty, septal defect closures, and the like, all performed in radiation-free in a single IMR session using the same IMR lab as the electrophysiologists. For patients, the clinical case is profound, and nowhere more so than in pediatrics. For children with congenital heart disease, they face repeat catheterizations across their young lives. Today, every one of those procedures adds radiation to a growing body. With MR guidance, that exposure goes to zero, the physicians gain richer functional data like blood flow dynamics and cardiac output, data the X-ray fluoroscopy system can never provide. For hospitals, the economic case is just as compelling. Today, a patient often needs a diagnostic MRI and then a separate X-ray catheterization. Two sessions, two rooms, 2 teams. In the IMR lab, it all becomes one. Our modeling shows that per-patient procedural time falls by around 35%, per-patient operational costs fall by around 43%. For a hospital doing 100 right heart caths a year, that's roughly $114,000 in direct savings. Importantly, it frees up the X-ray cath lab for higher revenue interventional work worth over $2 million per 100 cases moved into the IMR. That's better for the patient, it's better for the treating interventional cardiologist, and it's better for the hospital's bottom line. That's how a new standard of care are made. What does this new vertical mean for Imricor's revenue model? This slide shows it. One NorthStar sale creates 3 revenue streams. First, there's the capital revenue earned upfront on the NorthStar sale itself. Second, licensing revenue recurring for as long as that IMR lab is live and software-like margins, at software-like margins. Third, consumable revenue as IC devices are released to the market, pulled through with every procedure performed. Capital revenue lands at installation. Licensing consumable revenue recur and compound as the installed base and procedure volumes grow. Here is the strategic beauty of Imricor Cardiovascular. It drives NorthStar sales into hospitals today. Ahead of our full EP platform, opening a U.S. market of more than 250 children's hospitals and over 2,000 adult hospitals. Every NorthStar we place now becomes a beachhead for the full ablation platform later. We're at the early stages of commercialization in this vertical, we will share more details on the per-hospital economics over the coming quarter as the installed base and procedure volumes scale. Let's spend a moment reviewing the economics of electrophysiology in the IMR lab, because this is where the size of the prize becomes clear. Take a single IMR lab performing 500 ablations a year. That's roughly 2 per day, 5 days a week. Larger centers do a lot more. With a typical mix of 100 atrial flutter, 100 VT, and 300 AFib cases, the consumable revenue opportunity for Imricor is approximately USD 3 million per lab per year. Here's the part I love. All those same volumes, the same hospitals at those same volumes, the same hospitals save around $1.3 million a year in device costs alone, before you count the lab time, which can exceed $2,000 an hour. We win, the hospital wins, the patient wins. That alignment is what drives adoption in healthcare. On CapEx, an IMR lab costs about the same $3 million it takes to build up an X-ray lab. Unlike an X-ray lab, it can also generate diagnostic MR imaging revenue for the hospital when it's not being used for interventions. Take that and now scale it. There are more than 7,500 EP labs worldwide. Over 2,000 of them are in the United States alone. Each one is a candidate for this model. That is the market we are now positioned to pursue. Before I hand it over to John, let me bring the half together on one slide, regulatory, clinical, commercial, and financial. On the regulatory and clinical side, pediatric clearances for NorthStar and the diagnostic catheter. 510(k) submissions for the NavTrac introducers. The third PMA module is in. VISABL-AFL is enrolling its final patients across seven sites in U.S. and Europe. VISABL-VT is continuing in Amsterdam with further European sites to come imminently, and our first in-human VT work has been published in Circulation. Commercially, this is the headline of the half, the U.S. launch has commenced. Rady Children's Hospital in San Diego, home to one of America's leading pediatric cardiology programs, is our first U.S. customer pursuing purchasing NorthStar to build up a completely radiation-free cardiac catheterization program. As we've just announced this morning, Children's Medical Center Dallas will now be the second. Several additional U.S. hospitals are in the final stages of purchasing, we expect revenue from these initial NorthStar sales to be comfortably exceeding everything our European business generated in all of 2025. We're expanding the U.S. capital sales and operations team to match this demand, we expect that the recently announced Philips Declaration of Compatibility to open up the whole Philips installed base to NorthStar sales for the first time. Regarding the Middle East, the timing of the first ablation and sales in Saudi Arabia is hard to predict given the conflict in the region. Our sales leaders remain in close contact with our hospital customers there, and we stand ready to support the training installation the moment that it's feasible. And financially, the AUD 60 million placement at $1.85 provides a strong balance sheet to support the next few years. Operating cash outflows reduced quarter-over-quarter to USD 6.1 million, as we continue to be prudent with your capital. Imricor Finance is now live with DLL making Imricor even easier to do business with for our hospital customers. With that, I'll hand it over to John to take you through the numbers in detail. John?
Jonathon Gut
executiveThank you, Steve, and hello, everyone. As a reminder, all numbers are unaudited and in U.S. dollars. We generated total revenues of $61,000 for the quarter compared with $65,000 in the prior corresponding period. Revenue generation in Europe continued to be impacted by ongoing enrollment in our VISABL-AFL trial sites in Europe. It is important to remember that these trial enrollments are not revenue-generating procedures. Following completion of enrollment in the trial, we expect these sites will transition to commercial use of our devices, which will result in revenue increasing in future periods and will be further bolstered by new European sites alongside the U.S. commercialization, which is getting underway. Costs and non-R&D expenses increased by $933,000 compared to the prior corresponding period. This is primarily due to an increase in marketing costs related to trade show attendance, staffing costs driven by increased investment in our production team, and other professional services. The increase in marketing costs was partially timing related, as one of our major trade shows, the European Heart Rhythm Association, was held in April this year, while the 2025 event was in March, meaning those costs were not included in the prior corresponding period. R&D spend increased by $824,000 in comparison to the prior corresponding period, primarily due to investments in staffing to enable the multiple concurrent development programs and regulatory approval initiatives we have completed or are underway. The current period also included additional investments related to the VISABL-AFL clinical trial, where we onboarded new U.S. sites to support enrollment. 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 cash flow. The net loss for the quarter was $7.4 million, a decrease of 5% from the prior corresponding period, which was primarily driven by the movement and the fair value change recognized in the current period. Adjusted for this and the foreign exchange activity, our underlying net loss for the quarter was $7 million, an increase of 38% compared to the prior corresponding period's adjusted net loss of $5.1 million. This increase is the result of the operating expense investments noted earlier. We continue to maintain a strong balance sheet with over $67 million of funding on hand, reflected by our cash and cash equivalents, plus the marketable securities held at the end of the period. The outstanding convertible notes at the end of the period are recorded at their estimated fair values, which total approximately $33 million. Both notes are now classified as current liabilities due to their maturity dates in December 2026 and March 2027. It is important to note that 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 June 30 totaled $6.9 million for both notes, including $3.3 million related to the first note that matures in December 2026. 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 were set to expire in July 2026, but were exercised by the holders after the end of the quarter. Our operating cash outflow for the quarter amounted to approximately $6.1 million, an increase of $1.6 million compared to the prior corresponding period, but down from the $7.9 million in the first quarter of this year, which was in line with guidance provided last quarter. This increase is primarily driven by the increased investment in our manufacturing, development, and regulatory affairs teams, along with costs related to the ongoing clinical trials. Proceeds from the maturity of marketable securities represents US Treasury bills that were held as part of our ongoing treasury management efforts. At the end of the quarter, we held $6.9 million of these securities, leaving us with a combined cash and marketable securities balance of $67.5 million. After the quarter ended, certain options to purchase CDIs were exercised, which generated gross proceeds of approximately $2.1 million, leaving us with a pro forma June 30 cash and marketable securities balance of nearly $70 million. I'll turn it over to Steve to continue with the rest of the presentation.
Steve Wedan
executiveThanks, John. Let me finish by taking a look forward because as proud as I am of this half, it's clear to me that the most exciting chapters are the ones that are directly in front of us. First, let's remember the market we're walking into. Catheter ablation has been called the largest and fastest-growing market in medtech, compounding at around 15% a year, driven by the rising incidence of cardiac disease, the shift to minimally invasive procedures, and the cost-effectiveness of ablation as a treatment. It's very important to remember Imricor is not trying to create this market. It already exists, and it exists at enormous scale, and it's growing rapidly. We're entering it with a technology designed to materially improve outcomes, remove radiation entirely, and lower costs for the healthcare system. Here are the value drivers ahead, and these are not aspirations, they're measurable milestones. First, the FDA decisions on the remaining submissions that complete our U.S. platform, like the 510(k) devices, VISABL-AFL completion, and the final PMA module that follows. Second, VISABL-VT expanding to high-volume European sites with prominent KOLs, pay attention to that line, sparking the potential to redefine the field. Third, NorthStar accelerating in the United States, paving the way for EP, IC, remember, that's interventional cardiology, and all the verticals that will follow with the Philips Declaration of Compatibility, opening the Philips installed base for the first time. Finally, pulsed field ablation, which is super cool because whatever energy source physicians prefer, only MR can provide the advantages that we discussed today. Doesn't matter if it's RF, PFA, or whatever. Simply put, we entered 2026 with momentum, we are exiting the first half with scale beginning to show, and the second half is about execution. This is a revenue inflection point for Imricor, and we intend to deliver it. Before we go to questions, I just want to say a quick thank you. To our team at Imricor, the scope of what you have delivered in 6 months across regulatory, clinical, and now commercial fronts is extraordinary, and it is unique in our industry. To our hospital partners and the physicians pioneering this new field with us, thank you for your courage and your partnership. To you, our shareholders, thank you for backing this vision of a better patient care, safer procedures, and lower healthcare costs. That vision is now becoming commercial reality on 2 continents. Simon, I'll hand it back to you, and we're happy to take any questions.
Operator
operator[Operator Instructions] First question is from Tristan Maher at Jarden.
Tristan Maher
analystSteve, obviously you've spoken to the launch of Imricor Cardiovascular today, which is your sort of first expansion out of pure-play EP. Can you just sort of talk us through where you see that vertical going? Obviously, there's opportunity to do a lot more than just right heart caths, and maybe sort of how it may support the rollout of the EP ablation platform as that receives full approval in the U.S.
Steve Wedan
executiveYes. That's a great question, Tristan. The thing is we wanted to expand. We've always talked about Imricor being more than just electrophysiology and ablation, that it could apply to structural heart, cardiovascular interventions, neurology, oncology. Any time a doctor's come to me and said, "Hey, Steve, if I could see the soft tissue I'm working on, I could do a better job for my patient." Now more and more, "Hey, Steve, if I could get my team out of this X-ray lab, that would be a fantastic thing for everybody." What we looked at is how can we keep our focus on electrophysiology, keep driving that forward, just go from the low beams that we had going down the highway to our high beams. What's the easy stuff that we can grab on the external, outside of EP, that adds value to EP as well as adding value in its own self? This cardiovascular vertical was the first natural application. We'll talk more about it in the coming months, but what you can imagine is this. First, it gives us a place to settle NorthStar into the U.S. market. Every time we do that, we've set up a lab that's ready to do EP procedures as the EP devices come online. That's important. It builds on EP. Also, and this is where I can't get too far ahead of myself, there are lots of intervention. We can step-by-step work our way into easily deployable licenses for NorthStar, easily deployable new consumable devices that all go after this cardiovascular space until we've moved not just electrophysiologists out of the X-ray lab into the IMR lab, but also interventional cardiologists out of that X-ray lab and into the IMR lab. Next, look at the interventional radiologists and the folks treating cancers and tumors and things like that. That's an easy thing for us to approach after that. It just goes on and on. This is a huge business that we're building, and now's the right time for us to flex a little bit and show that we can add value to these other areas as well.
Tristan Maher
analystYes. Just one more, if I may. How does reimbursement look in the U.S. for a sort of right heart cath procedure? Does NorthStar-guided catheterizations fit into that existing reimbursement?
Steve Wedan
executiveYes. That whole analysis that you saw earlier was a detailed study that our marketing team put together with survey data and economic data that we have from the United States. Those aren't just guesses. That's what the data shows, and that's based on the reimbursement that exists today. It's an easy step. That's why it was such a natural, if you go back, golly, I don't know, 18 months, when I made an announcement that we are going to prioritize the deployment and the regulatory approval of NorthStar ahead of our consumable devices, this is why we did that, and this makes total sense. Now when the ablation devices come on one by one, there's a whole infrastructure and installed base ready for them.
Operator
operatorNext up we have Nick Lau at Taylor Collison. Nick, please go ahead.
Nicholas Lau
analystIf I can ask 2 questions, the first one being in regards to the Philips compatibility. Are we saying that there's 4 Brownfield and 5 Greenfield, are these sites a part of your sales pipeline or it's something extra? Also, with the clinical trial recruitment and the final patients, are we saying low double-digit patient numbers left or mid-single? Can you give some directionality in regards to the number of patients left?
Steve Wedan
executiveI can tell you this, Nick, we've got dates for every remaining case that we have to do in this study. It is August, summertime, but they're on the calendar and barring anything that happens with the patients or whatever, getting sick when their procedure is scheduled, we see the end clearly. This isn't a black box type of operation where we just submit stuff to the FDA, hope that it comes back, do the trial. As soon as the trial's done, we submit that, and then wait some undetermined amount of time. This is in a collaborative process with the FDA. We speak with them regularly. In fact, our last conversation with them was 2 days ago on Friday. We are planning carefully with them, both the module, what am I trying to say? The module reviews. Because look, they could pop them out one at a time, and they get the next one out and get the next one out, but there's no reason to do that. They can, as they are burdened with their work as well, they can time those things to get everything sort of cooking at the same time, and ready at the same time. We'll start to see those things happening. That's our opportunity, these ongoing meetings with FDA to talk about these things. Like, okay, here's the last patient. Here's when we expect to submit. Can you clear your calendar for those days and get the review started quickly? That's what we're doing. It is not as clear cut as it seems from the outside.
Nicholas Lau
analystWith the Philips systems, are those sites already incorporated into your? There's several hospitals in the final negotiation of sales?
Steve Wedan
executiveLet me think about the final negotiation of sales. I think there are a couple of them that are Philips sites. There are also Philips sites that we've been talking about for a long time, and really what we just did in Dallas shows the power of how quickly we can move, how ready these sites that have Philips systems are. Once we get the compatibility statement, then Philips will unlock the licenses that let NorthStar connect to the system in the R12 and R13 software packages, and on and on. We've been waiting that for quite a while. This is brand new for Philips too. You've got to remember, when we said, "Look, we're compatible. NorthStar's compatible," and even they agreed NorthStar's compatible, everything works. In order for this to be something that they can sign off on as we not just do a research project, but launch a new field. They got to get buttoned up. They had to re-qualify everything that we make. They had never qualified our gen 2 catheters, so they did that. They just wanted to run the process one more time. In doing that, this is the first time ever for Philips this has happened. They had to make the process up first, invent the process, and then execute it. It took a while from the time when we were like, "Hey, NorthStar is ready, let's go" for them to say, "Okay, now we have our Declaration of conformity." Meanwhile, we've got sites like the Charite in Berlin with Gerhard Hindricks, one of the largest KOLs in the world, waiting to get software update to their scanner so they can start doing atrial flutter cases now, and very soon then doing VT cases as part of our VISABL-VT trial. That's one of the reasons, and that we've talked about it before, that it was important for us to, look, focus on VISABL-AFL at Amsterdam, get them into their new lab so they can do VT cases on a more regular basis without having to wait for the one slot or 2 slots they get each month. At the same time, give Key Opinion Leaders with, frankly, stronger voices in the medical field, the ability to get involved in the study so that they are doing a significant number of cases, not just the last 2 or 3 at the end of a relatively small clinical trial. Remember, VISABL-VT is a small trial. It's only 64 patients, it can go very quickly at the volumes that these sites do VT procedures. We wanted to make sure that we got the right people at the table. Well, Philips was a bottleneck for that, and now it is cleared in the Charite in Berlin, which is really great news.
Operator
operatorNext up, we have Scott Power from Morgans. Scott, please go ahead.
Scott Power
analystJust following on from your comments then, Steve, around that VT trial. In your commentary, you did say to keep an eye on that going forward. You partly answered that. I'm just wondering if you put a little bit more meat on the bone around the VT, just remind us how many patients you're looking for, and why you're so excited about that part of the business?
Steve Wedan
executiveYes. The biggest thing that I'm excited about the VT trial is how it dovetails into the Philips compatibility and getting Hindricks started. Once Hindricks starts, and really it's Felix Hoen Donner, one of his leading EPs there who will be doing the procedures. Having both Felix, who is an up-and-coming KOL, and Gerd Hindricks talking about these things as an established KOL, these are big deals. As our sales team goes around, not just Europe, but around the whole world, it's important that we have these sites because the first thing people ask is, "Okay, well, I like what you're doing. Who else is doing it?" Before COVID, we used to be able to say Gerd Hindricks and blah, blah, and Christopher Piorkowski and on and on. All that changed and shuffled around, now we're getting back to where, okay, we've got the right people doing these procedures and the right names. It makes everything easier as we push forward. Meanwhile, in the U.S., the Imricor Cardiovascular, both I should say, the VISABL-AFL trial and getting VCU, that's Virginia Commonwealth University, and the University of Virginia, and Oklahoma Heart, and Johns Hopkins all doing procedures. These are huge places with huge KOLs in the U.S. and around the world as well. They are, of course, excuse me, they are, of course, great candidates for expanding into the VT trial also once they complete the VISABL-AFL study. Now with Imricor Cardiovascular, we bring pediatric sites, both their interventional cardiologists and now their electrophysiologists are in the sidelines waiting for our EP equipment to get approved as well, so they can jump into that same lab and do their procedures. It's all building. This is the snowball that we've been waiting for.
Operator
operatorJust finally, we've got Sarah Mann at Moelis Australia. Sarah, please go ahead.
Sarah Mann
analystCan you hear me okay?
Steve Wedan
executiveSure can.
Sarah Mann
analystYes, I guess a follow-on question just with regards to the Philips compatibility. Clearly, it unlocks a lot, particularly for the VT trial with Charite coming online. Are there any other sites in Europe that the Philips compatibility unlocks? Just how should we think about, I guess, the pace of finishing off that VT trial in Europe and the number of sites you'd like to add?
Steve Wedan
executiveSarah, that's a great question, it's also a complicated question and involves some things I can't yet talk about. Let me try to cage it this way. There are additional Philips sites all over that will get unlocked, but sometimes it's not just about the system needing to be unlocked, it's also about the doctor's moved away, we have to reengage with new physicians and so forth. We're doing that. That is naturally going to grow. What it does is it unties our hands so we can start to pursue those things that right now we've just been sort of stuck and couldn't really do anything with the Philips sites, there's no sense in doing anything except sort of just keeping them warm. Now we can push forward with those sites. When it comes to VISABL-VT, I think I just have to hold back for a while. I'd love to tell you all sorts of cool stuff, I think I should wait.
Sarah Mann
analystUnderstood. Okay. Then just in terms of, I guess, a normal course of business volumes in Europe, I know clearly a lot of your sites are tied up with the clinical trial, but how does the Philips compatibility, I guess, unlock volumes at, say, existing Philips sites and hopefully, potentially lead to new European sites signing up as well?
Steve Wedan
executiveYes, definitely leads. The volumes, it won't change the volumes much because Philips, they've all been. The one site that's doing procedures actually is still using the old iSuite software, but they're at a dead end, they'll have to upgrade their scanner and then move to NorthStar pretty soon. Then the other sites, Yes, I guess it will. I actually haven't been thinking about in terms of what would the volumes do with the Philips compatibility, but places like Charite aren't going to jump into ventricular tachycardia ablations. They're going to start doing routine atrial flutter ablations. I remember years ago, we never got a chance to do it, but years ago, Gerhard Hindricks said to me, he said, "Right now, at this stage," this was actually in the early days of the pandemic when we thought that it'll come and go. He said, "This is when it's important to do procedures, procedures." He said to me, "I've launched with companies, I've launched technology like this before. It's important for us as a site to do them, to just make them super routine, and work out every little workflow item so that people can follow our lead. It's important for you as a company to establish this procedure." Before that, I should say, this is why it's kind of a telling thing, before that, it was like, "Steve, the most important thing we can do is safety of the patient, safety of the patient, safety of the patient. That's all that matters." We 100% agree with that's how you go through your clinical work. Once you get past the tipping point where this all clearly works, he said, "Procedures, procedures." That's what we're getting back to now when we go into a place like the Charite, which makes it exciting. The other thing that's going to We knew this was going to happen all in the right timing. Amsterdam, who's moving from one day a week or one day a month on a Siemens scanner that they borrow time from or rent time from their radiology group, they're moving into, in September, their new cardiology wing. It's brand new. Everything in there is brand new. Philips won that bid. We're moving into a brand new Philips IMR lab with our technology. Two things happen. One, they can do procedures in a regular course of business like they would do any other procedure. They don't have to wait for patients, their care to line up with when the MRI is available. Now their IMR lab is there, just like every other X-ray cath lab they've got, and the anesthesiology team is all right there in the same spot. They can do them as they need to. If we didn't do the Philips, if we didn't have the Philips Declaration of Compatibility, we'd be stuck at another dead end with a site that's got the perfect lab and not able to do anything. Of course, this lined up perfectly for them as well as they move into that new Philips lab. There are other sites that the team has been working on, and again, we could only push so hard when we knew that it's a Philips site, but we didn't have the compatibility statement yet. Now we do, there's a lot of really cool things coming with respect to Imricor and Philips, look forward to telling you about that more in the very near future.
Operator
operatorJust a couple of final submitted questions, Steve. Just a continuation on the compatibility. Now that Siemens and Philips are compatible, what's the status with GE?
Steve Wedan
executiveYes, GE is still moving forward. We have the software that NorthStar is released on. It's our internal software number is 1.4. The 1.5 software for NorthStar will be the NorthStar version that connects to the GE scanner. There's a lot of work on the GE side as well, and they're doing it. This is one of the things that is, we've been doing this for 20 years, right? Where I'm trying to work with huge companies. They have other priorities as well. It's not just about MR and interventional MR, there's also X-ray, CT, ultrasound, PET. There's a lot of stuff going on, and this is important to them, but it's not everything they do. We've been shepherding them along and moving along as best we can for decades. That's what we're doing with GE. That's coming along. We have a schedule. We hope that everybody stays on it, we'll be talking about the release of 1.5 pretty soon, the second half of this year, I hope. Again, that's not something that is in complete control of Imricor, and that's fine because we've got 2/3 of the world's leading MR vendors part of our IMR toolkit. We have plenty of open space to go and grab. Where GE becomes important is sites that are stuck with the GE, and we want the doctors. That's why we're pushing so hard. We want those doctors, those KOLs doing our trials and so forth, and they're stuck on a GE platform for now.
Operator
operatorDave, just the final question. Can you discuss the biopsy opportunity and perhaps comment on the size of the opportunity and roadmap to commercialization?
Steve Wedan
executiveYes, I'm going to have to save that. It's a good question. I'm going to save that until our marketing team puts or delivers to me. I don't have numbers memorized off the top of my head, so I'd want them to validate those first. I actually didn't mention earlier, but that, of course, is a big part of this expanding field or the expanding case scope with interventional cardiology, because those folks can do those procedures as well. It's not clear to me if the biopsy's going to fit into the IC vertical or the EP vertical, or if we just offer that in both of those things. It's a big opportunity for different reasons. EPs say, "I would like to do this because it helps guide my therapeutic decisions with respect to ablation." Interventional cardiologists for different reasons, and even for transplant reasons, is the reason they'll do biopsies today. There's a lot to put together. Now I'll stop short of throwing that out there. If it weren't a significant opportunity, we would not be pursuing it. It'll be coming.
Operator
operatorThat concludes the Q&A segment. I might just hand it back to you for closing remarks.
Steve Wedan
executiveWell, gosh, that's it for me. I'm so thankful for everyone who joined us today and really for everyone who supported us through the last especially 18 months. It's been a rebirth of our balance sheet, which has put us at the birth of a new field. It's really a fantastic time for us here at Imricor, and we couldn't be more pleased with the support that you've given us. Thank you so much.
Jonathon Gut
executiveThanks all.
Operator
operatorThanks.
Read the full transcript via the API
You're viewing the first half of this call. Get the complete Imricor Medical Systems, Inc. transcript — plus 251,000+ transcripts from 12,000+ companies, speaker segments, AI summaries and full-text search — through the EarningsCalls.dev API.
Get the API View API docs →This call discussed
For developers and AI pipelines
Programmatic access to Imricor Medical Systems, Inc. earnings transcripts and 251,000+ others is available through the
EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments,
full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.