Q2 2026 Imricor Medical Systems Inc Earnings Call

Speaker #1: You have joined the meeting as an attendee and will be muted throughout the meeting.

Speaker #2: 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 Weeden, and the company's CFO, Jonathan Goode.

[Company Representative] (Imricor Medical Systems): Welcome to Imricor Medical Systems' H1 of financial year 2026 investor presentation. From the company today, we have the Executive Chair, CEO, and Founder, Steve Wedan, and the company's CFO, Jonathon Gut. Before I hand it over to Steve to go through the presentation up on your screen, I will just remind you that analysts can raise their hand and ask a question audibly, or for others, you can submit a question through the Q&A button at the bottom of your screen. With that, Steve, I might just hand it over to you. Thanks for that.

[Company Representative] (Imricor Medical Systems): Welcome to Imricor Medical Systems' H1 of financial year 2026 investor presentation. From the company today, we have the Executive Chair, CEO, and Founder, Steve Wedan, and the company's CFO, Jonathon Gut. Before I hand it over to Steve to go through the presentation up on your screen, I will just remind you that analysts can raise their hand and ask a question audibly, or for others, you can submit a question through the Q&A button at the bottom of your screen. With that, Steve, I might just hand it over to you. Thanks for that.

Speaker #2: Before I hand it over to Steve to go through the presentation on your screen, I'll just remind you that analysts can raise their hand and ask a question audibly.

Speaker #2: Or for others, you can submit a question through the Q&A button at the bottom of your screen. But with that, Steve, I might just hand it over to you.

Speaker #2: Thanks for that.

Speaker #3: Thanks, Simon. And 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.

Steve Wedan: Thanks, Simon. Hello, everyone. Thanks for joining us today to discuss Imricor's results for the H1 of 2026. I want to open with a simple statement because it frames everything you are going to hear today. The Q2 of 2026 is the quarter Imricor arrived in the United States. For close to 2 decades, we have 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 is exactly what is happening. Our US commercial launch is no longer a plan. It is underway.

Steve Wedan: Thanks, Simon. Hello, everyone. Thanks for joining us today to discuss Imricor's results for the H1 of 2026. I want to open with a simple statement because it frames everything you are going to hear today. The Q2 of 2026 is the quarter Imricor arrived in the United States. For close to 2 decades, we have 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 is exactly what is happening. Our US commercial launch is no longer a plan. It is underway.

Speaker #3: The second quarter of 2026 is the quarter IMRICOR arrived in the United States. And for close to two 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. And in May, we told you that the capital raise would give us the strength to move decisively from momentum to scale.

Speaker #3: 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.

Steve Wedan: We have our first US customers, more hospitals in the final stage of purchasing, and a new business vertical that opens a market of more than 2,000 American hospitals, and a balance sheet that funds us into 2028. Today I will walk through the highlights of the H1, remind everyone what the problems are that we are solving, and why the world is now demanding them to be solved. We will cover extraordinary regulatory ground that we have covered and introduce you properly to Imricor Cardiovascular, our newest growth engine. John will then take you through the financials, and I will come back to talk about the value drivers for the H2 and beyond. We will leave plenty of time for your questions. Here is our disclaimer, which I invite you to all read at your leisure. Here is a roadmap for today.

Steve Wedan: We have our first US customers, more hospitals in the final stage of purchasing, and a new business vertical that opens a market of more than 2,000 American hospitals, and a balance sheet that funds us into 2028. Today I will walk through the highlights of the H1, remind everyone what the problems are that we are solving, and why the world is now demanding them to be solved. We will cover extraordinary regulatory ground that we have covered and introduce you properly to Imricor Cardiovascular, our newest growth engine. John will then take you through the financials, and I will come back to talk about the value drivers for the H2 and beyond. We will leave plenty of time for your questions. Here is our disclaimer, which I invite you to all read at your leisure. Here is a roadmap for today.

Speaker #3: Customers, more hospitals in the final stage of purchasing, and a new business vertical that opens a market of more than 2,000 American hospitals. And a balance sheet that funds us into 2028.

Speaker #3: So today, I'll walk through the highlights of the half, remind everyone what the problems are that we're solving, and why the world is now demanding that they be solved.

Speaker #3: We'll cover extraordinary regulatory ground that we've covered, and introduce you properly to Imricor Cardiovascular, our newest growth engine. Jon will then take you through the financials, and I'll come back to talk about the value drivers for the second half and beyond.

Speaker #3: We'll leave plenty of time for your questions. Here's our disclaimer, which I invite you all to read at your leisure. And here is a roadmap for today.

Speaker #3: We'll start with a quick overview of Imricor and some key highlights. Then I want to talk about radiation for a moment, and after that, I'll discuss our regulatory momentum and U.S.

Steve Wedan: We'll start with a quick overview of Imricor and some key highlights. I want to talk about radiation for a moment, and after that, I'll discuss our regulatory momentum and US commercial launch. John will go through the financial results, and I'll 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.

Steve Wedan: We'll start with a quick overview of Imricor and some key highlights. I want to talk about radiation for a moment, and after that, I'll discuss our regulatory momentum and US commercial launch. John will go through the financial results, and I'll 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.

Speaker #3: commercial launch. Next, Jon will go through the financial results, and I'll wrap up with a look ahead. For those new to the Imricor story, this is the company in 60 seconds.

Speaker #3: 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, which the field calls an IMR lab.

Speaker #3: 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.

Speaker #3: 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.

Steve Wedan: 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? Well, a capital sale of $500,000 to 700,000 US 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?

Steve Wedan: 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? Well, a capital sale of $500,000 to 700,000 US 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?

Speaker #3: 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.

Speaker #3: When you can see the heart, you can see the things that are wrong with the heart and fix them. And 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.

Speaker #3: How do we earn? Well, a capital sale of $500,000 to $700,000 per lab installation, followed by a high-margin consumable and software license annuity that recurs every year and scales with utilization.

Speaker #3: I'll come back to those economics in detail, because they're central to the investment case. And where are we? Well, we're commercial in Europe, we're expanding indications into ventricular tachycardia there, and as of this half, we have substantially cleared U.S.

Steve Wedan: Well, we're commercial in Europe. We're expanding indications into ventricular tachycardia there. As of this half, we have substantially cleared US platform and US commercial launch in motion today. This slide is the scoreboard for the half, and I have to say it's one of the strongest scoreboards in our history. On the regulatory front, four FDA clearances secured in 6 months. The Vision-MR Diagnostic Catheter's cleared, NorthStar is cleared, we've cleared pediatric label expansions for both of them, meaning our cleared US 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 and every single remaining 510 device shortly after the quarter ended. Everyone.

Steve Wedan: Well, we're commercial in Europe. We're expanding indications into ventricular tachycardia there. As of this half, we have substantially cleared US platform and US commercial launch in motion today. This slide is the scoreboard for the half, and I have to say it's one of the strongest scoreboards in our history. On the regulatory front, four FDA clearances secured in 6 months. The Vision-MR Diagnostic Catheter's cleared, NorthStar is cleared, we've cleared pediatric label expansions for both of them, meaning our cleared US 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 and every single remaining 510 device shortly after the quarter ended. Everyone.

Speaker #3: Platform and U.S. commercial launch in motion today. This slide is the scoreboard for the half, and I have to say it's one of the strongest scoreboards in our history.

Speaker #3: On the regulatory front, four FDA clearances secured in six months. The Vision-MR diagnostic catheters cleared, NorthStar is cleared, and then we've cleared pediatric label expansions for both of them, meaning our cleared U.S.

Speaker #3: Products can be used in patients of any age. On top of that, we submitted the Advantage MR system as well as our third-party, or third PMA module, and every single remaining 510(k) device shortly after the quarter ended.

Speaker #3: 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.

Steve Wedan: 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 $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.

Steve Wedan: 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 $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.

Speaker #3: On the clinical front, we added Virginia Commonwealth University and the Oklahoma Heart Institute to the VISABL-AFL trial. And the first in-human IMR-guided VT ablation was published in Circulation, which is the flagship cardiovascular journal of the American Heart Association.

Speaker #3: 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 $70 million U.S.

Speaker #3: dollars, around $100 million Australian dollars on a pro forma basis, funds the company into calendar year 2028, and that means we are executing this launch from a position of financial strength.

Speaker #3: And on the corporate front, Imricor became U.S. SEC registered, and we launched Imricor Finance, a vendor financing program backed by DLL Group, one of the world's largest medical equipment financiers.

Steve Wedan: On the corporate front, Imricor became a US SEC registered, and 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 to 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 four 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.

Steve Wedan: On the corporate front, Imricor became a US SEC registered, and 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 to 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 four 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.

Speaker #3: Hospitals can now spread payments over 1 to 7 years, while IMRICOR is paid in full upfront, with the credit exposure carried by DLL. That helps to remove friction from hospital purchasing decisions.

Speaker #3: Now, let me step back for a moment and remind everyone what this is all for, because the essence of Imricor fits into four words: from inferring to visualizing.

Speaker #3: 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.

Speaker #3: So, 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 incurring extra costs.

Steve Wedan: 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.

Steve Wedan: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: It's a step change—a reset of what's possible in an interventional lab, and a new era for image-guided therapy. Now, 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.

Steve Wedan: 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 14 July, not long ago, six 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, and 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.

Steve Wedan: 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 14 July, not long ago, six 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, and 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.

Speaker #3: On July 14th, so not long ago, six 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.

Speaker #3: 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.

Speaker #3: And 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. Eighty-five percent of brain tumors for these operators occur on the left side of the head, the side that's always facing the radiation source.

Speaker #3: Nearly 60% of the operators now report orthopedic injury from wearing lead garments, up to 10 points up 10 points in the last decade. And for a child, a single fluoroscopy-guided ablation can add measurably to their cancer risk over their lifetime.

Steve Wedan: 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 medical establishment itself is calling for urgent action, we are providing the solution. We're not pushing against the tide of radiation denial anymore.

Steve Wedan: 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 medical establishment itself is calling for urgent action, we are providing the solution. We're not pushing against the tide of radiation denial anymore.

Speaker #3: 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.

Speaker #3: Thicker aprons, more barriers—more weight on the spines of the people doing the work. But the shielding for the operator is not the same as removing the radiation.

Speaker #3: IMRICOR doesn't shield the hazard—we just remove it. And 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.

Speaker #3: We're not pushing against the tide of radiation denial anymore. This tide is with us. Now, let's talk about regulatory momentum—or, 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.

Steve Wedan: This tide is with us. Let's talk about regulatory momentum, or 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 US regulatory position at the fiscal year 2025 results in February, and just 6 months ago against where we stand now. 15 FDA submissions make up our complete US platform. 11 510s and four PMAs. In 6 months, we went from a handful of clearances to four 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.

Steve Wedan: This tide is with us. Let's talk about regulatory momentum, or 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 US regulatory position at the fiscal year 2025 results in February, and just 6 months ago against where we stand now. 15 FDA submissions make up our complete US platform. 11 510s and four PMAs. In 6 months, we went from a handful of clearances to four 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.

Speaker #3: As they should be. This slide might be my favorite in the entire deck. It shows our U.S. regulatory position at the full year or fiscal year '25 results in February—yeah, just six months ago—against where we stand now.

Speaker #3: Fifteen FDA submissions make up our complete U.S. platform: eleven 510(k)s and four PMAs. In six months, we went from a handful of clearances to four clearances secured, and every remaining 510(k) device submitted, with the final device lodged just after the period.

Speaker #3: Fourteen of fifteen 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 Visible AFL trial, and that trial is now enrolling its final remaining patients.

Steve Wedan: 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.

Steve Wedan: 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.

Speaker #3: Keep in mind that securing regulatory clearance for a single medical device is a major milestone for any company. Now, consider what this table represents: an entire platform, consumables, capital equipment, and the world's only MR-native mapping system, all moved through the FDA process at once.

Speaker #3: 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, and I want to take a moment actually to thank GenWise, our Vice President of Regulatory and Quality, and her regulatory team. What they delivered in this half was truly exceptional.

Speaker #3: It enabled us to launch in the U.S. this past quarter. But 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.

Steve Wedan: It enabled us to launch in the US this past quarter. Before I introduce our newest growth engine and our recent US 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 office without tripping over a few echo machines. They're all over the place. This is the result of cardiologists organizing themselves and demanding control of ultrasound technology for their medical practices. Take a look at this chart.

Steve Wedan: It enabled us to launch in the US this past quarter. Before I introduce our newest growth engine and our recent US 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 office without tripping over a few echo machines. They're all over the place. This is the result of cardiologists organizing themselves and demanding control of ultrasound technology for their medical practices. Take a look at this chart.

Speaker #3: 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.

Speaker #3: And 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.

Speaker #3: 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. Now, take a look at this chart.

Speaker #3: 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 fewer than 300 delegates to more than 1,700.

Steve Wedan: 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, 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.

Steve Wedan: 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, 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.

Speaker #3: And 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.

Speaker #3: 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.

Speaker #3: And 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.

Steve Wedan: 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. The 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, 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, 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.

Steve Wedan: 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. The 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, 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, 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.

Speaker #3: 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.

Speaker #3: The cardiologists are building it for us, and they're doing so at a structural, compounding rate. And that brings me to the announcement I'm most excited to talk about today.

Speaker #3: 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, valvuloplasty, septal defect closures, and the like, all performed radiation-free in a single IMR session using the same IMR lab as the electrophysiologists.

Speaker #3: For patients, the clinical cases are profound, and nowhere more so than in pediatrics. For children with congenital heart disease, they face repeat catheterizations across their young lives.

Steve Wedan: For patients, the clinical case is profound, 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, two 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.

Steve Wedan: For patients, the clinical case is profound, 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, two 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.

Speaker #3: Today, every one of those procedures adds radiation to a growing body. With MR guidance, that exposure goes to zero, and the physicians gain richer functional data, like blood flow dynamics and cardiac output—data the X-ray fluoroscopy system can never provide.

Speaker #3: And 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, two teams.

Speaker #3: In the IMR lab, it all becomes one. Our modeling shows that per-patient procedural time falls by around 35%, and per-patient operational costs fall by around 43%.

Speaker #3: For hospitals doing 100 right heart caths a year, that's roughly $114,000 in direct savings. And 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.

Steve Wedan: 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. 1 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.

Steve Wedan: 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. 1 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.

Speaker #3: 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 is made.

Speaker #3: Now, what does this new vertical mean for IMRICOR's revenue model? This slide shows it. One NorthStar sale creates three revenue streams. First, there's the capital revenue earned upfront on the NorthStar sale itself.

Speaker #3: Second, licensing revenue is recurring for as long as that IMR lab is live, and at software-like margins. And third, consumable revenue as IC devices are released to the market, pulled through with every procedure performed. Capital revenue lands at installation; licensing and consumables revenue recur and compound as the installed base and procedure volumes grow.

Speaker #3: And here is the strategic beauty of Imricor Cardiovascular. It drives North Star sales into hospitals today, ahead of our full EP platform, opening in the U.S.

Steve Wedan: Here is the strategic beauty of Imricor Cardiovascular. It drives NorthStar sales into hospitals today. Ahead of our full EP platform, opening a US 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.

Steve Wedan: Here is the strategic beauty of Imricor Cardiovascular. It drives NorthStar sales into hospitals today. Ahead of our full EP platform, opening a US 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.

Speaker #3: market of more than 250 children's hospitals and over 2,000 adult hospitals. Every North Star we place now becomes a beachhead for the full ablation platform later.

Speaker #3: We're at the early stages of commercialization in this vertical, and we will share more details on the per-hospital economics over the coming quarter as the installed base and procedure volumes scale.

Speaker #3: Now, 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.

Speaker #3: Take a single IMR lab performing 500 ablations a year. That's roughly two per day, five days a week. Larger centers do a lot more.

Speaker #3: With a typical mix of 100 atrial flutter, 100 VT, and 300 AFib cases, the consumable revenue opportunity for Imricor is approximately $3 million per lab per year.

Steve Wedan: With a typical mix of 100 atrial flutter, 100 VT, and 300 AFib cases, the consumable revenue opportunity for Imricor is approximately $3 million USD per lab per year. Here's the part I love. All those same volumes, the same hospitals at those same volumes, those 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.

Steve Wedan: With a typical mix of 100 atrial flutter, 100 VT, and 300 AFib cases, the consumable revenue opportunity for Imricor is approximately $3 million USD per lab per year. Here's the part I love. All those same volumes, the same hospitals at those same volumes, those 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.

Speaker #3: And here's the part I love: all those same volumes, the same hospitals at those same volumes, those same hospitals save around $1.3 million a year in device costs alone, before you count the lab time.

Speaker #3: Which can exceed, you know, $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, as it takes to build out an X-ray lab.

Speaker #3: And 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.

Speaker #3: 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.

Steve Wedan: 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 Vision-MR Diagnostic Catheter, 510 submissions for the NavTrac introducers. The third PMA module is in. VISABL-AFL is enrolling its final patients across seven sites in the US 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 US launch has commenced.

Steve Wedan: 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 Vision-MR Diagnostic Catheter, 510 submissions for the NavTrac introducers. The third PMA module is in. VISABL-AFL is enrolling its final patients across seven sites in the US 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 US launch has commenced.

Speaker #3: That is the market we are now positioned to pursue. So, before I hand it over to John, let me bring the half together on one slide.

Speaker #3: Regulatory, clinical, commercial, and financial. On the regulatory and clinical side: pediatric clearances for North Star and the diagnostic catheter; 510(k) submissions for the NAV track introducers; the third part, the third PMA module, is in; VISIBLE-AFL is enrolling its final patients across seven sites in the U.S. and Europe.

Speaker #3: Visible VT is continuing in Amsterdam, with further European sites to come imminently, and our first in-human VT work has been published in Circulation.

Speaker #3: Commercially, and 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.

Steve Wedan: Rady Children's Hospital in San Diego, home to one of America's leading pediatric cardiology programs, is our first US 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 US 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 US 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.

Steve Wedan: Rady Children's Hospital in San Diego, home to one of America's leading pediatric cardiology programs, is our first US 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 US 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 US 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.

Speaker #3: A customer is pursuing purchasing NorthStar to build up a completely radiation-free cardiac catheterization program. And, as we have just announced this morning, Children's Medical Center Dallas will now be the second.

Speaker #3: Several additional U.S. hospitals are in the final stages of purchasing, and we expect revenue from these initial NorthStar sales to comfortably exceed everything our European business generated in all of 2025.

Speaker #3: We're expanding the U.S. capital sales and operations team to match this demand, and we expect that the recently announced Philips Declaration of Compatibility will open up the whole Philips installed base to NorthStar sales for the first time.

Speaker #3: 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.

Speaker #3: Our sales leaders remain in close contact with our hospital customers there, and we stand ready to support the training and installation the moment that it's feasible.

Steve Wedan: Our sales leaders remain in close contact with our hospital customers there, we stand ready to support the training and installation at the moment that it's feasible. Financially, the AUD 60 million placement at AUD 1.85 provides a strong balance sheet to support the next few years. Operating cash outflow is reduced quarter on quarter to $6.1 million USD, 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?

Steve Wedan: Our sales leaders remain in close contact with our hospital customers there, we stand ready to support the training and installation at the moment that it's feasible. Financially, the AUD 60 million placement at AUD 1.85 provides a strong balance sheet to support the next few years. Operating cash outflow is reduced quarter on quarter to $6.1 million USD, 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?

Speaker #3: And financially, the $60 million Australian placement at $1.85 provides a strong balance sheet to support the next few years. Operating cash outflows reduced quarter on quarter to $6.1 million, as we continue to be prudent with your capital.

Speaker #3: And IMRICOR Finance is now live with DLL, making IMRICOR even easier to do business with for our hospital customers. So with that, I'll hand it over to John to take you through the numbers in detail.

Speaker #3: John?

Speaker #1: Thank you, Steve. And hello, everyone. As a reminder, all numbers are unaudited and in U.S. dollars. We generated total revenue of $61,000 for the quarter, compared with $65,000 in the prior corresponding period.

Jonathon Gut: Thank you, Steve, and hello, everyone. As a reminder, all numbers are unaudited and in US 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 US commercialization, which is getting underway. Costs and non-R&D expenses increased by $933,000 compared to the prior corresponding period.

Jonathon Gut: Thank you, Steve, and hello, everyone. As a reminder, all numbers are unaudited and in US 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 US commercialization, which is getting underway. Costs and non-R&D expenses increased by $933,000 compared to the prior corresponding period.

Speaker #1: Revenue generation in Europe continued to be impacted by ongoing enrollment in our visible AFL trial site in Europe. It is important to remember that these trial enrollments are not revenue-generating procedures.

Speaker #1: 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 those in the U.S.

Speaker #1: Commercialization, which is getting underway, has led to costs and non-R&D expenses increasing 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.

Jonathon Gut: 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 US sites to support enrollment.

Jonathon Gut: 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 US sites to support enrollment.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: The current period also included additional investments related to the VISIBLE-AF 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.

Jonathon Gut: 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. 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.

Jonathon Gut: 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. 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Jonathon Gut: 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 30 June totaled $6.9 million for both notes, including $3.3 million related to the first note that matures in December 2026.

Jonathon Gut: 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 30 June totaled $6.9 million for both notes, including $3.3 million related to the first note that matures in December 2026.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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 U.S. GAAP.

Jonathon Gut: The option 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, down from the $7.9 million in Q1 of this year, which was in line with guidance provided Q4. 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.

Jonathon Gut: The option 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, down from the $7.9 million in Q1 of this year, which was in line with guidance provided Q4. 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.

Speaker #1: A portion of these options were set to expire in July 2026, but were exercised by the holders after the end of the quarter.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: Proceeds from the maturity of, excuse me, proceeds from the maturity of marketable securities represent U.S. Treasury bills that were held as part of our ongoing treasury management efforts.

Speaker #1: 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.

Jonathon Gut: At the end of Q2, 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 30 June cash and marketable securities balance of nearly $70 million. I'll turn it over to Steve to continue with the rest of the presentation.

Jonathon Gut: At the end of Q2, 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 30 June cash and marketable securities balance of nearly $70 million. I'll turn it over to Steve to continue with the rest of the presentation.

Speaker #1: 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.

Speaker #1: And I'll turn it over to Steve to continue with the rest of the presentation.

Speaker #2: Thanks, John. So 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.

Steve Wedan: Thanks, John. Let me finish by taking a look forward, because as proud as I am of this H1, 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 med tech, 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.

Steve Wedan: Thanks, John. Let me finish by taking a look forward, because as proud as I am of this H1, 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 med tech, 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.

Speaker #2: 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.

Speaker #2: And 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.

Speaker #2: We're entering it with a technology designed to materially improve outcomes, remove radiation entirely, and lower costs for the healthcare system. So here are the value drivers ahead, and these are not aspirations.

Steve Wedan: 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 US platform, like the 510 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 install 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. It doesn't matter if it's RF, PFA, or whatever.

Steve Wedan: 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 US platform, like the 510 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 install 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. It doesn't matter if it's RF, PFA, or whatever.

Speaker #2: They're measurable milestones. First, the FDA decisions on the remaining submissions that complete our U.S. platform, like the 510(k) devices, visible AFL completion, and the final PMA module that follows.

Speaker #2: Second, visible VT expanding to high-volume European sites with prominent KOLs. Pay attention to that line. Sparking, the potential to redefine the field. Third, North Star 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 install base for the first time.

Speaker #2: And finally, pulse field ablation—just super cool—because whatever energy source physicians prefer, only MR can provide the advantages that we discussed today. It doesn't matter if it's RF, PFA, or whatever.

Speaker #2: Simply put, we enter 2026 with momentum, and we are exiting the first half with scale beginning to show. The second half is about execution.

Steve Wedan: Simply put, we entered 2026 with momentum, and we are exiting H1 with scale beginning to show, and H2 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.

Steve Wedan: Simply put, we entered 2026 with momentum, and we are exiting H1 with scale beginning to show, and H2 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.

Speaker #2: This is a revenue inflection point for Imricor, and we intend to deliver it. So, before we go to questions, I just want to say a quick thank you.

Speaker #2: To our team at Imricor, the scope of what you have delivered in six months across regulatory, clinical, and now commercial fronts is extraordinary, and it is unique in our industry.

Speaker #2: To our hospital partners and the physicians pioneering this new field with us, thank you for your courage and your partnership. And to you, our shareholders, thank you for backing this vision of better patient care, safer procedures, and lower healthcare costs.

Speaker #2: That vision is now becoming commercial reality on two continents. Simon, I'll hand it back to you, and we're happy to take any questions.

Steve Wedan: Simon, I'll hand it back to you, and we're happy to take any questions.

Steve Wedan: Simon, I'll hand it back to you, and we're happy to take any questions.

Speaker #1: Thank you so much, Steve, and thanks, John. First question is from Tristan Marr at Jarden. Tristan, please go ahead.

[Company Representative] (Imricor Medical Systems): Thanks so much, Steve, and thanks, John. First question is from Tristan Maher at Jarden. Tristan, please go ahead.

[Company Representative] (Imricor Medical Systems): Thanks so much, Steve, and thanks, John. First question is from Tristan Maher at Jarden. Tristan, please go ahead.

Speaker #3: Oh, hi. Good morning, Steve and Jonathan. Steve, obviously, you've spoken to the launch of Imricor Cardiovascular today, which is your first expansion out of pure-play EP.

Tristan Maher: Hi. Good morning, Steve and Jonathan. Steve, 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 cath, and maybe sort of how it may support the rollout of the EP ablation platform as that receives full approval in the US.

Tristan Maher: Hi. Good morning, Steve and Jonathan. Steve, 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 cath, and maybe sort of how it may support the rollout of the EP ablation platform as that receives full approval in the US.

Speaker #3: 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, cath, and maybe sort of how it may support the rollout of the EP ablation platform.

Speaker #3: Is that perceived as full approval in the U.S.?

Speaker #2: Yes, 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.

Steve Wedan: Yeah. 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. Anytime 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, but just go from the low beams that we had going down the highway to our high beams.

Steve Wedan: Yeah. 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. Anytime 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, but just go from the low beams that we had going down the highway to our high beams.

Speaker #2: That it could apply to structural heart, cardiovascular interventions, neurology, oncology—any time a doctor is coming to me and says, "Hey, Steve, if I could see the soft tissue I'm working on, I could do a better job for my patient." And 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." So what we looked at is, how can we keep our focus on electrophysiology, keep driving that forward, but just go from the low beams that we had going down the highway to our high beams.

Speaker #2: 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?

Steve Wedan: 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. What you can imagine is this: first, it gives us a place to settle NorthStar into the US 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.

Steve Wedan: 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. What you can imagine is this: first, it gives us a place to settle NorthStar into the US 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.

Speaker #2: And this cardiovascular vertical was the first natural application. And we'll talk more about it in the coming months. But what you can imagine is this.

Speaker #2: First, it gives us a place to settle North Star into the U.S. market. And every time we do that, we've set up a lab that's ready to do EP procedures, as the EP devices come online.

Speaker #2: So that's important. It builds on EP. But also, and this is where I can't get too far ahead of myself, there are lots of interventions we can step by step work our way into—easily deployable licenses for NorthStar, easily deployable new consumable devices—that all, you know, go after this cardiovascular space.

Steve Wedan: 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 is the right time for us to flex a little bit and show that we can add value to these other areas as well.

Steve Wedan: 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 is the right time for us to flex a little bit and show that we can add value to these other areas as well.

Speaker #2: 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.

Speaker #2: And 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.

Speaker #2: It just goes on and on. This is a huge, a huge business that we're building, and now is the right time for us to flex a little bit and show that we can add value to these other areas as well.

Speaker #1: Yeah. And just one more, if I may. I mean, how does reimbursement look in the U.S. for a sort of right heart cath procedure?

Tristan Maher: Yeah, just one more, if I may. How does reimbursement look in the US for a right heart cath procedure? Does NorthStar-guided catheterization fit into that existing reimbursement?

Tristan Maher: Yeah, just one more, if I may. How does reimbursement look in the US for a right heart cath procedure? Does NorthStar-guided catheterization fit into that existing reimbursement?

Speaker #1: And does NorthStar guided catheterizations fit into that existing reimbursement?

Speaker #2: Yeah, that whole analysis that you saw earlier with the it was a was a detailed study that our marketing team put together with with survey data and and economic data that we have from the United States.

Steve Wedan: Yeah, 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 install base ready for them.

Steve Wedan: Yeah, 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 install base ready for them.

Speaker #2: So those aren't just guesses. That's what the data shows, and that's based on the reimbursement that exists today. So, it's an easy step.

Speaker #2: That's why it was such a natural— I mean, 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 North Star ahead of our consumable devices, this is why we did that.

Speaker #2: And this makes total sense. So now, when the ablation devices come on one by one, there's a whole infrastructure and install base ready for them.

Speaker #1: Yeah, great. Thank you. Next, Tristan. Next up, we have Nick Lau at Tyler Collison. Nick, please go ahead.

Tristan Maher: Yeah. Great. Thank you.

Tristan Maher: Yeah. Great. Thank you.

[Company Representative] (Imricor Medical Systems): Thanks, Tristan. Next up, we have Nick Lau at Taylor Collison. Nick, please go ahead.

[Company Representative] (Imricor Medical Systems): Thanks, Tristan. Next up, we have Nick Lau at Taylor Collison. Nick, please go ahead.

Speaker #4: Thank you very much. Hi, Steve. And John, thank you for your time. If I can, I'd like to ask two questions. The first one is in regards to the Philips compatibility.

Nick Lau: Thank you very much. Hi, Steve and John.

Nick Lau: Thank you very much. Hi, Steve and John.

Steve Wedan: Hi, Nick.

Steve Wedan: Hi, Nick.

Nick Lau: Thank you for your time. In regards to, if I can ask two questions, the first one being in regards to the Philips compatibility. Are we saying that there's four brownfield and five greenfield, and are these sites a part of your sales pipeline or it's something extra? 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?

Nick Lau: Thank you for your time. In regards to, if I can ask two questions, the first one being in regards to the Philips compatibility. Are we saying that there's four brownfield and five greenfield, and are these sites a part of your sales pipeline or it's something extra? 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?

Speaker #4: Are we saying that there are four brownfield and five greenfield sites? And are these sites a part of your sales pipeline, or is it something extra? And also, with the—oh, sorry.

Speaker #4: Yeah. 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?

Speaker #2: I I can tell you this, Nick. We've got dates for every remaining case that we have to do in this study. And it is August, summertime, but but they're on the calendar, and, you know, barring anything that that happens with the patients or whatever, you know, getting sick when they're when their procedure is scheduled, we we see the end clearly.

Steve Wedan: I 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. Importantly, 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?

Steve Wedan: I 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. Importantly, 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?

Speaker #2: And importantly, this isn't a black box type of operation where we just submit stuff to the FDA, hope that it comes back, and do the trial.

Speaker #2: As soon as the trial is done, we submit that and then, you know, wait some, you know, undetermined amount of time. This isn't a collaborative process with the FDA.

Speaker #2: We speak with them regulatory or regulatory. We speak with them regularly. And in fact, our last conversation with them was two days ago, on Friday.

Speaker #2: So we are planning carefully with them, both the module—I'm not 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.

Steve Wedan: The module reviews, because look, they could pop them out 1 at a time, and they get the next one out and get the next one out. 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.

Steve Wedan: The module reviews, because look, they could pop them out 1 at a time, and they get the next one out and get the next one out. 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.

Speaker #2: But there's no reason to do that. So they can, you know, 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.

Speaker #2: So we'll start to see those things happening. But that's our opportunity—these ongoing meetings with FDA—to talk about these things. Like, okay, here's the last patient.

Speaker #2: Here's when we expect to submit. How's your—you know, can you clear your calendar for those days and get the reviews started quickly?

Speaker #2: That's what we're doing. So, it is not as clear-cut as it seems from the outside.

Speaker #4: Thank you very much, Steve. And and with the the Philips systems are those sites already incorporated into your there's several hospitals in the in the final negotiation of of sales?

Nick Lau: Thank you very much, Steve. With the Philips systems, are those sites already incorporated into your? There's several hospitals in the final negotiation of sales?

Nick Lau: Thank you very much, Steve. With the Philips systems, are those sites already incorporated into your? There's several hospitals in the final negotiation of sales?

Speaker #2: Let me think about the final negotiation of sales. I think there are a couple of them that are that are Philips sites. There are also Philips sites that we've been talking about for a long time and really it's you know, what we just did in in Dallas shows the the the the the power of how quickly we can move, how ready these sites that have Philips systems are once we get the compatibility statement, then we then Philips will unlock the licenses that let North Star to connect to the system in the in the R12 and R13 software packages and on and on and on.

Steve Wedan: Let 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, Philips will unlock the licenses that let NorthStar connect to the system in the R12 and R13 software packages and on 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 is compatible, everything works.

Steve Wedan: Let 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, Philips will unlock the licenses that let NorthStar connect to the system in the R12 and R13 software packages and on 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 is compatible, everything works.

Speaker #2: We've been waiting for that for quite a while. But this is brand new for Philips, too. So you've got to remember, when we said, "Look, we're compatible, NorthStar is compatible," and even they agreed, "NorthStar is compatible."

Speaker #2: Everything works. In order for this to be something that they can sign off on—as we now don't just do a research project but launch a new field—you know, they’ve got to get buttoned up.

Steve Wedan: In order for this to be something that they can sign off on as we not don't just do a research project, but launch a new field, they got to get buttoned up. They had to requalify everything that we make. They had never qualified our gen 2 catheters, 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, execute it. That's why 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.

Steve Wedan: In order for this to be something that they can sign off on as we not don't just do a research project, but launch a new field, they got to get buttoned up. They had to requalify everything that we make. They had never qualified our gen 2 catheters, 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, execute it. That's why 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.

Speaker #2: So, they had to requalify everything that we make. They had never qualified our Gen II catheters, so they did that, and they just wanted to run the process one more time.

Speaker #2: And in doing that, this is the first time ever for Philips this has happened. So they had to make the process up first, invent the process, and then execute it.

Speaker #2: That's why it it it took a while from the time when when we were like, "Hey, North Star is ready. Let's go for them to say, 'Okay, now we have our our declaration of conformity.'" Meanwhile, we've got sites like the Cheretee in Berlin with with Garrett Hendricks, 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 visible VT trial.

Steve Wedan: Meanwhile, we've got sites like the Charité in Berlin with Gerhard Hindricks, one of the largest KOLs in the world, waiting to get software updates to their scanner so they can start doing atrial flutter cases now, and very soon doing VT cases as part of our VISABL-VT trial.

Steve Wedan: Meanwhile, we've got sites like the Charité in Berlin with Gerhard Hindricks, one of the largest KOLs in the world, waiting to get software updates to their scanner so they can start doing atrial flutter cases now, and very soon doing VT cases as part of our VISABL-VT trial.

Speaker #2: And that's one of the reasons—and we've talked about it before—that it was important for us to focus on visible 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 two slots they get each month.

Steve Wedan: 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 two slots they get each month, but 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 two or three at the end of a relatively small clinical trial. Remember, VISABL-VT is a small trial. It's only 64 patients, so it can go very quickly at the volumes that these sites do VT procedures.

Steve Wedan: 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 two slots they get each month, but 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 two or three at the end of a relatively small clinical trial. Remember, VISABL-VT is a small trial. It's only 64 patients, so it can go very quickly at the volumes that these sites do VT procedures.

Speaker #2: But 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 two or three at the end of a relatively small clinical trial.

Speaker #2: Remember, visible VT is a is a small trial. It's it's only 64 patients. So it's it's you know, it can go very quickly at the volumes that that these sites do VT procedures.

Speaker #2: So 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 in the Charité in Berlin, which is really, really great news.

Steve Wedan: 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 Charité in Berlin, which is really great news.

Steve Wedan: 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 Charité in Berlin, which is really great news.

Speaker #4: Thank you very much, Steve.

Nick Lau: Thank you very much, Steve.

Nick Lau: Thank you very much, Steve.

Speaker #1: Nick, next up we have Scott Power from Morgans. Scott, please go ahead.

[Company Representative] (Imricor Medical Systems): Nick. Next up, we have Scott Power from Morgans. Scott, please go ahead.

[Company Representative] (Imricor Medical Systems): Nick. Next up, we have Scott Power from Morgans. Scott, please go ahead.

Speaker #5: Thanks. Thanks, Simon. Can I, Steven, team? Just 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.

Scott Power: Thanks. Thanks, Simon. Good day, Steve and team. Just 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'd 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.

Scott Power: Thanks. Thanks, Simon. Good day, Steve and team. Just 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'd 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.

Speaker #5: You partly answered that. I'm just wondering if you could put a little bit more meat on the bone around the VT. Just remind us how many patients you're looking for.

Speaker #5: And why you're so excited about, you know, that part of the business.

Speaker #2: Yeah. The the VT I mean, the the biggest thing about the the that I'm excited about the VT trial is is how it dovetails into the Philips compatibility and getting Hendricks started.

Steve Wedan: Yeah. 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 Hoendervanger, one of his leading EPs there who will be doing the procedures, but having both Felix, who is an up-and-coming KOL, and Gerrit Hindricks talking about these things as an established KOL, these are big deals. This is how, 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 Gerrit Hindricks and blah, blah, and Christopher Piechowski and on and on.

Steve Wedan: Yeah. 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 Hoendervanger, one of his leading EPs there who will be doing the procedures, but having both Felix, who is an up-and-coming KOL, and Gerrit Hindricks talking about these things as an established KOL, these are big deals. This is how, 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 Gerrit Hindricks and blah, blah, and Christopher Piechowski and on and on.

Speaker #2: Once Hendricks starts and really it's it's Felix Hondaner the the one of his leading EPs there who will be, you know, doing the procedures, but having both Felix, who is an up-and-coming KOL, and Garrett Hendricks talking about these things as an established KOL, this these are these are big deals.

Speaker #2: This is how, you know, 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."

Speaker #2: "Who else is doing it?" Before COVID, we used to be able to say, "Garrett Hendricks and blah, blah, blah," and, you know, and Christopher Perkowski, and on and on.

Speaker #2: All that changed and shuffled around, and now we're getting back to where, okay, we've got the right people doing these procedures, and the right names. So, it makes everything easier as we push forward.

Steve Wedan: 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 US, 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 US and around the world as well. They are, of course great candidates for expanding into the VT trial also once they complete the VISABL-AFL study.

Steve Wedan: 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 US, 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 US and around the world as well. They are, of course great candidates for expanding into the VT trial also once they complete the VISABL-AFL study.

Speaker #2: Meanwhile, in the US, the IMRICOR cardiovascular both both, I should say, the visible AFL trial and getting VCU, that's for Jim Virginia Commonwealth University and the University of Virginia and Oklahoma Heart and Johns Hopkins, all doing procedures.

Speaker #2: These are huge places with huge KOLs. In the US and around the world as well. So they are, of course, excuse me, they are, of course, great candidates for for expanding into the VT trial also once they once they complete the visible AFL study.

Speaker #2: And now with IMRICOR cardiovascular, we bring pediatric sites, both their interventional cardiologists and now their intervent or their electrophysiologists are in the sidelines waiting for our EP equipment to get to get approved as well so they can jump into that same lab and do their procedures.

Steve Wedan: Now with Imricor Cardiovascular, we bring pediatric sites, both their interventional cardiologists and now their electrophysiologists are on the sidelines waiting for our EP equipment to get approved as well. 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.

Steve Wedan: Now with Imricor Cardiovascular, we bring pediatric sites, both their interventional cardiologists and now their electrophysiologists are on the sidelines waiting for our EP equipment to get approved as well. 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.

Speaker #2: It's all building. This is the snowball that we've been waiting for.

Speaker #5: Thanks, Steve.

Scott Power: Thanks, Steve.

Scott Power: Thanks, Steve.

Speaker #2: You bet, Scott.

Steve Wedan: You bet, Scott.

Steve Wedan: You bet, Scott.

Speaker #1: Just finally, we've got Sarah Mann at Mollis Australia. Sarah, please go ahead.

[Company Representative] (Imricor Medical Systems): Just finally, we have Sarah Mann at Moelis Australia. Sarah, please go ahead.

[Company Representative] (Imricor Medical Systems): Just finally, we have Sarah Mann at Moelis Australia. Sarah, please go ahead.

Speaker #6: Hi, guys. Can you hear me okay? Thanks for taking my question. Yeah, I guess a follow-on question just with regards to the Philips compatibility.

Sarah Mann: Hi, guys. Can you hear me okay?

Sarah Mann: Hi, guys. Can you hear me okay?

Steve Wedan: Sure can.

Steve Wedan: Sure can.

Sarah Mann: Thanks for taking my question. I guess a follow-on question just with regards to the Philips compatibility. Clearly, it unlocks a lot, particularly for the VT trial with Charité coming online. Are there any other sites in Europe that the Philips compatibility unlocks, and 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?

Sarah Mann: Thanks for taking my question. I guess a follow-on question just with regards to the Philips compatibility. Clearly, it unlocks a lot, particularly for the VT trial with Charité coming online. Are there any other sites in Europe that the Philips compatibility unlocks, and 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?

Speaker #6: Clearly, it unlocks a lot, particularly for the VT trial with the Charité coming online. Are there any other sites in Europe that, you know, the Philips compatibility unlocks?

Speaker #6: And 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?

Speaker #2: Sarah, that's a great question, but it's also a complicated question. It involves some things I can't yet talk about. So let me try to gauge it this way.

Steve Wedan: Sarah, that's a great question, but 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'll get unlocked, but sometimes it's not just about the system needing to be unlocked, it's also about the doctors moved away, so we have to re-engage 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, so there's no sense in doing anything except sort of just keeping them warm. Now we can push forward with those sites.

Steve Wedan: Sarah, that's a great question, but 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'll get unlocked, but sometimes it's not just about the system needing to be unlocked, it's also about the doctors moved away, so we have to re-engage 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, so there's no sense in doing anything except sort of just keeping them warm. Now we can push forward with those sites.

Speaker #2: There are additional Philips sites all over that'll get unlocked, but, you know, sometimes it's not just about the system needing to be unlocked.

Speaker #2: It's also about the doctors who moved away, so we have to reengage with new physicians and so forth. And we're doing that.

Speaker #2: So 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.

Speaker #2: So there's no sense in doing anything, except sort of just keeping them warm. Now we can push forward with those sites.

Speaker #2: When it comes to visible VT, I I think I just have to I just have to hold back for a while. I'd love to tell you all sorts of cool stuff, but I I think I should wait.

Steve Wedan: 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.

Steve Wedan: 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.

Speaker #6: Understood. Okay, thanks, Steve. And then just in terms of, I guess, 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, you know, hopefully, potentially, you know, lead to new European sites signing up as well?

Sarah Mann: Understood. Okay. Thanks, Steve. Just in terms of, I guess, normal course of business volumes in Europe. I know clearly a lot of your sites are tied up with the clinical trial, 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?

Sarah Mann: Understood. Okay. Thanks, Steve. Just in terms of, I guess, normal course of business volumes in Europe. I know clearly a lot of your sites are tied up with the clinical trial, 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?

Speaker #2: Yeah, definitely leads. I mean, the volumes, it won't change the volumes much because Philips they they've all been the one site that's doing procedures actually is is still using the old iSuite software, but they're at a dead end and they'll have to upgrade their scanner and then move to Northstar pretty soon.

Steve Wedan: Yeah, definitely The volumes, it won't change the volumes much because Philips, The one site that's doing procedures actually is still using the old iSuite software, they're at a dead end, they'll have to upgrade their scanner and move to NorthStar. Pretty soon. The other sites, yeah, it will. I actually haven't been thinking about in terms of what would the volumes do with the Philips compatibility. Places like Charité 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, years ago, Geert Hendriks 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.

Steve Wedan: Yeah, definitely The volumes, it won't change the volumes much because Philips, The one site that's doing procedures actually is still using the old iSuite software, they're at a dead end, they'll have to upgrade their scanner and move to NorthStar. Pretty soon. The other sites, yeah, it will. I actually haven't been thinking about in terms of what would the volumes do with the Philips compatibility. Places like Charité 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, years ago, Geert Hendriks 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.

Speaker #2: And then the other sites, yeah, it will—it will. I actually, I haven't been thinking about it in terms of what the volumes would do with the Philips compatibility.

Speaker #2: But, you know, places like Charité aren't going to jump into ventricular tachycardia ablations. They're going to start doing routine, you know, atrial flutter ablations.

Speaker #2: And I remember years ago, we never got a chance to do it, but years ago, Garrett Hendricks said to me, he said, "Right now, at this stage, this was actually in the early days of of the pandemic when we thought that, you know, it'll come and go." He said, "This is when it's important to do procedures, procedures, procedures." He said to me, "I've launched with with companies I've launched technology like this before.

Steve Wedan: He said, This is when it's important to do procedures, procedures. He said to me, 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.

Steve Wedan: He said, This is when it's important to do procedures, procedures. He said to me, 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.

Speaker #2: 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.

Speaker #2: And it's important for you as a company to establish this procedure. Before that, I should say, and this is why it's kind of a telling thing.

Speaker #2: 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."

Speaker #2: That's all that matters. And we 100% agree with that. And that's how you go through your clinical work. But then, once you get past the tipping point where this all clearly works, he said, "Procedures, procedures, procedures." So that's what we're getting back to now when we go into a place like the Charité, which makes it exciting.

Steve Wedan: 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 Charité, 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 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.

Steve Wedan: 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 Charité, 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 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.

Speaker #2: The other thing that's going to—you know, we knew this was going to happen, all in the right timing—but 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.

Speaker #2: It's brand new. Everything in there is brand new. And Philips won that bid. So we're moving into a brand-new Philips IMR lab with our technology.

Speaker #2: So two things happen. One, they can do procedures in the regular course of business, like they would do any other procedure. They don't have to wait for patients.

Steve Wedan: 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 Conformity, 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.

Steve Wedan: 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 Conformity, 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.

Speaker #2: 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.

Speaker #2: So they can do them as they need to. And, you know, if we didn't do the Philips, if we didn't have the Philips declaration of conformity, we'd be stuck at another dead end with a site that's got the perfect lab and not able to do anything.

Speaker #2: So, of course, this lined up perfectly for them as well as they move into that new Philips lab. And this—You know, 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.

Speaker #2: Now we do. And there are a lot of really cool things coming with respect to Imricor and Philips, and I look forward to telling you about that more in the very near future.

Steve Wedan: Now we do. There's a lot of really cool things coming with respect to Imricor and Philips, and look forward to telling you about that more in the very near future.

Steve Wedan: Now we do. There's a lot of really cool things coming with respect to Imricor and Philips, and look forward to telling you about that more in the very near future.

Speaker #6: Great. Thanks so much, Steve.

Sarah Mann: Great. Thanks so much, Steve.

Sarah Mann: Great. Thanks so much, Steve.

Speaker #1: Yeah, just a couple of final submitted questions, Steve, just to continue on the compatibility. Now that Siemens and Philips are compatible, what's the status with GE?

[Company Representative] (Imricor Medical Systems): Just 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?

[Company Representative] (Imricor Medical Systems): Just 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?

Speaker #2: Yeah, GE is still moving forward. We have the, the, the software that Northstar is released on. Its, our internal software number is 1.4.

Steve Wedan: Yeah, GE is still moving forward. We have the software that NorthStar is released on. Its 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. They're doing it, but 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.

Steve Wedan: Yeah, GE is still moving forward. We have the software that NorthStar is released on. Its 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. They're doing it, but 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.

Speaker #2: The 1.5 software for Northstar will be the Northstar version that connects to the GE scanner. And there's a lot of work on the GE side as well.

Speaker #2: And they're doing it, but, you know, this is one of the things—we've been doing this for 20 years, right? Where I'm trying to work with huge companies.

Speaker #2: 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.

Speaker #2: And this is important to them, but it's not everything they do. So, you know, we've been shepherding them along and moving things forward as best we can for decades.

Speaker #2: And that's what we're doing with GE. That that's coming along. We we have a a schedule. We hope that everybody stays on it and and we'll be talking about the release of 1.5 pretty soon the second half of this year, I hope.

Steve Wedan: We hope that everybody stays on it, and we'll be talking about the release of 1.5 pretty soon, the H2 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 two-thirds 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.

Steve Wedan: We hope that everybody stays on it, and we'll be talking about the release of 1.5 pretty soon, the H2 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 two-thirds 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.

Speaker #2: But again, that's not something that is in complete control of Imricor. And it's fine, because we've got two-thirds of the world's leading MR vendors as part of our IMR toolkit.

Speaker #2: So, we have plenty of open space to go and grab. Where GE becomes important is with sites that are stuck with the GE, and we want the doctors.

Speaker #2: So 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.

Speaker #1: David, just a final question. Can you discuss the biopsy opportunity, and perhaps comment on the size of the opportunity and the roadmap to commercialization?

[Company Representative] (Imricor Medical Systems): Dave, just a final question. Can you discuss the biopsy opportunity and perhaps comment on the size of the opportunity and roadmap to commercialization?

[Company Representative] (Imricor Medical Systems): Dave, just a final question. Can you discuss the biopsy opportunity and perhaps comment on the size of the opportunity and roadmap to commercialization?

Speaker #2: Yeah, 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.

Steve Wedan: Yeah, 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, 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, this expanding case scope with interventional cardiology, because those folks can do those procedures as well. It's actually not clear to me if the biopsy is 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.

Steve Wedan: Yeah, 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, 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, this expanding case scope with interventional cardiology, because those folks can do those procedures as well. It's actually not clear to me if the biopsy is 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.

Speaker #2: 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 this earlier, but that, of course, is a big part of this expanding field, or the expanding case scope, with interventional cardiology.

Speaker #2: Because those folks can do those procedures as well. Actually, it's not clear to me if the biopsy is going to fit into the IC vertical or the EP vertical, or if we're just, you know, going to offer that in both of those areas.

Speaker #2: But it's a big opportunity for different reasons. EPs say, you know, I'd like to do this because it helps guide my therapeutic decisions with respect to ablation.

Steve Wedan: 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. 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.

Steve Wedan: 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. 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.

Speaker #2: Interventional cardiologists for different—for different reasons. And even, you know, for transplant reasons is the reason they'll do—they'll do biopsies today. So there's a lot to put together.

Speaker #2: What I have now, I stopped short of throwing that. It's just—if it weren't a significant opportunity, we would not be pursuing it.

Speaker #2: So it it'll be coming.

Speaker #1: Thanks for that, Steve. That concludes the Q&A segment. I’ll now hand it back to you for closing remarks.

[Company Representative] (Imricor Medical Systems): Thanks for that, Steve. That concludes the Q&A segment. I might just hand it back to you for closing remarks.

[Company Representative] (Imricor Medical Systems): Thanks for that, Steve. That concludes the Q&A segment. I might just hand it back to you for closing remarks.

Speaker #2: Well, 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, you know, especially the last 18 months.

Steve Wedan: Well, 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.

Steve Wedan: Well, 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.

Speaker #2: 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.

Speaker #2: And we couldn't be more pleased with the with the support that you've given us. Thank you so much.

Speaker #1: Thanks, all. Thanks, Steve. Thanks, Shawn.

[Company Representative] (Imricor Medical Systems): Thanks, all. Thanks, Dave. Thanks, Sean.

[Company Representative] (Imricor Medical Systems): Thanks, all. Thanks, Dave. Thanks, Sean.

[Analyst]: Goodbye

[Analyst]: Goodbye

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Q2 2026 Imricor Medical Systems Inc Earnings Call

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Imricor Medical Systems

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Q2 2026 Imricor Medical Systems Inc Earnings Call

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Sunday, August 9th, 2026 at 10:45 PM

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