Good morning, everyone, and welcome to Medistim's Capital Markets Day. I'm very happy to see also people here in the room, in the conference center in London, but I know that we have a lot of people following us online. We have a packed agenda for you today. You will see that the first half of our meeting here will concentrate on the cardiac market and tell you more about our new launch of the INTUI software and what that will mean for us and for the surgeons in this space. Then we will have a Q&A session, and we will continue with talking about the vascular market, and we will learn about the new PATENT study that is just starting.
But first, I will start with sharing some comments about where Medistim is today and put this into the context of next steps and innovations for accelerated growth. So, Medistim's journey, as you probably know, started already 40 years ago, where we were a distributor of heart valves in the Norwegian market. And shortly after, the company started to develop its first proprietary product, the first flow meter, the CardioMed, which was put on the European market in 1994. And since then, we have stayed committed to develop and refine these technologies for the surgeons out there in the world. And today, we can say that we are a truly global organization with subsidiaries and direct sales and support teams in the U.S.A., Canada, China, Germany, Spain, U.K., Denmark, Sweden, and Norway. Let's also remind ourselves a little bit about the medical need and the technology.
Medistim helps treat cardiovascular disease, and cardiovascular disease continues to be the leading cause of death globally. The target applications that Medistim is serving are coronary bypass surgery. It is also peripheral bypass surgery and carotid endarterectomy as some of the most important application areas. In all of these spaces and in CABG surgery, it's always been this big question. When a patient needs revascularization, what is the optimal treatment? Should it be a percutaneous coronary intervention using stents, or is the patient benefiting more from open CABG surgery? We will have comments from surgeons here today, which will put more light on this question. It's a fact that 80%-90% of patients in need of revascularization are referred for a PCI. Still, more than 700,000 patients are getting a CABG surgical procedure annually, and it's been a pretty stable number over the years.
When we are putting patients through this pretty invasive procedure, it is very important that we are making sure that the graft is patent. Here is where Medistim's technology, the transit time flow measurement technology, comes in. The beauty of this technology is that it really gives instant feedback on graft functionality. It provides the surgeon with the opportunity to correct and to revise while the patient is still on the operating table. Right here, we can see indications on the top right of a suboptimal graft. We see a very spiky flow curve here, and we see a low flow. In this example, the surgeon decides to revise the anastomosis, and we see a much better flow result. Fixing the problem there and then.
But if the flow is low, there's not always a technical issue with the anastomosis that can be fixed. So, that's also very important. And Medistim felt that, you know, we should develop a tool that could help investigate these instances. And that's why we came out with the high-frequency ultrasound modality and putting that into the same device. And today, we are then delivering an expanded value proposition. It's a new workflow, and we're working and believing that this, in the future, will become the new standard of care. The use of our technology is extensively documented. We have more than 600 clinical papers with Medistim's technology, and we have also received endorsement from a number of clinical guidelines, both on the cardiac procedures, vascular procedures, both for flow and for imaging. And the MiraQ, this is the latest generation.
This can be purchased as a flow-only system, or you can have it as a flow and imaging system, or you can actually upgrade it to imaging later on if that is of preference. The probes, so the TTFM flow probes, that's the sensors of this technology, they're sold as consumables and are reusable. And on the slide here, we can also see our imaging probe, which is unique in being approved for direct contact with cardiac tissue. It provides really excellent resolution in the near field, and it has a small probe head that allows for use in small incisions, and that's important. We're trying to provide our products in the most flexible way. We are using alternative business models here, so the systems can be bought as capital.
We are also offering a pay-per-procedure type of model in the United States and in the U.K., and we're also providing lease options. Let's take a little look at the market. So, starting with the coronary artery bypass graft market. So, I already mentioned that we are counting more than 700,000 CABG procedures being performed every year. It's somewhere between 700,000 and a million. And based on the number of probes that we are selling, we are estimating that we are serving about 37% of these 700,000 procedures. Then we are also estimating that competition may serve about 8%, so let's say around 45% of the market is then supported. It means that more than half of the procedures are not assisted with any type of technology and are supported only with finger palpation.
So, it means that we are looking at the total addressable market for the company based on flow only of NOK 1 billion annual sales per year. And if we are counting in the high-frequency ultrasound modality as well, that addressable market is double the size. Looking at the TTFM adoption in CABG, so I think this is still a very interesting map. We see that Japan has been the leader, is still the leader, and most of the procedures being performed in Japan are served with Medistim's technology. This is also the situation for most of Europe, so Central Europe and the Nordic countries. I'd say more than 80% of procedures are served. And we can also see that in the United States, things are moving. So, based on the probe sales, we can now estimate that we're serving about 35% of these 200,000 procedures.
In the future, of course, markets like India with a growing population and also a growing number of CABG procedures being performed, this is an important future market for Medistim. It's also interesting to see that following this increasing adoption, we are seeing an increasing number of publications coming out there. So, the last 15 years, we've seen a tremendous growth in publications. And I think this talks to the relevance and the importance of the technology and the interest from the surgical community to investigate further its value. And of course, CABG surgery is dominating here, but we're also seeing an increased number of publications on vascular applications and transplant as well. So, surgical guidance and quality assessment are needed in vascular surgery as well.
This market is actually larger than the CABG market, both in terms of the number of procedures being performed annually and also then providing a larger market opportunity for Medistim. We will talk a lot about peripheral bypass surgery later today. As you can see, that market research that was performed last year found that it's more than 500,000 peripheral bypass surgery procedures being performed every year globally. Quick look at the financial performance. We see that over time and over the past two decades, we've seen strong revenue and profit growth from the company. Last year, we delivered NOK 526 million in revenues, and 69% of this is what we call recurring revenue. It comes from probe sales, from sales of probe procedures, and also from lease income. The EBIT margin last year was at 25%.
I think it's a solid margin, but a bit lower than we have been used to seeing, so we would like to take that up to the more normal levels. On the balance sheet, we see strong cash flow, high equity ratio, and no long-term interest-bearing debt, so a solid position. Taking a look at the year-to-date numbers per September. Last year, we actually delivered growth in Norwegian currency, but due to the weak Norwegian krone versus both US dollars and euro, if we compensate for that, we actually had a slight decline on our sales revenues last year, and we are pointing to the sort of macroeconomic headwinds with high interest rates and inflation as one of the components for actually making purchasing and investment decisions a bit harder. We've seen this lightening up through this year.
We had a growth since the first quarter and a higher growth as the quarters have combined. After three quarters, we are looking at 5.3% revenue growth in Norwegian currency, and the currency adjusted this correlates to 3.7%. Still in the lower range compared to what we have used to see. Thereof the current topic for today, how to accelerate growth going forward. We'll come back to that. I think it's great to see that the Americas region, of course, with the U.S. being the most important market, came back very strongly in the third quarter with 17% currency neutral growth. That is a sign of recovery. The Europe, Middle East, Africa is doing well at 6.8% growth, and Asia-Pacific has been influenced by the transition of going from a distributor to direct operation in China and also some challenges in Japan.
Third-party products had a really strong year so far this year with 14% growth, which is actually untypical. Sales revenues, of course, have an impact also on EBIT, but we also know that we are now running the operating expense level at a higher level due to these new direct countries and also because we introduced a double shift in our probe production. So, EBIT margin has been a bit lower than we have been used to seeing, but it has been recovering, and 25.6% EBIT after three quarters, I think, is decent. We need to talk about our growth strategy, and we remain committed to converting the high-penetrated flow-only CABG markets to flow and imaging, and the REQUEST study, as I think many are familiar with, will continue to be a very important tool in achieving this goal. Further growing adoption in under-penetrated markets.
I have pointed to several regions of the world where the use of TTFM is still sort of in the early days, and product innovation for ease of use is central to get some traction there. I pointed to flexible pricing and business models and that we are building a position in vascular surgery, and we will continue to expand our direct market coverage also. But let's go into the product innovation part here. So, as I think many companies in this space have experienced over the past several years, regulatory requirements have really made it, yeah, it's a bit hard to allocate as much resources to innovation and product development compared to earlier days. We've seen that a lot of our resources have gone into maintenance and really being able to keep the products on the market. So, we found that we had to actually reimagine our innovation process.
We wanted to create a team that could work looser, so in a more agile way and very much in close collaboration with users, and we also wanted to ensure that the voice of customers is also meeting the voice of technology, so let's also ask, you know, with the new technologies available to us, how can we exploit them and how can we put them into action into our own products, so with this group, we have been able to deliver more defined concepts and handing this over to the engineering team so that their job becomes more effective. At the same time, we had to also increase the capacity, so the number of heads in our product development, and it's been doubled since the pre-COVID time, so just reminding ourselves on sort of the history here, so we launched TTFM in the mid-1990s.
We had several generations of the flow meter, then launched a new paradigm of adding high-frequency ultrasound in 2010, and we are now working on the sixth generation, which is in development, and going forward, of course, we will continue to work on the hardware side of things, so we will continue to develop the systems, the devices, and the probes as well, but I do believe that we will be seeing a lot of innovation where we're adding value from data, data from the systems and data from the clinical cases as well, and that's what we're going to learn more about today, the INTUI software, and I will just say that based on this platform, we will also see imaging upgrades. We will see increased connectivity both to the patient journal and to enabling us to do remote servicing.
A little bit later, we will also see, hopefully, interpretation guidance based on machine learning. I'm using my time here and the INTUI software. Tore, my good colleague, will talk more about this. What it is, first and foremost, it's a response to users' requests. It is really point by point trying to address what they have told us. More intuitive user interface. They wanted reference values, more context data. We will learn more about that. It's also a fact that the old software has created some type of technology debt for the company. We took the opportunity in this project to actually revamp the whole software architecture. We're now looking at the cutting-edge future-proof software architecture that will help us shorten the development time for the next innovations.
And on the vascular side, we will also today learn about the PATENT clinical study, very important because there is a lack of interpretive guidance and completion control for peripheral bypass surgery. And the timing for this study is really good because here, as in CABG, there is a debate on what is the best procedure. Is it endovascular alternatives or open surgery? And a recent study, the BEST-CLI trial, is concluding that endovascular treatment is today, well, it's the first choice, but the recent study has shown that the open surgery provides better results. So, it's really timely to investigate further how our technologies can help manifest this. And I'm very, very proud to present the investigator team for the PATENT study. Here we have Professor Michael Conte as the lead investigator, who is also the first author of the global guidelines in this space.
We have the Secretary General from the European Society for Vascular Surgery, Maarit Venermo, which we will also hear from later in this presentation today. We have the P resident of the Japanese Society for Vascular Surgery, Professor Azuma. We have Professor Alik Farber, which was the first author of this BEST-CLI trial. And we have Professor Clement Darling and Professor Joseph Mills, who are both past presidents of the American Societies of Vascular Surgery. So, a great group of people, and it's going to be very interesting how this study will both start and continue, and we will see what it will lead to. To summarize, why should revenue growth accelerate? So, this is really the big question, right? And first of all, I will say that I believe market dynamics is getting back to a more normal state.
In the U.S.A., we see that macro improvements with inflation stabilizing at a lower level. This should lead to continued relief and greater investment capacity. So, this is also already what we're seeing signs from in our own sales processes. In Asia-Pacific, we expect to be past the transition time in China, and we also expect Japan to normalize. And then, of course, these new initiatives that we've just mentioned and we will learn more about, the INTUI software on the cardiac side and the PATENT study on the vascular side will help us spur interest and awareness and thereby also adoption of these technologies. Continuous improvement is always important for us, and we will definitely continue to concentrate on that. The EBIT is also expected to come back to more normal levels, although I'm not ashamed of the EBIT margins that we are currently delivering either.
But with higher growth in own products compared to the third-party products that will drive EBIT margin, higher growth of the imaging will drive the same, and also seeing higher margin sales from U.S. and other direct markets will help us in this direction. And we're also working on automating our manufacturing process of probes, and that will, in the little bit longer term, help us also. So, with this, I've spent all my time and more, so thank you very much for listening to that. Now, I will give the word to the product and business manager for our cardiac business, Tore Skjeggestad, and the title of his talk will be "Introducing INTUI, our new software platform, Tore, an intuitive solution optimized to provide data interpretation guidance and enhancing surgical decision-making for better patient outcomes."
Thank you, Kari. That is right. That is the title of my presentation. I took the liberty of shortening a little bit in the sense of type. But yes, I'll be here to introduce the new MiraQ Cardiac INTUI software platform. I am very excited and very proud of this, and I'm glad to have the opportunity to talk to you people about this. But what is this MiraQ Cardiac INTUI software platform? As Kari said, we have been focusing our innovation lately into collaboration with the surgical communities. This software platform is developed in collaboration with surgical communities worldwide. That has been very important for us that this is something that is developed in accordance and in collaboration with these surgical teams. This is not something that a bunch of engineers have cooked up in a corner in a corporate building. This is useful stuff.
Our focus has been on improving the system interactions and providing better support for interpretation of flow measurements to make it easier to use for the users and, in the end, to create a wider adoption and more routine use of our systems in the market. We have already a well-established market base. We've already sold all the early adopters. Now we need to reach the normal surgeons and the normal surgical teams. To do so, we need to remove all of the hurdles and the barriers of entry. This is a software that we believe does that. With that said, INTUI has for us been about simplification. In the sense of simplifying things, I'm going to, we've done a bunch of changes. There's a lot of changes in the software, but I'm going to boil it down to four main points.
We have been improving on our dual modality setup. So, our system does two things. Having a system do one thing really good is a lot easier than having a system do two things really good. So, we have doubled down on that. We have, as you'll see, modernized the user interface quite radically. We have added context for the decisions with some graphical elements that I'll show you. And we have greatly improved the reporting functionality as well. Go first to the merging of the ultrasound imaging and the transit time flow measurements. So, in medicine, we believe that these two modalities go perfectly well together. They are fantastic in the way that they provide different types of data that are useful for the surgeon. So, the ultrasound imaging gives you the contextual information.
It gives you a picture, a map if you want, of what is actually going on. And then you get the hard data from the transit time flow measurement that gives you actionable numbers that you can correlate with your previous knowledge. And now with the INTUI software, you can have some guidance in there as well when you do this. And the improvements we've made to these two modalities in the INTUI software is that we've made the interactions smoother, so there are less button presses. Ultrasound imaging is a complicated modality. We have boiled it down to the minimum amount of button presses so that it's easy for the operating team in a stressful environment to correctly set up the system and use it optimally.
Now, the user interface has been greatly modernized throughout the whole software, but the words most apparent is probably here in the ultrasound, sorry, in the transit time flow measurement live measurement screen. The top illustration here is the current software, which is perfectly functional, but when you compare it to the bottom version, which is the new INTUI software, you see that there's a lot of changes, and we've kept all the good things, of course. The flow curve is essential. The mean flow pulsatility index, diastolic filling, all of these things that are important for how you interpret the transit time flow measurement, all of that information is still there, but now it's grouped in a logic way on the top of the screen so that you, at one glance, can take in all of these parameters and see everything you need to see quickly.
You don't have to search around the screen to find the numbers. They're all up there very easily identifiable. Also, on the right side of the INTUI screen, you see that we have added a work list, as we call it, that tells you where you are in your procedure. There is a graphical representation of your graphs instead of just a text that tells you which components you've used. This type of information makes it much more obvious for the rest of the surgical team where you are in the procedure. If a more expert surgeon needs to come and help a less expert surgeon, he will quickly know where the procedure stands just by looking at the screen very quickly. So, like in this example case, this is a relatively bad flow curve.
If somebody needs to come in and rescue the day, they will take one look at the screen. They'll know where they are, and they will understand the problem quickly. And also, with the graphical representation of the graphs instead of using words, this was a complex problem for us to solve because there was no standardized way of naming these graphs. And that was a problem if you want to create a large set of data because you need that data to be standardized and analyzed correctly if you want to do some further analysis on it. Now, with this graphical representation, with the drawings or the subway maps, as we like to call them, it is standardized, meaning that we can collect data from large sources and start actually crunching these numbers and hopefully get some interesting findings. I've been promising context for decisions.
What I've been talking about is, of course, the gauges or the dials on the top of the flow measurements here. It's very colorful. We're using the traffic light convention, red, yellow, green. These are all user configurable so that every surgical team and every surgeon can input their own values that they like to use for their decisions. These are numbers that the surgeon will previously have had to keep in their mind all the time. They'll have to read them, memorize them, and remember them during high-pressure situations like surgery. This can be difficult in a pressured situation, so we just put them on screen for them instead. It's a very simple fix, but it's a very important one.
The values they want to use can be individual, or they can be set up by an institution, or they can be tweaked to the different types of measurement steps as well. It's very flexible. This will be a great tool for less experienced surgeons. They can have these values input. They can read publications, put them in there, and they will always be there and help them. We also improved our reporting. Bottom left picture here is Dr. John Puskas that is proudly reading his report after trying the system. The reporting was previously just a printout of whatever you'd measured.
Now, in this new and improved reporting scheme, you get a one-pager that summarizes your whole procedure and shows you at one glance what you've done, all the graphs you've performed, the measurements you've done in a small thumbnail that captures the most important characteristics of the measurement. And then, of course, in the subsequent pages, you have the actual measurements. So, this front page, the feedback on this from our early access sites has been that this will actually save the surgeons a lot of time because a lot of time they will have to hand-draw this picture of the heart instead. Now, you get a beautiful illustration created by the system that can be used to communicate with your peers at the hospital or even maybe patients and relatives if you choose to do so. And this INTUI software is just the first step.
It's the start of the INTUI experience. This will be the software platform that medicine will use to continue innovating on, building new features, introducing new functionality in the future, and as Kari said, we've redone the whole thing. It makes it easier for us to innovate quicker, be faster to the market with new features, and I, as a product manager, am very much looking forward to releasing a bunch of new and exciting features on this platform in the relatively short future, so thank you. That was all for me today.
I am very happy to be able to introduce the next speaker. That is Professor Puskas, who is the Chief of Cardiothoracic Surgery at Emory University Hospital Midtown in Atlanta, Georgia. He's also one of the founders of a very, very important organization, the ISCAS organization and the ICC meeting that has just celebrated, I would say, the 10th anniversary of their inception. John Puskas has a lot of experience with our technology, and I would say he's absolutely one of the most influential voices in cardiac surgery today. Please, John, the stage is yours.
Thank you, Kari. And thank you for the opportunity to address this important group of people who are helping to lead and I imagine also fund a technology that is focused on improving the quality of coronary bypass surgery, at least in my world. I know you have a focus on vascular surgery and other things that are not part of my day-to-day life. But we at the International Society for Coronary Artery Surgery live and breathe coronary surgery. And we rely on the Medistim portfolio of products to help us be sure that at the end of each operation, we've done the excellent job that every patient deserves. So, my topic is the role of Medistim in quality improvement for coronary bypass surgery. These are my disclosures, the most important of which is that I am a consultant to Medistim for training and also new product development.
I was privileged to have a small role in helping the engineering team refine the INTUI software and also participate in some of the ongoing efforts towards improvement in hardware. I agreed to serve as a consultant to Medistim because the corporate mission of Medistim and the corporate mission or the academic mission for my own career and for the International Society for Coronary Artery Surgery are perfectly aligned, namely to improve the quality of care of coronary bypass patients globally. So, what is coronary bypass? Well, just for the newcomers, perhaps, coronary bypass surgery is the only surgical treatment for coronary artery disease, which is the number one killer of human beings. Blood vessels from elsewhere in a patient's body are harvested and redeployed to the heart, becoming conduits to deliver blood supply beyond blockages in the arteries that normally feed the working muscle of the heart.
What future will this surgical procedure or this set of surgical procedures have? I believe it's a bright and growing future. It will require ongoing collaboration between innovative surgeons and innovative corporations to improve coronary bypass surgery. But as Abraham Lincoln said, the best way to predict the future is to create it. I think it's important to focus or to realize that Medistim addresses the value imperative in surgical therapy in general, that is, that we must provide value by improving quality at a reasonable cost. Now, coronary bypass surgery is expanding worldwide, and adoption of the transit time flow meter technology that Medistim has introduced is also expanding worldwide. We anticipate the number of global coronary bypass operations rising towards 1 million in the next year or two. This is largely due to growth in China and India.
It's also due to an aging population in the developed world and the rapid, remarkable expansion of what we think of now as a pandemic of cardiometabolic syndrome, which is a combination of obesity, diabetes, and systemic inflammation. This produces coronary artery disease and peripheral vascular disease, both of which are the two primary disease processes that Medistim addresses. Another important concept, well, and I will say without going into a very long discussion of the new pharmaceuticals that have been brought to the market in the most wealthy portions of the world, the Ozempic-like medicines are having an impact on primary care. But if you measure simply the proportion of human beings on this planet who have access to those drugs presently, it's minuscule, almost very difficult to measure. It's so small compared to the total number of patients globally with coronary artery disease.
Another sort of seismic change that's coming is an evolution away from the role of the interventional cardiologist performing an invasive diagnostic coronary angiogram to function as a gatekeeper to assign patients to have either stenting or percutaneous coronary intervention or coronary bypass surgery. The very fact that the ratio of PCI or stenting to coronary bypass surgery varies by tenfold among different practitioners, different cities, and different countries tells you that there is a great deal of influence on that decision-making that is not evidence-based and, frankly, probably not appropriate or in the patient's best interest. This is fundamentally possible because the person doing the diagnostic test presently is an interventional cardiologist who can simply proceed with a stent procedure without further delay or discussion or involvement of a coronary surgeon.
That gatekeeper role is changing, and I think it will change fundamentally over the next two to five years throughout the developed world. And I mentioned the epidemic of diabetes and cardiometabolic syndrome. Well, India has the distinction of being the diabetes capital of the world. We're now approaching 60 million diabetic patients in India, 40 million in China, and a little over 20 million in the United States. These numbers are rapidly rising with no end in sight. And that leads to an accelerating burden of cardiovascular disease with India now outstripping all other nations on Earth. And I think that's to a degree because we're not able to measure it as well in China. But suffice it to say that this burden of cardiovascular disease is ramping up globally with no end in sight. And coronary bypass surgery subsequently is also rising.
After a dip during the pandemic, coronary bypass cases in India continue to rise, and we now have clear evidence that India is the nation that performs the largest number of coronary bypass operations globally at about 200,000 individual cases. Why does that matter? Because coronary bypass surgery works better for patients with diabetes than stenting does. And this is the data from the FREEDOM trial published in the New England Journal, actually a decade ago, which randomized patients to have multivessel stents or coronary bypass surgery. And all of these patients were diabetic. And you can see that for the hard endpoint of death, stroke, and myocardial infarction, coronary bypass beat stenting. And the curves really began to diverge at about two and a half years and continued to diverge through the first five years with a striking benefit of coronary bypass over multivessel stenting for patients with diabetes.
Again, the epidemic of diabetes is very relevant. When we follow those same patients in that trial through seven years of follow-up, the curves continue to diverge further in favor of coronary bypass, and why is that? It's because coronary bypass protects patients not just from the effects of a present flow-limiting upstream blockage in a coronary artery, but also protects patients against acute events caused by non-flow-limiting lesions, which can rupture and have an acute thrombosis in the future, so coronary bypass surgery benefits patients more than stenting because it protects against future myocardial infarction. It does so at the expense of more invasion and more perioperative risk, and the number one thing that we think about is stroke. These are also data from the FREEDOM trial showing you that the risk of stroke is about twice as high in coronary bypass compared to stenting.
But there are things that can be done to mitigate against that risk. And primary among them is use of ultrasound at the time of surgery to interrogate the aorta and to decide exactly where to put cannulas and how to apply clamps to the aorta to safely accomplish the operation while reducing the risk of stroke because most strokes come from atheroembolism, that's to say embolism of atherosclerosis from the aorta itself during the operation. And the Medistim high-frequency ultrasound or epicardial ultrasound probe is especially useful in this regard. And you can see images that we can get from this kind of tool to interrogate the aorta and plan where we're going to apply a clamp because we don't want to apply it over an image or rather over a sort of fungating atheroma that you see there in this aorta.
Even this kind of thickened aortic wall can spill debris into the bloodstream if a clamp is applied at that spot. So, my favorite operation involves completely avoiding any manipulation of the aorta. And here you see an image of that where two internal thoracic arteries are used for inflow, and there is no manipulation of the aorta at all. This is also ensconced within the European guidelines recommending minimization of aortic manipulation. And prior to aortic manipulation, the use of epiaortic ultrasound, again, one of the key technologies that Medistim brings to the operating room for us. The other key technology is the transit time flow meter tool that was described earlier and shown.
This is the device that measures by an ultrasonic technology, a flow meter technology, the actual flow within the bypass grafts, the resistance of flow, the characteristics of the pulsatility of the waveform of that flow. And it helps us understand the quality of the bypass graft and the accomplishment of our goal for that patient. It also allows us to do it again, to revise a bypass graft if we see with immediate feedback in the operating room that the bypass graft we've constructed is not doing the job we expected it to do. And Kari mentioned earlier the request registry or clinical study. I was privileged to participate in this. And it was and is, I think, a landmark study of 1,000 patients from seven sites in Europe and North America having first-time coronary bypass surgery.
We used the Medistim transit time flow meter and epicardiac ultrasound imaging probes to study the grafts and to document the quality of the grafts with the older MiraQ technology. But even with the previous generation of software, this tool was extremely useful. In fact, 26% of patients had at least one change or adjustment in surgical strategy driven and guided by the information the surgeons received from the Medistim tools. And the adjustments were where to manipulate the aorta, where to bypass the actual coronary target, whether to revise the bypass anastomosis, and to interrogate the quality of the conduits themselves. So, 10% of patients had a change in planned aortic manipulation based on the identification and detection of atherosclerosis in the ascending aorta.
To adjust for that potential risk, the ultrasound guides the surgeon to individualize the application of cannulas and clamps to the aorta to minimize risk. About 20% of patients had a change in the anticipated site on the coronary artery where the anastomosis would be constructed to ensure that the bypass graft goes beyond, not in front of the blockage in the artery that is visualized on the angiogram. About 3% of bypass grafts were revised, that means to say redone at the time of surgery because the flow of the TTFM was unsatisfactory. And typically, after they were revised, the flow was much improved. And that, of course, is the primary purpose. Now, until recently, we hadn't a peer-reviewed publication that said, well, that makes patients live longer. But this paper from Italy actually does exactly that.
This is an analysis published in December of 2023, presented last year at the American Association for Thoracic Surgery by Dr. Lally and her colleagues, an analysis of a multi-center registry evaluating the role of TTFM or transit time flow meter in coronary artery bypass surgery, so this is 1,600 patients who had coronary bypass surgery at nine sites, and basically, they sought to identify whether there was a cutoff point in the TTFM that would predict poor outcomes for patients, and they determined that accepting an inadequate, that is to say less than 15 mL per minute flow to the LAD was, in fact, predictive of adverse events during clinical follow-up.
And here you see that the MACE, the likelihood of death, stroke, or myocardial infarction was about 3.5x higher in patients who were left with a flow to the LAD less than 15 compared to those whose LAD flow was greater than 15. Moreover, as you can see in the lower panel, when graft flow was poor and the graft was subsequently revised, the later graft flow was much improved. And similarly, the pulsatility index or PI, which was too high before revision, was suitably lowered after revision. So, these are direct measures that the Medistim technology guides surgeons to make appropriate changes in the operating room. And those changes improve graft function as measured by the Medistim device. And that improved function correlates to better clinical outcomes for their patients. This is an important three-step logic that validates the utility of the Medistim technology in coronary surgery.
I'm going to show you a couple of cases because it relates to that LAD flow. What should one do with a skeletonized left internal thoracic artery graft, the typical conduit we use to bypass the LAD, if it has poor inflow? We had a resident learning to harvest skeletonized ITAs, and the ITA had mediocre flow. We assessed it with the ultrasound probe and identified a portion of that arterial conduit, which was damaged during the harvest. It had what's called a dissection. We excised that segment, reconstructed it, and then used it for the bypass graft, resulting in a good outcome for the patient. Now, what to do if you've already done the anastomosis to the LAD and the flow is not so good? Of course, we measure the flows.
Here's an ITA to the LAD that looked visually to be just fine but had a flow of only five cc per minute and a pulsatility index that was much too high at eight. We were guided by the TTFM and ultimately made the decision to redo the left internal thoracic artery graft to the LAD, then after repeating the TTFM, we see that the flow is now 23, the pulsatility index is less than three, and the patient did well. I will confess that I assisted my junior to do that anastomosis, and I thought he was doing a perfectly good job, apparently I wasn't doing such a good job supervising him, I will confess that this is, you know, I've done this for 30 years. Apparently, I missed a maneuver that he performed that limited the flow at the toe of that anastomosis.
And when I personally redid it, the flow was, you know, 5x higher. I wouldn't have noticed that in the absence of using TTFM. I thought that I had seen him, watched him adequately, and the graft was fine, but in fact, it was not. So, this is why the European guidelines recommend routine intraoperative graft flow. And I think it's bizarre to perform coronary surgery without that. I'm going to segue before closing to a new technology that, as I mentioned earlier, will change the gatekeeper role for the interventional cardiologist. And I believe will lead to a higher portion of patients having coronary bypass surgery rather than multivessel stenting that is inappropriate for them. And that new technology is an imaging technology, not a surgical technology.
This technology allows a non-interventional cardiologist or even a radiologist to perform a study that will reveal and document the existence and location of blockages in the coronary arteries without involvement of an interventional cardiologist, so that one can imagine a family practitioner or a non-interventional cardiologist subsequently deciding whether the patient should have coronary bypass surgery, multivessel stenting, or just medical therapy. These are the kind of images that are available that can be produced with commonly available CAT scanners today. The numbers represent the nomenclature of the branches of the coronary artery. This is actually a patient of mine, and here you see blockages in the right coronary artery, very carefully identified, their exact location pinpointed. Here are blockages in the left anterior descending or LAD, again, with bright calcium specks indicating where the blockages are tight and where they are calcified.
The left circumflex, the other artery of the heart, again, demonstrating the exact location and tightness of the blockages. This particular patient has a SYNTAX score of 66. Now, a SYNTAX score is a way of quantitating the complexity and degree of coronary artery disease. Anything over 33 is considered severe. This patient has extremely severe coronary disease. This technology also tells us a fractional flow reserve derived from CAT scan, FFRCT. Any number less than 0.8 indicates a blockage that is flow limiting. You can see this patient has numerous branches of those three coronary arteries where that hemodynamically calculated flow blockage is significant. The functional SYNTAX score is also extremely high. We plan to do this operation, a complex double mammary artery operation with radial artery outflows to five targets based on the non-invasive imaging.
This is what we did: exactly that operation we planned. Then, a month later, we did another CAT scan demonstrating that all of these grafts are open. I'll just jump through some of these, but each of the grafts can be carefully documented in a follow-up and demonstrated to be open with a residual SYNTAX score that's only two. From 66, we've got it down to two. This is without an interventional cardiologist doing a diagnostic test. Therefore, in this case, the role of the interventional cardiologist as gatekeeper was eliminated. I think this will change the pattern of coronary disease allocation to the alternative therapies of multivessel PCI medicines or coronary bypass surgery. In fact, this could even be truly unbiased with AI algorithms.
The SYNTAX score II 2020 is actually an AI algorithm, which incorporates characteristics of the coronary angiogram, the CAT scan angiogram, with clinical features of the patient to predict the 10-year mortality risk or 5-year major adverse cardiac event for that particular individual patient if they are assigned to have coronary bypass surgery versus multivessel stenting. And I think this is the kind of thing that will ultimately drive more patients towards surgical revascularization and fewer patients or a lower percentage of patients towards multivessel stenting. This is an analysis of the SYNTAX score 2020 as it applies to the old SYNTAX score. They retrospectively looked at that dataset and determined that only about 20% of patients in the SYNTAX trial were better off in terms of 10-year predicted survival with PCI rather than CABG. So, I think we're going to see an increase in the volume of coronary surgery.
That will be aided and abetted, I think, by the Medistim technology. I'm not going to go through in detail these INTUI slides. You've seen them before. But this is truly an intuitive way of providing the feedback for the surgeon in real time so that she or he can revise grafts when appropriate to ensure that the patient leaves the operating room with a perfect revascularization. That's the goal of the International Society for Coronary Artery Surgery. We had our 10th annual meeting just these last few days here in London. One of the sessions was this one, "Intraoperative quality assessment in CABG should be mandatory." You can see that this really focused on TTFM and high-frequency ultrasound evaluation of coronary grafts.
This was a well-attended session with leaders from America, from Israel, from Japan, from Italy, and from Edinburgh, all addressing the utility of the Medistim technology. We will do a similar session at our next meeting in New York in 2025. Thank you for your attention.
Thank you so much, John, for that very insightful presentation. Now, I'm very proud also to be able to introduce Associate Professor Gianluca Torregrossa, coming from the revascularization program at Lankenau in Philadelphia, and he is a guy who is really passionate for minimally invasive and robotic surgeries and has also been one of the early users for the INTUI software, so please, we would like to hear about your experience and your thoughts about this.
Thank you so much. Good morning, everyone. My name is Gianluca Torregrossa, and I am currently an Associate Professor in Philadelphia. As you can hear, my background is definitely not from the United States of America. I'm from Italy, where I completed my training and left for the U.S. when I was a fellow after spending one year in Africa. John Puskas, you heard him, is my most important mentor in my own journey, in my own career, and it's always a pleasure to be here in front and giving a lecture to people that are not physicians, and for me, it's an extremely new type of feedback. When you have to start to give a lecture, it's always complex to engage the interest of an audience that you don't know. Some of you are not even in this room, and most of you are not in this room.
So, telling you a story has a power to bring you back to a very special moment in a way, in your life, where someone was putting you to bed and telling you something that was nice and making you comfortable. So, the words of "Once Upon a Time" have a special effect, as a special power, a special effect in your own brain. So, let me start with a story. Once upon a time, there was a company that was named Nokia. And Nokia was the fourth or fifth most valuable brand in the world, making billions of dollars in revenue capital. And in less than eight years, Nokia failed. The analysis of Nokia was extensive, but most of the analysts agreed with the last words of the CEO during the last day in which he closed and filed Chapter 11. Nokia that was then acquired by Microsoft.
We didn't do anything wrong, but somehow we lost, and the reason why Nokia lost, and the reason why I bet that every one of you, or 95% of you, has a different type of brand phone in their pocket, and I know which phone you have, is because Nokia did not innovate enough. They didn't do anything wrong, but they were not fast enough in providing innovation. Their competitors were innovating faster than they were, and that's what disrupted the fifth most valuable brand of Nokia. You can be sitting on a phenomenal technology leading the market, but if you don't innovate, you lose your market, and this message has a lot to say in each one of our worlds for your industry, for you investors, for me as a surgeon, and these rules, it's applicable to the life of each one of us.
It's applicable to me as a cardiac surgeon. If I don't innovate, I will lose my job. I will lose what I can do. We are in a very incredible moment facing challenging minimally invasive PCI. We are always checking this number, medical therapy. But the reality is that coronary artery bypass grafting is evolving itself. It's evolving towards a new level of minimally invasive that can provide something incredibly new, the exact long-term quality of life that bypass offers with respect to PCI without the burden of a sternotomy, without the burden of an aggressive invasive procedure, so let me bring you to a journey. The journey starts with this picture, and the journey starts with a picture that shows you the two systems, one beside the other.
IGIA on the left.
The new and old system, the new and old software that can allow us to pivot around this new technology of coronary artery bypass grafting. And here we are. You are about to sit to the console of a robotic surgical system, and we are about to enter inside the chest of a human being and to perform what we call robotic bypass surgery. Come with me. You are seeing the heart from the left side of the chest. We are opening the sac that contains the heart. I hope that your breakfast has already been digested. We are looking inside the pericardium. That is one of our coronary targets. And now you are looking into the chest wall where these arteries that we call internal thoracic arteries serve the chest wall, and they can be rerouted, deployed to the heart.
You see how this magnification. You see how beautiful we can see, connect, and operate to the heart itself. Even more, come with me and see how we can connect these arteries together. You see, you are seeing a heart moving, an LAD, one of the targets that we are doing, a suture, and up there, the Internal Thoracic Artery previously harvested. So, a truly pure minimally invasive approach to assess and address coronary artery bypass grafting. And more than my words, more than what I can tell you, more than what I can convince you.
You know, I'm retired.
Listen to the words of a physician.
I knew what my apprehension was, my remembering of my experiences training at the Cleveland Clinic and people undergoing open heart surgery. And you made me feel very relaxed with our preoperative visit and with the anticipated procedure that you wanted to perform. And I felt very confident with.
How many days you have been in the hospital?
I was discharged 26 hours after the procedure.
How did you feel back then?
I felt really comfortable. Once all the chest tubes and the arterial lines and the IJ line were removed, I felt very comfortable. I was able to walk in the hallways on the surgical floor or on the postoperative floor.
You were telling me about the dental procedure in 2017.
Oh, yeah. I've had dental extractions that were more uncomfortable than this procedure, literally. No exaggeration. If anybody has had a root canal, they know what I mean.
A physician who had a double bypass, two mammary arteries deployed to the best target of the left coronary system, 26 hours after, he's at home. This is innovation. This is the future. Where do you sit as TTFM? TTFM sits here. I want to go a little bit fast on these slides. TTFM sits here. Medistim sits here, sits at the center, at the key point of all of this. There is no way I can innovate. There is no way I can perform a robotic bypass. I can perform this level of surgery. I can discharge a patient one day, 26 hours after a surgery, if I don't have the opportunity to test those grafts intraoperatively and know that for sure those grafts are nice, are patent, and they're serving this patient well.
I feel confident to send this patient home because I can perform an assessment intraoperatively. Moreover, I can teach how to perform this surgery to someone else. As you heard from Dr. John Puskas, he taught me how to perform bypass surgery and robotic bypass surgery. He was feeling comfortable to let me take the ownership and the responsibility to perform something that has a huge impact, the most important impact in the 10-year life survival of an individual, of a father, of a husband, of a grandfather of someone, and you can let this huge responsibility in the hands of the next generation because I can test the bypass that my trainee nowadays does in my operating room. That is training. That is the keystone technology. That's the most important stone of that Roman arch that sustained innovation, education, and, of course, patient safety.
So, the gold standard and the key cornerstone is Medistim. In this sense, the innovation that you are bringing in becomes essential. And this innovation becomes essential because we are now, with this new software, not only able to have a more clear and a more important view, but we are also able to create reports, reports that now can be spread around, can be spread to patients, can be spread to families, can be spread to referring physicians, creating a culture around these numbers, around these values that we have seen. These numbers mean a lot to people like me, Dr. John Puskas, and even to people that have spent all of their life with Medistim personally embracing this technology as industry, as partners. But there is still a lot to do. There are a lot of physicians.
There are a lot of cardiologists out there that take care of patients. And then when you tell them, "I have done a triple bypass, and I checked the graft, and these were the flow of your own patients," they still don't know what exactly it means. And it's in our important mission to educate everyone, the general practitioner, the patient's family. But providing a report, providing a physical copy of something that can be intuitively seen, that has graphics in their pictures that depict what type of surgery they receive, that has a huge impact. And I want to go to this video showing you some of the features of this device. You see that we can now address and draw the type of and measure the type of devices that we do. We can check and draw the pictures of the bypass that we are doing.
We can teach, thanks to a very intuitive level of red, green, and yellow, what type of flow you should expect. I can put my eight-year-old daughter and tell me if she wants green, yellow, red. I'm sure what color she will decide to pick. So, that is intuition. That is INTUI. That's the software that allows us to really bring back interest, bring back culture, bring back new technology and education for the next generation of surgery. And you see the opportunity here that we have to literally create graphics, a graphic that explains to a patient. You now see in something that gets printed at your own home after your own surgery what really happened during that six hours when your chest was open or when someone was operating you robotically and did a series of bypass.
You understand graphically what happened to you. It has a level of comfort and adds a level of comfort for yourself, for your families. That has a huge important element even in the care, even in the success recovery for that patient, and again, most importantly, we educate the people around us. We educate cardiologists. We educate general practitioners, distributing and spreading the news of what medicine has done in the last 30, 40 years of success story. And you see these are some of the results. These are the value. These are the report. These are the pictures that can be printed and come home with the patient itself, and again, a system that provides in a very simple color-coded understanding of all of the flow that has been taken and all of the picture and images modality that we can acquire for.
Here you see more from an open case. There is a heart beating. Still not lunchtime, guys. You see one of the bypasses there and the probe that is positioned on the graft to connect and detect the flow. In the side screen, you see me moving around the probe on the heart of the patient and check the flow and making sure that all of the parameters are in line with what I expect. This is innovation. This is future. This is what we need for our patient. In conclusion, you guys are the keystone, the elements of an arch that extend from innovation to education and patient safety. All of this is possible because we can check the results of what we are doing.
Innovation is the most important element that pushes us to be better, to be relevant, and to maintain the benefit of the best treatment for coronary artery disease that is coronary artery bypass grafting in the next 20-plus years to stay strong and be relevant. I'm extremely excited for the future of coronary bypass grafting. As you heard from Dr. John Puskas, the future is bright. The future is bright because new imaging technology will reassign patients. AI will reassign patients, decreasing the disproportion between PCI and CABG. The future is bright because you have a new generation of surgeons interested in minimally invasive robotic approaches that will be able to guarantee the same quality of the work that our mentors have done in revolutionizing the post-op recovery for our patients. The future is bright because we can educate.
Education is the only element in which we can bring innovation and continue to build up on innovation. We can educate because we can assess that the trainee has done the same perfect job that I would have done if I were sewing the bypass grafting on my grandmother, on my father, on someone of my own family. Thank you so much. I'm happy to take any questions from the audience.
Wow. Wow. That was a story very well told and very inspiring to all of us. We have set aside some time for Q&A. I assume we're a little bit behind our time schedule here, but we would like to take questions, first and foremost, to our surgeons that are here with us. So, do we have any questions?
So far online, we have not received any questions. I guess the presenters have been very, very clear. But here we have a question.
Yeah.
Sorry.
Hi, there. Thank you very much for the great presentation. This is Hemal from Montanaro. Really interesting to hear about building a new standard of care for CABG in the U.S. Could you explain in a bit more detail what is the current standard of care in the U.S. and maybe sort of the counterarguments that are made by some of your colleagues if they're not currently adopting this technology? Thank you.
Yeah. We come here so also we have someone who can see our faces online. Great question, and I figured both of us should reply. You know, one of the slides that I skipped was all about why we don't do more of this robotic, why we don't do more of this. The reality is that we are looking for more enabled technology. The current standard of care for coronary artery bypass grafting still remains sternotomy, so a frontal approach, opening the chest and performing two, three, four bypasses to bring new oxygen, new blood to the heart of the patient, but more and more, these robotic and minimally invasive coronary artery bypass grafting are gaining interest. There is evidence that is growing. There is interest from a younger generation. We have more technology.
And for technology, I mean robotic platform with new industries coming into the robotic field that are facilitating the opportunity for us to perform the surgery that we have seen before. So, the expected rate of interest and expected rate of numbers of cases that will be allocated in a form of robotic is in continuous growth. I can tell you that the number of demand of training from all over the centers around the United States to be able to perform the surgery that I show you, that I learned from Dr. John Puskas, is extremely big. Our schedule is constantly booked with visitors from any hospital, from Cleveland Clinic that come to Dr. Puskas and me to learn this robotic minimally invasive to the best hospital of Europe, the United States, and East Asia.
Dr. Torregrossa has touched on the movement towards more or less invasive, more minimally invasive surgical approaches to coronary bypass. As he pointed out, being certain that the bypass grafts are good is a key safety net, if you will, for the surgical team to push the boundaries of limited exposure. These operations that he's showing you are much more technically demanding than a routine open operation. And so, as we evolve those operations and teach those operations to larger numbers and newer generations of surgeons, we have to know that the bypass graft is good. And that's where the Medistim technology comes in. It gives us the confidence to push the boundaries. Without that confidence, then you're really in the category of a cowboy. And that will eventually end badly for a patient and then for that surgeon.
And that's, frankly, what limits the growth of the minimally invasive approach. Now, there's another aspect of coronary surgery that is evolving, and that's the operation that's performed through an open incision, the sternotomy. We know that using arterial grafts instead of vein grafts leads to longer life for the patients. But once again, it's technically more demanding for the surgeon. And in order to do the more demanding all-arterial or multi-arterial bypasses instead of the vein graft bypasses, surgeons have to know that the graft is good to move on to the next one and to adopt a more aggressive approach towards multiple arterial bypass grafts. And as I pointed out, to teach those, we absolutely need to have that safety net of knowing that the bypass graft is okay. The expectation is a near-zero mortality for coronary bypass surgery.
When a graft closes acutely, that risks the life of the patient. It's not very long before that takes a patient's life. And that's simply a situation we can't tolerate. So, therein lies the necessity of intraoperative graft assessment.
Any more questions? Yeah, please.
Yeah. I'm Geir Holom, analyst from DNB. First of all, thank you very much for extremely interesting presentations. I actually have only a commercial question for Kari. So, with this new innovative software platform, do you plan to raise the prices for MiraQ?
Yes, there will be a price increase for the new device when the new software is uploaded on it, and we will also sell an upgrade kit for the install base. We have around, well, more than 1,000 MiraQ systems out there that can be upgraded to this INTUI software, so of course, it's providing a commercial opportunity for us as well.
Thank you.
Thanks. It's [Jan Kockel ] from Alpha Star Capital. One quick question regarding the upgrade. So, will this upgrade basically require somebody to actually come in, put a USB stick in or something like that, or will it be over the air?
No. Yeah, no, it will happen physically on site and will be handled by our sales and service team.
Okay. And then I'd have a question to, say, the experts in the field. If there's data on the amount of people that get a PCI, even though they have a multi-vessel disease or high SYNTAX score, if there is a certain, say, range or rule of thumb or so where you see, especially the U.S., basically, yeah, not optimally treating them?
It's really interesting. The data are not widely discussed, but they are out in the published literature demonstrating that the ratio between the number of PCIs and the number of CABG procedures is highly variable, extremely variable by a factor of 10x. There are some places where the PCI to CABG ratio is 25 to 1, and others where it's 5 to 1. These two different locations may be in the same country or even the same city, but they certainly differ between countries. They differ between different operators and different healthcare systems within one nation. Obviously, it cannot possibly be that human beings are that different in those different locales such that everybody's getting just the right therapy for them. That is not plausible. There have to be other factors at work other than a perfectly judicious allocation of patients to the alternative therapies.
Frankly, it's politics and money. I mean, if you really want to know why a thing or a situation is the way it is, follow the money. This is not news. We've known this. It's been in the popular literature for thousands of years. And it's still true today. The gatekeeper role has a huge impact. And it's a variable impact depending upon the culture of that place or that institution or that office. That role will be weakened and then eliminated by the broader application adoption of these non-invasive technologies to image the coronary arteries. And patients will drive it. Family practitioners will drive it. You don't need to have an invasive angiogram. And in fact, there are now about 300 single-photon-counting CAT scanners installed in the world. These are manufactured by Siemens. They're the only company that now has this technology on the market.
300 is not a big number, but it's rapidly expanding. They are literally manufacturing these devices as fast as they can, and they've stopped selling all of their previous models to reboot their factories to only make the latest model. We are waiting for one at my hospital, but the images I showed you are from the previous level of technology. This new hardware, combined with rapidly evolving software, provides the clinician with much more information than an invasive angiogram will do, so not only is an invasive angiogram invasive and carries a certain degree of risk, it's also costly. It requires a level of skill of an operator to do it safely, and the new technology is easier, safer, faster, cheaper, and gives much more information, so there's no scenario in my mind where this new technology does not wipe out the old.
This is like streaming video compared to a VHS tape. The VHS tape is dead. You cannot buy one. It's over. Invasive coronary angiography for diagnosis is dead. It just hasn't fallen over yet.
And if I can add, I can tell you that this also there is a recognition even among the heaviest PCI users that the continuous repetition of that PCI exposes you to. You get a stent, and then after one year, you get another stent, or two years after, you have to go and clean up that stent, creating not only a burden for any healthcare system, patients that keep coming back, but also a burden for the families. Like nowadays, patients don't want to go back to the hospital.
Try to convince my dad, who is 80 years old, living his own life, going out with friends and family around Europe, having dinners, to go back every four, six months because he needs to have a checkup of the stent. That's not something he's interested in. So, the growing evidence is bringing at the end even the heaviest PCI users to adopt the concept of what we call a hybrid. Hybrid is basically a robotic bypass in association with PCI. And probably the future is that a lot of patients that are currently receiving multi-vessel PCI, multiple stents, will be deployed into one or two robotic bypasses and maybe a stent in the least important territories of the heart. So, again, bypass is here to stay.
Bypass is healthy, and bypass is actually here to grow because it's supported by a lot of technologies that are coming up that will redistribute patients to the best treatment that it is, coronary artery bypass grafting.
We also have another question here for the specialists. This is related to robotics.
Yeah.
How is TTFM and imaging used when you use robotics versus a more manual procedure? And how much of the surgeries are done with robotics today?
How much? Sorry, the second part of the question.
How is TTFM and imaging used during robotics, and how much of the surgery is performed on robotics today?
Yeah. So, I have a video. If I can get back to the I think at the end of the video, there was the flow probe deployed. Can I get my presentation back on? So, Medistim has developed a minimally invasive probe that can be used robotically to address the thank you to address the flow intraoperatively. Looks and works exactly as one of the flow probes that you see in open. But it is instead in the gives the opportunity to be introduced via what we call a small trocar, so a very small opening in the chest. And this probe gets basically been used to test the bypasses. I don't remember if it's at the end of this video. I don't have control of this.
If someone can advance the video to the end, we should be able to see, yeah, to the end of the video. You can do it. Yeah. But basically, we have probes. Medistim has developed the probes. Part of the video, if I can show it to you. So, how much is the current market of robotic? So, right now, we are still in the single digit for the percentage performed of robotic. But we have never had a robotic company that took robotic coronaries seriously. And this is because, as Dr. Puskas has said, this was performed by very few surgeons in the past. Extremely challenging, extremely difficult. But technology is coming. Technology is coming back. And a new company, a robotic company, are coming. I can tell you, the surgery that you have seen has just been performed already.
15 of them have been performed with a new robotic system invented in India, currently starting an FDA trial in the United States. And for a cost that is one-fourth of the cost of the only other robotic big player company player. So, the expected growth of the robotic coronary bypass grafting is really going up, both for interest from the surgeons, interest from the interventional cardiologists who are pushing towards this concept of hybrid, interest from the patients that want, of course, the least invasive possible procedure.
Follow-up question with robotics. The cost, what is the cost related to robotics versus manual surgery? And seen in the light that the patient can be discharged after 26 hours versus weeks.
I publish about it, and I have the most important publication in robotics. And I actually took three years' results, and I proved that my hospital has saved something like $8 million in three years based on numbers in a propensity match score of patients that could have been allocated for a sternotomy. And instead, I performed a robotic or an hybrid, a robotic plus stenting. So, first of all, I gave this paper to the presidents of my hospital. And second, I gave it to the publication. So, there is a cost upfront, of course, the cost of the robot, the cost of the training. But then you save important money for the length of stay, recovery.
Remember that there is also more to the cost of healthcare that patients go back to be a grandfather, to be a worker, to be the CEO of a company back in a couple of weeks. So, you save money from a social point of view. I did my mother-in-law's surgery. I offered her a robotic takedown, exactly a complete robotic bypass on my mother-in-law, who three days after surgery was on the carpet of my house playing with my daughter that at that time was four years old. So, I can tell you that there are complete changes in the dynamics of what this patient can do when they go back home, reinstituting them in the normal social life. But from a healthcare point of view, it's a huge benefit. It's a huge economic benefit.
There's another driver that's at work, and it depends upon which healthcare system we're thinking of. In the healthcare system in which Dr. Torregrossa and I work, there's an element of competition for cases. So, his hospital president not only looks at what can he make per case, but will this technology and the halo effect of having that kind of expertise and that kind of technology in his hospital, will that actually draw more patients? Now, that may be a little different in a national healthcare system, for instance, in the U.K., where it may be simply dollars per case that is a driver of behavior and adoption. But we think about it a little differently in the United States. Yeah. Very good point.
Last question.
Yeah, please.
I'm Hemal from Montanaro again. Just on the, I like the bit about following the money. Could you explain the reimbursement situation for CABG in the United States? Is that relevant for the uptake of TTFM? Thank you.
Reimbursement for coronary bypass is pretty stable. I don't think that the reimbursement model for coronary bypass has a big impact on Medistim going forward. It's a demographic change that's going on that is going to lift more cases and therefore lift Medistim. Reimbursement seems very stable for coronary surgery. It's slowly declining for stenting, interestingly. I think that has in some ways and the profit margins for stent companies are declining due to competition and stents coming off patent. And now you're seeing more of these drug-coated balloons being used without stents. I'm just going to hypothesize that actually the longer-term results with drug-coated balloons will not be as good as stents. But at the present time, the profit margin on drug-coated balloons is about 10 x the profit margin on stents. Hence, I think, follow the money.
Drug-coated balloons are becoming surprisingly popular in a surprisingly short period of time. But I think when we get the longer-term data on them, they will fall away as well.
Good. Thank you so much.
So, yes, we are a bit behind our schedule here, but who can resist listening to these experts in the field? So, we just need to allow them to finish. Okay. We will change the subject a little bit, and I will now introduce our Vice President of the Medical Department talking about the PATENT, a new clinical study on the use of flow and imaging in peripheral bypass surgery for treating critical limb-threatening ischemia, CLTI. The stage is yours.
Thank you so much, Kari. And good morning. Yes, the PATENT study is another bypass study in the lower limb in patients with critical limb-threatening ischemia. And CLTI is the most severe stage of patients who have peripheral arterial disease. So, it's a subset of these patients with PAD that get CLTI. But still, it's a large population because the number of patients with PAD is over 200 million new cases per year, and around 10%-11% of them progress to CLTI. The symptoms of CLTI are pain at rest. It's non-healing ulcerations, and it's necrosis or gangrene. And without being treated, these patients do really bad. And around up to 20%-25% of them die within the first year of diagnosis. And it's also associated with a high risk of amputation.
So, unless these patients get revascularized, either by endovascular treatment with balloon, without the stent, or they get open surgery, they have a very poor prognosis. So, why have we initiated the PATENT study? We have initiated it because it's a large and severely diseased patient population with more than 500,000 bypasses done per year. And many of these bypasses fail. So, we have numbers indicating that around 20% of these fail within the first year. So, how can TTFM and high-frequency ultrasound add value? Well, this is a bypass. You know, they have a proximal, and they have a distal anastomosis. And several things can happen to the anastomosis. It could be a stenosis, which is basically a narrowing. It could be caused by a misplaced stitch or some other cause. Or it could be an intimal flap, which is an injury of the vessel wall.
Or it could be a thrombus, which is a clot formation. And none of these can be seen visually or detected by palpation. But TTFM can easily detect a flow-limiting impact. And you can see with ultrasound what is causing this. And this image below shows an intimal flap with a thrombus. Between the anastomosis, you have the graft, in this case, a vein graft. And you want this to be open or patent. And you know, if it's twisted, that will impact flow. And also, if it is a kink, that will impact flow. Or you could have a small or large leakage. If you have a kink or a twist, you can see it if you use an open surgical technique, like you see at the bottom here.
But if you use a bridged technique, like, and that is very common, you can't really see the kink or the twist. Or if you have an open vein branch, it's similar. If you don't see it, you can't detect it. And if you have for certain techniques, you need to take out the vein valves. And they are small and tiny, but can be very important. And all of this, if it has an impact on flow, you can easily detect it with TTFM. And you could study it and see what is causing it by high-frequency ultrasound. So, here, you are probably very familiar with the curves. If the flow is high, like in this first case, you have a repetitive curve with a low PI. In the middle, you have an obstructed bypass. And with a low-flow, spiky curve, high PI.
That was revised, and flow got much better. You have here; you see these TTFM probes. This is without and with handle. This is the type of probe that is used during robotic surgery. They are very small, easy to place. Here, they are snapped on the vessel. Then you see ultrasound both in the longitudinal and the transverse view. We think that the combination of using flow and imaging complements each other. They are a perfect match. TTFM can rapidly detect flow-related issues, and ultrasound can describe what the problem is. You may wonder, are there any other techniques that could be used to detect these problems? There are. There are a variety of techniques that can be used. It's duplex ultrasound, angiography, Doppler, and ours. We think that there are no standardized methods recommended.
You will hear more from Professor Venermo talking about the advantages and the disadvantages of these different types. Also, as Kari mentioned, there have been recent studies showing that some patients benefit more from having a bypass as their first choice instead of endovascular treatment. Professor Conte will talk more about this in his presentation. The goal of the PATENT study is several-fold. It's to detect technical issues that can be identified and corrected intraoperatively. It's to identify the grafts that have a high risk of failure and separate those from the grafts that have a low risk. We also want to collect data for later health economic analysis. The design of the study is prospective. It's international, multi-centered. We expect the enrollment of patients to take around two years. Then we will follow up each patient for one year.
Then you will have the analysis and publications. We plan on enrolling 450 CLTI patients in 15 sites in the U.S., in Europe, and in Asia. That's a short introduction to the PATENT study. Thank you for your attention.
Then, the time has come to listen to a pre-recorded presentation from Professor Michael Conte, Professor at the Division of Vascular and Endovascular Surgery at the University of California, San Francisco. Professor Conte will be the lead investigator of the PATENT study.
Good afternoon. I'm Michael Conte, Chief of Vascular Surgery at the University of California, San Francisco. I'm pleased to join you today to speak about the clinical value of completion assessment in leg bypass surgery and the rationale for the PATENT study that we are now launching with Medistim. These are some disclosures I have relevant to this talk. Peripheral artery disease, or atherosclerosis, affecting the arteries of the lower extremities is a growing global health problem due primarily to the aging of the world's population, as well as the ongoing epidemic of diabetes. Estimates are that currently, more than 200 million people in the world are affected with peripheral artery disease. It increases significantly with age, and it affects all socioeconomic strata and has grown by almost 25% over the first two decades of the current century. Indeed, PAD is a major global health problem.
Revascularization is a cornerstone of treatment for advanced PAD to relieve symptoms, improve quality of life, and avoid major amputation. Traditionally, open bypass surgery of the leg has been an effective and durable treatment option for many patients and is well established in the surgical literature. Over the last number of decades, increasingly, technologies of the endovascular arena have allowed us to cross, open, and dilate a wide range of lesions in the lower extremity, such that endovascular therapies now are the dominant form of treatment for PAD. However, many patients will either not be good candidates for endovascular intervention or have failed endovascular intervention, and there remains an open question: which patients are best served by which type of revascularization? Lower extremity bypass is best performed using an autogenous great saphenous vein. This is something that's been well established over many years in the surgical literature.
This is a typical study looking at a single-center large retrospective series of autogenous lower extremity bypass grafts performed at my prior institution in Boston. 75% of these bypasses were done for an indication of so-called chronic limb-threatening ischemia or critical ischemia to preserve limb function. What's evident from this graft patency curve is that there's essentially three phases of graft failure. In the first 30 days, there's a failure rate of between 5%-8% or 10% that is largely deemed due to technical factors. This is a range of issues related to performance of the procedure, including the quality of the actual conduit, the size of the target artery, and also technical defects within the grafts or at the anastomosis.
The largest drop in patency of bypass grafts occurs in the first two years, secondary to a process that we call intimal hyperplasia, which is the development of stenosis within the conduit, often at focal sites, perhaps at valve sites, and sometimes at the anastomoses. This is a process of scarring that occurs within the graft, but may also have relationships to the initial technical treatment of the bypass, including retained valve sites and hemodynamic effects. And then, at subsequent time points, the graft stabilizes, and the failure rates reduce over time, largely related to what we believe to be atherosclerosis development in the inflow and outflow arteries and also within the graft. But this too is related to the pre-existing intimal hyperplasia that occurs within the conduit, which may be the soil for the atherosclerosis that develops later.
All in all, the initial implantation time is a critical time for the adaptation of the vein graft and may set the stage not only for immediate technical events, but for downstream events. In the early 2000s, I was a lead investigator of a large clinical trial that tested a novel drug that was a molecular therapy that was targeted to reduce graft failure by reducing scar tissue formation. This was a study of over 1,400 patients with critical limb ischemia who underwent lower extremity bypass grafts with a primary endpoint of non-technical graft failure. This study, importantly, included duplex ultrasound imaging of the bypass over time so that we could accurately monitor what was happening in these bypass grafts. In this study, which was a landmark study, we found that the overall primary trial endpoint occurred in 25% of patients in both groups.
And if we looked at primary patency in the first year, there was about a 40% loss of patency, primarily due to the development of focal lesions that were treated successfully by re-interventions to maintain secondary patency. So, this trial establishes that a technical failure, while relatively low in this trial, is potentially a downstream surrogate for later events. The goal of completion assessment at the time of the procedure is to ensure the technical adequacy of the bypass. We want to make sure that there are no significant anastomotic defects, no problems within the conduit itself, such as a retained valve or a damaged segment with underlying pathology. We want to make sure there are no tunneling errors in the leg or compressions, areas of kinks or twists. And also, we want to examine the runoff in the leg itself.
There are several approaches to achieve this that are in common use, and standard of care is really unclear. Different vascular surgeons and different institutions tend to have their own patterns of use. Angiography, by placing a needle or catheter in the graft and injecting contrast with X-ray imaging, is a common modality. Duplex ultrasound is another common modality, and some surgeons just perform a simple handheld Doppler and pulse exam. With that background, it's important to know that in recent years, we have seen several new large clinical trials trying to help determine which is the most effective way to revascularize patients with advanced PAD or chronic limb-threatening ischemia, and the largest of these trials is the BEST-CLI trial, which was reported in 2022 in the New England Journal of Medicine.
This is a trial that basically randomized patients who were felt to be good surgical candidates and who had a reasonable option for either open or endovascular intervention to bypass or endovascular treatment upfront. The trial was intentionally divided into two parallel studies based on a preoperative assessment of whether or not the patient had a good quality great saphenous vein. So, in these two parallel trials, there were actually two separate hypotheses. In the larger cohort, with a good vein, the hypothesis was that the vein would outperform endovascular therapy. Whereas in the cohort two, patients who did not have a good vein, the hypothesis was that endovascular therapy would outperform bypass.
In the end, what was found was that in cohort one, patients who had their bypass performed with a good quality saphenous vein had a significantly better long-term clinical effectiveness, as demonstrated across multiple endpoints, but including, importantly, this primary endpoint of major vascular re-intervention, amputation, or death. You can see that surgical patients had a much lower event rate over time, that these curves separate early and continue to separate over the course of the first year, after which they remain relatively parallel. Importantly, that's just a time to the first event, but the value of a well-done bypass surgery is evident also by the total number of repeat procedures that these patients receive over time.
In fact, less than half the incidence of additional procedures was less than half in the surgical group of the patients with a good vein compared to the endovascular arm, suggesting a much higher burden of retreatment for patients who received endovascular therapy. Well, what about just doing the bypass after the endovascular treatment fails? Why isn't that just an okay way to practice? And in many places, that is an approach that is undertaken. But many studies have shown that secondary bypass works, but it's simply inferior. This was a recent systematic review that looked at a number of papers pulling data from nearly 12,000 patients and showing that patients who had a primary bypass had about a 60% reduction in or improvement in amputation-free survival compared to patients who had their bypass only after a failed previous catheter therapy.
We looked at this same question within the BEST-CLI trial and found the same exact finding. This was recently presented at the ESVS meeting. This is data that shows the major amputation rate for patients in the trial who had a primary bypass in the solid line versus those who underwent a secondary bypass after failed endovascular. And you can see that this is a significant reduction for the patients who had a primary bypass. That's nearly half within the first year. In reality, we know that these two therapies both have important and complementary roles and that there are certain patients and anatomic factors that are more favorable for one versus the other.
Hence, the decision-making really hinges on a number of important factors: patients who are higher surgical risk, patients who have less complex lesions in their arteries, and patients who don't have a good quality vein are going to always be favored for endovascular intervention. However, patients that present with more severe limb-threatening conditions, such as extensive gangrene, who have more complex lesions, who have had previous failed multiple endovascular treatments, and especially those who have a good quality vein and are good surgical risk, may do better with a bypass first, and this is what the data is increasingly showing. In fact, recent practice guidelines, including that from the European Society for Vascular Surgery, for example, show an expert opinion suggesting that if a patient has long occlusions, is fit for surgery, and has a saphenous vein, they should preferentially get a bypass first.
The Global Vascular Guidelines, published in 2019, suggest that one should have a selective process of deciding between open bypass and endovascular based on the patient's overall risk, the degree of limb threat or limb severity, which is shown on the x-axis here, and the anatomic complexity as well, such that patients who have advanced limb threat and complex lesions are probably best served by an open bypass first, whereas many other patients are good candidates for endovascular first. In reality, how often is open bypass being used in patients with CLTI? That's a difficult number to come upon, but if you look at a number of recent large registries, national registries, and other large multi-center studies, it looks like between 25% and 35% of patients are generally getting an open bypass for CLTI.
Based on my own personal experience, I think the number between 20% and 30% is probably about appropriate given the types of patients and complexities that we see with CLTI. That brings us to the current importance of the PATENT trial, which really is an opportunity for us to define the best approach to completion assessment after open bypass surgery to raise the quality and the consistency of open bypass surgery for CLTI. In this trial, we aim to test both transit time flow measurement and high-frequency ultrasound imaging in patients needing a vein bypass for below-the-knee target in CLTI. This will give us an opportunity to develop and essentially confirm or validate certain flow measurement criteria as validated criteria to confirm a high likelihood of technical success and sustained one-year patency.
I think that this trial will be an outstanding opportunity for us to elevate the field of vein bypass surgery for CLTI, to get more vascular surgeons comfortable and familiar with the use of TTFM, and also to raise more attention to the importance of completion assessment in bypass surgery. Thanks very much. I really appreciate the opportunity to participate in the conference, and I would hope to be available to you as needed for any questions in the future. Thank you.
Yes. And then we will have the next speaker as well, and then we will have a Q&A session on this topic. So I hope we will be able to connect with Professor Maarit Venermo, who is the Professor of Vascular Surgery at Helsinki University. So she will be live with us over Zoom and, yeah, available for questions. So, Maarit, please, the stage is yours.
Yeah, thank you very much. And good morning. My name is Maarit Venermo. I'm a Professor of Vascular Surgery in Helsinki University Hospital. And I'm very happy to present our practice in Helsinki for completion control after lower limb bypass surgery. I don't have any conflicts of interest related to this topic. So here you can see the most important risk factors for arterial disease. Management of hypertension and hypercholesterolemia has improved, and prevalence of smoking decreased, the one circled with green. At the same time, the prevalence of diabetes has increased and is increasing, and the number of elderly people, as well as we live longer. In Helsinki University Hospital, we do a lot of procedures. We are the biggest vascular surgical unit in Nordic countries. Our catchment area is 1.7 million inhabitants, the primary one.
Here you can see the evolution in the number of endovascular and open surgical procedures since the 1970s. Nowadays, we do about 2,500 endovascular and 1,600 open surgical procedures. In the 1970s, smoking was the most important risk factor, and bypass surgery to prevent amputations was not yet a routine procedure as it is today. In the end of the 1980s, bypass surgery started to increase in numbers, and in the 1990s, the prevalence of diabetes started to increase, increasing also the number of procedures for arterial disease. Today, the prevalence of diabetes continues increasing, but at the same time, people live longer, increasing the prevalence of arterial disease even further. Here you can see the role of leading countries in terms of prevalence of diabetes, top five being Mexico, Turkey, Spain, the U.S.A., and China.
On the right, in turn, is the development of the number of populations with diabetes and its prevalence, and it's growing. Patients who undergo distal bypass surgery usually have advanced peripheral artery disease, and the procedure is limb-saving. In most of the cases, the question is bypass or amputation. We have done a lot of studies on CLTI in Helsinki, several doctoral theses. Here is a picture from one of those. If we use autologous vein, we can achieve excellent limb salvage after bypass surgery. Here is the curve from one of our doctoral theses in Helsinki showing the limb salvage for 600 patients after bypass surgery. This is from another thesis showing a survival status five years after either bypass or amputation for a patient who originally is living independently at home.
On the right, you can see that after major amputation for a patient living at home in the beginning, the majority of the patients live at the institution after five years. When, in turn, if they undergo bypass and save their leg, the majority of the patients are able to continue independently living at home. The cost saving is obvious for society because of the fact I showed that after amputations, patients usually have to go to the institution. This leads to significantly higher costs compared to bypass surgery. The reasons to do completion control are obvious. We want to prevent graft failure and optimize long-term patency. As the best bypass graft is autologous vein, and its availability is limited, we do not want to lose a good bypass with single segment and great saphenous veins because of problems which we could fix in the first place.
One individual has about two meters of saphenous vein , not more. This is a paper on the causes of primary graft failure after saphenous vein bypass published already in 1992, and it included over 450 bypass operations. Primary graft failure rate was 20%, and in 63%, the reason for graft failure was related to a problem with graft itself. You can see the reasons for graft failure here on the left. Almost all of these problems leading to graft failure can be distinguished with completion control, and they can be fixed at the first place before patient leaves operating theater. The most common completion control methods are ultrasound, angiogram, or transit time flow meter. There are still places that are not doing any kind of completion control because we don't yet have proper recommendations in our guidelines. There is no scientific data for comparing these methods.
In Helsinki, we use transit time flow meter in all cases as completion control. If any problems are suspected, we first make ultrasound to scan the graft to distinguish the problem. We do angiogram if ultrasound is inconclusive or when we suspect inflow or outflow problem, which we fix immediately. However, we do angio in less than 10% of the cases. Angiogram is not good because we have to give the patient toxic or nephrotoxic contrast media. We made several studies in early 2000s showing that flow measurement can distinguish graft-related problems as well as compromised inflow and outflow. Compared to ultrasound and routine angiogram as completion control method, transit time flow meter is significantly quicker to perform and non-invasive and safe. Furthermore, you can always use these methods as an additional component if any suspicion in TTFM, and here I show you a video on our routine case.
First, we measure flow 2 to 5 centimeters distal to the proximal graft and take a look at the contact of the probe and also the shape of the curve. Here we can see that the curve is good, but the diastolic flow is a little bit low, which means that there is resistance in the distal part. And this is why we then want to dilate the distal vessels by giving some papaverine. And then we see the reaction of the papaverine, how the end-diastolic flow will increase. And it shows that we don't have any problems in the graft itself. If it doesn't increase, then we can suspect that there is some stenosis after the distal anastomosis, and we can perform first ultrasound and then angio and fix the problem.
Also, a pulsatility index is important, and we want it to decrease less than two. Here we can see that actually the flow itself almost increased 4x from the baseline. Here is another procedure where we do have some kind of problem. The first one was really good. Again, two centimeters after proximal anastomosis. You can see clearly that the curve is a little bit flat. Also flow 97, well, it's okay, but it's not really good. Then we do ultrasound, high-frequency ultrasound. Again, measure the flow there with the probe, and you can see that the curve is pretty much similar, a little bit flat, and velocity is low. Because we didn't see any problems in the proximal anastomosis, we made angiogram, and we saw stenosis in the iliac part and made stenting to the external iliac artery.
After the procedure, after the stenting, the curve you just saw was good. After papaverine, very, very nice reaction, and the flow increases to 4x . The pulsatility index also decreases below 2. We made an analysis of our 700 infrainguinal bypass grafts and divided the patients according to the flow into tertiles. 71% of the grafts were single-segment greater saphenous veins, and overall occlusion rate at one year was 19.6%. We could clearly see, and you can see here actually limb salvage rates were 93%, 86%, and 77%, and survival of the patients 81%, 76%, and 71% at one year. Here you can see the Cox proportional hazards model adjusting with graft material, and we can see significantly higher graft failure rate in the group with the lowest tertile flow.
The failure occurs during the first year, and it's relatively equal with the groups thereafter. I also analyzed how papaverine response predicts graft failure, and indeed response to papaverine further predicts graft failure irrespective of the primary flow measurement. Yeah, the transit time flow meter and high-frequency ultrasound are used in Helsinki in all areas of vascular surgery, in bypass surgery and other lower limb revascularization procedures after open aortic surgery and also carotid surgery. We do 250 carotid operations annually, and this is really nice to see the flow and also the anastomosis or the patch area with HFUS. The reasons are it's quick, it's non-invasive. It gives very valuable information on the inflow and outflow as well as possible graft problems. We use angiogram only when we suspect problems in TTFM or HFUS.
It's, as I already told, it's less than 10% of the cases. PATENT is prospective trial. We will investigate the possible benefit of completion control with TTFM and HFUS in patients with CLTI who undergo below the knee and crural vein bypass surgery. Several centers of excellence in Europe, U.S.A., and Asia are joining to this unique and important trial. Our aim is to create evidence, which we use to build clear standards for completion control of bypass surgery and have recommendations at guidelines level to improve patient care and limb salvage globally. Thank you very much.
We will take some questions to the vascular topic if we have any. Is there anyone in the room?
Yes. You first, you were first.
Thank you so much. It's [Jan Kockel] from Alpha Star Capital. I'd have a question regarding a gatekeeper role. So who's actually to decide if you'll have an open procedure or an endovascular procedure and are there some conflict of interest that must be taken into consideration? Thanks.
Thank you. Very relevant question. Well, I think that, well, for example, in Finland, we have vascular surgeons who treat patients, and we usually do the decision what we do with patients. We have several randomized trials now to guide us, and of course, we have to think what is the best for patients. There are so-called TASC classifications for the lesions, and it means that if it's a very long lesion, it's impossible to treat with the endovascular procedure, then there is TASC B and C lesions, which are sort of in the middle, so if patient is very high-risk patients, we may start with endovascular procedure. However, if it fails, as it many times does, we go for surgery.
Then there is TASC A lesions with short lesions, which we always usually go for endovascular first. In this equation, we of course always think patients' risk factors and age and things like that.
Thank you.
Did I answer your question? Thank you.
Okay.
Geir Holom from DNB again. Thank you very much for, again, very interesting presentations. One commercial question from me again too. What is the cost for Medistim for running the PATENT study?
Yeah. So we are investing about NOK 25 million into this study. Yeah, so that covers sort of the external costs. Then we are, of course, also using some internal resources in the medical department, but I would say quite low internal costs.
Okay, thank you. Is there any other questions? Then I think we can continue the program, Kari.
Okay. So thank you very much, Maarit. So we will close the line with you. And thank you so much for participating.
Thank you.
Okay, so in the beginning of 2023, we had another Capital Markets Day, if you remember. And during that meeting, I showed this graph at the end and claiming that our growth will definitely continue and that it's realistic that we will reach the NOK 1 billion milestone in a few years. And since then, we did meet some economic headwinds in 2023. I have told that we are seeing some relief from that already this year and that we are expecting this to provide, yeah, to be even further relief in 2025. So I will actually close this meeting, or at least from my part, to say that I still believe that this billion is within reach and that we will reach it within a few years still.
I don't know whether there are any other sort of overall questions to me or other people here in the room. It doesn't look like we have more questions, so then I will just take the opportunity to, of course, thank our speakers and participants very much for their insightful contributions, and thank you all who have joined us here in the room today and also online, so thank you very much.