Medistim ASA (MEDI) Earnings Call Transcript & Summary

So 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. And we have a packed agenda for you today. We 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 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. So Medistim helped treat cardiovascular disease and cardiovascular disease continues to be the leading cost of death globally. And the target applications that Medistim is serving is 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. So when a patient need 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? So we will have comments from surgeons here today, which will put more light on this question. But it's a fact that 80% to 90% of patients in need of revascularization are referred for PCI. Still more than 700,000 patients are getting CABG surgical procedure annually, and it's been a pretty stable number over the years. And when we are putting patients through this pretty invasive procedure, it is very important that we are making sure that the PATENT -- or the graft are PATENT. And 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, so it provides the surgeon with the opportunity to correct and to revise while the patient is still on the operating table. So at right here, we can see indications on the top right of suboptimal graft. We see a very spiky flow curve here, and we see a low flow. So in this example, the surgeon decides to revise the anastomosis, and we see a much better flow results. So fixing the problem there and then. But if the flow is slow, there's not always a technical issue with the anastomosis that can be fixed. So that's also very important. And Medistim felt that 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 are 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 are 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 contacted 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 1 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 is 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. Then 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 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 increased number of publications on vascular applications and transplant as well. So surgical guidance and quality assessment is needed in vascular surgery as well. And this market is actually larger than the CABG market, both in terms of 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. And 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. A quick look at the financial performance. So we see that over time and over the past 2 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, so it comes from probe sales from sales of pay-per-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 a 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 for September. So last year, we actually delivered growth in Norwegian currency. But due to the weak Norwegian krone versus both U.S. 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. So we had a growth since the first quarter and a higher growth as the quarters has combined. So after 3 quarters, we are looking at 5.3% revenue growth in Norwegian currency and the currency adjusted, this correlates to 3.7%. So still in the lower range compared to what we have used to see. So thereof the current topic for today, how to accelerate growth going forward? So we'll come back to that. I think it's great to see that the Americas region, of course, with U.S. being the most important market, came back very strongly in the third quarter with 17% currency-neutral growth. So 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 a 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, has 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 at -- after 3 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 underpenetrated markets, I have pointed to several regions of the world where the use of TTFM is still sort of in the early days. 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 has experienced over the past several years. Regulatory requirements has really made it -- 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 has 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 with user. 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 are also meeting the voice of technology. So let's also ask, 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 refined 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 the -- sort of the history here. So we launched TTFM in the mid-'90s. We've 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. And a little bit later, we will also see, hopefully, interpretation guidance based on machine learning. So I'm using my time here. And the INTUI software. So Tore, my good colleague, will talk more about this. But what it is, first and foremost, it's a response to users' request. So it is really point by point trying to address what they have told us, more INTUI, intuitive user interface, they wanted reference values, more context data. So we will learn more about that. But it's also a fact that the old software has created some type of technology depth for the company. So we took the opportunity in this project to actually revamp the whole software architecture, and 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 interoperative guidance and then 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 of Vascular Surgery, Maarit Venermo, which we will also hear from later in this presentation today. We have the President of the Japanese Society of Vascular Surgery, Professor Azuma. We have Professors, Alik Farber, which was the first author of the 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 -- yes, 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, stabilizing at the lower level, this should lead to continued relief and greater investment capacity. So this is also already what we are seeing signs from in our own sales processes. In Asia Pacific, we expect to being 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 owned 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 & 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 time. So -- 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. So what is this MiraQ Cardiac INTUI software platform? Well, as Kari said, we have been focusing our innovation lately into collaboration with the surgical communities and this software platform is developed in collaboration with surgical communities worldwide. And that has been very important for us that this is something that is developed in accordance and in collaboration with the surgical teams. This is not something that a bunch of engineers have cooked up in a corporate building. This is useful stuff. And 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 markets. So 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, and this is a software that we believe does that. So 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've doubled down on that. We have, as you'll see, modernize 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. I'll go first to the merging of the ultrasound imaging and the transit time flow measurements. So in Medistim, 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 and the INTUI software is that we 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 where it's 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 at 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 worklist as we call it, that tells you where you are in your procedure. There is a graphical representation of your grafts 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 recuse 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 grafts instead of using words, this was a complex problem for us to solve, because there was no standardized way of naming these grafts. And that was a problem if you want to create a large set of data, because you need that data to be standardized and annotized 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 or 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. And the values they want to use can be individual or they can be set up by 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 lesser-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 he's reading -- proudly reading his report after trying the system. The reporting was previously just a print out 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 grafts you perform, the measurements you have done in like 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 have been that this will actually save the surgeons a lot of time, because a lot of times, 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 is -- this INTUI software is just the first step, is 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, I'm very much looking forward to releasing a bunch of new and exciting features on this platform in the relatively short future. Thank you. That was all for me today.

Well, I am very happy to being able to introduce the next speaker that is Professor Puskas, who is the Chief of the Cardiothoracic Surgery at Emory University Hospital Midtown in Atlanta, Georgia. And 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 since the inception. And John Puskas have a lot of experience with our technology. And I would say he's absolutely one of the most influential voices in cardiac surgery today. So 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 and 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 of 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 #1 killer of human beings. Blood vessels from elsewhere in a patient's body are harvested and are redeployed to the heart, becoming conduits to deliver blood supply beyond blockages in the arteries that normally feed the working muscle of the heart. And what future will this surgical procedure or the 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 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 2 years, and 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, 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 miniscule, almost very difficult to measure it, 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 cardiologists 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 10-fold among different practitioners, different cities in 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 2 to 5 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 with -- 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 it is suffice 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 and 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 2.5 years and continued to diverge through the first 5 years with a striking benefit of coronary bypass over multi-vessel stenting for patients with diabetes. Again, the epidemic of diabetes is very relevant. When we follow those same patients in that trial through 7 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 #1 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 epicardiac 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 ensconce 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 wave form 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. 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. So to adjust for that potential risk, the ultrasound guides the surgeons to individualize the application of cannulas and clamps to the order 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 review 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 '23 presented last year at the American Association for Thoracic Surgery by Dr. Lali and her colleagues, an analysis of a multicenter 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 mls per minute flow to the LAD was, in fact, predictive of adverse events during clinical follow-up. And here you see 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 ml compared to those whose LAD flow was greater than 15 ml. 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 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 3-step logic that validates the utility of the Medistim technology and coronary surgery. So 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? So we had a resident learning to harvest 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. So 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? Well, of course, we measure the flows. Here's ITA to the LAD that looked visually to be just fine, but had a flow of only 5 ccs per minute, and a pulsatility index that was much too high at 8. Well, we were guided by the TTFM and ultimately made the decision to redo the left internal thoracic artery graft to the LAD. And then after repeating the TTFM, we see that the flow is now 23, the pulsatility index is less than 3, and the patient did well. So I will confess that I assisted my junior to do that anastomosis, and I thought he was doing a perfectly good job. So apparently, I wasn't doing such a good job supervising him. And I will confess that this is -- I've done this for 30 years, it's -- 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 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 cardiologists, 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 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 with -- 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 specs, indicating where the blockages are tight and where they are calcifying. And the left circumflex the other artery of the heart again demonstrating the exact location and tightness of the blockages. So 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. And this technology also tells us a fractional flow reserve derived from CAT scan, FFR-CT. Any number less than 0.8 indicates a blockage that is flow-limiting. And you can see this patient has numerous branches of those three coronary arteries, where the hemodynamically calculated flow blockage is significant. The Functional index 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 -- we did exactly that operation we planned. And then a month later, we did another CAT scan demonstrating that all of these grafts are open. And I'll just jump through some of these, but each of the grafts can be carefully documented and follow-up, and demonstrated to be open with a residual SYNTAX score that's only 2. So from 66, we've got it down to 2. And this is without an interventional cardiologist doing a diagnostic test. Therefore, this -- 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. And in fact, this could even be truly unbiased with AI algorithms, the SYNTAX Score 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 signed 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. And that will be aided in a better, 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. And 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 being 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 minimal invasive and robotic surgeries and has also been one of the early exercise 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 Associate Professor in Philadelphia. As you can hear in my background are definitely not from United States of America. I'm from Italy where I completed by training and left for the U.S. when I was a fellow after spending 1 year in Africa. John Puskas, you heard him. He's my most important mentor in my own journey, in my own career. And it's always -- it's a pleasure to be here in front and giving a lecture to people that are not physicians. And for me, is 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 your way, in your life where someone was putting you too bad and telling you something that was nice and making you comfortable. So the words of once upon a time have a special act, has a special power, a special reflect 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 the fifth most valuable brand in the world, making billions of dollars in revenue capital. In less than 8 years, Nokia failed. The analysis of Nokia was extensive, but most of their analysts agreed with the last words of the CEO during the last day in which he closed and file 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 beat that every one of you has -- or 95% of you has a different type of brand phone in their pocket and I know which phone do 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 what disrupt 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 I -- this message has a lot to say in each one of our work for you, 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 minimal invasive PCI. We are always checking this number, medical therapy, but the reality is that coronary artery bypass grafting is evolving itself, is evolving towards a new level of minimal invasive that can provide something incredibly new, the exactly long-term quality of life that bypass offer respect of PCI without the burden of sternotomy, without the burden of an aggressive invasive procedure. So let me bring you to a journey. The journey start with this picture and the journey start with a picture that shows you the two systems, one beside the other, 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 see it 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 a robotic bypass surgery. Come with me. You are seeing the heart from the left side of the chest, we are opening the sac that contain the heart. I hope that your breakfast as has already been digested. We are looking inside the pericardium, that is one of our coronary target. And now you're looking into the chest wall where these arteries that we call internal thoracic artery leaves serving the chest wall and they can be a reroute deployed to the heart. And 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 these are -- you are seeing a heart moving. An LAD, one of the targets that we are doing is future and up there the internal thoracic artery previously harvested. So a truly pure minimal 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, listen to the words of a physician. [Presentation]

So a physician who had a double bypass two mammary artery deployed to the best target of the left coronary system, 26 hours after he's at home. This is innovation. This is the future. So where do you sit as TTFM? TTFM sits here, and I want to go a little bit fast on these slides, but 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 patients 1 day, 26 hours after surgery, if I don't have the opportunity to pass those graft intraoperative and know that for sure those grafts are nice, are patent, and they are serving this patient well. I feel confident to send this patient home, because I can perform an assessment intraoperatively. More, I can teach how to perform the surgery to someone else. As you heard from Dr. John Puskas, he told me how to perform bypass surgery and robotic bypass surgery. He was feeling comfortable to let me taking the ownership and the responsibility to perform something that has a huge impact, the most important impact in the 10 years 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 training nowadays does in my operating room. That is training. That is the key point technology. That's the most important stone of that Roman arch that sustain innovation, education and, of course, patient safety. So the gold standard and the key corner point is Medistim. In this sense, the innovation that you are bringing in become 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 patient, can be spread to family, can be spread to referring physicians, creating a culture around these numbers, around these values that we have seen. These numbers means a lot to people like me, Dr. John Puskas and even to people that has spent all of their life with Medistim personally embracing this technology as industry and 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 check the graft and these were the flow of your own patients, they still don't know what exactly it means. It is 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, there has a 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 feature 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 drawing 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 8 years 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 allow 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 6 hours when your chest was open or when someone was operating you robotically, indeed a series of bypass, you understand graphically what happened to you has a level of comfort and added 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 practitioner, distributing and spreading the news of what Medistim has done in the last 30, 40 years of successful 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 patients itself. And again, a system that provides in a very simple color-coded understanding of all of the flow that has been taking and all of the picture and images modality that we can acquire for. And here, you see more from an open case. There is a heart beating. Still not the lunchtime guys. And you see one of the bypass 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. And this is innovation. This is future. This is what we need for our patients. In conclusion, you guys are the key stone, the elements of an arch that extend from innovation to education and patient safety. And all of this is possible, because we can check the results of what we are doing. Innovation is the most important element that push 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 minimal 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. And education is the only element in which we can bring innovation and continue to build up on innovation. And we can educate, because we can assess that the trainee has done the same perfect job that I would have done if I were showing the bypass grafting on my grandmother or my father or someone of my own family. Thank you so much, and I'm happy to take any questions from the audience.

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 for online, we have not received any questions. I guess the presenters have been very, very clear. But here, we have a question.

This is [indiscernible]. 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?

We come here. So also, we have a -- someone can see our faces on the online. Great question. And I think both of us should reply. One of the slides that I skip 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 remain 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, this 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 being 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, they come to Dr. Puskas and me to learn this robotic and minimal invasive to the best hospital of Europe, 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 you 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 the 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-0 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? Yes, please.

Yes. I'm Geir Holom, analyst from DNB. I actually have on the commercial question for Kari. So with this new innovative INTUI 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 installed 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.

It's [indiscernible] 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. Yes, it will happen physically on site and will be handled by our sales and service team.

Okay. And then I 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 multivessel disease or higher SYNTAX score, if there is a certain, say, range or a rule of thumb or so where you see especially the U.S. basically -- yes, 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, it's highly variable, extremely variable by a factor of 10x. There are some places where the PCI to CABG ratio is 25:1 and others where it's 5:1. And these two different locations may be in the same country or even the same city, but they certainly differ between countries and they differ between different operators and different healthcare systems within one nation. And obviously, it cannot possibly be that human beings are that different in those different locales, such that everybody is getting just the right therapy for them. That is not plausible. So there have to be other factors that work other than perfectly judicious allocation of patients to the alternative therapies. Frankly, it's politics and money. I mean, if you really want to know why I think -- or a situation is the way it is, follow the money. This is not news. We've known this, that'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 about now 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 the 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 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. It's -- 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 expose you do, you get a stent and then after 1 year you get another stent or 2 years after, you have to go and clean up of that stent, create 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 in back to the hospital, try to convince my dad, who's 80 years old, living his own life going out with friends and family around Europe, having dinners, to go back every 4, 6 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 multivessel PCI, multiple stents will be deployed into one or two robotic bypass and may be 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 technology 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. How is TTFM and imaging used when you use robotics versus 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?

Yes. 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? There is -- so we are currently and Medistim has developed a minimal invasive probe that can be used robotically to address the flow intra-operatively. Looks and work exactly as one of the flow probe that you see in open and -- but it is instead in the -- gives the opportunity to be introduced via what we call a small trucker so a very small opening in the chest. And this probe gets basically being 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 to the end of the video. But basically, we have probes. We have -- Medistim has developed the probes part of the video, if I can show it to you. So how much is the growth -- like is the current market of robotic? So right now, we are still in the single digit for the percentage per form of robotic, but we have never had a robotic company that took robotic coronary seriously. And this is because, as Dr. Puskas 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, one, 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 United States and for a cost that is 1/4 of the cost of the only other robotic big player company players. 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 wants, 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. We -- and I actually took 3 years results and I prove that my hospital, it saved something like $8 million in 3 years, based on numbers in a propensity match score of patients that could have been allocated for a sternotomy. And instead, I perform a robotic or an hybrid 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. And remember that there is also more of 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 last surgery, I offer her a robotic pickup, exactly a complete robotic bypass on my mother-in-law, who 3 days after surgery was on the carpet of my house playing with my daughter that at that time was 4 years old. So I can tell you that there is a complete change 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 economical 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's maybe a little different in a national health care systems, 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.

[indiscernible] again. Just on the -- I like the bit about following the money. Could you talk to us -- could you explain the reimbursement situation for CABG in the United States? Is that relevant to the uptake of TTFM?

Reimbursement of 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 it 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 10x 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.

So yes, we are a bit behind our schedule here, but who can resist listening to these experts in the field. So maybe just need to allow them to finish.

Okay. So we will change the subject a little bit. And we will now -- 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. It's -- the symptoms of CLTI is 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 with or 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 indicated in that, around 20% of these fail within the first year. So how can TTFM and high-frequency ultrasound add value? Well, this is a -- it is a bypass. 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 course or it could be an intima flap which is a injury of the vessel wall or it could be a thrombus, which is the clot formation. And none of these can be seen by the vision -- visually or detected by palpation, but TTFM can easily detect a flow-limiting impact. And you can start to see with ultrasound what is causing this and this image below shows an intima flap with thrombus. Between the anastomosis, you have the graft, in this case, the vein graft and you want this to be opened or PATENT. And if it's twisted, that will impact flow. And also if it is a kink that will impact flow or you can have a small or large leakage. If you have a kink or a twist, you could see it, if you use an open surgical technique like to 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 the low flow spiky curve, high PI and that was revised and flow got much better. And you have -- here, you see these TTFM probes. This is without and handled and this is the type of probes that is used during robotic surgery. So they are very small, easy to place. Here, they are snapped on the vessel. And then you see ultrasound, both in the longitudinal and the transverse view. So we think that the combination of using flow and imaging complement each other. They are a perfect match. And you can -- TTFM can rapidly detect flow-related issues and ultrasound can describe what the problem is. So -- and you may wonder on the other techniques that could be used to detect these problems. And there are and there are a variety of techniques that can be used. It's duplex ultrasound, angiography, Doppler and our -- but we think that -- but there are no standardized method recommended. And you will hear more from Professor Venermo talking about the advantages and the disadvantages of these different types. And 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, and Professor Conte will talk more about this in his presentation. So the goal of the PATENT study is several fold. It's to detect technical issues that can be identified and corrected interoperatively. It's to identify the grafts that has a high risk of failure and separate those from the graft that has a low risk. And we also want to collect data for later health economic analysis. So the design of the study is prospective, it's international, multicenter. We expect the enrollment of patients to take around 2 years, and then we will follow up each patient for 1 year, and then you will have the analysis and publications. So we plan on enrolling 450 CLTI patients in 15 sites in the U.S., in Europe and in Asia. So that's a short introduction to the PATENT study. So thank you for your attention.

And then the time has come to listen to a prerecorded presentation from Professor Michael Conte, professor at the division of Vascular and Endovascular Surgery at the University of California, San Francisco. And Professor Conte will be the lead investigator of the PATENT study.

Good afternoon. I'm Mike 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 and 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 are atherosclerosis affecting the arteries of the lower extremities is a growing global health problem due primarily to 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 2 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 study looking -- 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% and 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 graft or at the anastomosis. The largest drop in patency of bypass grafts occurs in the first 2 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 anastomosis. 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 these too -- this too is related to the preexisting intimal hyperplasia that occurs within the conduit, which may be the soil for the atherosclerosis that develops later. So 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 is 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 is 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 reinterventions 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. In geography, by placing a needle or a 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. Well, 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 grade saphenous vein. So that in these two parallel trials, there were actually two separate hypotheses in the larger cohort with a good vein hypothesis was that the vein would outperform endovascular therapy, whereas in the cohort 2 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 1 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 important this primary end point of major vascular reintervention, 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 European SVS meeting. This is a 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 the -- 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 favorable 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 a good surgical risk may do better with a bypass first. And this is what the data is increasingly showing. And 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 endovacular based on the patient's overall risk, the degree of limb threat or limb severity as shown on the X-axis here and the anatomic complexity as well, such that patients who have advanced limb threat in 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? Well, that's a difficult number to come upon, but if you look at a number of recent large registries, national registries and other large multicenter studies, it looks like between 25% and 35% of patients are generally getting an open bypass for CLTI. And based on my own personal experience, I think the number of between 20% and 30% is probably about appropriate given the types of patients and complexities that we see with CLTI. So 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 or 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 high likelihood of technical success and sustained 1-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'll have a Q&A session on this topic. So I hope we will be able to connect with the Professor Maarit Venermo, who is the Professor of Vascular Surgery at Helsinki University. So she will be live with us over Zoom and yes, available for questions. So Maarit, please, the stage is yours.

Yes. 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 allowing bypass surgery. I don't have any conflict of interest related to this topic. So here, you can see the most important risk factors for arterial disease. In the treatment of hypertension and hypercholesterolemia has improved and prevalence of smoking decreased the one circle with green, at the same time, the prevalence of diabetes has increased and is increasing and the number of elder people as well as we live longer. In the 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. And here, you can see the evolution in the number of endovascular and open surgical procedures since '70s. Nowadays, we do about 2,500 endovascular and 1,600 open surgical procedures. In '70s smoking was the most important risk factor and bypass surgery to prevent amputations was not yet routine procedure as it is today. In the end of '80s, bypass surgeries started to increase in numbers and in the '90s 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 leading countries in terms of prevalence of diabetes, so five being Mexico, Turkey, Spain, U.S.A. and China. In the right in turn is the development of the number of population with diabetes and its prevalence and it's growing. Patients who undergo distal bypass surgery usually have advanced peripheral arterial 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 thesis. And here is a picture from one of those. So if we use, [indiscernible] we can achieve excellent limb salvage after bypass surgery. Here is the curve from one of our doctoral thesis in Helsinki showing the limb salvage for 600 patients after bypass surgery. This is from another thesis on living status, 5 years after either bypass or amputation for patients who originally is living independently at home. In the right, you can see that after major amputation for a patient living at home in the beginning, majority of the patients live at institution after 5 years when in turn, if they undergo bypass and save their leg, majority of the patients are able to continue independent living at home. And the cost saving is obvious for society as because of the fact I showed that after amputations, patients usually have to go to institution, mainly, this leads to significantly higher costs compared to bypass surgery. The reasons to do complete 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 autologous saphenous vein, because of problems which we could fix in the first place. One individual has about 2 meters of saphenous vein, not more. This is a paper on the causes of primary graft failure of saphenous vein bypass published already in '92, and it included over 450 bypass operations. Primary graft failure rate was 20% and in 63% reason for graft failure was related to a problem with graft itself. And you can see the reasons for graft failure here in the left. And 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's no scientific data for comparing these methods. In Helsinki, we use transit-time flow meter in all cases as called completion control. If any problems are suspected, we first make ultrasound, 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 it we have to give 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 methods transit-time flow meter is significantly quicker to perform and non-invasive and safe. Furthermore, you can always use these methods as additional component if any suspicion in TTFM. And here, I show you a video on our routine case. So first, we measure flow 2- to 5-centimeter [indiscernible] proximal graft and take a look to contact to probe and also the curve of 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 fix the problem. And also, pulsatile index is important, and we want it to decrease less than 2. And here, we can see that actually the flow itself almost increased 4x from the baseline. And here is another procedure where we do have some kind of problem. The first one was really good. Again, 2 centimeters after proximal anastomosis. And you can see clearly that the curve is a little bit flat. And also [indiscernible] well, it's okay, but it's not really good. And then we do ultrasound, high frequency ultrasound. And 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 flow. 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. And after the procedure, after the stenting, the curve saw was good. After papaverine, very, very nice reaction and flow increases to 4x. And pulsatile index also decreases below 2. So we made analysis to our 700 intra-operative bypass grafts and divided the patients according to the flow into tertiles. 71% of the grafts were single segment great saphenous veins and overall occlusion rate at 1 year was 19.6. And we could clearly see -- and you can see here actually limb salvage rates were 93, 86 and 77 and survival of the patients at 81, 76 and 71 at 1 year. And here, you can see the Cox proportional hazards model adjusting with graft material, and we can see significantly higher graft failure rate in the probe with lower transit flow and the failure occurs during the first year and is relatively equal with the probes thereafter. I also analyzed how papaverine response predicts graft failure and indeed responds to papaverine further predicts graft failure irrespective of the primary flow measurement. You -- so yes, the transit flow meter and high frequency ultrasound are used in Helsinki in all areas of vascular surgery, in bypass surgery and other rolling 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. And we use angiogram only when we suspect problems in TTFM or HFUS. And it's, as I already told, it's less than 10% of the cases. And 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 coronal 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 the bypass surgery and have recommendations at guidelines level to improve patient care and limb salvage globally. Thank you very much.

So we will take some questions to the vascular topic, if we have any.

Is there anyone in the room?

It's [indiscernible] Capital. I have a question regarding gatekeeper role. So who's actually to decide if you will have an open procedure or endovascular procedure and are there some conflict of interest that must be taken into consideration?

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 patient. 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 task classification for the lesions. And it means that if it's very long lesion, it's impossible to treat with endovascular procedure, then there is B and C lesions which are sort of in the middle. So if patient is very high-risk patient, we may start with endovascular procedure. However, if it fails, as it many times does we call for surgery. And then there is task A lesions which are short lesions, which we always usually go for endovascular first. And in this equation, we, of course, always think patients risk factors and some things like that. Did I answer the question?

Geir Holom from DNB again. One commercial question for me again, too. What's the cost for Medistim for running the PATENT study?

Yes. So we are investing about NOK 25 million into this study. And -- yes, so that covers sort of the external costs and then the -- or 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. Bye-bye.

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 we -- it's realistic that we will reach the NOK 1 billion milestone in a few years. And since then, we did meet some economical 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 yes, 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 NOK 1 billion is within reach and that we will reach it within a few years still. I don't know whether are any others or 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 has joined us here in the room today and also online. So thank you very much.