All right, so I know we'll still have some individuals joining later today, but just in the sake of time, we'll go ahead and get started. Good afternoon. Thank you all for joining this webinar today. I'm Matthew Weaver, Manager of Industry Partnerships here at MedAxiom and fortunate enough to be your moderator and host today. Looking forward to the webinar today on early stage innovations from the next wave of industry disruptors. This session is gonna focus on solutions from five companies really pushing the boundaries of cardiology, but also digital technology. So today we're really lucky to have Frank Cheng, CEO of Caristo, Dr. Marijuka, CEO and co-founder of Multiply Health, Naud Stephens, Chief Commercial Officer and Steward Head, Chief Medical Officer of Airmonix, Chris Darlin, CEO of PeerBridge Health, and last but not least, Yosef Harb, Founder and CEO of HappyTech. Before we get started, we'd like to address a few housekeeping items on our end. So thank you for switching that slide. So as you can see at the bottom of your screen, you'll see a Q&A function. So that's there for you as an audience to pose any questions that you guys see fit for our panelists. Throughout the presentation, we have about 15 minutes reserved after the presentation for a live Q&A with our panelists today. So please, I encourage you to ask those questions throughout the presentation. The other call out here is going to be the chat function. This is really reserved for the commentary on the presenter side. So panelists, if there is any issues with your sound or video, please let us know and we will have our Academy team iron that out. Awesome. So with those agenda items taken care of, we're going to go ahead and transition into the presentation portion of this webinar. And we're going to go ahead and start with Frank Chang of Karisto. So thank you guys for joining and enjoy. Well, thanks to Matt Atrium for the invite. Karisto is eliminating heart attack by uncovering an invisible coronary disease that leads to 300,000 unneeded U.S. death a year. My name is Frank Chang. I'm the CEO of Karisto Diagnostics. Heart attack is a major health and economic challenge in the United States, which causes over 300,000 deaths and $18 billion a year. Although 800 Americans undergo cardiac CP imaging annually after they experience chest pain, unfortunately, heart attack risk of two thirds of these people may still have been either underestimated or missed altogether. The missing risk is actually called coronary inflammation, which is unfortunately invisible to existing imaging techniques. Coronary inflammation actually initiates and then drives disease progress eventually toward heart attack, either by causing a substance called plaque to grow inside the coronary vessels or by causing even a small amount of this plaque to rupture. As a matter of fact, our research found that two out of three heart attacks happen in patients only with minimum plaque, but with significant inflammation. So therefore we now know tracking and detecting coronary inflammation is important. During the last several decades, advances in imaging and AI have actually been pretty transformative. That includes the invasive coronary angiography, which emerged several decades ago, back in 70s. And then followed by cardiac CT imaging, which emerged in the 90s. And then more recent, 10 to 15 years, CT-based AI analysis tools will either measure FFR or plaque. However, none of these techniques can actually measure coronary inflammation. Based on breakthrough research at Oxford University, Carissa now has invented novel technologies that can reliably measure coronary inflammation, which can lead to accurate prediction of both fatal and non-fatal cardiac events, both in the short term and in the long term as well. Our technology is protected by 37 granted patents and validated through tens of peer-reviewed publication in top journals. Not only our technology can predict cardiac risk, it can actually lead to personalized therapeutic treatment, which has proven to significantly reduce risk of major at-risk cardiac events as well. Now I'd like to show you a case study of two actual patients. It shows two male patients, the images on left and the right-hand side. They presented both with typical chest pain, both have hypertension, and both are on staph in treatment. Their cardiac CT images show that they do not have obstructive coronary disease. Normally, today's standard care, both of them would be sent home with minimum or no treatment. However, using our technology in a retrospective way, you can see the patient two, which is on the right-hand side, had high inflammation in all arteries. That shows that this patient has high disease activity and is of high cardiac risk. This patient would have been aggressively treated if we were able to analyze this technology before his death and the death could have been avoided. Our comprehensive offering has three components. For each set of CT scans, we start by analyzing coronary inflammation, which is the left-hand side icon, and followed by quantitative coronary plaque and a stenosis analysis. Finally, by combining inflammation on plaque and other risk factors, we estimate a patient's individualized risk for cardiac mortality. Our CARI plaque offering was just received FDA marketing authorization in the U.S. and will be covered by a Category 1 CPD code starting next year. The CARI heart component was recently granted a Category 3 CPD code by the American Medical Association and now is available for research in the U.S. market. Globally, where we have been able to deploy our full solution, the solution has led to optimized treatment for 45% of patients. And multiple studies have demonstrated that our solution reduced major adverse cardiac events by about 30%. To summarize, our solution is well-positioned to further transform cardiac care by visualizing the missing piece of the puzzle, which is coronary inflammation. As Dr. Eric Topol recently said about our technology, we now have a new way to find people with heart attack liability. It's exciting to see this. Now, I really appreciate your attention and I'm happy to answer your questions. Thank you very much for being here. I'm Santiago Mediuca. I'm a cardiologist, but also I've been working a long time in RNA and artificial intelligence. And we have developed this new test in Multiply trying to improve how we diagnosed these two main problems, coronary artery disease and statutory liver disease in our patients. So I'm going to discuss a little bit about the genomic landscape in cardiovascular disease diagnosis test. So basically, every year we're improving in our understanding of genomics. And of course, we make use of this knowledge to perform better and develop new tests. And essentially what we have seen in the last 20 years is that we are now being able to identify many, many monogenic diseases. And of course, whenever we see someone with high cholesterol, we wonder if there's a point mutation and we have a ton of tests to identify these type of diseases. However, in the last few years, we have now a new test, which is based on the polygenic risk score. Basically, these are many, many point mutations that essentially provide us with a higher or less risk of developing different traits. However, it is clear and clear now that these tests are telling us the inheritance of developing a problem and not necessarily that the problem is already developed. So based on that, it's now acknowledged that these tests are better for younger people instead of people with established disease. The limitations of the current tests are based on this. Of course, monogenic diseases are relatively rare. And as I said, the polygenic risk score is mostly for younger people. So basically, what is interesting is that when you discuss genomics with people working on this, they tell us that coronary artery disease is about 46% explained by genomics. So definitely we need more tests in this space. In Multiply, we have developed a blood test that is based on the RNA gene expression. And basically, what we have done is to develop tests based on the whole blood. We don't perform any cell separation. We get the whole trans-symptomics of the peripheral blood. And we make sure that we don't manipulate the RNA so there's no post-extraction manipulation. We used commercial tubes for this. And this has been a recent development in the last few years. Really, RNA remains very stable in these NU buffers. So essentially, our test is based on the complex trans-symptomics in the peripheral blood, hundreds of thousands of different RNA molecules. And then we perform, we apply extensive bioinformatics and machine learning analysis to identify these two traits, coronary artery calcifications and fatty liver disease. Why these two traits? Because this has been very clear in the past years that the presence of calcium or the presence of fatty liver disease really is very clear, the risk of having cardiovascular events in the near future. So essentially, after taking the blood sample, we applied on the bench, we applied different processes for RNA extraction. We perform our bioinformatics and machine learning. And what is interesting is that we applied more than 800 different algorithms until we come up with a very clear idea of the gene networks that are associated with these two traits. Now, we performed several clinical studies. This one, for example, is based on a CT scan performed to patients and the whole blood RNA analysis, as I said. The definition of coronary artery disease, as I said, we identified the presence or absence of calcium in their arteries and for certificate liver disease is the current accepted definition. And of course, this is our experience as everybody will identify people with low risk and high risk based on their clinical variables. And this shows how bad we are using our clinical perception. Many people with low risk develop calcium and many people with high risk present with no calcium at all. So there's a lot of improving for improving there. And essentially, this has been shown in our study with that whenever we apply the trans-symptomics plus the clinical variables, the AUC is 0.92 compared to 0.72, just using a clinical risk score like the Framingham score. So we are way better than the clinical variables alone. And these results are consistent across the different risk score that the patient may have. Regarding liver sciatosis, we are even better. The AUC is 0.97 compared to clinical variables. And this is because these patients really have a lot of the arrangement in the trans-symptomics in the peripheral blood as expected. And to show this, this is very interesting, but essentially, whenever we take a look at the gene networks that are regulated in people with fatty liver disease, we found that those genes are related to insulin resistance and liver metabolism, two hallmarks of fatty liver disease physiology. So as we have always said in Multiply, we believe that we need to be pulling people out of the river, and we need to improve and detect people before falling into the river. So thanks, everybody, and hopefully you enjoyed this talk. Good afternoon, everybody. My name is Nout Steffens. I'm the Chief Commercial Officer of Harmonix. We are a Dutch, the Netherlands-based startup focusing on post-operative recovery after cardiac surgery. And I'm here together with Stuart Head. Stuart, you might want to introduce yourself briefly. I'm Stuart Head. I'm the Chief Medical Officer of Harmonix, a previously cardiac surgeon, well aware of this problem that we're trying to address with Harmonix. So we are focusing on preventing post-operative cardiac surgery complications. We're focusing on bleeding reduction. It's a problem that's well-known in the cardiac surgery space. And we are introducing a device made by an invention from Dr. David Koolbergen from the Amsterdam University Medical Centre, which is called pericardial flushing, and we're going to explain to you what we're doing here. So just a brief explanation of the problem. Two problems occur more or less in postoperative recovery after cardiac surgery related to bleeding. So the first problem is that the drains get occluded after, can get occluded after cardiac surgery, and if the drains get occluded, it can lead to excessive bleeding problems, and in the worst case, even to a re-operation for the patients. Another challenge at the ICU is that the monitoring is cumbersome. At a lot of ICUs, they still have an analogue pod below the bed, whereas nurses every 50 minutes or every 30 minutes have to go back and look at how much blood loss has been in the last period, and this leads to very insufficient insights into the complication that's occurring with the patient, and the combined problem of this leads to longer hospital stay, additional re-operations for patients, and unfortunately, too, a lot of cost for the healthcare system. We estimate the cost at $4 billion globally. Because of this problem, the ERAS Cardiac has also, a few years back, recommended to keep the drains always open to prevent these problems from occurring. Stuart is going to explain a little bit more about the solution that Dr. Kohlbergen has invented. Yes, so what often happens in patients that have occluded drains and have basically pressure building up in the pericardial space is that they need a re-operation to alleviate this tamponade that has developed over time. What is often being done during that re-operation is to flush the pericardial space with warm saline to get rid of all of the blood clots and to identify the source of bleeding and also to reset the coagulation pathway with this warm saline. So Dr. Dave Kohlbergen, instead of doing this reactively, in patients thought about the idea to do this proactively. So our solution is based on the principle to flush the pericardial space after cardiac surgery with warm saline, and with that flushing, remove blood and clots that are in the pericardial space, which that removal essentially then stops the bleeding because it stops the fibrinolytic activity that is being maintained with blood and clots. And besides cleaning the pericardial, it also takes care of continuously keeping the drains open because we flush it with the saline, with the clots being watered down basically. So what Harmonics provides is an all-in-one preventive flushing solution to prevent these postoperative bleeding complications. Next slide. So we've assessed and evaluated this technique in now about 750 patients being treated in five trials. The initial feasibility study was a single arm study, which we evaluated against a historic control. A similar study like that has been replicated independently from our company by a hospital in Turkey. And Harmonics has performed three randomised control trials where we randomised patients to postoperative flushing versus the standard drainage and the standard POTS to see what the direct impact in these randomised trials was on the reduction of bleeding-related complications. We've analysed these five clinical studies of which the three were randomised and all of these patients of which 500 patients were randomised. And we saw that there was a huge impact on clinical outcomes. So 40% reduction in the number of re-interventions that were required after surgery, about one fourth reduction in the number of blood transfusions that were required after surgery and overall about 35% blood loss after cardiac surgery. So it's clear that with this postoperative flushing, postoperative bleeding complications, it can be prevented. Now, what we've done in all of these studies was with an experimental setup initially with just an infusion bowl, warm saline and a pump and a nurse calculating how much goes in, how much of the fluid comes out. But we've also in the last trial used an investigational device and with the trial and the feedback that we received from that trial, we've invented a final device. On the next slide now, the device, what you can see on the left here is the Harmonix Pure system. It's a system that has benefits in two folds. First of all, to reduce the postoperative complications that I just mentioned by automatically flushing the pericardial space and removing the blood, the clots and keeping the drains open, but also to enable prompt clinical decision-making after cardiac surgery. So with the device, as you can see on top, there's a sort of an iPad device, which will give all of the parameters of how much fluid goes in, how much fluid goes out, but also provides an insight into how much of the fluid is actually blood. And we do that by providing advanced sensors to measure the amount of blood in the fluid that is being discharged. And on top of that, we provide a pericardial pressure measurement in the pericardium to see with elevation of the pressure, you can see a tamponade developing early on and intervene earlier rather than later when it's really in an emergent situation. The word back to you, Nout, with the next slide. Thanks, Dries. So what we have done as well is we have calculated the economic impact on the healthcare system based on direct and indirect clinical results that we have seen. And our estimation is that the savings for the healthcare system is around $6,000 per patient on average. And based on this number, we have decided to price our system at $1,500 per patient. And it's a pricing per treatment, so patient fee. And that includes all the disposables, equipment, and service. So that's what we're looking at. This is the presentation. Thank you for your attention. Here on the right side, you see the device on Monix Pure being used in the Amsterdam University Medical Center with Dr. David Kohlberg next to the bed. Thanks again. And if you have any questions, let us know. Thank you. Thank you. Good morning, everybody. My name is Chris Darlin. I'm the CEO of Pure Bridge Health. I'm really happy to be here to talk you through what we're building and some of the partnership we've already started with a few of the clinics with MedAxiom. So the problem we're trying to solve is what we see is really a pretty dramatic supply, demand imbalance for cardiac care in the U.S. with heart disease outcomes kind of worsening at the same time the number of cardiologists not keeping up. And our view is that it's not due to a lack of expertise with cardiologists or necessarily the tools, but the tools remain largely in the hospital. And for a lot of the communities that are impacted the most, there's not any cardiologist presence at all. And really, our whole goal is kind of bridging that gap between these hospital grade tools and the expertise that exists in large swaths all over the country. And how do we really, really inexpensively get that knowledge and kind of diagnostic capability out to the rural communities and the communities that are being missed today, which is, you know, a lot of my family and my background and tens of millions of other people as well. So in terms of what we've built, there's really three key pieces of the technology, the most basic of which is a three-lead ECG system based on Eindhoven's triangle design, which allows us to get to ultimately deriving all 12 leads. But we're really proud of the signal fidelity, both spatially and spectrally of the device. And we combine that with some quantum physics and AI work that allows us to amplify the signal even more. So this ultimately allows us to get to little tells in the ECG over a three to four minute window that can tell us way more about the cardiac function of a patient than we ever thought possible in the past. And we're really marrying that signal with explainable biomarkers. So this is sometimes even research from the 50s and 60s that says, hey, you know, for certain rhythms or certain P wave activity or anomalies, you can get to a lot of diagnostic power directly from ECG, not only things such as measuring or estimating ejection fraction, but structural defects, even respiratory patterns and being able to diagnose sleep apnea with the addition of accelerometer getting the cardiac output and stroke volume. We think we can do all from one device and it's all about building more and more capability from a very simple, kind of very inexpensive piece of hardware. And ultimately for the business, the ethos of the company is everything is ultra low cost. We think any kind of pursuits of underserved communities or improved access without also trying to make the cost as low as possible is ultimately just kind of a little bit of a virtue signaling exercise. And we need this to really reach all communities, which means that everything we do is with low cost in mind. And importantly, as we think through the tool from the eyes of the clinician, it's really our success is amplifying your all's expertise. So we're not trying to be the cardiologist in a computer, so to speak, but if we can get your expertise and give you tools that you're used to having in the acute care setting to reach patients anywhere in the country, as well as get a more sophisticated view of your patients really quickly in the office setting, we feel like we've had success. So think about this as a superpower for you all if we build everything that we think we can do. So the initial offering, and this is what we're doing our pilot with with HeartX is what we call the core insight program. So anytime you would prescribe an extended halter today, our device is cleared as an extended halter. You could prescribe our device and not only are we going to give rhythm context, but we can also give heart failure detection, structural abnormalities, hemodynamic input, sleep, apnea, like AHI measurements on a nightly basis, with the thought being that the real power of what we're building is not each individual piece, but really the insights you can get from having the context of everything all at one time in terms of getting to care quicker, monitoring patients. After an acute event, only having rhythms as an example is good, but not fantastic and having it all at one time, and in our case at half the price that it would cost just to get one rhythm assessment, is ultimately what we're trying to provide to you as a tool. The company, we feel like we have a pretty good lead in this space right now from a variety of things. What differentiates us in a very competitive market is the hardware that I talked through, the software that allows us to get to even better signal fidelity, and then ultimately we have our algorithms that we've built, these explainable algorithms to get diagnostics. As we get more and more patient data, the algorithms will only become better and better performing, and then if we have let's say 31 diagnostics a day, we think we can get to 100 plus, so it's kind of a flywheel effect as we continue to grow, which does a couple of things for us. It allows us to continue to lower the cost ultimately for the technology to you, all the clinicians, and also allows us to increase more and more utility at the same time. The diagnostic panel could almost think about a blood test like as you get a rhythms report from Zio or Barty, you get the same from us, then you get this panel as well. So anyone who's interested in being part of the trial, we are kind of launching this. We launched in January as a 15,000 patient IRB trial. We're kind of opening exclusively for MedAxiom clinics for the next three or four months. We have the first one starting here in April, but this is essentially in effect what we're offering on top of the rhythms that you would get for every patient. So reach out anytime if you have any questions or have interest in being a part of the trial, this is launched and ready to go now. Thank you everybody for your time. Like I said, very thankful and blessed to be a part of the Hardax program and to be associated with MedAxiom. We really think we have something that could be a huge help for you all, not only economically, but ultimately for your patients, and that's what we're probably most excited about right now. My name is Jos-Safi Harp. I'm the founder and CEO of HappyTech. Detecting AFib can be like finding a needle in a haystack. Patients are often prescribed monitoring devices anywhere from 24 hours up to 30 days, but episodes can happen outside the time of monitoring, making it difficult to detect. Now, existing solutions are great, but they're constrained by cost, monitoring window, and availability, leaving a gap for long-term accessible AFib monitoring that is affordable and available to the patients when needed. So AFib obviously affects 6 million patients in the US alone, including unfortunately my father. And so we looked for a solution that could monitor AFib with something that 86% of the world already has right in their pocket, the smartphone. So we detect AFib just using a phone. By placing your finger on the camera, waiting 90 seconds, we can do that. So how does it work? When you put your finger on the camera, the camera sees the slight color changes that are caused as blood is pumping through your fingertips, expanding the capillaries. Then our medical device that's approved in Europe using AI is able to detect these irregularities. And we've also invested in the clinical evidence in Europe to make sure that we show the right validation data, but also outcome data in some of the best journals, including the AHA Journal, Heart Rhythm Society, Europe Pace Nature. And the proof of that is that HappyTek is now trusted by about 50% of the cardiology hospitals, and we're collaborating with top research institutes in the United States as well. And together, we have impacted close to half a million lives in over 11 countries, which is a great testament to its accessible and easy to use nature of the device. Now, hospitals use this for a variety of use cases, from screening, triaging, and monitoring. Now, let me explain those three, with monitoring being our most popular one. These are use cases where physicians are looking for recurrence of AFib, whether it's in a cardioversion, or an ablation, or post-surgery. There's often a recurrence of AFib, but often the monitoring window is very short, leaving the physician often in the dark with no information. So here with Haputec, physicians can monitor for a year or two or longer simply using the phone and using the CPT codes around remote patient monitoring. Now, the second use case is the triaging of patients with a high risk. So that could be sleep apnea, post-stroke, COPD, diabetes patients where the combination of diabetes and AFib increases their risk of stroke. And then finally, screening, which I will touch more upon in a second. So moving forward, why do hospitals choose for Haputec? It's really, it's accessibility and scalability. Whether you're a four hour drive away on another continent, it's really, really easy to use. And what's good to share is that we're not competing with existing, we're completing them. So think about Haputec as a funnel, as a first line of defense triaging and allowing you to take decisions whether or not to escalate, whether it's a patch or a halter or a single lead ECG, just by using the phone. And this project is a testament to Haputec's core value is we're doing 160,000 screening campaign that's kicking off in April. Just by using the phone, Haputec screens those patients, the ones that are positive will be receiving a Philips patch. And this is a partnership with the Heart Association, the Cardiology Association, and a lot of great strategics. Now, Haputec is supported by a team that's helped build three of the four largest cardiac monitoring companies with a very wide experience in cardiac monitoring, but also in new technologies like iRhythm and Google Health and Verily. And we're very proudly supported also by HeartX and Medaxim, which is part of ACC, as well as the AARP, which is representing the community of retirees. Now, my ask here today is for those watching, we're looking for sites to support and accelerate our FDA study to allow for a more equitable and accessible care as 86% of rural counties have no access to a cardiologist. And we could transform this simply by using the phone. And we have the great honor of collaborating with St. Vincent and St. Bernard in a study, but we're looking for more sites to be able to accelerate the inclusion of patients and get through FDA faster. So if you have any availability, please let us know. It's gonna be a really simple study. As the patient's going through a 12-week checkup, take a measurement of the PPG. That's it. And we collect this data and we use that for validation information for the FDA. So going back to my father, unfortunately, we weren't done with device development when he had the episodes. But fast forward a few years later where he was feeling a bit dizzy. He used HappyTek and discovered a high heart rate, shared it with me, shared it with our CMO who recommended calling an ambulance. They came, they stabilized them. And that's really the power of HappyTek. It allows you simply from your pocket to monitor your heart. So thank you for your time. And if you see any space and time to support us in our FDA studies, that would be highly appreciated. Thank you. Thank you, Yosef. And I wanna take the time to thank all of our speakers today. We know your schedules are incredibly busy trying to get these solutions and offerings to market and just really excited to see the growth and where you guys end up in the cardiovascular sector. So again, thank you guys for your time, your energy and your efforts here for today's presentation and looking forward to transitioning over to the Q&A portion. As we transition, again, just wanna call out if you do have any questions for our panelists today, go ahead and throw those in the Q&A part of the function down at the bottom of your screen and we can go ahead and get started. I think we do have some questions already. So I'm gonna go ahead and get started. So panelists, as I call on you just with these questions, you can go ahead and unmute and share screen and just go ahead and answer. So the first one is actually gonna be for PureBridge and that's going to be, how much data do you need for your insight indications and can it be done in a setting outside of ambulatory cardiac monitoring? Sure, good question. So for almost everything except for sleep where you need to wear it overnight, we need about five minutes of data. And that, I mean, it opens an interesting opportunity for us that we're looking for in the future is ideally you can just wear this in a waiting room in a primary care office, collect everything you need and sort of have a blood panel as source of truth of cardiac function really inexpensively and quickly. So yeah, a lot of it's five minutes is the fastest we've been able to do to date but it doesn't need to be a seven day usage or a 14 day usage for sure to get to the insight indications. Thanks, Chris. Our next one is going to be for Karisto. So before FDA clearance of Karisto's inflammation detection technology, the next question for us is can we conduct research with the company? Frank, you want to take that one? Yes, absolutely. Actually, we just came back from ACC over the weekend. There's a growing number of hospitals, healthcare providers, very, very interested in conducting research for both of our technologies. So as I mentioned earlier, the Cary-Plaque technology was recently cleared by the FDA is also supported by a existing CPT code for building purposes. In addition, even though we're pre-FDA clearance for Cary-Plaque, but under IRB cleared or approved the research, we certainly can support providers and hospitals conduct the meaningful research as well. So certainly happy to talk to anybody around the country who is interested in jumping in to do research for the portion of our solution that pending FDA clearance. Awesome. Thank you, Frank. Next one is actually going to be for HappyTech. Yosef, is HappyTech exploring integration with consumer wearables or EHR systems to enhance monitoring and provide access to data? A great question. So I think interoperability and EHR integration is key for any medical solution to have impact on clinical workflows. And our way of doing that is we integrate with the, I don't know if familiar, but the remote patient monitoring companies like a Pacemate, Emerge, Ortegos. So our solution seamlessly fits in there. So you're already have that infrastructure at your clinic and we are able to do, we call it maybe the Intel inside. So we don't offer the full solution, but whatever you have, we embed inside of the patient facing app. So we don't have our own standalone solution, but we use what's already there to make sure that data is able to flow from the patient phone into the EHR. And it's a big reason why hospitals love working with us because that's what's very important. Awesome. Thank you, Yosef. Next one I have for Harmonix. So Stuart or Noud, up to you on who answers this, but for the clinical study in the US, what would be the end points that you are collecting or would be collecting for that study? That's a good question. So we're aiming to do an FDA study starting towards the end of this year. And with the device focusing mainly on bleeding related complications, we're gonna collect end points such as blood loss, blood transfusions, re-expirations for bleeding that happen after cardiac surgery, usually within the next couple of days, but also some later interventions that may be required for pericardial fluid or peripheral fluids. But we have to show to the FDA for safety data. So we'll need to collect also other adverse events that happen such as infections, sternal wound complications, but that should give us a good sense of performance and safety and convince the FDA that we can enter the US market. Awesome. And then actually a follow-up here for Harmonix as well. So you're charging for disposable items, but maybe you have the capital equipment on loan. Would there be a possibility to buy the capital equipment as well? Yeah, absolutely. So we're, I mean, we're in that sense flexible. We don't have a product on the market yet, so we don't wanna be too strict. Some hospitals would rather prefer to own the capital equipment and also of course buy the disposals that are required. Some other hospitals, it might be easier that we provide the capital equipment on loan. So we're flexible and happy to discuss with hospital administrators on what will be the best to get it into their hospital. Awesome. Great to know. This one's gonna be for Multiply. So Dr. Mariuca, how does your RNA-based screening integrate or how do you see it integrating into existing clinical workflows? Very interesting. So I think that there's a need for tests that very early identify those people at risk of undergoing vascular changes that in the midterm eventually will lead to a myocardial infarction, for example. And we don't have good tools. And as we have seen, the clinical variables are not enough and the tools that are available, for example, of course, performing a CT scan is very useful, but you can implement that population-wide. So you need what has been proved for many years in medicine is that blood tests are really qualified for that. So we do think that the place that our tests should be work is in those middle-aged asymptomatic patients or subjects that actually are absolutely unaware of their risk of having cardiovascular disease in the future. And there's for sure, and we have seen that there are many, many signals present already in their blood that could really illuminate us and eventually anticipate to any major cardiovascular disease or cardiovascular event that may happen in the future. And of course, if that is, if those patients are put on statins or they are closely followed, of course, that could have a tremendous impact in the high rates of mortality that these diseases have. Awesome. Thank you for that insight, Dr. Merduca. I'm gonna go back over to Chris here at PeerBridge Health. So going back to your study, how quickly are the results generated after completing an insight study? Quite quickly. So with the next generation device, we'll have a cellular chip. So the data will come essentially immediately to us from the device. If we're using the current device, which we have today, you mail it back to us, we download, and it can process with the results coming back within a day. Perfect. I'm gonna go back to Frank here at Karisto as well. So I have a question here. How is Karisto's solution different from other cardiac CT AI technologies out there today, Frank? Oh, great question. So there's multiple kind of tools out there based on AI analyzing cardiac CT. However, the prior generation technology is quite different from what we're offering here. So as I mentioned, Karisto's AI technology focus on analyzing inflammation in the fat tissue surrounding coronary vessels. So that is not only pattern protected, but also proven to be very, very predictive to down the road, both fatal and non-fatal heart attack. There are other technologies out there that are different. For example, AI technology measuring narrowing of stenosis within the coronary vessel, and also using AI to analyze just the plaque composition as well as quantity. Those things, both narrowing, stenosis, and plaque happen to minority number of patients in the late stage of the disease. Our inflammation technology can be measured on pretty much everybody who receive a cardiac CT scan, regardless how late or early stage of the cardiac disease they may present. Awesome. Thank you for answering that, Frank. Just a couple more that I see here. So back to Yosef here. Do patients need internet access at all times to use the active app effectively? And if not, how does that function or how does that part of the technology work? Yeah, so thanks for that question, Matthew. Everything is processed offline. So the patient doesn't need a direct internet connection, and the measurements are stored till there is a connection with the internet, whether it's the Wi-Fi at home or 4G, 5G. So that's, you're thinking they can take the measurements and once they find a hotspot, they can send out the data. Okay, awesome. Thanks for that clarification. Let's see, I have one more here. So Stuart or Naud, when do you estimate FDA approval for this device? You have Stuart? Not sure if Stuart is still there, but we expect towards the end of 2026. End of 2026, okay, awesome. I don't see any more questions right now. If there are any, please go ahead and fill those into the Q&A chat function. And we can give it a couple seconds. But if there is no other questions today, again, I just wanna take the time to thank our speakers, our panelists today and the companies for presenting their solutions and their products here today to our audience. If you guys have questions for these individuals, we will be sending up a follow-up email connecting you with their email and their title. So please look out for that email as we send that out post-live webinar. Again, this will also be housed on our MedAxium Academy for you guys to access at any time should you have missed part of the recording. I don't think there's any more questions that I'm seeing. So thank you again for everybody joining today's webinar. And then if there are any questions, please don't hesitate to reach out to them individually or here at ventures at medaxium.com. Thank you again for joining and we look forward to seeing you guys on future webinars.

cardiology innovations

digital technology

coronary inflammation

RNA-based blood test

postoperative bleeding

multi-diagnostic ECG

AFib monitoring

patient outcomes