Welcome again, this is Chris Romeo. I'm the Senior Vice President of the Ventures Team here at MedAxium. Today's presentation is Unveiling Pardex Innovation, Cutting Edge Solutions from the 2023 Cohort Companies. A few housekeeping items. If you look to the bottom, in the chat section will be a link to today's presentation. You can actually download that, and it's available for you to disseminate to your colleagues, and so feel free to do that. Also, if you have any questions during the presentation, you can put that there is a Q&A button down at the bottom. Feel free to put all of your questions down there, and at the end of the presentation, we're going to pose those to your panel here. Real quickly, as an overview, HeartX is an accelerator that MedAxium has in collaboration with Health Tech Arkansas. This has been, I think, the seventh year of doing this, and it's an exciting program where we're identifying breakthrough technologies. Typically, over 100 companies are applying for this accelerator, and five are chosen, and so out of those five, SmartCardio is one of them. So this is going to be really exciting. Today's presenter is the CEO and founder, Sreeni Murali, and the description is this webinar is going to feature SmartCardio. SmartCardio produces the 7L patch. It's a revolutionary platform, seven-lead EC patch for cardiology and remote patient monitoring. With that, I'm going to turn the presentation over to Sreeni, and again, I'll come back on at the end of the presentation if there are any questions, but for right now, Sreeni, good luck. Share your screen. Thanks, Chris. Hello everyone. I am Srini Murali, CEO and co-founder of Smartcardia. Thanks to Hotex and Medaxium for giving us this opportunity to present our company here. Smartcardia's AI platform and seven-lead ECG and vital science patch covers the entire spectrum of cardiac and remote patient monitoring, from cardiac screening to post-discharge home monitoring to RPM. In cardiac screening, our patch and solution transitions from a 24-hour to 48-hour holter to a 14-day extended holter to a 30-day MCT or an even monitor seamlessly. The same solution can also seamlessly transition from monitoring patients in wards, like in the hospital wards and cardiac wards, as well as for hospital at home with continuous live monitoring of ECG and vitals. And the solution can also be used as an RPM solution, remote patient monitoring solution, for monitoring patients from weeks to months to years. Our cardiac solution also has significant adjacent market potentials and clinical applications. From the same patch, we get, apart from ECG, other vitals that allow us to screen for sleep apnea and sleep disorders and also to provide combined reporting of arrhythmia with apnea. Our solution is also useful for monitoring patients with heart failure and hypertension. Smartcardia's solution is a fully integrated platform that consists of a seven-lead ECG patch. The patch connects to the mobile phone and transmits live ECG data to the cloud. So all the seven ECG leads are transmitted live. The patch also measures other parameters that you typically see on a bedside monitor, like oxygen saturation, respiratory rate, temperature, activity, and posture of the patient. All of this data is available live on the dashboard, and clinicians get access to the live ECG. On the portal, we also have alarms, typically how you find in a ward monitoring system. So we have audio and visual alarms for arrhythmia. We also have MCT-style notifications, and the platform also allows for a very quick overview of the ECG and other data. All the data is analyzed by our proprietary AI, that is FDA-cleared, and the AI algorithms call out different arrhythmia conditions and notify that in real time. The patch has really low noise. The seven ECG leads gives us an opportunity to provide an ultra-low noise ECG, and the lead locations also allow to provide a much better view of the heart in terms of the electrical activity of the heart. The patch is waterproof, stays for 14 days, and patient can shower and do the normal activities. And the material is really skin-friendly. It has been tested in tens of thousands of patients across 70 countries, and it's a very high-quality material. It's been tested in several countries in Europe and Asia, and we are just launching in the U.S. All the data is live transmitted, and the data is also stored on the device. So the device has storage for 30 days of data, so in case a patient goes out of network and comes back in, all the data is synchronized automatically by our platform. And it can also be used during activity. And so our system has also been used under intense physical activity, like by the where we are located, where we monitor athletes even during rowing and activities that have a high artifact usually in ECG. So we're able to get a fantastic ECG signal. As a clinician, you would see the data coming in, so you have multiple different ways in which you can view the data. So you can have a live ECG feed, typical to bedside monitors, along with the other parameters. We also provide interpretation service where technicians can look at this data and notify clinicians only upon a real event. Our system also provides real-time burdens, so burdens of atrial fibrillation as and when they happen. So you could also start treatment early on in the ward or in the hospital at home program. Our solution has been recognized with Frost and Sullivan as one of the leading product innovation in the global ECG patch and wearable space, specifically with respect to the AI aspects where we combine multiple different vitals together and inability to detect these arrhythmias in real time and notify them accurately to the clinicians. Our patch goes beyond the conventional patch monitoring that is in the market today. We make arrhythmia monitoring more conclusive to what exists today, as well as our solution allows clinicians to go beyond arrhythmia monitoring. I would like to present just two use cases from the market. So on the left is the patient's ECG that our patch detected. This patient was being monitored for 14 days. On the sixth night of monitoring, the patient had a transient chest pain during night, and even before the patient could have the symptom and notify the doctor, our patch and our solution picked up an ST elevation for the patient immediately, and we could notify the clinician. And the patient was called the next day and angiography was performed and the patient was stented. And we routinely see that our patch is able to get reciprocal ECG leads, get newer information that is currently missing in the market and that has huge clinical significance like ST elevation, accurate QT detection. The right side is an example of an arrhythmia, a WPW syndrome, where the ECG pattern is the WPW pattern is visible in some ECG leads, but in not all the leads. And our solution is able to see that uniquely in the sense that we have reciprocal leads. So even if it's present in some of the leads, we're able to pick that out. And there's a great challenge today with cardiac monitoring where the morphology of the different waveforms are not really great with single lead patches or with patches where the electrodes are at the same location. So we are the first truly unique seven lead ECG solution in the market that matches the gold standard for ambulatory monitoring. That clinicians are used to with wired monitors for decades, but we are making it in a fashion where you can monitor patients seamlessly for weeks to months. Our solution is well-proven globally. We are present in over 10 countries in Europe, in Asia, where our company is located in Switzerland. We recently got an FD approval and just entering the US market. We have performed over 10 trials, mainly done in Europe. We have also performed trials at UCSF in the US and through the HeartX program, we are starting a couple of trials this year in the US. Our solution is widely used in other countries, over 200 plus hospitals, 100 percent approval from electrophysiologists in places where they use our solution today. We are a team of about 70 people now, mainly located in Switzerland and other countries in Europe. My background, I have a PhD at Stanford in computer engineering and I was at IAMEC as a program manager. We made one of the earliest ECG patches and chips and that powers patches that is monitoring millions of patients a year in the US. Thanks, Srini. Again, if anybody has any questions, you can post them in the Q&A section below. There is a button you can put. And we already have one question. No, we have more than one question. The first one is, does the patch itself monitor temperature and oxygen saturation, or is that just on the platform of the third-party device? Right, so the patch monitors the temperature and oxygen saturation directly on it. Let me just show you the product very quickly. So this is the electronic unit that is measuring all the different data, the 7-lead ECG, oxygen saturation, temperature, posture activity. And this goes into a disposable part. The unit is reusable. It's battery-free. And it goes into a disposable patch that stays on the body for 14 days. Let me also show you the patch very quickly. So this is the patch that goes on the skin and goes around like this. And all the sensors are integrated on the same patch. OK, we have some more questions here. What additional diagnostic information do I get with the 7L technology in a patch? With 7L, what we first are able to provide is a truly unique accuracy for ECG monitoring. So we have ultra low noise. Typically, the multiple leads, especially the longer lead that is going across the chest, is excellent, even during activity. And patches may have sometimes a lot of noise. So what we are able to do is give out the lowest noise ECG. Secondly, we are able to provide much better morphology, better P-wave, better QRS. So you have more accurate detection of atrial fibrillation. P-wave quality is way better than single lead patches. Also, to provide newer things like in arrhythmia monitoring, like bundle branch blocks and Ulf Parkinson syndrome that are more challenging with single lead patch, and also going beyond arrhythmia monitoring. So monitoring patients with QT interval changes, drug titration, drug loading, and taking those patients under drug titration away from hospital for home monitoring. And ST elevation, like chest pain related changes and getting all of those. So those are the ECG specific advantages. Then what we also do is combine ECG data with other widens. So we provide, for example, the activity information, respiratory rate, and other parameters with the ECG changes as well. So you would know the 14-day activity pattern and how that affects the heart rate or how that affects arrhythmia. So not only you would know, for example, if the patient has been active and you could provide a better treatment plan for the patient, but you would also know if that particular arrhythmia is related to an activity or not. So is that tachycardia under a patient performing an exercise or is just the patient on the bed? So that contextual information is unique and providing contextual information with other widens as well, like respiratory rate and all of that. Then all this data is live transmitted. So you have like a bedside monitor field. The ECG is coming in live. So that means there are multiple different opportunities and use cases apart from outpatient monitoring. So this can be used as a hospital at home solution where you have immediate detection of arrhythmia, immediate detection of conditions. Multiple vitals also allow us to be like a bedside monitor in a wearable fashion. So you have newer use cases with live monitoring. So the three unique things would be seven-lead ECG, multiple vitals, live monitoring in a wearable patch that stays for 14 days without patient manipulation. So a single patch stays for 14 days live transmitting all this data. I'll combine the next two questions are about pricing. So they're asking about pricing. And then do you have models where I can build a technical for MCT? Do you have models in which you do the monitoring for us? And is there a hybrid model? I can jump on that one for you, Srini. I think the first one about the page two pricing, that more represents what the reimbursement is per use for each modality. It isn't necessarily our pricing. So for instance, like if you're billing for Holter, extended Holter MCT, the reimbursement is 90 to 100 bucks or 90 to $1,000 per patient per use. The hospital stay piece, that's obviously a costly expenditure. The RPM codes are billable up to roughly $1,500 per year per patient. So that's what that was referring to. Yeah, and obviously all cardiac monitoring companies, we have an IDTF that we're gonna plan on billing all of our patients through so we can do the traditional split billing route, but we're gonna be as flexible as possible. So whatever is best for the practice is really how we need to do business. We don't wanna limit this technology from any customer out there. You guys are the practitioners and the ones who have the patients and we wanna do business with everybody. So yeah, we're gonna have hybrid models and I'd love to talk to anybody about whatever billing model they wanna propose. Adam is their VP of sales there at Smartcardia. Another question, will you use this advanced data to diagnose other conditions such as aortic stenosis? How will your platform advance in the coming years? So we plan to, I mean, first thing is the amount of data that we collect is massive compared to say other solutions, right? So we are able to collect all the different vital CCG together. So we can look at other applications beyond cardiac monitoring. So one is immediately asleep where we have done multiple trials to get apnea and correlate apnea with arrhythmia in a seamless manner. But this is just the starting point. So all these vitals allow us to go into multiple different areas which we would happy to explore going forward in terms of clinical trials, validation, use cases and working with partners such as hospitals in this call. Okay, next question, compared to other cardiac monitors how are you different? And what is the value add above the current status quo? Right, so the first major differentiation with respect to other monitors in the market is we are truly a seven lead solution that is providing a much better accuracy and conclusive arrhythmia diagnosis. So many instances where cardiologists get say ECG reports, they're not very sure as the time goes on. They're not sure is it a AFib or is it a junctional rhythm because the P wave was maybe smallish. They don't see, for example all the different arrhythmias really well and they don't track, they cannot track easily say QT changes or ST elevation. So we are truly an accurate cardiac monitoring solution to what exists in the market. In the extended holder space, since we live transmit data we are able to provide reports immediately. So we could provide an intermediate report in the seventh day or even in between monitoring period if patients have an arrhythmia, a significant arrhythmia. And our end of monitoring after 14 days is also really fast because the data is already available. In the MCT space, we are a full disclosure solution. So we provide the complete ECG data and we analyze all the data, not just events that are triggered from the patch. That means our accuracy in MCT matches to what an extended holder solution would look like. So extremely accurate burdens, accurate beat counts. As a patch and sensor, it's also very low cost operation. The sensor is reusable across patients. So it is much lower costs than a fully disposable for example, a patch where electronics need to be disposed off. And our sensor is reusable, lower cost. Our patch is also low cost. So it's a much better financially viable solution that not exists today in the market. And also seamless for a patient. So in many instances, when clinicians provide an MCT product the patients get five or 10 patches and they have to keep changing patches every few days. And the patient maybe forgets to charge the device or the compliance is poor. In our case, a single patch stays for 14 days. And after 14 days, all they have to do is swap out the unit, put on a new patch without any requirement to charge the device. And immediately the patient is monitored continuously. So it's also much easier to use in terms of practice as well as for the patient than what exists today in the market. Love it. And Chris, I'd love to throw it to Ken here briefly. Ken's got a tremendous amount of experience here as far as being the CCO at Bardi before and obviously commercializing the bio-telemetry team and the iRhythm team previously. So Ken, anything you want to add on there? Sure. And this is Ken Nelson. Go ahead, Ken. Yeah, so thanks, Adam. So one of the reasons that I got interested in Smartcardia is that they were able to commercialize this product and are commercializing this product in India. And if you think about global products and you think about patch companies that are out there today, most of the patch companies are not able to commercialize anywhere outside the US other than maybe a few select countries in Europe, the UK, Germany, maybe one or two others because it's just not cost-effective for them. Some of the companies out there still aren't profitable today. With the Smartcardia technology, the way that Srini designed it with the sensor that can be taken in and out of a disposable patch and used over and over and over again, the cost-effectiveness and the margins make it a global product. And when you think about inequities in care around the world, this is a product that anybody in the world should have access to, but they don't today. So I love the fact that Srini built something he could commercialize and has commercialized in India and they will bring it to other parts of the world. So that's one of the things that I think is unique about the company. The seven-lead real-time capabilities combined with other vital signs is also really, really important. I think the next phase of explosive growth in clinical-grade wearables will come from multi-parameter devices, so not just a cardiac monitor that looks at arrhythmias and heart rate, but one that also has things like respiration rate and other similar vital signs in it so that they can become not only a monitor, but also more of a chronic condition management tool. And I think that's what makes this company really interesting. And then the third big area is that Srini has a vision for this company that's very unique and very different from some of the other companies that I've worked with in the past, where he has that cost-effectiveness in mind and he wants this to be a global product. And so having that mindset, I think has really made this a unique company. And it's great to see that this is really, and this is the fourth thing that I'll mention, in my mind, this is two companies in one. It's a more modern-day VitalConnect type of patch if people are familiar with that company. It's a multi-parameter vital signs product with real-time clinical-grade ECG, but it has a seven-lead as well, four-in-one, so it's an extended Holter, Holter 30-day event, and MCT, but also has vital signs in it, and it's on a Bluetooth 5 platform. Combined with, trying to think of the best way to describe this, combined with an AI overlay. So many of the companies out there partner with a third-party AI vendor to enable their technology with artificial intelligence. Srini and team have actually built two companies in one. They have an AI technology similar to what Cardiologs developed, and then they developed this next-gen VitalConnect type of multi-parameter device. So it's two companies in one, more cost-effective and global player. Thanks, Ken. And we have more questions. So, do you think your monitor will be more focused on the traditional continuum of care, meaning will it be an outpatient device, or do you think that there's an opportunity to change the landscape and cover both inpatient and outpatient care? That's a great question. So our solution can seamlessly transition from in-hospital care ward monitoring to hospital at home and outpatient screening. The beauty of the solution, it's like a telemetry system. So when a patient is wearing the patch, the data is live fed to the cloud. So clinicians have dashboards which look very familiar to what they use in ward monitoring solutions. And also the ultra-low noise ECG allows them to do true ward monitoring or hospital at home monitoring, where you really need to have very low false norms. In fact, recently, we just completed a trial in Switzerland, and our solution, when compared to, say, wired telemetry devices in hospital, we have a much lower false positive rate and much higher accuracy in calling out arrhythmias, and that has just recently been published. So the solution can transition from... So what you can imagine is the patient being monitored with a patch in the ward, getting discharged after a couple of days, and then continuously being monitored at home. And maybe there is a screening after that, after a few weeks, again, the patient is moving into an external holder, an MCD. All of that from a single device. So all of this is feasible with our platform. Okay, Srinu, what is the turnaround time for the reporting? So the reporting is quick. So in essence, for example, for an extended holder, we even provide an intermediate report that would be, say, for example, a 14-day test. Even on a seventh day, if a patient is having significant arrhythmias, we provide a seven-day report. And the 14-days report is... The turnaround time is less than 24 hours. And for even monitoring, the turnaround time is in minutes. So usually it's like less than 30 to 60 minutes. One of the things that our platforms, since the data is truly live, so the data is transmitted all the time, so we are able to churn out events and then look at them very quickly, say, compared to solutions that are storing data and transmitting once in a while. Is Smartcardia used in the U.S. already? So we have done trials in some sites in the U.S. and we are just starting a commercial launch. Maybe, Adam, you want to comment on that? Yeah, I mean, we've been putting our toe in the water. As we work out the kinks, we don't want to commercially launch our product without making sure that we have a fully developed solution for them, mainly just the logistics on the billing aspects of that and the collection of data. So the device is ready to rock and roll and we are happy to offer it to anyone in the United States. But as of right now, we have really only been focusing on our clinical trial locations right now, but we are happy to build the funnel list of folks who are interested. It's been rewarding to see just how interested people are so far. Hey, how do you plan on serving underprivileged communities around the world who don't typically have access to computer technology? How do you plan on serving underprivileged communities around the world who don't typically have access to cutting-edge medical technology? Like Askin was mentioning, right? So we are a truly global patch monitoring solution. So today we monitor tens of thousands of patients a year in India. We have the cost of monitoring or how much we bill the insurance of patient is maybe one fifth to one tenth of the cost in the US. So what we have done is from design, there are interesting products in the US market, but they have been cost prohibitive to be even used in European markets. But the challenge of cardiac condition is global, right? So you have millions of patients with arrhythmias in India and in developing countries. So we wanted to build a solution that can apply globally. And the way we have designed this sensor, the superior AI that reduces technician time, all of this together produces a system where the cost is dramatically low and we are able to scale in other markets. Right, fantastic. We don't have any more questions at the moment. Again, I want to remind our attendees that if you want to get into the chat section, you can get to their website and also download this presentation. So that is available. Srini, any last comments that you'd like to tell the audience in the MedAxian community? We would love to work with clinicians on new use cases, you know, in trials, looking at particular application scenarios. So there is a lot of sensing that we can perform, but we would love to explore newer application scenarios working with clinicians. And if somebody wants to get in touch with Smartcardia, what's the best way to reach out to you? Just through the website? You can reach out website or by email, or you can give Adam a call. He will immediately reply back. Okay. Adam, you want to share your cell phone real quick? Yeah, I'd love to. If anybody wants to get a hold of me, 916-599-9839. Love to partner. Obviously, you know, I'm a sales guy, so I want to get this in the hands of as many patients as possible, but really it's been pretty rewarding to see all the cool ideas that, you know, some of the heart X associates have been coming up with, clinical trials that have been tremendously creative. And I'll just add, I mean, what Sreni has built is something that isn't available out there at all. And I know everyone just thinks a patch is a patch, but it's just not what the device can capture. It's the seamless way that you can access all the data in a really enjoyable manner. It's not like you have to go through, you know, this incredible data deluge to get to what you want. If the doctor is missing something and wants a quick answer on anything that was missed during any of the wear time or the use, they can scroll back through any of the data whenever they want on any platform, not just in our portal. They can do it as seamlessly on their phone. The patient has access on the patient app. It's a really intuitive device and software platform that Sreni has built. And I think the users out there are really going to enjoy it. While we're talking, we've got another question that came in from the audience. What is the process on working with clinicians in the US? It's from like a clinical trial standpoint or from a commercial, you know, like actually let's sell this product kind of standpoint. I guess both. I mean, from a clinical trial standpoint, we're up for all creative ideas. We're, you know, some of the ideas that have already been proposed are things that, you know, I hadn't really been thinking about and that would be a value add for us from a commercial standpoint and things that we hadn't really been thinking about that would be capable with our device and we're exploring. So I think any ideas that are out there, we would love to partner with them. There's, you know, it's an honor for me to be able to work with teaching institutions and people that are involved with clinical trials. So, you know, we're up open to all ideas. So please call, text, or email. And from a commercial standpoint, it's even easier than that. You know, give me a buzz and we'll be right there. Awesome. Well, listen, we want to thank Smartcardia, Sreni, Adam, and Ken Nelson, their advisor. Appreciate you all joining. Again, we're going to be recording this presentation. We'll be sending that out and making that accessible to the entire MedEx and community. So with that, we're going to close up. Mentioned as someone who's gone through the HeartX program, I guess back when it was HealthTech Arkansas, kind of evolving into HeartX, I found it very, very impactful, especially in terms of helping to raise awareness and drive adoption of the technology. So for people who are startups out there with cardiac focused, highly, highly endorse that you look into this program and apply to get into the program. Okay. Thank you all very much. With that, we'll close out. Have a great afternoon, everybody. Thank you for joining us. Thanks, everyone.

Chris Romeo

Senior Vice President

MedAxium

Smartcardio

HeartX accelerator program

Health Tech Arkansas

remote patient monitoring