Hi, everyone. This is Chris Romeo with MedAxiom. We're going to let everybody just register here and just log on. It's going to be just about another minute, and we'll get started. Thank you for joining today. Okay, while we're waiting for other people to log on, let me go through just a couple of housekeeping items, if I could. So the first thing is, if you look to the bottom of your screen, you've got two primary buttons that we're going to concentrate on today. One is the chat button. On that chat button will be the presentation. You can access this presentation and download it, and you can reference that for that to your colleagues, et cetera. If you have any questions during this presentation, there's a Q&A button that we're going to be monitoring throughout the presentation, and if there are any questions, we'll be sure to pose those to Anna. So with that, we're going to go ahead and get started. Today's presentation is Unveiling Hardex Innovation, and today's spotlight is on one of our Hardex companies called MindMics. MindMics has fascinating technology that delivers heart monitoring through low-frequency acoustical vibrations detected in the ear canal with technology embedded in earbuds and hearing aids. The results are highly accurate regardless of skin tone, skin thickness, and body mass. The sound-based technology has been clinically validated in collaboration with leading researchers at world-renowned medical institutions. This is very exciting. I'd like to introduce Anna Bernatka. She is the CEO and founder of MindMics, and with that, I'd like to turn it over to Anna. Thank you, Chris, so much for the introduction, and I'm Anna Bernatka, and I'm CEO and founder of MindMics, where we invented this technology that literally is using the ear canal as a speaker, and as the ear is functioning as a speaker, it's broadcasting everything that is happening in our body, and in particular, it can broadcast every heartbeat as the heart is one of the loudest organs we have, and with that, we can truly bring the next generation of wearable technologies. The first generation of wearable technologies we all know, and I'm sure many of you watching this webinar have a watch or the system that is using the optical technology that is looking at the blood flow just below the skin. That first generation of the technology, it truly created a huge market for wearables for health monitoring. Today, we all monitor our heart rate, but also this technology has limitations, like for example, it does require a working sensor because it's using the optical technology only below the skin, and the rest is very hard, very far from the heart, which means we cannot get as precise insights as we could if we were closer to the heart. This is where we go to the next slide, where we introduced our new solution that enables this next generation of health monitoring. We called our technology in-ear infrasonic hemodynography, because what we're capturing are frequencies below our hearing range, in that infrasonic range, and because the ear canal is positioned in the way, so it's able to actually capture the internal vibrations of the cardiovascular system, we truly can see also the hemodynamics, therefore, we call it in-ear infrasonic hemodynography, and it has multiple advantages. Number one, it does not need a bulky sensor. It's very difficult to fit to earbuds, it's good, it's great for the rest, for the watches, but not so much visible for the ear. With my mics, instead of putting the bulky sensor to the earbud, we can actually use the microphone that is already in the earbud for the noise cancellation. With this technology, we don't really have to increase the price of the earbud to enable this technology. On top of that, because with me listening to the human body, to those vibrations of the human body, they're all below our hearing range, it means that simultaneously, we can listen to music without affecting the signal quality. On top of that, because there is no extra sensor, it does not affect the battery, and the sound propagates through our body, which works irrespectively of the skin tone. Plus, because now with this sound-based technology, we're not limited to just see the signal below the skin, we actually can see, or rather hear what's happening inside our body, which provides us completely new level of insights. Since the very beginning of this technology, we will go to the next slide that I will focus a little bit on clinical validation that we have done. Because from the very beginning, when we built even the first prototypes, we've seen an incredible amount of details with every heartbeat recorded with the earbud, and we partnered with a few cardiologists to look into the potential of this technology. So we look at atrial fibrillation, there is a little bit of data showing in the gray, the tracing for the ECG, and in the black, this is mind mics, those are heartbeats for a patient with atrial fibrillation recorded with an earbud. And yes, you can see this characteristic changes, random changes from them in terms of the duration of the inter-repeat interval, which we can measure, which we show that we can measure as well as ECG with the correlation down to 0.99, even for a patient with atrial fibrillation. But what was even more striking was that with mind mics, not only we can see, we can measure precisely those time between the heartbeats, you can actually see the changes, drastic changes to the human dynamics with every heartbeat. Each time there is a longer feeling time, we could actually see the larger amplitude, which immediately with those first patients led us to look into the human dynamics and understand how mind mics correlate with the stroke volume or the blood pressure. For that, we initiated study with Scripps Health, where we look into different cardiovascular diseases like coronary artery diseases, aortic stenosis, pulmonary hypertension, much of our regurgitation. So there is a lot of results still to come. But even with the initial data set, we've been able to show incredible insights and the correlation with the medical devices. So I will spend a minute just talking about our comparison of the echocardiogram and cardiac catheterization data. So on the top, you see echocardiogram, three heartbeats, blood flow for the aorta, and below signal three heartbeats again detected using the earbud, where we can see aortic valve opening and closing in real time with similar accuracy data with echocardiogram. Very quickly, we also compare our waveforms, the heartbeats recorded, the blood pressure in the aorta measured with the cardiac catheterization to heartbeats recorded for the ear, and again, we see a very high correlation. I will just, we will move to the next slide in the second, but I wanted to show you the last plot on the previous slide, where we look at the patient with a very severe aortic stenosis, very different hemodynamics, very different waveforms. As the valve is not opening properly, it takes a lot of time for the valve to open, and that creates this triangular shape of the waveform. And again, cardiac catheterization in black, below, mind mics in red, in data the heartbeats recorded with an earbud, and again, striking correlation. So this told us that there is incredible potential in utilizing the in-ear data in something that, using the earbud, something that there is such a huge adoption on the market, and creating a solution that could truly help people to monitor their health. There are so many applications we can do with this technology toward heart health. Now we will go to the next slide, and as we start, we cannot focus on all of them, but where we want to start is hypertension, as this is such a big, big problem globally, with, in worldwide, affecting about 1 billion people. So this is where we focused first, and we will go to the, very quickly, to the next slide, and to address, to start addressing that issue, we started developing our system from the patient or user perspective. We asked ourselves where this technology could add already value, even today, and going through a lot of market research and conversations with doctors, patients, we realized that whenever people go to a doctor, they, and hear about diagnosis about hypertension or any heart-related issue, they will always hear two things. Number one, to reduce stress, and the second one, to lock blood pressure twice per day. But doctor doesn't, it's difficult to manage stress, especially after such a significant development in health. So this is where with MindMics, taking into consideration the accuracy of MindMics data that we're gathering for the year, and those variation from the heartbeat to heartbeat, we created a system that first can help people control their stress response. We built the dashboard that literally can show how our heart is responding to different stimuli by mapping autonomic nerve system. And on top of that, to help people to better control that response, also we provide biofeedback tools with Breadthwork. Today, we also added a feature that helps people to just put the blood pressure when they do a recording with the blood pressure cuff. Now we're working, we do a lot of R&D, research and development toward data collection with the blood pressure, so we can actually also build our own algorithms to replace eventually blood pressure cuff as well. Already, our system is available for purchase on our website at mindmics.com. Our membership that includes annual membership subscription and our infrasonic earbuds is about $360 per year. Recently, we also obtained HSA eligibility as well. So that's our first step toward also going toward more health insurance payments. I'm going to get there step by step. So we'll go to the next step, next slide. And where MindMics is today, we're focusing on promoting a healthy lifestyle and living well with high blood pressure by providing those tools to help people focus on stress control techniques and simplifying the process of logging blood pressure readings. And as of today, this general wellness system does not need FDA clearance. But for us, where we want to focus next is to build the roadmap, building the roadmap toward hypertension management. And we're working with HeartX toward much large-scale data collection with the blood pressure, but also looking at the health outcomes as well. And also, we're working toward understanding the path toward the FDA. We know that this is the novel system, so it will take us a little bit more time. And also, understanding the reimbursement process for this technology so we can also expand how people could get the access to this system. And we'll go to the next slide. And with that, we already built the system that, from the user perspective, can help patients monitor stress. And now, we are working on the next big feature of the system, which is the blood pressure. Plus also, our next goal is to understand, OK, now first we started with providing the great user experience and usability from the patient perspective. To make it cool, to make it fun, like people depend these days. And now, we also want to work with the hospitals with the primary objective of also running the pilot studies to evaluate how our technology, how the MindMix heart health system could also be integrated with hospitals EMRs to reduce the burden on cardiac care teams as well. For that, we are now putting together the new study with the goal to collect more data for the blood pressure, but not only. We also want to evaluate the impact of the breathwork as an intervention on different metrics, like for example, blood pressure, heart rate, and heart variability. We know that heart variability is so critical, one of such a critical metrics when it comes to the heart health. And also with that in mind, this will create those first studies, will help us to create the framework toward understanding how we could reduce the hospitalization rate as well. And the study cohort that we're looking toward, we will start with about 20 participants discharge after heart failure with reduced ejection fraction and 50 with preserved ejection fraction. And those patients will receive our devices for about at least a month after the discharge. So every day we will ask them to do the short breathwork that we have shown before that can help people reduce blood pressure, also improve different heart health metrics. And that will be for us to understand, to collect more data with the blood pressure, but also to start looking at the health outcomes as well. And on top of that, in another part of this project, we will be looking at 1,000, we want to collect the blood pressure data from about 1,000 participants with different age, different gender, different demographics to further drive the development of our blood pressure algorithms. And we will go to my last slide on which I wanted to encourage everyone to reach out to us and join our pilot studies and help us keep developing that system that will truly solve the problem and the big need. So thank you everyone. And I look forward to questions. Thank you, Anna. That was excellent. I want to remind everybody that if you do have a question, just enter it in the Q&A section below. There's a little button you can post your question in. Let me see if we do have a couple of questions already. Here's one. Chris, maybe also before you jump actually. Yes. I almost forgot to show the product itself. So this is the iMAX Heart Health System that people can order through our website. We're waiting for the next batch of our earbuds. So the system comes with our infrasonic earbuds and great experience with it. Plus also iMAX app with multiple breathwork exercises as well. People also can look at their health history and also the dashboard as well that can show the response of our body in real time. All right. That's fantastic. All right. Here are a couple of the questions, Anna. The first one is where is the technology at with measuring blood pressure? Yes. With measuring blood pressure, we already, we used early in the data set that we collected with scripts, which is simultaneous data with MindMax in the ear and cardiac catheterization to build our engine with the algorithms and create a strong evidence toward sensitivity of MindMax data toward the blood pressure. And now we're gathering more data. So now we are in the process of gathering more data to be able to expand our algorithms so they can work on much broader population. Another question is how long do you need to wear the earbuds to get accurate measurements? That's also excellent question. It depends on the metric. Heart rate can, we can show the heart rate literally within a few heartbeats. We show the heart rate variability for that to measure the variability, we need a little bit longer chunk of data, which is about 30 seconds. So literally within one song, you will know pretty well how the body is responding. How can I use them as a measurement tool in my practice? And how do I sterilize in between patients? The way how we are, so the question, the answer is yes, MindMax can be purchased at mindmax.com, our earbuds. In terms of sterilizing it, in doing our clinical studies, in doing our clinical studies, we're using simple tools to sterilize them actually, and that has been sufficient. So we are happy to share our protocol to sterilize the earbuds as well between the patients. We have a couple more here. Can this tech be used with hearing aids? We are in the conversations with multiple hearing aids toward enabling our technology on their hearing aids as well. It has the technology has to be enabled. We have to make sure that all of the components are right. And we have to work directly with manufacturers to enable the proper firmware. And the fingers crossed that we will get much more traction soon. So also this technology could be available through the hearing aids as well. For us, as MindMax, our primary business model is actually working with businesses and enable this technology inside many earbuds and hearing aids. Our big goal is to enable this technology in all earbuds, so everyone can have the health monitoring for the ear. But it will take some time, step by step. All right, and I think I know the answer to this question, but I'll still pose it anyway. Can people still listen to music when using this product? Oh, absolutely. Since MindMax is listening to the human body below our hearing range, we can at the same time enjoy their favorite tune. And then the last one I have here is, when can I buy this? I invite everyone to mindmax.com. And from our website, people can purchase the earbuds. Also, we have a subscription model that it's not with our earbuds. Our earbuds has very limited edition. We also have, our system also integrates, for example, with Polar ECG strap. And people can go to the Apple store, download MindMax app. We also have a subscription version that can work just with Polar ECG strap as well and get all of the functionality. So to get the membership with our infrasonic earbuds, mindmax.com and our subscription model with Polar H10 ECG strap is also available through the Apple store. A couple more have come in, Anna. How many hours per day do you see people wearing this? So actually, we don't want to change people's behavior. And I would say that a big advantage of this technology is that there is already existing behavior of wearing the earbuds. What we're seeing, so it's more about looking at the trends of people using the earbuds. And every year, actually, Qualcomm is conducting a pretty broad research, a market research about the usability of earbuds. And what we're seeing is that from the last year, people almost double the time they're wearing the earbuds. So now in average, people are wearing earbuds for about three hours per day. And three hours per day, if we can measure the heartbeats with such accuracy, this is tremendous amount of data. If we could, from my perspective, if we could have the data of people wearing earbuds for two minutes per day, one song, and we could look at the changes to human dynamics or any aspects related to heart health, this is tremendous amount of information when we integrate it over long period of time that people are wearing the earbuds because they wear it every day to listen to music, to listen to be on the call. So this is the great opportunity. And especially seeing that the trend of how long people are wearing them is also increasing, is doubling, actually. It's literally doubled from the last year. And we want to build on that behavior. And here's another question that dovetails into that right now. Would a patient wear this in a continuous fashion for days or weeks and place them in an event monitor? And could they sleep with it? That's a good question to which there is no simple answer. So in principle, earbud, I would say the hearing aid has the capabilities of the people can wear it for the extended period of time. Earbud has to be designed for the specific use. So it wouldn't be one earbud that could be used 24 hours, definitely. So during the day, we already know that hearing aids are designed to have the capability of being worn for such a long extended period of time. There are also companies that build really excellent sleep buds as well, because they have to be smaller. They have to be lighter. They have different properties toward the noise cancellation. So the way how I see the future is there will be different earbuds for different use cases. And this technology, I don't see it as replacing 24-7 monitoring, especially when doctors need the ECG for that. This is a little bit different technology. So I would, the way how we think about this is how we can use the existing behavior and the use pattern and those new capabilities with the human dynamics to look toward prevention and also building the new habits, but especially prevention and early diagnosis for which we don't need to have 24 hours monitoring. It's more rather how we could detect things earlier. So then we could be much more targeted with those other devices that can provide 24 hours monitoring. And what is the battery life per charge of the MindMix earbuds? MindMix earbuds have about three hours, four hours battery charge. It's standard in terms of the earbuds. So we are not the best in terms of the battery, but we are also not the worst. So we are somewhere in the middle. We are the best when it comes to the bio-signal. Fantastic. What valve conditions have been detected? So far with the data we had, we look at the artery stenosis and we've shown that we can see the changes to human dynamics. Also that patient, we published the report about that patient with severe artery stenosis, because we look, that patient also went through TAVR, the valve replacement. So we were able to see it before and after. And also we've been able to see the murmur, the systole murmur before the valve replacement and then disappearing after. That was the one that we have published so far. We have also some data for mitral valve regurgitation that still need a little bit more analysis. So definitely for us, we're looking for a partner, a pilot site that we could collect more data and look at the different conditions as well. Because definitely as a startup, we only have a few cases so far of the data, but we would love to have a partner that would have the access to that specific patient where we could understand how we could, what are the different conditions that we could also detect? Here's a question. If I hear correctly that this tech could be used with other earbuds, and if so, what would be the effect on battery life and or other functionality? So today Mimix is working with our own earbuds. We already have the first partnership where we put in this technology, what we have being a manufacturer to add this technology to their earbuds. And we have also conversations with the multiple brands as well to bring it to a lot of earbuds. In terms of, so that's the first part of the question. Yes, today it's available with our earbuds, but soon there will be, at the end of this year, there will be other earbuds as well coming with this technology, and we're working hard to put it to much more earbuds as well. In terms of the impact on the battery life, today, all of the advanced analytics are actually happening in the cloud. On purpose, we did that because number one, to secure the data, and number two is to not compromise accuracy with the battery life. So all of the analytics are in the cloud. We are, with the current chipset, so we only enable to do heart rate on the device, but we also have a strong partnership with Qualcomm where they are building the next generation of chipsets that are going to be much more powerful and also will affect the battery life much less. And with that changes, I hope also once we get, they already have a pretty interesting chipsets in their portfolio coming in the next two to three years, so also I hope that once we get to the blood pressure, we'll be also able to put the blood pressure directly on those devices because this would also enable us to push those critical metrics to the devices as well. So as of now, there is really not much impact because the analytics is in the cloud. Great. Wow, that was a lot of great questions. I'll monitor it for the next minute or so to see if any last questions come through, but for the moment, that's what we have. So Anna, let me turn this back over to you for any closing comments you have for the Medaxium membership. I wanted to thank you everyone for participating in this webinar. And if someone is interested in joining our journey and helping us do the collection or piloting our system, please reach out to me. Very good. Again, thank you all for joining us today. Thank you, Anna. Thank you, Mike and Mike, and have a great day.

Anna Bernatka

MindMics

heart health monitoring

acoustical vibrations

atrial fibrillation detection

health technology integration