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Samay - The AI wearable bringing hospital-grade lung diagnostics to billions of people

62m 58s

Samay - The AI wearable bringing hospital-grade lung diagnostics to billions of people

This episode of the Epic Angels podcast features Dr. Maria Artenwagga and Ricardo Garcia, co-founders of Samai Health, which has developed Silvie—a wearable AI-powered lung diagnostic device. COPD is a devastating disease affecting 550 million people globally, yet 80% are undiagnosed because the only accurate test requires a 40-minute session with an $80,000 machine in a specialized clinic. Silvie solves this by using acoustic resonance technology: it injects sound into the chest and analyzes changes in lung resonance during breathing, delivering the same pulmonary function numbers in just five minutes with a device the size of a TV remote. Maria, a Harvard- and Berkeley-trained physician-scientist, was inspired by her grandmother Silvia’s death from a COPD attack. Ricardo, a former Google engineer whose audio code runs on billions of devices, brought his expertise in sound processing. Together, they built a company that generates commercial revenue even before FDA approval. The technology is protected by 18 patents across 20 countries, covering the core methodology. Samai Health aims to empower patients to manage their disease at home and predict exacerbations days in advance, reducing costly hospitalizations. The founders emphasize their data-driven approach and complementary skills as a married couple, making Silvie a breakthrough in accessible lung diagnostics.

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11368 Words, 62056 Characters

English
[MUSIC PLAYING] Welcome to the Epic Angels podcast. Every episode, we put the spotlight on one of our portfolio starters. My name is Mikey, and my name is Hester. After the conversation with the founder, Mike and I will have a conversation together with one of our Epic Angels to reflect on this investment. Picture this. You're struggling to breathe. Every single breath feels like you're trying to exhale through a wet sponge that won't let the air out. You're terrified. And the most heartbreaking part? You might have been living like this for years. Slowly getting worse before anyone diagnosed you. Not because treatment doesn't exist, but because the only test that can find it is a 40-minute ordeal in a specialized clinic with an $80,000 machine that most doctors simply don't have. That is COPD, Chronic obstructive pulmonary disease. It's the fourth leading cause of death worldwide. 550 million people have it, and 80% don't know. And by the time most find out, they've already lost 40% of their lung function, permanently. 3.5 million people die from it every year, and it costs you less alone 50 billion a year in healthcare costs. Now, what if you could screen for it in five minutes, anywhere in the world, with a small device, the size of a DV reload, no specialist, no lab, no force breathing exercises, just press it through your chest and listen. What if the breakthrough technology behind this was essentially headphones for your lungs, sending acoustic pulses through your chest, the way you tap a drum to hear if it's healthy or hollow? That is exactly what Samai help has built. And today I'm speaking with the two people behind it. Dr. Maria Artenwagga, Harvard and Berkeley Trains Physician Scientist, and CEO, and Ricardo Garcia, her co-founder and CEO, a former Googler whose audio code runs on three billion devices every single day. Together they've built Silvie, a wearable AI-powered lung diagnostic, already generating commercial revenue before FDA approval, which trust me, almost never happens in medical devices. Maria and Ricardo, welcome to the podcast. I'm so excited to have you both here. That was a long introduction, because there's so much to say about this, but I want to start with the two of you as a person. Maria is starting with you. Your Harvard and Berkeley Trains, you have publications in the nature and a New England Journal of Medicine, you were in the middle of a plastic surgery residency and you walked away from all of this. What was the moment yet you decided this was the problem you had to solve? Yeah, so, so, Colombe and Bornen and Adi Kyrithis Ischen, I actually was doing a plastic surgery here at the University of Chicago. I decided to walk away because of my grandmother, Silvia, that was her name. She died from a C.A. PD respiratory attack we call that an exacerbation. She was at home back in Colombia. She couldn't breathe and by the time that anyone could realize how sick she was, it was too late. And I kept thinking if someone had been monitoring her lungs, we will have cut it, right? She didn't have to die. So that question became some eye. Yeah, and usually a lot of people, they have the problem and then you're going to look for your technical solution, but you had something different. Basically Ricardo here, who's not only the CTO, but also your husbands. And I think this is what makes your story very unusual because Ricardo, you spent 30 years obsessing over the power of sounds. And you did the MIT Media Lab, my 11 years at Google building the audio architecture for Android. Your code is literally running on three billion devices right now. So tell me more about you and this background. I'm also from Colombia and I'm in here, even Colombia, and since I was growing up, I started my engineering, but I was also doing music and I was doing electronics synthesizers and I had my band, I even had longer, and I had a whole story there. But I always found that sound is very rich and it carries a lot of information. And that became a passion. What can you do with sound that is hardcore engineering? And from that, I went to build synthesizers to do hearing aids and I joined Google and NowMeta where I have been using computational audio to process audio and to process information and extract meaning out of audio. And that also carried out home. And Maria was always listening to my beeps and boobs and doing things there. She was really curious about that. And I did that passion translate to a lot of things that we do in some eye. And then what happened? When did this come together? Being ready at your obsession over how can we fix the COPD issue and then the sounds knowledge with Freddie Carter? What happens? That is a very, very, very nice story. So we've been together for a long, long time, Ricardo, what, almost 20 years. But back in 2018, I was completing my last master's at the University of Berkeley, completing a business class. I had a project where I had to contribute 100 people. As a physician myself, I was more interested in solving a problem that creating technology, of course. I did complete about 100 interviews, many, many patients, and doing a one of these interviews with a pulmonologist he was talking about, is to decade long research on air trapping. Air trapping, what it is, a phenomenon that happens with patients that exacerbate or that have respiratory attacks more often. And he is strongly believed that it's the best predictor or prognosticator of mortality, quality of life, and morbidity, like disease in general. We were the better, first hospital here in San Francisco. He was showing some pictures. And then what he immediately clicked in my head was what if we use the resonance properties of the long or any object. And if we sent mechanical music or sound, in this case, you have mechanical energy and make the long by rate of resonator at a particular frequency, we should be able to capture the changes of resonance because if you think about it, if it's a recent object and it changes physical characteristics, and it has more air, that resonance or perhaps to change. So right after I finished that conversation, I called Ricardo on the phone, it was like 11 a.m. from morning, I think it wasn't one of the, and I told him, I think I have this idea on reporting the sensors that we're always playing with at home because he was always making experiments with his phones from Google at the time. We will send signals using a phone, and you usually thought that the phone itself will work alone. And then we make the long person aid and we need to, we should be able to capture changes of resonance if we use computational power in a single person. Like computers nowadays can do amazing things, right? Like why not? He said, well, it has a lot of science, Ricardo, you can go over this. But in long story short, we did a lot of experiments at home. We completed like a mini clinical trial on our results, a few friends to patients with COPD that we found on a Facebook group and we did the trip. And we got our first grant from the National Science Foundation about five months later. So Maria, I came with the idea, I say, you know, make sense. Let's do some experiments. We started like coding some things on the phone and actually soldering speakers, microphones, and starting creating a band around the chest and creating the first prototypes that someday they will go into a museum. We still have them in there. But just to show that the principle has sense and that we actually a cool sense of signals in two directions, we could capture those signals and those signals have statistical significance that we really were capturing changes there. And of course, it started a big process of iterating, making things smaller, making things acoustic, like acoustic seal and that. But the first principle, it was like, it makes sense. We need to gather some data and see what it works in our head, it actually works in the real world. And it is. Before I go into the product itself, I also want to understand your husband and wife almost 20 years to get her, as you just said. And now you're working to get her on some eye. How does that work? I regard it. You need to ask this question. And the boss only hates me sometimes. It's difficult, but the thing is, we are very scientific oriented people and we really like data, like data-driven decisions. So we really like to have proof or a theory or something that we go and say, this is the way we need to do things. And there is a reason for that. And so we have a lot of arguments and things, but it's usually a reason when this is what we need to do, this is what it needs to be done, this is what we need to test. So it's not that difficult. It's just like we come up to agreements, data-driven agreements, I will say. (laughs) I love that. It's interesting. I would say we complement each other very well. We are nerds, we love data, we love science, but personally, otherwise we are super different, right? So the crazy hustler who really likes to do things super quick, I'm a former soldier, right? I'm a type, a personality and our achiever. And I would like to go through the data, think more carefully, he's the one always stopping me with my, you know, willing to do everything one of the 24 hours because that's sort of like my mantra. So it's a good balance, a good complement, and this is not the first time that we work together. We've done over the past 20 years, a lot of projects, a chatty of all work, I mean, we've done a lot of things, and that's why the reasons, I don't know why we are still together, He hasn't killed me yet. But I mean, I think it's wonderful. And the way how we run the company as well, it's super interesting because we have about 2022 people. He manages half of the team. I do the other half. The team is very, very happy with the way how we run it. I think it's been great. - I love how you say the database, which is when you need as a startup as well. There's so many assumptions that you have and you need to figure out which assumption is true. So it's good if you have a different opinion that just means, okay, let's test both. And then the data will tell us what the truth is. It's not about our own opinion. It's about what is the data show us? What is that next step that we can take? Love that. So back to your products. So you've built Silving. The world's first AI-powered active acoustic wearable for long diagnostics. So as we already mentioned, it's about the size of a TV remote. You press it against your chest, takes less than five minutes, and it gives you the same long function numbers as the $80,000 speed rummetry machine. Without the specialist, without the lab, without the 40 minutes of force breeding that many elderly or sick patients simply cannot do. And that is all based on the technology what is called the acoustic resonance. And so that is the whole sound what you just mentioned. Can you talk us through like how does this work? And what does it tell a doctor? - So the acoustic resonance. So first, a couple of words about that. What we're doing is like, it's more than a digital statistical. A lot of people confuse with that. So we are actually an active statistical wearable. What we're doing is we are injecting sound, inject a signal into the lung, and then we listen. When the lung, when you are breathing, doing health and exhaled, this sound that is injecting the lung is changing in very small ways, but it's changing in ways with our microphones. We can capture those changes, and then we do a lot of the number crunching. So we see that someone, that for example, that is healthy, versus someone that is sick, when you inhale and exhale, that rate of change of the energy of the lung is going to change slightly different. It's going to be healthy, slightly different ways. And we collect thousands of data points every time that you inhale and exhale. We transform that data, and we put those numbers into what we call a model factor. And so we can actually get a lot of data points from when you were doing your respiratory maneuvers in the report-money function lab, and we correlate to them. So we take our acoustic data, we take the clinical data, and we create our models to follow the data, but also we validate against all the already diagnosed patients. So we have a big database of patients, but the important thing there, in the acoustic resonance, is very easy to do. We can capture not only when the people are doing the maneuvers, but when people are breathing normally. And this is one of the big differences. We can capture the data over a longer period of time, and we can, from that data, we can infer what is the lung function at different states, and all the data becomes the pulmonary function number. So I know that it's un-moutful, but of things that, right, you want to do. - But Mikey, I'm going to give you a scientist's answer, because obviously, Ricardo is the engineer. What I wanted to build was a new way of phenotyping or understanding, characterizing the lungs, with sensors that were so affordable that we could go anywhere in the world. And that's what I told him the first time I called him. It's like, no other sound, that's forbidden, prohibited. Those are super expensive sensors. I really want to build a company that could help have a billion people globally, especially because 90% of the patients that are dying are dying overseas, nothing that you ask. So the main idea is, can we use these acoustic sensors that define on consumer products, such as phones or headphones, and can we use our resonance as a proxy to understand the numbers that we as physicians understand very well? So the second thing I told him was, we cannot come up with a new sort of like volume marker or parameter because doctors, it takes forever to just convince them, a lot of clinical evidence, longitudinal trial, front of my control trials for several years. So it's very difficult to come these doctors to change their ways. And I know that because I come from family physicians after all. So the main idea, and I don't even know how this was going to work, and I told him we need to take this, put it on the patient's chest, 500 people if we can, and we need to fear it our way to output the same numbers that the big machine is giving us. That's the only thing that we need to do, and I don't care. I mean, we need to make it happen. We took us about two years to fear out. The actual sensor, the measurements, the architecture, the microarray, the type of sensors, the way we put things together, obviously the form factor, so that it wouldn't like break in the middle of the exercise because these patients are breathing in and out like crazy people, right? And then more importantly, it's like all of that data coming from a machine, so it's about, we have about two hours of data from a primary functioning testing person, and then we also have CT scans. So it took us an additional two more years to fear out what we were seeing. Obviously, for the first time that we saw the data, it was a mess. It was just annoying. And I was like, Ricardo, oh my goodness, what are we going to do? I remember that we were working with a physicist from University of Philadelphia. I don't know, a very close friend, a friend who also went to Harvard, and they finally did it. I mean, I don't know how to do that, but the team did it and on the span of two years or so, we have various wrong models that have accuracy sub to 93%. And we are not only doing COPD, we are doing earlier detection of COPD and even of fructive sleep-up in our days. Yes, and I think that that's a very important thing from a startup. And it's like, we collected all these data, so we created the sensor. So we are a data company, but the sensor didn't exist, so we created the sensor, so we can collect these data, but we are a data company. That's the way that we position ourselves. And we did to choose where to attack first, even though that we have a ton of data in there, we needed to be very strategic on to where we're going to start looking at first, which of the maneuvers and which segments, when you're in hell in an escalating, where we're going to start focusing first to create our models. And to see that we were looking at the right place, and as Maria mentioned, like the CT scan data, we had that data there sitting for a while, until we say, okay, now it's time to go and crunch those numbers and start creating models against the CT scan. So that's one of the important decisions that you need to make is to know where to spend your resources. So the beginning say, we are going to collect that ton of data, we are going to start crunching the data in a clever way to show the feasibility and to show that we are in the right path, and we have been doing that. - Yeah, and I'm jumping ahead. But what you see is you have, right now, you're working with the physicians, you're working with the hospitals and so on, but eventually this could become something that people can use at home, just themselves, without any knowledge, basically. You just stick it on and it doesn't job. - Yeah, that's your regional idea. Can we empower patients to be the ones managing their own disease with the help of the AI? So we are actually building an AI native company in every way, we run the business, and we are obviously building the models, and one of our partners is that is coming up with two of them, they're the largest payer in Colombia, they are investing in us, is how we build a platform that could help patients that are already diagnosed, but that they exacerbate frequently every year, those hospitalizations coming from those exacerbations are the highest drivers of expenses everywhere in the world. So just to give you an example, the US is around $45,000 for exacerbation and hospitalization, and probably in Latin America's around, I would say $5,000, which is still extremely, extremely high. So the main idea is, can we use this longitudinally, remotely, non-invasively, all the time on your chest, and more importantly, give me the numbers that you need to understand how you're doing, and if we can't predict exacerbations, three, four days in advance. - No, okay, and also you've protected this with 18 grand of patents across 20 countries, US, Europe, Asia, and so you, and you didn't just patents the design of the device, but really the methodology itself, so can you elaborate a bit more on the patents? - So we have a very robust patent, but very broad patent, which is a very good thing, because we really own the way that you inject sound into the lungs and you use it to estimate pulmonary function values, which is a very broad thing, and we focus also on air trapping. So we own that technology and we own the patent to that. So pretty much we compute the transfer function of the lung, we inject sound, we assess when you're in healing and excelling, and from that we derive all the things that we just mentioned. So we own that patent. In addition, we have patents that, continuation patents that also cover the design of the device. At this moment, we are using a single device, but we have also envisioned, can you have a constellation of devices? Can you have multiple devices, multiple sources, multiple microphones, and having like a bigger picture of the lung, we have the math, work out for data, we have patents on that, but we still not working on that problem. And we have patents, ambition also, protecting how we collect the data and crunch the numbers and the type of models that you can create for that. So we are very well covering them. And as you mentioned, it's in many countries. I'm very, I can tell you more about the territories that they call it. Oh my gosh, yeah, way too many. I'm so super happy about that. We have six patents in the US. We have Tweet Australia, Tweet China, Tweet Japan. We have one in Chile. We have dry now one in Europe. It's super exciting because I was there. one came up with the idea. Exciting for me. I always saw people add narrow envision myself as the inventor of any patent whatsoever. I'm a very good student. I'm a nerd, but creating an original idea. And it was for some reason, I don't really know why nobody had ever patented the use of active acoustic sensors to fear out Palmer and diseases ever before. And that's it's super broke. The patent anyone would come after this territory like using their resonance as the measurement for or as a proxy for Palmer function. That's us on the IP side of things. Some eyes probably one if not the strongest respiratory startup right now. But I want to mention one thing in the intellectual property to there. We also have many parts of the chain things that they are protected as a trade secret. So we have a they know how we have the in-house know how we have the expertise that is very difficult to replicate. So because we have a lot of experience there through a lot of the steps that are very it took a while to figure them out. And we are not revealing the whole secrets in some of those things. I love how you've built it. How you rethought it through also into the patents. Now I want to move on to where you are at right now because you've developed the device. It's working. You now need to get your FDA approval which we all know takes forever. And it's very costly. But I think that is where you've been able to crack the codes a little bit and see like what can we do. You actually managed to get already revenue now before getting your FDA approval. To be honest, I've never seen that with another medical device company. One of your major partners there is a KSC, a huge pharmaceutical company from Italy. They already paid 175K for a pilot. And you're now negotiating a multi-million dollar contract with them. Can you tell us a little bit more about like why are companies already why do they want to work with you even pre FDA approval? Yeah, it's even for us. It's sort of like a surprise because we didn't expect to work this early on with a strategic sort of any one major. I mean, because we are still you know about two or three years away from FDA. So everything starts in 2024. We in October of 2024, we won Medtech Innovator which is the world's largest and most sophisticated accelerator for all things healthcare, especially on medical devices and the ERAHUF. Out of 1,300 companies, we made the cut and we were chosen and the very first letterman company in fact in the history of our program. We won. It was a wonderful experience. We did a really great job and mainly what it was is that the strategics chose us for the finals because they thought that this was still a problem that hasn't been solved. That there are many startups doing it or trying to solve in a very intelligent way as we do. Everybody else is just using the status group that's primarily what they are doing. I was at a health conference in Vegas and at my booth within IH and then there was a person coming through and he was then executed from a pharmaceutical company. In fact, he comes to me and he says, I think we are connected on LinkedIn and we're supposed to talk about like two years ago during the middle pandemic after something happened. You are the only company working on the opening. The entire conference, by the way, like so and so and this is what we're doing. We're working on respiratory as well. So, yes, it's a family company from Italy. They are almost like 80 years old. They make about $3 billion in IRA recovery remedy and half of that money is coming from the respiratory franchise. They are particularly interested in something called a smaller weight disease, which is the predecessor of COPD and asthma. So, the earlier stages of the disease when it's still reversible, that's what they are trying to target. I was telling him about how the technology worked and more importantly, how we were obsessed with our trapping because again, I want to solve the problem that killed my grandmother and her trapping is the propnius dictator for the exacerbation of the text. I was telling him about her trapping and he said, well, by the way, her trapping is also a parameter that we use for smaller weight disease detection. We should keep talking. And later on around July of the following year, we had already negotiated a contractor. They chose us out of, like, probably like 300 companies or 500 companies that they were scoping out from the entire world. And they chose some eye to be one of the five companies chose me. Cleaning and a couple of other big-name hospitals in the US, our focus was some more weight disease, which is for them extremely valuable. So right now, we have finished the pilot. It's been very successful. We already seated all over our technical milestones by very percent. When we discuss these things through the course, it's like, oh my gosh, this is way better than we had ever imagined, especially because we are running new models, especially one against cities can't ride. So, they are flying me to Italy, and early May, hopefully, for the contract we could have a milestone-based pavement contract if I'm able to convince them. We could come by, also, which I think is going to move forward. We're just negotiating a big contract, hopefully, by June or July of this year. And it could be anything between five to 20 to 25 million. And hopefully, because we are starting to craft everything, what exactly how we are going to make it work. But the expectation is to have something where we can start working together for the next three to five years. Yes. And that is so amazing. You can do that. Before the FDA approval is. So, you're already expecting four or five hundred K of revenue this year. And that's an even girl, two 83 million by 2030, which is going to happen. Because, as you said, you're also not only speaking with CKSE, but also with companies like ResMed, which is looking into CKSE as well. Yeah. It's so interesting. It's the technology. If you talk to our scientists or our explanation from any of these strategies, they truly believe that this could be something that could help them differentiate their own products. And more importantly, help them phenotype or understand each person. How these patients are responding to the therapies in a particular way, especially when they are at home, which is the thing that we don't really know nowadays, right? Like, we don't really know how these patients are responding to these interventions. So, it makes it super interesting. Right now, we are working on particularly as a sleep apnea. We are going to start having a few partnerships on even epilepsy detection for apnea at night that are killing most of these epileptic patients. I just came back from a meeting just yesterday. We are talking on how we could report this for a spinal cord injury in the ICU. We honestly are building a platform, an AI platform that could expand through at least five to ten different locations. And one of the most exciting things about Pseonmai right now is that we are setting a clinical trial with 2005 hundred patients. And well, subjects actually, because we're including healthy people too, in Colombia, we're going to phenotype a lot of these patients and controls people with lung cancer, with tuberculosis, cystic tuberculosis, which is an orphan disease, by the way. Same thing with asthmatic kits and adults. Same thing with motoroid diseases and COPD. We could do a lot of things and that's the main thing. How can we build a company that could help billions of people? And this is interesting what you just say. You're now going to start doing that already in Colombia. You mentioned early in our conversation, Suda, which is your lead investor, but who's also one of the largest health insurance companies in Latin America. So, they also have the network, of course, that enable you to find the patients a lot faster and a lot cheaper than if you would have to do that within the United States. So, can you tell us a little bit more about how that go to market is working for you? Yeah, and everything that I talked about in 2024, the Medtech Innovator Award was definitely the main catalyst for us. About two months later, we were having, for regard, it was actually our breakfast with the CEO of Suda. And he was telling him about what we had just accomplished, the award, beating a lot of companies from everyone in the world, especially coming from Colombia. That's a big deal. So, many other days, they are coming on our table with a million dollars of investment. A million kind. We are going to use that money to cover two clinical trials. One of them is an exacerbation detection trial with 200 people that we will follow up for about six months. We're trying to prove that we could predict exacerbations and we are already seeing actually very good signals because we had completed the follow-up for about 12 of those patients already on our own. And then a cohort of the thousand patients that could help us will definitely help us improve our algorithms to accuracy is over 90%. And the main idea with Sura is that they have a presence in seven different countries covering 20 million people. For Colombia, particularly, they are like a Kaiser. If you are familiar with the US system, they are a peer and shooter about themselves, they have a health care system. So, they are providers. They have the doctors, they have the hospitals, they have the clinics. So, the main idea is that we launched in Colombia in 2028. They have had around, I remember correctly, a thousand and 500 hospitals and clinics where we will deploy the technology primarily as a point of care, meaning as a diagnostic, somebody who's coming through the door with respiratory symptoms, they are over 40, they might have these either smokers or maybe they were working carpenters, people who were working, I don't know, mechanics. Anyone who was exposed to something that could damage their lungs, per the guidelines, they should be screened for COPD. So, that's a main purpose is starting with Colombia in 2028 and skipping rapidly through the entire country in 2029 and eventually in at least three other geographies in Latin America, primarily targeting of course, Brazil, which is the largest one, Chile and Mexico, where they have also the strongest networks to make it happen. Yeah. So that is for you to hit the commercialization. So in the meantime, of course, you're fundraising, but also you have so far, half of your funding has been non-dilutive. So it came from grants. Yeah. You already mentioned the winner of the Metacinvator definitely helped. And you're now also lined up for $4 million grants. I think being a founder, an immigrant founder and a woman, I'm very resourceful. I really like to run a company that is smart in a way that we are using all of the resources that are out there. We don't shy away from writing grants. We actually love it. We have been funded with $3 million in school SBIR. So federal grants coming from the federal government and also status prices, such as Metacinvator. The plan is to secure at least $4 million or a reservation that is going to happen in the next month or so. Having that $4 million in at least by, I would say probably by December. And we have a plan, a pipeline of at least $10 million in non-dilutive funding. Also from the federal government, from the Department of Defense, from ARPAH, which by the way, that contract could be all the way up to $40 to $60 million. So we are in early conversations with ARPAH, for example. So yeah, I mean, we are very smart about that. I'm more importantly, the fact that we are having sales because we are literally being hired by the strategic to develop companion diagnostics. In other words, AI algorithms that they could eventually license out and buy. So we right now have a business model that it's called Bill to Buy. And that's the one that we are running with strategic before an exit or an acquisition offer by 2029. We should probably just raise around 2230 million in dilutive funds. And that should be it. Everything else probably about 15 million in non-dilutive. Maybe for the contract for ARPAH actually burns out. It could be really super big. Yeah. Because maybe to talk about your business models, well, you're not there to sell the hardware devices. That is not your long-term goal. You're not a hardware company, even though you have the device right now. You're a data company. So it's all about building the models, as you said, licensing those models. So that means you're getting subscription fee, you're getting recurring revenue coming in. That is the big play going forward. Yeah, absolutely. So we are running as software as a service type of company AI on top of that. A recruitment revenue, for example, is an annual subscription where the doctors have access to the sensor, to the patches and to the algorithms and the software platform to test as many patients as they would like. And any decades of these pharmaceutical and medical device strategies is the same thing. The device, we are about six months from the same freeze. We are very close to have it finished and contract manufacturer probably about a year. And again, it's a device that is simple to build and to put together. I can explain it perfectly at the beginning. It's like having headphones for the chest. I've recorded you can go over the components and you can explain us way better how we are making it, how we are pulling it together. I can mention a couple of things that are important. As mentioned, the device has speakers and microphones, but we also have a microcontroller and a signal processor in there because when we are generating the signal, the stimuli that we're putting the long, we are crunching the numbers a little bit in the device itself and we have memory in the device. And this is an important thing because audio is very rich. It has a lot of information there. It's very heavy. And we connect the device via Bluetooth to a mobile application in a phone and a tablet, but you don't need to be connected a lot of time to be able to capture data. So that's where the first part of the data storage happens on the device. And opportunistically, it downloads data into the application, into the mobile phone or the tablet. In there, we can do some more number crunching if we want. So we could have some models that are running on the tablet, but we also upload the data to our backend. So it's all hyper protected. It's prepared to be GDPR compliant so we can really deploy globally in the cloud and in the server, it's where we do a lot of the number crunching where we apply a lot of the models. We have the bigger models in there and we can have all the historical data do the follow-up of the pages. We have actually already a portal, a web platform where doctors and clinicians enter and follow and see all the information there and the pages as well. And the final step of that is to be determined depending on how the progress is going to be going into market. But the platform itself is like we have already. We know what we need to do and we just need to pull this. How is going to be presented to the final customers to the doctors to the patients in there? I love it. I can clearly see the whole Silicon Valley mindset coming through in the company. That is amazing. Now let's talk about your team because it's not only the two of you. You have a lot more super storm people building Silicon Valley also in Colombia. So who are the main people on your team right now? Besides us, we are working with two veterans in the world-level industry. For example, there is Martin. He is the co-inventor of the world's most sophisticated world-level. He was approved by FDA. He has spent about 10 years working on a world-of-rerelator that's, you know, its weights is probably less than a pound if I remember correctly. They just got about a year ago a PMA approval, which is the most, my goodness, the really, really most difficult thing that you could do with FDA. They spend a long time doing it and he knows everything on all things, you know, contract manufacturing industrialization design. He has almost three decades of experience. Team ZO, the other person, helping us out. He's a serial CTO and CPO. He was part of the IRADF founding team. He has, again, like over 25 to 30 years of world-level device experience. We have a lot of contractors and consultants. Oh my gosh. I have access to probably 10 to 15 people who has done this in the past as a medical device company or a data company or a viral, single processing product. And on top of our, of course, we have our team in Colombia and our Argentina, by the way, right now. We're about to hire our second person in Buenos Aires and then in Colombia we have around 20 people. So for engineers, we have data scientists, we have operators, of course, and clinicians and make a trying engineers for their hard work. We are 60% women right now, which is something that I'm truly proud of. I'm very intentional about democratizing our cap table, our team, and make a company that it's super diverse in every sense. And I'm trying to build a business or an organization that follows my principles as a woman founder and more importantly, I'm trying to become the leader that I've never had in the past. That's what's my issue. Right now, you're raising funds on your in your seat rounds and you already have 60% secured. A lot of the money is going to go to people because what I understood is not everyone on the team is full time because, of course, all these specialists that you're mentioning to get them full time on the payroll, that would be pretty expensive. So how do you make sure they actually stay on like what's the incentive and what's that plan for the longer term? That's a great question, Mikey, because I mean, most of our money is going to go to the doubling the size of a team in Colombia primarily. So we are a mission driven company. And we are very good at convincing excellent people in the industry to help us out with equity. So right now, these two people that are helping us, I'm working on team, they are a sweat equity, a type of payment. The same thing with our advisors, for example, I have people from a pharmaceutical industry, from a medical device industry. This be a yard that went the moment that kicks in into the December. We are going to do at least three hires here in the US because it's going to be 4 million. We might over subscribe, by the way. We might go all the way up to 5 million and we can talk about the investor. So we are under due diligence with two funds for $1 million each. And we're having toss of structure right now with ancient groups. The women's dedicated primarily right now. So we might just close up what a million dollars between now and late May and maybe be older, million or two million by July. So excellent news. And you have Surah on board. Of course, what are the VC firms that you currently already have on board? So sent email, they are Chilean they spawn, they are formal operators at $20 million fund and they had invested already a million and 100,000. They were our seedly, tree seed leads, Surah is putting a million. We have a lot of angels for this route particularly. I'm a first time founder, you know, Mikey show I'm very cognizant of my gaps and that I need a lot of help and better people, the people who have done things before and that I have not. So I'm very coachable and I'd really like to bring on board at least for this round the people who can help build and move the company forward. So we have far-max executives, we have excugulars, we have CTOs and C.E.Ls from VC back to empanies from Silicon Valley from from my network. We have everything I'm under due diligence with a family office in Mexico from a pharmaceutical due diligence also with an impact fund that is managing the family offices from all across Latin America. They are here in the Bay Area. And I am also company after due diligence with another fund in Canada, they are deep tech fund. And I came back from a metaconference just two way four hours ago exactly and I met 27 months, 80% of them wanted to have a follow-up conversation. So they know that this KSC contract is a high stakes and likely to happen under the next four months or so so they really went on getting when we're still cheap. But the moment that we sign it, we would travel double triple hour evaluation because that contract could be Definitely large and more importantly it proves It's part of market feeding away commercialization validation not only coming from KS because we have ongoing conversations with our strategic as well And now let's talk about exits because what you see in in medical companies You don't always need to wait till you have all the revenue. There's also opportunities to get acquired before What do you see as as potential exit hats for some I? Yeah, so Historically what happens with medical device companies is that you one either get acquired a moment that you hit about 20 million dollars Revenue from an extra to you that is building in the respiratory space. I Always get this question. I tell them I'm already working with my acquire Freshman particularly it's a company that really likes to do mergers and acquisitions But very acquisitions in the respiratory space they usually acquire one or two companies every year They have obviously an especially a position on abstractivist papnea But they are trying to increase their market size and moving forward beyond only abstractivist papnea See a pity to one of the markets that they are already working on If you if you listen to their CEO McVorel he's pretty much obsessed with where I was with where I was Home diagnostics personal personalization in general. We are a really good to it. Actually I just met with him about two weeks ago. He really liked it So that's one thing and then the second it also happens the moment that you get a regular clearance if you are a denoubled technology What it happens is that the novel makes it extremely special as a technology meaning that it's very difficult to replicate not only because we have a device that it's Powerful enough to capture data from the long-spot more importantly all of the property data and the clinical mode around how we did it and put it together Our competitors won't have access to the documentation that we submitted to the FDA So we are the only ones in the world who know how to make it happen So that's what makes us extremely interesting and obviously at that stage is where they have quarters The strategies we like would love to buy as the career is still cheap We haven't gone into full commercialization deployment meaning that the moment that the surgery in revenue and let's say we become extremely sticky And you're served for example growing two times year after year That's where we get super extensive So what what has been seen historically is that that's exactly the perfect window where this is strategy Will come and ask us to get at choir we are projecting at position in 20 I at least $500 million and the moment that we start scaling we might just decide you know Maybe we haven't done it ourselves enough We might just do an outer round and try to scale it so that we could probably Triple our valuation and it gets obviously more money for all of our stakeholders Interesting enough opportunities there Maria Nick Carter have one final question for you For all all the angels that are listening right now. Why should we invest in some I why is this the best investment that we can make? Thank God you want to go? Well, no, no, I think that well some I like as Maria mentioned like we are a mission driven company We know that we are creating a device a solution a platform that is going to be not only very Useful for a lot of people in the world that it's going to change their lives for the better But it's also going to be monetary like really good investment like we can make this a very good Business that everybody's going to win is going to win the money side is going to win in the social impact side And we are creating a company that also like the people that work for us We get stuck like we give them in the earned a Colombia But we give the stuff that is not normal to that because we believe that we are also school for the people that are working With us they are going to someday they are going to capital it themselves They are going to be investors in other companies. They are going to grow the tech market in also in the American other parts of the world So it's going to spread so we are not only a company doing a device We are a company with a mission that is going to make things better in many Reans so that's that's what we think that we are yeah, my and my answer is I really like the numbers I've as a CEO become a little says with money and obviously the numbers and on impact on the impact side Obviously is the fact that we are revolutionizing an industry that hasn't seen a really three innovation at 170 years and what's really what makes me super upset Obsessed obsessed and upset The statistics tells us that one of every ten people worldwide will have a chronic respiratory condition within the next 20 to 30 years Mainly driven by climate change and air pollution So we can help a lot of people and more importantly we can detect earlier disease to the point that we can't Prevent the respiratory attacks and exacerbations and the Severally in the later stages that are driving most of the expenses for the health system So it's not only the people that you're helping to improve quality of life to detect earlier disease and to have them on treatment earlier on enough So all of the money that we can save so right now is spent 143 billion dollars just in CFPD globally every year just one condition one So probably triple that if we wanted to like cover everybody else and the second thing is that if you come and board right now It's probably our cheapest or the best window of opportunity to invest because we are projecting tripling our evaluation within an ex 12 months or so and that's precisely the reason why I wanted to invest right now because to me This round is all about the people that are mission oriented that are lying and more importantly I want more women might have to go to me. It's about again Tensionality right like women don't have access to very good deals whatsoever like overall We are very interesting company because we are by national so we are helping obviously Patients and employees in emerging markets, but at the same time we have a food here in Silicon Valley So we have access to the most sophisticated people in the world. So Chua is Is it or that right? Jim fest now you you can see a very good return of investment probably over seven times or so on our expectations to have an exit to under four to five years Super Well, Maria Ricardo. Thank you for sharing the story and for sharing silly story As you said, this is a billion dollar market the technology is protected by 18 patents Farmy giants are already paying for it the fourth largest insurer in Latin America is investing and it was built by Maria physician who lost her grandmother to a disease that could not be diagnosed and an audio engineer Ricardo who spent 30 years making sound do things in nobody thought was possible And these two people happen to share a life for the past 20 years before they started this company That is amazing Of course, it's all early stage. There's always risk, but if they're executed right They're not just building a company. They're actually replacing a 60 year old diagnostic standard that has filled half a billion people This could transform the whole landscape similar to how the Glucometer transform diabetes care For everyone listening stay tuned next you'll hear from our epic angel investor Paula about why we are so excited to invest Thank you Now let's hear from the investors what they have to say about this startup and please remember we're not a financial advisor All opinions expressed by epic angels are intended as educational and reflect the personal research and experiences of the team Today we are joined by Paula Ristrepo epic investor and board member with over 30 years experience across finance and strategy sustainability and impact both in Colombia and Spain She brings a very strong focus on investing on impact driven investments and equitable access to opportunity Based in Colombia she's at the heart of where let them stop class healthcare is being developed and delivered And that is also as we heard the launching market of summer Paula welcome. It's great to have you with us And Q has turned my case great to be here with you. What was your first impression when you saw some my pitch and what excited you most right away Well You have to see the page when you listen to Maria and Ricardo When you're here their story their narrative their passion And you just have to fall in love. They were solving a huge problem with a great solution In a very methodical and organized way I feel So it was just great and it's just the way they transmit what they're doing you just falling alone I love their story how they started at home. Just kind of hustling. This must work. There must be something A very data driven and she said very methodical That really goes in you already mentioned Mike the Silicon Valley a way of doing things. That's also part of it I don't know if any of you guys have done a thrometer. I've had to do a test with the thrometer I have no I have and let me because I love focus groups of one I called them, you know So it's in my focus group of one when I had to do the spirometer I thought it was the most Ancicated difficult exam I'd heard to doing my whole life and I was actually in the clinic in this place and I was there with some kids that had to do it and with some older people that had to do it and they couldn't, they just literally couldn't do it. So when I heard the solution I was like, oh my goodness, this is the solution to that problem I had eight years ago when I had to do it. So everything about what they're doing I think is fantastic. And maybe, Paul, can you tell us a little bit about healthcare in Colombia because for many of us, we've never experienced a healthcare in Colombia. It's actually very high quality health. We actually have a lot of health tourism because I mean, we have great trained doctors, we have great hospitals, we have great technicians, we have a lot of investment. Recently we've had a lot of foreign investments in hospitals and in diagnostic centers. So it's an industry that changes a lot but it's characterized by its high quality. Yeah, it is for sure. It's very good. But I think as well that what I'm interested in things about Samae is that yeah, they're going to launch in Colombia but their market is not only Colombia. I mean, if they manage to launch with Suda, I immediately put something all up that time. And what I find particularly interesting is that they have a lot of time, they have the US and they have Europe. I've never seen a company that's ready to launch or could be ready to launch in three different areas of the world in such a short time. Which can also be a risk of spreading themselves to sin if they go out to quit. But as they said, we have food in both Colombia and Silicon Valley, which gives them access to talent and very experienced people, which is just an advantage. I mean, it's still that execution still kind of needs to be proven when it comes to the commercial side of things. They're developing Sylvia's device. They are building up their database as they say their data company. It's a deeply impactful solution. So they want awards. But the commercial side of the business, it's all about the money. So what is it that gives you the confidence that they are able to deliver this and execute? No, I guess the number of things. One is them, the founders. I always look at the founders first before the solution because the solution can change through time. So it's them. I love that they have Tim and Martin with them as well. I don't think Tim and Martin would have joined them if they wouldn't believe that they could pull this throw. So I think that gives me a lot of confidence. I think the grants they've had as well because it probably had to submit really tough grants with a lot of information. So I'm pretty sure they're going to be able to have a very accessible device in the beginning and then the data and everything they want to do. And they might change. They might end up being only the wearable or only the database or they'll be able to do everything they want to do. It might change through time. But they're going to develop a great solution for a huge problem. I'm pretty sure of that. I think they're a track record, both they're track records, both Maria's and Ricardo's, again, the rest of the team. I think that contract they have with KSC is very interesting as well. Like I said it and I repeat it, but having revenue already without the product really, it's incredible. It's incredible. So I'm pretty sure they're going to do great things. They already have a million science now, which is, yes, we never see that in a medical company. And that's really true about their commercial and the about the hustle, the way they look into it and understand the value that they're delivering. They're going very fast, right? And so that might create a little bit of vertigo. And so this is a tsunami and they're going very fast. Maybe at some point they're going to have to just settle down a little bit, work on the things that they probably don't like doing a lot, which is the operations and all the other stuff. I think they're surrounding themselves with great people who wouldn't want to work with them. I mean, if I was a 20 year younger, I would love to work with their company with them and with such a mission and a drive. So I'm pretty sure they're going to be able to pull it through. I was saying to one of our other angels, so yesterday when we were talking about them, they go, I really would love to have a coffee at their kitchen table in their house, right? And just have a conversation with them. The two of them, they're so insanely smart and so insanely driven. So I can only imagine the conversation. So yeah, definitely. Yeah, it's amazing fit, these two. As you said, Mike, it's so complimentary. It's really good. And just want to add to that what I really like about their approach to commercial side of things is they go to market. I think that's really smart. Where this built by and this co-development, which also is a source of revenue already now, but in the end, they're still building the product and making it stronger. So that is very clever, I think. And I think so far, they already know exactly what their model is going to look like. They know even a number of hospitals and clinics that are going to be launching at in 2028. That's in two years from now. They know about how they're going to get going revenues to the licensing, etc. So yeah, very intentional, as you mentioned, a few times. And I really like that. They have a plan and they're executing. And not all founders have this strategic part and execution part. And they seem to have it both. So yeah, very, very exciting. They already know when and who hold their gun as sell and ask how much. So they already have on the roadmap their exit plans. I'm kind of sad because when I listened to that, so it probably could be bought in 2029, 2030, I'm like, that's like four years. The known. Let's be part of this for longer. So yeah, you feel a bit like your babies, your children, how you mess like no, stay with me a bit longer. Yeah, yeah. So yeah, they're actually how they mentioned and they're very also very clearly already what they have in mind. They say it's funny already working with with our acquirer. So yeah, for them it's quite crystal clear. So we go ahead with an investment that's super exciting. What would need to be true in five years for this to become one of our best investments? I think a number of things. One is that they're able to commercialize what they're dreaming of commercializing, saving millions of lives and billions of dollars because those are billions of dollars and those are dollars that could be used elsewhere. So I think that would be great. Well, multiplying by, I don't know, I'm thinking more than 10, 20X, 30X evaluation and you know what else I think. And it's if they're successful, if they manage an exit, I would love to see them creating something new and us investing in whatever they create because I just think they're so powerful as a couple and they could create so many great things when they combine their expertise that you never know. This might be what the first of many of things they create. What would be for you? What would be for you, Hester and for you, Mike, can tell me. For me, there would be indeed the execution on the commercial side. That is always something to be proven where there's a long science part. I don't have any doubt that they will succeed. Just by how they approach this whole thing, how smart they are by getting revenue in already before so many things are done. The patents that they have already in order, which is going to have value in the market, just their execution power from what we've seen now. I have no doubt, but that is for me the biggest thing that needs to be proven true. If they become truly successful and if they will make this huge increase in evaluation, like they're predicting, that commercial side needs to become true. That is for me the biggest thing that needs to be proven. For you, Mike. I think for me as well as that every time we have someone around us that needs some scans for the lungs, they are actually using this device, the Silvee device. We can say, "Look, we invest in them very early." It was just a little prototype that they manually manufactured, but now you see it literally everywhere in the world. Just like you see everyone with those patches for diabetes walking around, everyone has seen it. That everyone has seen the Silvee device and that we of course can say. We were part of them. We were part of that early journey and we've been alongside them along the right. That would be cool. Yeah, that would be amazing. Mike, I have one thing that I was wondering at, so you know San Francisco, you work there. You are right in the middle of it. Now you've been traveling in Latin. So you know both sides, both where they operate. From a found perspective, they're quite different. Where San Francisco is very much more developed and mature than Colombia and Latin. So how do you see this? How does this work in the benefit? Do you see any other dynamics in these that they have to feed in those different regions? Yeah, for me, it really is a Silicon Valley couple. That really comes through everything. The way they look at that, the way they are like, it's not about an opinion. We need to validate our assumptions. We need to obtain the data and that makes us decide on what's next. The way they have access to all these things. these AI folks around them in Silicon Valley the way they're thinking. I remember after the first call, I had a chat with my hospital and I was like, "Huh, I felt like I was in San Francisco again after this conversation." So they really, really have that. And at the same time, I can also see their roots, the Latin America roots in here as well. They understand the world is not the United States. They understand that there's a whole other world outside, which means access to these machines, access to these specialists, that simply doesn't exist in a lot of the emerging markets. And they clearly understand that and that's what they want to solve. It's not the problem in the US, they want to solve. They really want to solve that global problem, including the emerging markets. So for me, that's coming to get a beautiful. - Yeah, so the access to the resources that they have in Silicon Valley to solve a global problem. And really understanding it, not having read about it, but live through it, seeing it with their own eyes, being a part of it. - So any last comments or ideas? Why this point vested? - I think the problem is very important to solve. I love their solution. I love the passion. But I worked it with some time in the music industry. So I always knew that sound was very important. My music had this, our healing and everything. So when I saw this, I'm like, oh my, I think it's gonna be a great, very exciting investment. There's so many strong parts to this. The other thing is the data, right? That they're building up. We know the future's data and you know exactly what they're doing with their data. So that is very exciting for the years to come. So I agree with you Paula. That this is a super exciting one. Where they sit, the stage that they're at, very exciting for angel investors to come in now, because it can only, when it goes, it goes fast and hard. It goes really up. So huge potential there. Very exciting to come in this stage. I always find it's the fun thing about being an angel investor. I'm very excited to see where this company is going. - Absolutely. - Good. Paula, thank you. - Okay. - You're so chill and thank you for having me here. And congrats again for the five years. I'm so excited again, yours. It's been great joining you. Been great having you. Thank you. We hope you enjoyed looking behind the scenes. The objective of this podcast is to demystify angel investing and to share insights so you can learn more about the world of venture capital. Interested to see if you can become an angel investor yourself? Contact us via [email protected] or go to our website and epicangelnetwork.com. (gentle music)

Podcast Summary

Key Points:

  1. COPD is the 4th leading cause of death worldwide, affecting 550 million people, with 80% undiagnosed and most losing 40% of lung function before diagnosis.
  2. Current diagnosis requires a 40-minute test with an $80,000 machine in specialized clinics, which many doctors lack.
  3. Samai Health has developed Silvie, a wearable AI-powered lung diagnostic device the size of a TV remote that can screen for COPD in 5 minutes using acoustic resonance.
  4. The device injects sound into the chest and captures changes in lung resonance during breathing, outputting the same pulmonary function numbers as traditional machines.
  5. Co-founders Dr. Maria Artenwagga (physician-scientist) and Ricardo Garcia (former Google audio engineer) are a married couple who combined medical insight with audio expertise.
  6. The technology is already generating commercial revenue before FDA approval, which is rare for medical devices.
  7. The company holds 18 patents across 20 countries, covering the methodology of using injected sound to estimate pulmonary function.

Summary:

This episode of the Epic Angels podcast features Dr. Maria Artenwagga and Ricardo Garcia, co-founders of Samai Health, which has developed Silvie—a wearable AI-powered lung diagnostic device. COPD is a devastating disease affecting 550 million people globally, yet 80% are undiagnosed because the only accurate test requires a 40-minute session with an $80,000 machine in a specialized clinic.

Silvie solves this by using acoustic resonance technology: it injects sound into the chest and analyzes changes in lung resonance during breathing, delivering the same pulmonary function numbers in just five minutes with a device the size of a TV remote. Maria, a Harvard- and Berkeley-trained physician-scientist, was inspired by her grandmother Silvia’s death from a COPD attack. Ricardo, a former Google engineer whose audio code runs on billions of devices, brought his expertise in sound processing.

Together, they built a company that generates commercial revenue even before FDA approval. The technology is protected by 18 patents across 20 countries, covering the core methodology. Samai Health aims to empower patients to manage their disease at home and predict exacerbations days in advance, reducing costly hospitalizations.

The founders emphasize their data-driven approach and complementary skills as a married couple, making Silvie a breakthrough in accessible lung diagnostics.

FAQs

COPD, or Chronic Obstructive Pulmonary Disease, is the fourth leading cause of death worldwide. 550 million people have it, and 80% don't know they have it, often losing 40% of their lung function before diagnosis.

Silvie replaces the traditional 40-minute, $80,000 spirometry test with a five-minute screening using a small, wearable device. It allows for early detection and monitoring of COPD anywhere, without a specialist or lab.

Silvie injects sound into the lungs and listens to how it changes as you breathe. These changes are captured by microphones and analyzed by AI to estimate lung function numbers, similar to a tap test on a drum.

The founders are Dr. Maria Artenwagga, a physician-scientist, and Ricardo Garcia, a former Google audio engineer. They are a married couple who combined medical expertise with audio technology.

Maria was inspired by her grandmother, Silvia, who died from a COPD respiratory attack in Colombia. She believed that if someone had been monitoring her lungs, her death could have been prevented.

They are data-driven and scientific, making decisions based on evidence and testing assumptions. Maria handles the business side, and Ricardo handles the technology, complementing each other with different strengths.

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