Greg Buchert, MD Presents Makani Science at LSI USA '24

Greg Buchert  0:03  
Good afternoon. I'm Dr. Greg Buchert. I'm a lifelong leader and entrepreneur and proud to be the CEO from economy science. And here we are, at the end of long week at the end of a long day. So everybody just pause a second, take a deep breath. Feels pretty good, doesn't it? Well, Makani Science was created, because everybody can't do that. And in fact, I make sure I get the right. Okay, the one of our co founders had a baby born with a collapsed lung. And she was appalled by the fact that she couldn't even hold her newborn baby because of the plethora of wires on the baby. But the second thing was that the respiratory monitor failed to detect the challenges of having a collapsed lung. And it wasn't until the baby was in severe distress that the diagnosis was made. So what's the problem? Currently, respiratory monitors have a lot of challenges. They're often inaccurate, not accessible, and generally just downright uncomfortable. And so that's where, you know, the Joint Commission came out and said, Here we are, we've got a respiration rate that could be an early predictor of disease. And yet, it's the most inaccurately measured and recorded vital sign. In fact, they went on to make a pronouncement to say that optimal optimal monitoring has four characteristics. And they are, that's minimally disruptive, that it provides continuous measurement, real time communication of data. And they use standard metrics that we all understand. So that's where makhani science comes in. So what we've developed is a small, stretchable electronic sensor, that's, again, it'll be invasive, incredibly high reliability. It's easily applied, it's comfortable, and it generates a waveform that is not only continuous in real time, like good monitoring is, but it's also accessible either from index information in the cloud, or in real time. The monitor comparison, extreme extremely favorably correlates well with spirometry, the gold standard of good respiratory monitoring. And we are proud to say that we've got nine patents, and are currently working with a number of different academic institutions. And what's been interesting is, I wasn't that we went out and sought them, they sought us, they said, you've got a monitor that does something different that no other monitor does. And we want to use it. The waveforms that we generate, have unique patterns are characteristic of the various diseases that we're monitoring. And unlike almost any other monitor, it's very effective during motion. And so you've got a wireless monitor, and to can stay on somebody while they're moving. So as you can imagine, there's a lot of market potential for the makhani Science Monitor. As you look at respiratory monitoring overall. And it's ironic, I think the last few presentations, the market signed up being about $3 billion. So maybe it's a universal thing. But indeed, that's where respiratory monitors are going is the expectation is that it's going to double over the next 10 years. And so there's a huge market potential there for a disruptive monitor. But the fact that there's a large market is a challenge for startup companies that we need to remain focused. And I don't want to ask to have a meet to monitor, I want us to be able to differentiate ourselves and take advantage of what's unique about our monitor, and where do we fit. And so our first generation device measures both rate, and it's for adult populations. And this is where our first application the FDA is, but we're focusing on markets where we know that there's we can provide a difference. So sleep studies and outpatient sedation activities. And so using sleep study, as an example, is there's a billion people across the billion adults across the world that have sleep apnea, and often is diagnosed with facilities where they have a sleep lab and do overnight sleep studies. And currently, they tend to measure the respiration using respiratory inductance plethysmography belts. So not only are those belts difficult to pronounce, but they're also an accurate often because they roll they're uncomfortable if somebody doesn't sleep well. And so the solution is a respiratory monitor made by makhani that is small, comfortable, allows a good night's sleep and provides the same or better data. The second area that we're looking at for a second generation device that will be longer than Testing and in applicable to everybody from neonates to seniors is our is the pediatric market. And what's interesting here is we're first focusing on neonates. And because of the small size of our monitor, we can put it on premature babies that are 27 weeks old, and looking at apnea of prematurity. And why is this important? It's because it's a real problem for for young babies. And what happens is they stopped breathing periodically, that heart rate goes down. Very rarely do they die, but they do this apnea prematurity is associated with multiple diseases. And more recently, they've identified that the frequency of these episodes and the duration episodes are correlated with challenges in language, intelligence, and motor development as these children age. And so again, having a monitor that can identify that, potentially interrupt that or even predict these apneic events can be very, very persuasive as far as use in the in the NICU. And the other thing is that current monitors can't tell the difference between central apnea and obstructive apnea, which have dramatically different clinical implications for intervention. Pediatric devices, it's definitely a growing market and growing at an 8% CAGR. And I'll draw attention to two areas of one being respiratory care devices, and two NICU devices. And these are the markets where makhani science will be operating. For the first generation device, we've already talked about being sleep studies and sedation, because there's a need there. But with the second generation device, all of a sudden, we have a much broader market, ranging from use in a hospital to opportunity for remote patient monitoring at home. comparing ourselves to the competitors, there's a lot of advantages Bacani monitor, and it's not that, you know, again, we're not me to monitor, We're different because of our small size, our ability to use it in neonates, the fact that operates so well into motion, as well as the fact that we have this continuous real time data that can be then be analyzed. As far as a product roadmap, we're well on our way to development of our first generation device, we've submitted our 510 K to the FDA and anticipate clearance by the end of the year, at which point, we can begin the whole commercialization process. And we've already started design of our second generation device. With regard to financial pro forma, we anticipate having a revenue in 2025 and becoming cashflow, positive, and 2027. And this whole area of monitoring there, you can see that there's been multiple notable exits, significant valuations. And one of the telling things I want to point out is, here, you've got a company that we've seen many times during this conference of Medtronic that was going to scrap all their respiratory monitoring activities, and decided to reverse that decision and only, you know, get off of their, you know, remove their ventilator units, but still keep the rest of the respiratory monitoring. So this all bodes well that there's an opportunity for an innovative monitor like McCartney's. If you look at the many strategics, in this area that operate in the spaces where the makhani monitor operate, you'll see that makhani is one that will be right in the middle of all these, and it will, and so it can augment their current activities, or be just enable their technologies that already exist. We have a team that's composed of multiple individuals that have been in the medical device market for decades, we've got a very involved board of directors that collectively provide all the components that are needed to have a successful company, or advisory board has multiple physicians in the areas where we'll be operating. And we are currently raising a bridge round of $1.5 million with investment tools that are very attractive for investors. So in summary, we have a really novel innovative one of a kind monitor that will be providing data that wasn't previously accessible. We have many large and diverse markets. And so there's lots of growth opportunities for those areas. And finally, we're well underway to commercialization. And we'll be you'll see us in the market as early as next year. So with that, I'd like to thank you and I'd be happy to answer any questions out in the lobby after we're finished. So thank you for your attention.