David Giarracco, Noninvasix - Non-Invasive Central Venous Oxygenation Monitor | LSI USA '24

David Giarracco  0:04  
Good afternoon. I'm David Giarracco. I'm CEO of Noninvasix (Non-Invasive Central Venous Oxygenation Monitor). I've spent my entire career at the intersection between technology and healthcare. First as a graduate student at Johns Hopkins University, then as an engineering leader with a company now known as leaving Nova, ultimately moving to commercial leadership roles at both Covidien and Medtronic. While at convenient, I had the responsibility and pleasure of being part of three of the four largest patient monitoring acquisitions that have occurred. You'll see that later. But now I'm leading non invasive acts and our plan to deliver to the market the first non invasive measure of oxygen in the veins, as a former colleague at Covidien called it the holy grail of vital signs monitoring. But before we dive into that, let's kind of take a look at our customer and who we serve. So Dr. Scott Smith, he's a critical care physician. He is lacks the right data to make real time treatment decisions. This affects patient lives, outcomes and the hospital's finances. He's one of 13,000 us physicians that have this problem every day. Information limitation, increases uncertainty, risks, and the difficulty in controlling the patient's course of care. He is frustrated by the status quo. What if you could personalize treatment in real time? What if Scott had the ability to tech sooner and safer? What if for the first time, he had access to point of care, venous oxygen measurements. And now let's take a look at maybe what you would look at. So sepsis, this is the US facts about sepsis. It is 6% of all hospital admissions are from patients with sepsis. Every year, that's 1.7 million adults presenting into the hospital. It represents 33% of all hospital mortality. So it's not just the 6% of patients that are admitted with sepsis. It's also the patients that develop sepsis while they're in the hospital. When sepsis occurs, the least critical critical of the versions, it increases cost by 20%. And the average per patient cost is $70,000 per patient. And again, that's not severe sepsis, and that's not septic shock. That's the least critical of them. Okay. And these facts are after 20 years of concerted effort in US healthcare, driven by the Society of Critical Care medicines, surviving sepsis guideline campaign, as well as CMS making sepsis care, a quality measure where hospitals can get financial penalties. And so why is this the case? Well, we think it's the current approach for monitoring sepsis. And we believe we can improve that status quo. So our product is live ox and it measures oxygen, the veins, as I said earlier, we received FDA breakthrough device designation for our technology. And it's a vital signs monitor. And you see on the left, there's the box, the hardware, as we call it, it's a capital cell. You see coming from that box, a black reusable probe that allows the hospitals to take measurements, it connects into a disposable patient interface, it sits right above your sternal notch just where your clavicles meet. And it actually measures oxygen in the veins. But from a business model with that approach, we have a an annuity right we have those patient interface, those sales, and we what we have is a razor razor blade sales model. But let's talk a little bit more. We work through Opto acoustics. That's how we measure oxygen in the blood, many and I want to take a moment to compare that to what maybe some of you are wearing on your wrist, pulse oximetry, if you're wearing it on your wrist, or you've been to your doctor's office and they stick a probe on your finger, that is pulse oximetry, it uses light in and light out to measure blood and the capillaries were light in and sound out to measure blood or measure oxygen in the blood and the deep vessels of the body and how we work as we pull slide in and we listen for that sound. And that sound gives us more information than optics alone. This approach has seven US and 16 worldwide patents, and we have three additional patents pending. So our performance equals the invasive gold standard. And let me take a moment when I say invasive gold standard. This is not the parent asking their child late night questions. Where have you been? This is actually a catheter being placed a central line into the body requires a physician that catheter is floated or moved towards the heart so that you can sample the blood from that location. Okay. And so now let's talk about sampling. You see on that chart, there are these blue open circles. Well, each one of those represents samples. And so in this study, which is actually a standard study, believe it or not, I'll explain that in a little bit. Each one of those represents a blood draw that a nurse has to take get it to the lab, that lab has to then do processing on it and send that number back to the doc you're all healthcare people. How quickly do you think that happens in practice? Alright, so that's the invasive gold standard and you see overlaid on that our black line of our Nan and As a continuous measure that can be done at the bedside. Okay. So as I said earlier, this would be called a breathe down study, believe it or not, it's a standard study to show how OXImeters things that measure oxygen work. And this is a study that's going to be required for our regulatory clearance. So just wanted you to park on that. So our technology in that approach, it actually wins awards. In 2023. At the Society for Technology and anesthesia, we won the best clinical application for those critical care physicians who see such prominence our technology. As I said earlier, if you had this venous measurement made, you turn and look at sepsis, this is the initial market for live VOCs. And I just want to briefly walk you through this. This is an annual revenue potential for the business. So what I've taken out of this is hardware, because in commercial execution hardware is what pays the reps. Disposable is what pays the business. And so you can see every year that we have a $1.2 billion opportunity, just from this technology, but we don't start there, right. That's where we aspire to get to. So we narrow it down and look at the 193 level one trauma hospitals that have more than 50 ICU beds. And that's where we're going to bring our commercial efforts to four with a selling organization supported by clinical specialists to drive adoption. So vital signs monitoring is a very acquisitive space over the last 14 years. I said earlier that I was part of the three largest three of the four largest acquisitions in the space. And that would be maytronics acquisition of aspect, the acquisition of Soma kinetics, and the acquisition of Meridian they should all be somewhere over my left shoulder if I know where I am on stage. But I'm really want to focus on two of these. Cheeta medical 2019 was acquired by Baxter. They're monitoring company, they informed therapy like we think we can do it non evasive acts. And they were taken out at 11x revenue, because they the way to kind of triage and show how therapy is affecting the patient. The other is Kestrel medical, and its acquisition by zine X.

And it's informative because that $31 million acquisition was not only a pre revenue acquisition, but actually pre approval. So all they had was technology. So I think it's kind of informative as you think about what are exit opportunities for the business, how that's informed. And then of course, the little take home message in the bottom, the average space is about 6x revenue. But as we think about our multiple exit opportunities in our timing, hey, that says it's possible based on what's happened in the space, that we can look at an exit in and around our regulatory clearance, which right now is planned for one to 26. But then as we grow our revenue, we established a second potential exit, as we start showing that the US sales model has some traction, and then a third potential exit as we continue to scale or inflict that revenue curve and get our Oh us clearances. And I really want to be clear. This is just for the live ox in measuring central venous. And I want you to remember that as we talk a little bit further. So this is the team, clear the team. This is the right team. I just want to highlight one and no, it's not me. It's Don pro. He's our MD founder. He's the chief of anesthesiology at the University of Texas Medical Branch. And he actually started developing this technology, not for what we're talking about today, but actually to measure vein in this venous sinus of young children to see what was going with their brains. Fast forward. This is where we are today. And our board of directors. Clearly we have some good supertankers on our board. Our largest shareholders are the Texas Medical Center venture fund, as well as green parking golf. But we also have Phillips as a board observer. And I do want to take a moment to highlight James Halliwell, who's our independent director. And he's a serial entrepreneur, as well as current CEO of apraxia, pharmaceuticals. And then our compelling vision where we take this non invasive technology and measure option in the veins to do something about sepsis. Well, that attracted some bitty big leaders in critical care medicine. But I want to focus on one solely, and that's Dr. Greg Martin. Now Dr. Greg Martin. He's in pulmonary critical care at Emory. But he's significant because he's one of the lead authors on the surviving sepsis campaign guidelines. So the de facto clinical protocol for what you do about sepsis. Dr. Martin was one of those authors. And he joined not because they knew him from Covidien or Medtronic, he joined because it cold called him. And I talked to him about what we could do in the space. And he joined the team to give us advice to bring this technology to market. So how are we going to do that? We're raising $6 million dollars to achieve commercial sales in 2026. You can see our key hires as we look to expand our team and see our milestones as we drive from regulatory submission to FDA marketing clearance. So we're noninvasive is an excellent investment opportunity, where platform technology addressing clinically relevant problems, starting with the $30 billion problem of sepsis, but then also be able to look at cardiogenic shock and traumatic shock from the same form factor. And no I didn't put those revenue curves in there. We're an experienced team with over 20 Five years in patient monitoring alone and as I said three of the largest acquisitions I was a part of and we're kicking off a series arrays to get to our marketing clearance and pilot sales so I want to thank you for your time and I look forward to getting your questions later