Joe Rinehart, Perceptive Medical - Novel Infusion Pump | LSI USA '24

Joe Rinehart  0:00  
Good morning, everybody. As introduced, my name is Joe, I am an anesthesiologist. I've been practicing at University of California Irvine for just about 15 years now. And Perceptive Medical is our startup, we've launched it out of the University. And I'm going to start with just a little bit of philosophy. As I mentioned, I've been practicing for a long time. And COVID, as I think many of you, in this space know, accelerated a lot of the problems that we see under the hood in the US healthcare system, primarily, we've got a lot of providers that are burned out, workflow problems, stress problems. On top of that, I spent a lot of my career doing research. And one of the things that was most frustrating about medical research is we have all sorts of things we publish on, that we can show are better for patients, but they don't get implemented, because there's so much work to get implemented. And the sustainability is just not there. So philosophically, what we set out to do was fix one of the bigger problems that we see in a way that is sustainable. And the way we're doing that is through automation. So I think in the year, let me see if this is this one wrong button, there we go. In the year 2024, we've got a few essentials for bedside medical devices, they've got to be individualized care, especially in the hemodynamic management space, they've got to improve outcomes. And they've got to reduce both direct and indirect costs. And I think, you know, the the fourth aim that I would add to that triple aim is reduction in bedside provider workload and stress, we can't be creating more stress for our workers. So the core problem that we set out to fix is hypotension, low blood pressure, there's a ton of evidence to show that low blood pressure daily harms people in the operating room in the intensive care units, you've got an increase in stroke, heart attack, kidney injury, death. You don't have to convince clinicians of this, there's a ton of data out there, clinicians accept our priori that low blood pressure hurts people. Despite that knowledge, it persists. And guys like Dan Sessler, at the Cleveland Clinic have shown consistently that the harms of hypertension are not reduced, even when you tell providers, hey, blood pressure is too low. And that's all related to workflow issues. So the workflow problem is that right now, if you get admitted to the ICU and you have septic shock, we're going to start showing a medication to bring your blood pressure back up. And that medication is going to be titrated by hand by a nurse at the bedside. That's a highly skilled qualified provider that is literally pushing buttons to hit a physiologic target. Our ovens have more automation than this, it's crazy that this is how we do this in 2024. So we built the barrel hook system. The barrel hook system is a platform. It's a fluid pump and infusion pump at its core, but it monitors the patient directly. We plug it into existing bedside monitors, we monitor patient, human dynamics, and then we use those hemodynamics to drive the titration of the pump. And by doing that we can reduce hypotension time and severity by 95% or more. It's not just hypothetical, we've done multiple human trials now in Europe, and consistently, we can reduce hypotension time alone by greater than 90%. Severity by 90%. So the area under the curve, it's like almost a complete reduction. This is a great example case. This is a post cardiac surgery patient in the cardiac ICU. So very skilled, very motivated nurses. The first two and a half hours here, the red line is a patient blood pressure. The first two and a half hours is the patient's blood pressure as being managed by the bedside nurse. So you've got these swings over where they're giving themselves buffer and then you've got the dips under that are actually causing harm those brief periods of hypotension are what lead to poor outcomes. A two and a half hours in we turn on the barrel hog prototype and you know the the differences visibly obvious. The nurses and physicians we've talked to love this, the health system nursing director UCI wants to know when she can start buying them. So I told her, we're working on it. Very exciting, very good feedback for us. Our business model, we've got a capital piece of equipment, we've reproduced, advanced team dynamic monitoring, in addition to our infusion pump, and then we've got our disposable our disposable fluid. Tubing is effectively where we generate most of our revenue, we've got a 90% revenue over cost of goods on that. Given that with just managing hypotension and one drug, we've got a two and a half billion dollar addressable market between the United States and Europe alone, when we start adding, again, this is a platform new drugs for high blood pressure for heart rate control for Anna Tropi. That market just multiplies from there. We can show a lot of costs direct cost savings over current management, if you get advanced team and endemic monitoring from the current market leader cost you $300 Our product provides all of that for almost nothing because we can sell that as a subscription model. And then even if we charge something like $200 for our disposable now you're getting an intervention for less than you're currently paying for monitoring alone. And in addition, we've Got the cost savings from the reductions and complications that we can show. And you've got the bedside nursing stress reduction, which is very difficult to quantify. But it's the leading thing that our customer survey interviews talk about the nurse managers and nurses love this concept. So our value proposition or triple aim, we've got individualized care with improved outcomes and reduced direct and indirect cost versus current care, reduction and bedside provider workload consistent management of the infusions across the institution, no more provider provider room to room and variability. And then we've got additional gains from reduced ICU and hospital lengths of stay. Nobody else is doing anything like this. I've been doing this for about 15 years in this space. This is my second startup company. The first was acquired by Edwards Lifesciences in 2014. Nobody else is really working on automation at the scale, and we got a huge head start with all of our clinical data. Pad strategy, we've got multiple issued allowed us and international patents, the key patents have been filed everywhere. And then we're focusing on US and Europe for some of the extension patents. This is a PMA regulatory path. The good news there is that we got a breakthrough device designation last year from the FDA so they see value in what we're doing. We also have the advantage that follow ons don't get the benefit of a 510 K because all closed loop controllers have to go through the PMA as a class three. Got a great team, I could talk at length about all of the people that I'm working with, but I have extreme confidence and confidence in my team, especially our regulatory and computational modeling, folks. As I mentioned, we already exited a previous company. We were basing all of the work we're doing in this company on our on the lessons learned from that first effort. We are heading into our IDE study at the end of this year, we hope to have IDE in hand. We're reaching design freeze right now. And so our ask is we're looking for a $5 million series A we've got about half of that already committed from inside and other investors, and we're looking for a new outside lead to help price around and lead things into the FDA study. Thank you for all of your time. Appreciate it and look forward to talking to some of you