Potrero Medical | Joe Urban, CEO

Joe Urban  0:01  
Hi, I'm Joe Urban CEO of Potrero medical, and we are pioneering predictive health. We're a commercial stage company. And today we're focused on three areas, digitizing the last offline organ with the kidney, we're bringing that to the world, and also introducing continuous intraabdominal pressure. And in doing both of these, it's expanded our use beyond just the ICU. And we started off with very invasive surgeries like solid organ transplants, open heart procedures, but understanding the fluidics and the pressures inside the abdominal cavity has opened up everything from labor and delivery to robotics, laparoscopic all-comers and the OR. And for the last four and a half years, I've been waving my hand saying we're going to do AI and machine learning. And I'm happy to announce in about two to three weeks we're submitting our 510 K breakthrough application for a predictive machine learning algorithm for acute kidney injury. So what's the problem? I come from a world in the operating room where we're fighting, we're fighting for slivers, and mortality and morbidity. And I think what was been exposed with COVID is the the lack and gap in the ICU. It's, it's catching up, but there's a tremendous need in the ICU, we asked the nurses to do 125 tasks per hour. And a lot of these are manual tedious and variable. And what we've done everything that you see on the screen we've automated and in doing so in automating this, we're providing bedside in the ICU, a dashboard to the clinician of what's happening with their patients real time specific to that patient. In addition, in the operating room, this resides with the anesthesiologist or the perfusionist, based on the part of the procedure they're in. our system is comprised of a couple of different components, a smart sensing Foley catheter and this Foley catheter and the first picture is the big balloon is typical in any Foley catheter.

What is 100% proprietary to Potrero is that secondary balloon, that's our balloon sensor, when that balloon catheter is engaged with the machine, that becomes a very intelligent data stream for the for the clinicians that are working with that patient, bedside or at the head of the bed with whether it's in the ICU, the operating room or the heart lung machine is the Accutab. We launched this about two years ago. And this is where all of our digital products are landing. And then finally, our our Accudata is residing with today on the  on the Accutab as well as the EMR in the future. We're developing mobile applications for this. Our intellectual property is built on two major families the intra abdominal pressure balloon that you see inflating and deflating here, we've built a tremendous moat around our intellectual property with that, and this is we believe, going to give us a significant head start in the market. The second thing is where you see those air bubbles traveling up. This is a pretty complex, it seems simple, just empty the drainage tube. It's as much of an air management issue as it is a fluid dynamic issue. And our engineers have figured out how to do this. Again, this is powering our predictive capability for acute kidney injury, and also enabling us to digitize the kidney for the first time. Clinical literature points to hospital acquired AKI can be prevented and we are we're highly focused today in our clinical studies with cardiac surgery. It's a gigantic market, you go in with a broken heart and your kidneys are okay. And one in three patients will suffer an acute kidney injury. This is something we think we can make a huge impact on and of these patients 20% will develop long term need for dialysis. This is something that we can impact from a hospital economic standpoint. This this is has huge economic consequences. One in five patients will be readmitted within 30 days. Okay, so our clinical studies, we have 1000 patients so far in our 2500 Patient Registry, and the signals are all pointing to the same thing. As soon as surgery ends, Intra abdominal pressure rises. So the pressures inside the abdomen are not just compressing the kidneys, they're compressing every abdominal structure. And so we are publishing and we have manuscript under view on the first look in this this registry, and we have two clinicians in Europe that will be presenting this next week.

This is hot off the press. This is a case study at Cedars Sinai and this was a heart transplant case. This is from an economic standpoint, a $1.6 million procedure for Cedars Sinai and what we found was during this heart transplant, you can see that the pressure throughout the procedure was normalized. And they are working in the thoracic cavity, they're not used to the abdominal cavity. As soon as the new heart was in the chest was closed. The clinicians, the hemodynamics, were going nuts on the patient, and they're trying to figure out what's happening. The anesthesiologist looked down at the machine saw that the intra abdominal pressure was three times the normal rate. They consulted with a vascular surgeon who did an emergent, exploratory laparotomy. And you could see the complete drop in pressure from opening up and they discovered a retroperitoneal bleed. This today, the patient not only survived, but is still with us today. So we're about to hit 30,000 procedures today. We're about a week out from that. So we're excited on that we're hitting our exponential reality rate with our commercial launch in the United States. And just to give you an example of the very first patient that we plugged this into with the Accutab, two years ago, the patient was trending towards AKI. And as soon as the clinician was alerted to this on the screen, they were able to administer a bolus of fluid and get the patient above that dotted line, that dotted line is the danger line. Six hours under that line, you're at stage one acute kidney injury, 12 hours, you're at stage two, and you're in renal failure at 24 hours. So you can see how easy it is to slip. And why this is a $24 billion problem to healthcare today. Totally invisible. And so this patient, the clinicians were able to help and again, get out of the ICU and back back to life. We launched this product, this addition to our technology two years ago, and now we're on a what we call patrols law, or we're going to launch a software digital tool every six to 12 months for the foreseeable future. Since we launched this, we've launched four different products. And today I'm going to announce a new product that we're going to launch, we launched the cardiac specific operating room mode, staging criteria on every screen for acute kidney injury, so you can see exactly what's happening with your patient's kidneys. And then the clinicians were asking us for the ability to annotate interventions. So we launched that technology last April, and that has been highly and very well received. And then finally, the furosemide stress test the ability to see the severity of acute kidney injury within that stage, we launched that November. beyond human capability.

This is an I joke with investors all the time, I've been waving my hands in the air for four years talking about machine learning, a lot of people do, it's a lot harder than it looks today. In a typical case, our Foley catheter and a cardiac surgery will go in to the patient in the operating room and come out in three days. We're measuring bladder pressure 25,920,000 times in those three, three days. And we're able to calculate intra abdominal pressure 8640 times, the reason we're doing a 2500 patient registry is we will have a library of 65 billion bladder pressure measurements and nearly 22 million intra abdominal calculations layered on to all the other signals that we're picking up with urine output, core temp, and the patient's EMRs. The other half of machine learning is you have to be in a huge population, there's 5 million patients each year admitted into the ICU. And of those 3 million will require a Foley catheter, we believe that every single one of these patients should have a smart sensing Foley catheter. That's how we see this as a 1/3, 2/3 play in a  $10 billion market 1/3 is just taking the existing market and expanding it with technology and sophistication with with that technology. And the other 1/3 will be or two thirds will be from the digital products that we launch in each category as we methodically go through this. And the way that we're doing this is the formula that we're utilizing is very similar to what we did in cardiac surgery. We started with a pilot study where we developed a hypothesis. And from that hypothesis, we now have a cardiac registry that's going to be that's global. And we have 1000 of the 2500 patients and leading institutions in the United States and Europe. From that we have 13 publications, manuscripts and 20 presentations out of the 50 that we expect from this registry, and we will have eight to 10 digital products. We have five to date and I'm about to launch a new one to the today.

Right behind it, I have two studies in pilot phase focused in general surgery, heart failure and trauma are right behind it and we're interviewing those candidates right now. To do this you have to have an A plus team we have among the best in the industry, and the directors are among the best also in the industry as well. So, to close out the presentation today I'm announcing a new product. And this is called Accuryn analytics. And if I told you four years ago that from a Foley catheter, you could see what we're about to show you, it would be probably laughed at. So here's what we're launching. And this is how we envision this. This is Accuryn analytics, we have a smart sensing Foley catheter that is able to see acute kidney injury. before it happens. We are submitting our 510 K as I mentioned, but this is a retrospective look, if you can see it, you can measure it, if you can measure it, you can improve it. And the way that we are going to utilize this is our clinicians, our clinical nurse team will go into the hospitals, download the data from our machines, and generate these reports for the clinicians, they will be able to see by patient, the acute kidney injury, what stage how long the patients were in that. But most importantly, they'll also be able to look across all the different hospital departments and see where they need to apply a different protocol, maybe a different approach, and improve that patient care. The intra abdominal hypertension that affects upwards of 50%, according to clinical literature, will also be highlighted. That's the purple area, and this will be launched effective today. So thank you very much. We look forward to building this smart technology with our clinical partners in the future. Thank you