Joe Urban Presents Potrero Medical at LSI USA '23

Transcription

Joe Urban  0:05  

Hey there, I'm Joe urban CEO of Potrero Medical. And since last year, we've had a significant, we've had a significant achievements in our technology clinically and commercially, we're just about to hit our 50,000 procedure, which should happen next month, the FDA in September of last year gave us a breakthrough designation. This is a follow on breakthrough from our 510 K approved product. And we have a continuous indication from the FDA for our vital signs, what we consider a vital sign that's intra abdominal pressure. And we'll talk about the clinical studies that are starting to come out, and some other very useful things for the company. So I always start with what is acute kidney injury. A lot of times, people don't realize how deadly acute kidney injury can be. It's a lethal problem that every hospital in the world faces upwards of 50% of ICU patients will have an acute kidney injury. And those that progressed to stage three, it can be very catastrophic. 300,000 people die every single year from AKI. And that's more than all these cancers breast breast, sorry, breast, prostate, colon and lung cancers combined. The economic toll is significant. Every time a patient has a stage three, renal failure, acute kidney injury for the hospital, it's 27 to 41,000 per literature, and the NIH has it pegged as a whole aggregate of $27 billion. And as a combat veteran myself, this next one is gets me one in four patients per a 1.6 million retrospective study at the VA found that patients that had acute kidney injury during their stay at a VA hospital had a one in four chance of one in four died. One of our mentors, investors and advisors and board members in the past Dr. Fred Moll stated perfectly when he first saw the technology, he saw that this is a way for us to elevate the standard of care that it's just lightyears ahead of what we do today and hospitals around the world. So what are we solving for? So this is the vital sign for the kidney, it's the last offline organ. Every organ is online, from the heart, lungs, everything. And this is the last one. And it's required, we're requiring a nurse to enter the room, hopefully every hour on the hour. And following the procedure that you see here where it's very manual and tedious. And in this world, it just doesn't exist. an ICU nurse has 125 tasks they have to do every single hour, this one task requires five minutes per hour per room, that's two hours per day, we have this down at Cedars to three minutes in a 24 hour period. So through the automation and workflow relief for the nurse, we've shown significant timing for where we are with a nursing crisis. The second thing is the limitations of the technology because of the technology that's 100 years old. And it's very little iterations. We have automated everything that you see on this screen. And in doing so we're already seeing reductions in catheter associated UTIs, which is a never event and other catastrophic events. But because we can address these things, it's also giving us a minute to minute feedback on what the kidneys producing. If you look at the other side of the equation, what goes into the patient is measured with absolute precision down to the milliliter. What comes out on the other side is a dirty bag that hangs from the bed. We've automated this. So what informs what goes into the patient is based on accuracy. And it's not based on hopefully when somebody was able to get in and check the vital signs. What we've done is we've cleared we've created a system that can actively cleared and sweep the line every couple of minutes. And this is giving us the high fidelity picture of what's happening with the kidney. And in doing so this takes weight off of the nurse and it powers the predictive capabilities that our technology has with providing what the kidney is producing. The second thing that we focused on as a company is intra abdominal pressure. Today it's a blackbox how much pressure is in the abdomen is usually done through a 20 minute procedure. And this 20 minute procedure takes in a requires a nurse to set up tubing sets and it's static one time pressure measurement. We have this now and approved by the FDA to provide a continuous stream of what's the intra abdominal pressure is inside the abdomen, which is at 100 hertz. So we're measuring 100 times per second, as truly and as truly automated as we possibly can. And the way that we do this is we placed a sensor on a Foley catheter. So the way that we discuss this when we're talking to clinicians are at the very top of the funnel. So as soon as a patient enters stage one AKI or their pressures inside their abdomen are abnormal, we are the very first technology to see this, we are inches from the kidney where the closest sensor, we are the very first thing at the top of the funnel before the patient starts spiraling down to provide that real time alert. Our technology is comprised of a couple of components, a smart sensing Foley catheter. And this is the the device I just showed you on the last screen. The accurate monitoring system, this is bedside and a companion tablet, this companion tablets used in cardiac surgery or transplant, or major major surgeries where underneath a sterile field is our Akron, that anesthesiologist and a perfusionist need access to this. And so they have this in their hands at the head of the table. In the ICU, this companion tablets with the infusion pumps, and this is primarily so it guides the infusion of what goes into the patient based on what's coming out. And then the AQI data is what we send to the EMR. It's where we're building all of our predictive capabilities and our algorithms. Alright, so today we are most of our businesses focused in cardiac surgery. And I'll give you an example of what we're competing against with the status quo, we rely on a lagging indicator one that will report to us whenever it comes back from the lab and somebody reviews it, and that's serum creatinine. It's blood value, and it shows the health of the kidney, there's two ways to diagnose acute kidney injury, urine output the function of the kidney, and serum creatinine, in this case, it can take 12 to 24 hours to find out that the kidneys even injured, what we're doing today is we pull this in hours in advance. So six hours in after the surgery we can see if a patient is is in acute kidney injury, stage one. And we've repeatedly shown in our clinical studies and also with our clinicians, that they're able to intervene much much earlier, because they have the data at their fingertips. And the primary driver of this is it's at eye level they receive as soon as a patient enters stage one Aki, they see this and this is what's enabling people like Dr. Outcome ra to intervene and prevent acute kidney injury. And Northwestern is an example. So today, the status quo is a highly manual variable procedure, where nurses are required to enter the room and do a vital sign every hour, and it just doesn't happen. We've automated this, we've brought the kidney online and we are reporting this to the clinicians. And in doing so, the FDA has agreed that the data that we provided from our 1200 Patient Registry, and that we can predict acute kidney injury per our initial data. And we are we were granted a breakthrough designation for this to be studied in a randomized controlled trial and taken to a 510 K pathway, or de novo based on predicting acute kidney injury. Last year, heading into LSI, we were just starting our clinical review of all of the work that we did in 2021. And what I said on stage last year was we're going to have some clinical studies to share with you this year. We have eight that have been published. We have 16 that are on the docket for this year. And the majority of these are cardiac focused their transplant focus, but they are investigator initiated, which are fantastic for a CEO that it's less of an industry focus, but it's also a validation that the clinicians are highly interested in what we're doing. And we're looking at everything from intra abdominal pressure, real time and being able to see this for the first time to the function of the kidney and the interactions with the aggregated vital signs to actually preventing, we believe catheter associated UTI because we're actively sweeping this line, and that's what we're continuing to put out. So 16 on the docket for this year, which is pretty exciting. We continue to grow our our procedures and were we closed out last year. We were we were closing out at 43,000. We're about to hit 50,000 and we're on an exponential path. Our monitor base in the US is about a little over 1000 ICU beds are covered and with between We now in the middle of this year, we'll have an additional 600 That that are on ICU beds, protecting the kidneys, and our total counts continue to grow. We're talking a good cross section of all types of accounts, large teaching facilities, DOD, VA, pediatrics, we're raising our series D. We're in the middle of it right now. So I look forward to having conversations with anybody that may be interested in this. And this is primarily to drive that commercial traction. That's, that's underway today. So thank you. Last thing is we have a world class team and a board of directors that are among the best in the industry. Thank you