Jon Hoem Presents Pacertool at LSI Europe '23

Transcription

Jon Hoem  0:05  
Thank you, Anthony. Pleasure to be here. I'm to present Pacertool to you today, we are developing a platform for position pacing. So this is patient specific selection for heart failure. Those of you that have been around, there are different approaches to heart failure, one of them are by ventricular pacemakers. It's been around from the mid 90s. Very successful technology and works in the majority of the patients. But it doesn't work in roughly 50% of the patients. So 50% of the patients will have a good response 25% will have a worsening of their heart function, and 25% will have a no change in the heart function. And that's what we want to change. If you look at the this is a little bit complex picture. But today, there are around 200,000 patients that are going on treated. In the class one indicated patients, they have a very good response rate around 70% response rate. And this converts to you know, a good outcome in these patients. However, in the class to indicate the patients, only 30% of the patients are being treated today. And 70% of the patients are going on treated. And the major reason for that is that the facility or the electrophysiologist don't know if the patients will get a response or not. So we believe that this market is potentially can grow from the current 200,000 patients to 400,000 patients worldwide. The system that we're developing consists of three major components. It's quite advanced, six French, two millimeter catheter with an electronic or optical pressure sensor, and five electrodes basically working like mimicking a pacemaker. This is a, this is a catheter that goes into the left ventricle sits in the mid portion of the left ventricle. It's connected to a single amplifier that is processing the data and can send signals back and forth from the catheter. And that's connected to a mainframe with a software and the secret sauce to measure this electromechanical biomarker, and it's an electromechanical biomarker. I'll talk more about that today. Down here you see how it looks today. The implantation lab for those that have been in the hospital is very simple. It's a patient is electrophysiologist is a CE arm, and the program that said, there are no guiding tools for these electrophysiologist. Country to an EP lab which looks like a spaceship. We believe that this is an underserved market. So the company overall perspective is that we want to know and own the implantation lab for these patients. This is a biomarker that we have worked on for love for a decade. It's quite intuitive actually. So from you have onset of EKG to maximum pressurize and left ventricle, that's an indication if that goes down. When you pace the heart, the patient, the heart will work better with a pacemaker. If that time from onset of QRS to maximum pressure it is increasing, then the heart cannot be resynchronize. So that's a direct and very, very specific and accurate biomarker that we'll use to differentiate these patients. So we have proof of principle data from 48. Class One indicated patients at the University Hospital in Oslo, Norway. And as you see here, in these 40 patients, even if they are class one indicated patients, these patients should really respond to a pacemaker. Six of the patients were clearly identify as being non responders, long term with with a high mortality with a very, very high accuracy. So what we see from our market research is that we need to have a market biomarker with a specificity that is higher than 70 Plus or 90%. The current approaches are higher than 70%. So we are functional actually secured in total, the company has raised 6 million US to get through our first five patients in our clinical trial that will commence shortly. On the patent side, we have a total of five patents timely is focusing both on the biomarker and the catheter itself. The competitive landscape is very interesting. seething up. For me, it's a validation that this is a really unmet medical need. Medtronic that recently published EKG belt study in a large randomized clinical trial 408 patients and failed miserably, P value of 0.26. And we believe that the reason for that is that you cannot understand the electromechanical activity of the heart by only looking at the electrical or the mechanical activity of the heart. So you need to combine those two, and that's what our biomarker is doing. Workflow wise, currently, this is really an underserved market. We will ask we think the most optimal way to treat these patients is to do the measurement directly in the implantation lab. So you will then provide the patients with heparin, get the catheter and the left ventricle measure the biomarker, reverse heparin when you made the decision on what kind of pacemaker the patient will get. And then, if you have a reduction in our biomarker, you will get a classical CRP. If it has a prolongation, the patient has a prolongation, then you can do conduction system pacing, a traditional ICD or other heart failure treatment options. And at the end, you can then still use the same technology to optimize lead position if you want to. So the overall market looks like this today. 200,000 patients 300 phase 4000 patients have an effect. What we want to do is to expand this market to 400,000 patients. The team is very solid, most of us based in Oslo, Norway. Hans Henrik has worked on the technology for the last decade. Ons Petr running the financial activity. But ammonia is heading the software team. It's the biggest part of the team, five people out of the time, doing a fantastic job on that. Mohamed just finished his PhD in this field, and is responsible for the quality system and for the Catholic development. And Vega is running our clinical activity and the signal amplifier development project. We have a solid scientific advisory board, we tried to balance it geography wise, both in the US and Europe. These are well known electrophysiologist that have been in the field and done many pivotal clinical trials and interacted with their day to get technologies to market. I'm very happy with this team. On the clinical side, we will in 40 days enter our first demand clinical trial. This is in class one and class two indicated patients. So in a way, it's an all comers study. So we'll enroll the patients. And so all the heart failure patients will get by ventricular pacemaker, so it will be a guideline selected patient cohort. So they will be standard of care. The only difference is that we will measure our biomarker at implantation. And we will follow them up to six months and look at the ejection fraction or ancestry volume at six months. And then we will basically reproduce the data that you saw in the proof of principle, but we'll get safety and efficacy data from the first demand study. When they look at the financing, in total, we have raised as I said 6 million, the last two and a half will bring us through the first in man clinical trial. And there are three pillars in the value creation number one, of course, getting the six month follow up data in up to 50 patients now, and that will allow us to complete the study and also prepare for design iterations both on the Katherine and the single amplifier. And then the next pillar is 510K clearance. And so we have already pre submission to FDA. FDA says that this is of heart and K on the catheter. And that will then move us into the pivotal clinical trial and with a new clinical indication if you want to. So the field electrophysiology, very active on the exit side there have been multiple large exits in this area of Medtronic both of Farah Boston Scientific, both Farapulse, it's a field that needs innovation. You see that from the lack of response for these pacemakers. And we think that we have an exit potential that is substantial inside a short timeframe. So thank you very much for your attention. Sorry, I went a little bit over time, but I would be happy to talk to you afterwards.