Video Transcription
Marcin Golebicki 00:01
So I'm the CEO of EP Solutions SA. This is a Swiss-based heart failure company. We are focusing on a significant issue, which is how to implant defibrillators properly. Can you imagine today when the patient is going for the defibrillation implant? So CRT, only 50% are successful. 50% are what is called non-responders, and we are solving this issue non-invasively. So if you look at the total heart failure patient population a year, it's about 18 million people. This is one of the biggest diseases, bigger than cancer, killing patients. 30% are treated with CRT, and with very experienced centers, 40% are non-responders. On average, if you look at emerging markets as well, it's 50% non-responders. The market is huge. We are talking four and a half billion, and only in the U.S., it's 1 billion a yearly cost of patients who are returning to be retreated or replaced with the system. We are having a very simple, non-invasive solution, which is not adding too much time to the procedure. And this is before the procedure and post-procedure. I will explain later on. So what is the patient path today? This is the ECGI, which we are producing with the map. Normally, the patient is coming about two weeks before the procedure for diagnostics; it's CT or MRI done, and the doctor is preparing for the CRT implant. On top of it, we are adding this system, which is called EP Solutions SA criteria, where we are putting together AI and machine learning with MRI or CT, along with our ECGI, and giving them an exact map of where they should place the lead. Because when you are sitting here, each of us has a different place, which is called the latest activation zone. It's patient-specific, and today, nobody can show us. Only we are able to show where to place the lead. This is the issue why we have so many non-responders. So let me show you how the doctor is looking at the preparation today. This is what he sees. This is what we are showing. The red is the latest activation zone; wherever the lead will be placed in the green area, this will work properly. So he will be a responder. Normally, in this particular case, without our marking, the doctor will go with this route because it's the easiest to get. This will be a non-responder. So he will be part of this 40% of patients who are not treatable with CRT, according to the present technology. We are showing the easiest route to get there. We have clinical evidence, which we published last year at HRS, and after our publication, which is not very typical for companies not having still FDA approval, we were quoted in U.S. cardiology guidelines as the technology which should be done before CRT implants. And this is significant, not only for us but for how the treatment should be done. If you look at our next generation, so on the last LSI, I promise you we will bring a faster, cheaper, and more effective technology. We did it. Guys, this is ready. We are preparing this for production. So this is the next generation. This is, as you can see, the amplifier is the size of two iPhones. The electrode is one size fits all. We wanted to have an easy system, which is easy from a hospital perspective and also from a distributor or direct sales perspective. So we have a front electrode and two back electrodes connecting all this information for us. We are very developed in terms of patents and publications, and the number of patients actually, including our latest study, we have 250 patients already, and this is key centers. So we are talking Karolinska, we are talking Oxford, King’s College, Cleveland, and Maastricht, Amsterdam. So if you look, it's the top cream of the cream. And they are believers. Actually, one of the professors from Cleveland Clinic told me, if you launch this technology in the U.S., nobody will pay for CRT anymore without doing this procedure before the implant. We are agnostic, so you can work on our technology with anybody who is producing CRT. I cannot disclose the full situation, but we have a clinical trial with Abbott which we finished. It will be published in November, December, with the big publication over HRS of 2025, and I can tell you, it's used a little bit differently than I show you here. It's used post-application, and look at the results. But what I'm hearing from PI and Abbott, they can improve how they can work with their algorithms based on our mapping system, which is quite interesting and will bring additional added value to our system. Our main goal is to grow CRT and to move this market in a different direction. And I tell you, I used to work for Saint Jude Medical, for Boston Scientific, and I was on the other side selling the product. And the biggest issue today, if you ask for sales representatives of any of these big multinationals which I showed there, they are not able to grow CRT because of the non-responders. This is what you will see from here, and this is why we focus on solving the issue. So we are at this stage in 2024. I show you we brought the next generation of the product. We are still working now on health economics evaluation for the U.S. market. The next year's goal is to bring the next generation with the FDA, MDR, and go commercial at the beginning of 2026. We did some investigation with distributors all over, both in the Middle East, Asia, Europe, and we discussed with some in the U.S. Everybody is excited. They are waiting for the next generation product to launch on the market. I can only share with you that so far, one of the multinational companies which is working for us is paying $2,500 for each patient for the data which we are providing. And the business model is the generator which you have seen. This is these three small containers which you are magnetically adding to the electrodes. The electrodes are single-use. This is multiple-use. And we are adding software with a laptop or iPad for the clinic. So this is how the system looks like. And we are raising now $14 million, which will bring us to the commercial stage. So FDA, MDR, next generation, fully produced and commercial launch, both in Europe and the United States. I have to tell you that we have already selected production partners, and they are in Belgium, Germany, and actually Portugal, so everything will be produced in Europe. Thank you so much, and I'm looking for investors in the coming days, so I'm available. Thank you. Thank you.
