Latest / Deep Tech Germany – AI, Robotics & Frontier Innovation by Startuprad.io™ / PRECISIS: Neurostimulation for Epilepsy — Karl Stoklosa
Transcript
- WEBVTT 00:00:05.117 --> 00:00:12.737 Welcome to StartupRed.io, your podcast and YouTube blog covering the German 00:00:12.737 --> 00:00:17.617 startup scene with news, interviews and live events. 00:00:13.040 --> 00:00:18.960 Music. 00:00:20.057 --> 00:00:25.177 Hello and welcome everybody. This is Joe from StartupRed.io coming to you, 00:00:25.457 --> 00:00:33.057 bringing you another awesome interview, this time from a healthcare startup based in Heidelberg. 00:00:33.177 --> 00:00:36.157 But first, I'd like to welcome Carl. Hey, how you doing? 00:00:36.857 --> 00:00:41.957 Great, great. Thank you so much for the invitation and for the opportunity to 00:00:41.957 --> 00:00:46.337 share the company and what we're doing at Precises. 00:00:46.837 --> 00:00:53.717 Appreciate it. Exactly. Talking about Precises, we'll soon get into this, but first, 00:00:53.977 --> 00:00:57.537 let's talk a little bit about you and the people who can see this, 00:00:57.697 --> 00:01:03.337 see that you are not in your 20s anymore, if I may be able to say that. 00:01:04.037 --> 00:01:08.017 Can you a little bit introduce yourself? What you've done before, 00:01:08.257 --> 00:01:11.317 including but not limited to, we talked before, 00:01:11.697 --> 00:01:17.217 staying in Singapore, doing a lot of medical stuff and even getting an MBA from 00:01:17.217 --> 00:01:19.717 the University of Chicago Booth School of Business. 00:01:20.384 --> 00:01:26.864 Yeah. So I've been in the medical device field for the last 20 plus years. 00:01:27.484 --> 00:01:34.544 And I actually started in the medical device just after completing my executive MBA with Booth. 00:01:35.064 --> 00:01:42.384 I was at the time based in Barcelona and that then transitioned me into medical device. 00:01:42.564 --> 00:01:49.304 And I spent time with Guidant back at the time, a very well-known cardiac rhythm management company. 00:01:49.304 --> 00:01:56.124 And did sales and field technical work, supporting implants in that, 00:01:56.264 --> 00:02:03.324 and then moved into marketing, but in the specialized area of upstream marketing. 00:02:03.464 --> 00:02:11.784 What that means is basically new product development and evaluation of new approaches 00:02:11.784 --> 00:02:18.404 to addressing disease. In this particular case, sudden cardiac death and heart failure. 00:02:19.524 --> 00:02:26.404 From there, I actually moved over to into St. 00:02:26.484 --> 00:02:31.884 Jude Medical and in that case moved at the time from the U.S. 00:02:32.164 --> 00:02:36.344 To Belgium, where I spent 11 years within St. 00:02:36.484 --> 00:02:41.824 Jude doing a variety of different roles in both marketing and commercial, 00:02:42.064 --> 00:02:45.584 everything and also in different divisions. 00:02:45.584 --> 00:02:50.024 So I spent time in the electrophysiology division, as well as cardiac rhythm 00:02:50.024 --> 00:02:52.604 management and neuromodulation. 00:02:53.424 --> 00:03:00.224 Most of those in commercialization of new products or products entering the market in Europe. 00:03:00.904 --> 00:03:06.244 And then with neuromodulation, a focus on the international side and not only 00:03:06.244 --> 00:03:11.364 marketing, but also then going into sales leadership and running sales for a 00:03:11.364 --> 00:03:12.964 period of time in Europe. 00:03:13.844 --> 00:03:20.804 For the entire division, but then migrating into a sales-specific role in DBS 00:03:20.804 --> 00:03:22.184 or deep brain stimulation. 00:03:23.444 --> 00:03:25.044 I then moved... 00:03:25.398 --> 00:03:29.718 St. Jude was acquired by Abbott, and I moved from there to Singapore, 00:03:29.738 --> 00:03:35.098 as you mentioned earlier, and spent three years as the regional marketing lead 00:03:35.098 --> 00:03:39.718 for cardiac rhythm management in Singapore and for the Asia-Pacific region. 00:03:39.718 --> 00:03:45.838 And then in 2021, moved over to the U.S. 00:03:45.958 --> 00:03:49.058 To take on a global role, global downstream marketing. 00:03:49.378 --> 00:03:55.658 So responsible for all commercialization of new and novel cardiac rhythm management products. 00:03:55.818 --> 00:04:00.858 That included new implantable cardiac monitors, as well as leadless pacemakers, 00:04:00.978 --> 00:04:03.378 both the single chamber and dual chamber leadless pacemakers, 00:04:03.578 --> 00:04:08.578 before joining Precisis this fall. So that's a little bit about my background. 00:04:09.718 --> 00:04:14.398 You have gotten around quite a bit. I've seen here Barcelona, 00:04:14.998 --> 00:04:21.258 Brussels, New Jersey, Singapore, and Austin, Texas. 00:04:21.458 --> 00:04:24.338 So did you always move around with your family? 00:04:24.818 --> 00:04:32.098 Yes. So from the very early stages, my wife and I decided we liked living and 00:04:32.098 --> 00:04:34.438 managing in different cultures. 00:04:34.438 --> 00:04:41.018 And so we we endeavor to find positions where where we could realize that from 00:04:41.018 --> 00:04:42.078 a professional standpoint, 00:04:42.078 --> 00:04:47.938 I find it very interesting to to manage the complexity of doing business in 00:04:47.938 --> 00:04:51.618 different cultures with different health reimbursement systems, 00:04:52.118 --> 00:04:54.098 different payer systems. 00:04:54.098 --> 00:05:01.618 And so that really keeps me engaged and interested and just the aspect of living 00:05:01.618 --> 00:05:04.898 and learning in different cultures and also raising the family. 00:05:05.350 --> 00:05:09.830 To have the experience of different cultures. And I have three sons, 00:05:10.010 --> 00:05:13.310 and two of them were born over the seas. One of them was born in the U.S. 00:05:14.250 --> 00:05:18.770 So, you know, a lot of international experience with them as well and exposure. 00:05:19.030 --> 00:05:21.170 Do they also speak French? Yeah. 00:05:22.430 --> 00:05:25.310 One of them speaks French. The other two actually speak Mandarin. 00:05:25.910 --> 00:05:27.190 Fei-Jang Hao. Very good. 00:05:27.830 --> 00:05:33.650 For me, I've also lived in many different places. and it's kind of like from 00:05:33.650 --> 00:05:37.850 every place I took some food with me from my time in China. 00:05:38.110 --> 00:05:41.670 I know it's not really Beijing food, but the big chicken plate, 00:05:41.830 --> 00:05:46.650 Dapanji, I took some food with me from a time in Spain, from a time in the US. 00:05:46.830 --> 00:05:51.530 Is it also the same stuff for you that you have certain dishes that remind you 00:05:51.530 --> 00:05:53.830 of certain places? Yeah, absolutely. 00:05:54.710 --> 00:05:59.690 You know, in Belgium, it's the traditional brasserie food that you get, 00:06:00.730 --> 00:06:07.250 mulfrit or waterzooie, very, very traditional Belgian dishes, which we truly love. 00:06:07.250 --> 00:06:12.210 And we have our favorite brasserie that we always go to in Brussels. 00:06:12.790 --> 00:06:18.490 In Singapore, it was chicken and rice. But because Singapore is also very multicultural 00:06:18.490 --> 00:06:22.130 and has a lot of other cuisines, 00:06:22.390 --> 00:06:31.150 we would also gravitate towards things like katsu curry, so Japanese katsu curry or even ramen, right? 00:06:31.150 --> 00:06:35.430 So and then, you know, recently in Austin, we like, of course, 00:06:35.550 --> 00:06:37.970 the barbecue in Austin is some of the best in the world. 00:06:38.270 --> 00:06:42.570 And so and we're living near a very famous barbecue restaurant. 00:06:43.710 --> 00:06:49.010 And and so that that is also something we really enjoy. But we we always are 00:06:49.010 --> 00:06:50.590 looking for that diversity in food. 00:06:50.730 --> 00:06:56.030 And it's a big part of it's a big part of why we like being in different cultures as well. 00:06:56.591 --> 00:07:03.051 We do have a lot of European executives, entrepreneurs, founders, 00:07:03.251 --> 00:07:06.131 co-founders, company owners here. 00:07:06.451 --> 00:07:13.691 How did Precises manage? I assume first they found you through a very highly paid headhunter. 00:07:13.911 --> 00:07:17.391 But how did they convince you to take over this job? 00:07:18.071 --> 00:07:22.271 Yeah, so I had been in discussions with them previously. 00:07:22.271 --> 00:07:25.591 And then there was about a year-long pause in the discussions. 00:07:25.591 --> 00:07:32.631 But they were moving Angela Liedler, who was the founding CEO of the organization, 00:07:32.831 --> 00:07:39.131 was looking to retire and still be involved, but in a different capacity. 00:07:39.351 --> 00:07:42.411 And she started to search for her successor. 00:07:42.871 --> 00:07:47.531 And we had continued to be in contact off and on. 00:07:47.651 --> 00:07:54.191 And we were reconnected and we decided to have a discussion around the opportunity. 00:07:54.191 --> 00:08:01.411 And then I had been following the the move from the the early phase development 00:08:01.411 --> 00:08:06.811 to the commercialization phase with a lot of interest on on social media and 00:08:06.811 --> 00:08:07.851 watching what they were doing. 00:08:07.991 --> 00:08:11.151 And and they they seem to be gaining some really good momentum. 00:08:11.511 --> 00:08:16.651 And also their their published clinical results and their future clinical results 00:08:16.651 --> 00:08:21.411 were really, really looking quite exciting. So that got me very interested. 00:08:21.871 --> 00:08:27.291 And then for me, it's it's what are we treating and is there a patient need? 00:08:27.831 --> 00:08:32.451 And because it really any therapy that I'm looking at, that's that's for me, 00:08:32.551 --> 00:08:34.771 first and foremost, and very important. 00:08:34.991 --> 00:08:38.431 I really feel that it's important to have an impact. 00:08:38.431 --> 00:08:43.991 And for me, what I'm doing tied to where the patient need is and what what the 00:08:43.991 --> 00:08:49.431 unmet need is and if we can address that need. We are addressing a real need 00:08:49.431 --> 00:08:53.331 in those patients who don't respond to drug therapy. 00:08:53.909 --> 00:09:02.169 And need an alternative to resection or other more interventional type procedures. 00:09:02.509 --> 00:09:09.709 Or that might end up on another drug regime instead of getting some sort of a stimulation. 00:09:10.169 --> 00:09:14.829 So that to me was really exciting about it. The technology was exciting. 00:09:15.069 --> 00:09:21.709 And then I also was meeting the other leaders in the organization, 00:09:21.709 --> 00:09:24.189 I think, and the team, right? 00:09:24.329 --> 00:09:27.769 So we have about 35 people across the team. And the team is, 00:09:27.889 --> 00:09:32.709 you know, everyone from scientists to engineers to salespeople. 00:09:32.709 --> 00:09:38.449 And we have a cumulative knowledge and medical device of over 250 years, right? 00:09:38.569 --> 00:09:45.649 So it's really deeply, it's deeply seated in great experience, 00:09:45.649 --> 00:09:51.589 and a lot of energy and the executive team, meeting them and making sure that 00:09:51.589 --> 00:09:55.589 there was a really good synergy between me and them was really important. 00:09:55.849 --> 00:10:04.849 And so it was very easy decision on my side to take this opportunity and run with it. I see. 00:10:05.029 --> 00:10:10.309 You've been already talking about stimulations. You've been already talking 00:10:10.309 --> 00:10:13.829 about somehow about the main idea. 00:10:13.969 --> 00:10:19.789 Can you tell us what the main product of Precises is and And what it is used for? 00:10:20.069 --> 00:10:27.029 So it's really the world's first minimally invasive brain pacemaker to treat 00:10:27.029 --> 00:10:32.469 what we call drug refractory epilepsy, focal epilepsy. 00:10:33.589 --> 00:10:39.689 And it's called the EASY system and it stands for the Epicranial Application 00:10:39.689 --> 00:10:42.829 of Stimulation Electrodes for Epilepsy. 00:10:43.009 --> 00:10:44.989 So that's the name EASY. 00:10:45.519 --> 00:10:54.719 And the name is great because it really pays homage to how they've approached this. 00:10:54.919 --> 00:11:00.679 It's a minimally invasive procedure relative to other procedures that would 00:11:00.679 --> 00:11:03.739 be used to treat this type of indication. 00:11:03.739 --> 00:11:09.119 And it's using novel stimulation 00:11:09.119 --> 00:11:18.099 forms or waveforms to treat or what we call reduce the excitation or the excitement 00:11:18.099 --> 00:11:24.459 of the different areas in the brain that can cause focal epilepsy. 00:11:24.739 --> 00:11:29.799 So that's really at the core what it's about. And the technology is twofold. 00:11:29.959 --> 00:11:34.719 One, it's the electrodes. So we have an electrode, what we call an electrode array. 00:11:34.939 --> 00:11:43.159 And that's a series of five electrodes in about a five centimeter ring. 00:11:43.359 --> 00:11:49.879 And those electrodes allow for a very unique stimulation pattern. 00:11:50.099 --> 00:11:55.219 And actually, we can modulate those two different stimulation patterns. 00:11:55.259 --> 00:11:59.339 And that's where the treatment comes in. And then the control of that, 00:11:59.479 --> 00:12:03.199 the other expertise and area that we have is around the control. 00:12:03.459 --> 00:12:08.319 So the device, so the device that goes into the patient that's connected to 00:12:08.319 --> 00:12:13.779 the lead has very specialized controls to be able to do these different stimulation modes. 00:12:13.959 --> 00:12:19.019 So that's a little bit on the technical aspect behind the product. 00:12:20.299 --> 00:12:25.159 I had to smile when you started out talking about what the product is for because 00:12:25.159 --> 00:12:30.079 for everybody without a medical background, you could have said blah, 00:12:30.179 --> 00:12:33.359 blah, shabla, blah, ding, dong. It would have had the same effect. 00:12:34.319 --> 00:12:42.279 So basically, we're talking about avoiding epilepsy here. What do you talk about or minimizing? 00:12:42.819 --> 00:12:49.119 Minimizing. So we're not curative in a sense. what we're doing is we're reducing 00:12:49.119 --> 00:12:54.079 the excitation of these focal areas, so the excitement. 00:12:54.399 --> 00:13:01.359 And by that, we can reduce the number of seizures that a patient may have that 00:13:01.359 --> 00:13:03.519 is suffering from focal epilepsy. 00:13:04.759 --> 00:13:13.219 We have some patients who are 100% seizure-free, but that is not the primary aim. 00:13:13.219 --> 00:13:20.479 The primary aim is to reduce by 50% or more from what we call a baseline. 00:13:20.859 --> 00:13:26.139 So they take a baseline of their seizures per month. And we want to see a reduction 00:13:26.139 --> 00:13:31.819 of that greater 50% or greater to say that this therapy is effective. 00:13:32.239 --> 00:13:37.739 And so we see that in our clinical results today. 00:13:38.642 --> 00:13:45.482 Many people out there will have never seen a seizure in real life. 00:13:45.582 --> 00:13:50.282 So it can be basically something that people just break down to really cramping. 00:13:50.402 --> 00:13:55.462 And it's not like you have a cramp in your leg and you just walk it off, 00:13:55.642 --> 00:13:57.182 you know, some motrin and walk it off. 00:13:57.602 --> 00:14:02.042 That just doesn't work. You can use completely control of your body. 00:14:02.142 --> 00:14:06.102 It can be very dangerous. For example, if you're handling just simply in the 00:14:06.102 --> 00:14:09.862 kitchen with a knife, if you're walking up or downstairs, If you're operating 00:14:09.862 --> 00:14:13.102 machinery, if you're driving a car, something like that. 00:14:13.262 --> 00:14:16.982 So it has a massive impact on your life. 00:14:17.282 --> 00:14:22.162 And when you talked about a resection, that is basically when some neurosurgeons 00:14:22.162 --> 00:14:27.122 take out like a little piece of the brain in some areas that is possible. 00:14:27.182 --> 00:14:30.622 And that can cure those seizures. 00:14:31.142 --> 00:14:36.882 And for some. Yeah, it can. It can be a cure. I mean, I don't think it's 100% 00:14:36.882 --> 00:14:40.022 in most cases, but it can be more of a cure. 00:14:40.202 --> 00:14:47.082 But of course, you can have side effects from any time you're opening the cranium 00:14:47.082 --> 00:14:54.042 or the skull and causing damage to or removing tissue can have other side effects as well. 00:14:54.902 --> 00:15:00.542 I was once talking to a neurosurgeon, and he said basically it's a surgery, 00:15:00.782 --> 00:15:03.302 but the effect is similar. 00:15:03.762 --> 00:15:09.322 Every neurosurgery is almost similar to have a heavy traffic accident. Yes. 00:15:10.342 --> 00:15:16.142 Most of those what you're speaking about is any procedure that requires opening 00:15:16.142 --> 00:15:18.402 the skull. So we call it craniotomy. 00:15:18.862 --> 00:15:23.922 Our device actually goes just below the skin, below the dermis. 00:15:24.042 --> 00:15:26.122 On the surface of the skull. 00:15:26.362 --> 00:15:30.762 So it's actually not going into the brain area. 00:15:30.762 --> 00:15:37.702 We are able with our, our unique technology and our algorithms to transmit the 00:15:37.702 --> 00:15:42.422 signals or the stimulation through the skull tissue, through the skull, 00:15:42.742 --> 00:15:46.662 through the bone and, and modulate the brain in that way. 00:15:46.722 --> 00:15:51.102 So we don't need, that's why in some ways it's, it's nice. 00:15:51.302 --> 00:15:55.582 The name is easy. It is, it is an easier procedure in the sense that you're 00:15:55.582 --> 00:15:58.742 not opening the skull in order to place the device. 00:16:00.002 --> 00:16:06.082 Um when we talked before you had some numbers about how many people do have 00:16:06.082 --> 00:16:12.742 epilepsy across the world what we look at is the in the total population so 00:16:12.742 --> 00:16:16.542 global population about one percent of of, 00:16:17.658 --> 00:16:24.958 the global population suffers from epilepsy and of that 30 percent of those. 00:16:28.058 --> 00:16:31.678 Are drug resistant and of 00:16:31.678 --> 00:16:35.738 those drug resistant patients 70 percent 00:16:35.738 --> 00:16:42.838 of those could be candidates for a product like easy could be candidates for 00:16:42.838 --> 00:16:52.018 easy drug resistance here means usually get some drugs and the epilepsy is much 00:16:52.018 --> 00:16:54.058 less worse or completely stops. 00:16:54.358 --> 00:16:59.598 And there are some forms of epilepsy where this simply doesn't work. 00:16:59.718 --> 00:17:00.938 It doesn't show any effect. 00:17:01.218 --> 00:17:07.158 Yeah. So in some cases, and when we say drug resistant or drug refractory, 00:17:07.278 --> 00:17:11.798 we mean they're resistant or refractory to two or more drugs. 00:17:11.898 --> 00:17:17.598 So that's what we consider to be drug resistant. 00:17:18.358 --> 00:17:24.538 And the likelihood that a third or a fourth or a fifth drug makes a significant 00:17:24.538 --> 00:17:29.478 improvement, it can make an improvement, but it doesn't make the same level of improvement. 00:17:29.478 --> 00:17:34.518 And what we would say over time is that we have an opportunity with our system 00:17:34.518 --> 00:17:42.358 to potentially give an alternative option before or potentially before trying 00:17:42.358 --> 00:17:48.458 other types of medication with those additional side effects and so on and so forth. 00:17:48.638 --> 00:17:53.318 So our real area of focus is the drug resistant population. 00:17:53.758 --> 00:18:02.638 But today what we say is, you know, we think that around that big level of population 00:18:02.638 --> 00:18:05.558 that around 70% of them are candidates today. 00:18:06.702 --> 00:18:14.422 I see. And then what you get is basically a cut in the skin on your skull and 00:18:14.422 --> 00:18:18.682 the implementation of your, let's call it a little machine. 00:18:19.542 --> 00:18:28.002 How big is it? So the system consists of the electrode array, 00:18:28.262 --> 00:18:32.022 and that's the electrode array, so you can see the size. 00:18:32.442 --> 00:18:37.542 And that's what goes, and it's great that I don't have much hair, so you can see it. 00:18:37.802 --> 00:18:43.702 There's an incision in the skin, and then up against the skull, 00:18:43.702 --> 00:18:46.742 you place the lead over the focal area. 00:18:46.742 --> 00:18:57.062 And then the wire is tunneled down into a location in the, depending on the 00:18:57.062 --> 00:19:01.482 side of the left or the right in the clavicular area, the clavicle. 00:19:01.862 --> 00:19:07.962 And the, what we call the pulse generator, and this is the pulse generator, 00:19:08.322 --> 00:19:14.682 is then inserted with the lead and then inserted into what we call a pocket. 00:19:14.682 --> 00:19:17.962 A pocket is made and that's inserted similar to a pacemaker. 00:19:19.198 --> 00:19:23.138 And that's how that's how the implant is done. And and again, 00:19:23.378 --> 00:19:29.258 this is a very common procedure, this tunneling and placement of the of the pulse generator. 00:19:29.498 --> 00:19:35.358 That's very similar to a pacemaker or even a deep brain stimulation device. 00:19:35.938 --> 00:19:39.458 And the electrode, like I said, is is is very simple. 00:19:39.618 --> 00:19:46.078 It's simply an incision. And the beauty of our system is that when or if, 00:19:46.278 --> 00:19:49.958 for example, there is no effect, if it doesn't have an impact, 00:19:50.158 --> 00:19:55.438 the entire system can be removed and you are left with the scars, 00:19:55.438 --> 00:20:00.838 but you don't have any hardware or any hardware left behind. 00:20:01.038 --> 00:20:07.978 That's not the case with other solutions or alternatives for treatment of focal 00:20:07.978 --> 00:20:10.398 epilepsy, drug resistant focal epilepsy. 00:20:10.398 --> 00:20:16.158 Since a lot of people will also listen to this, so the electrodes have fit in 00:20:16.158 --> 00:20:20.418 the palm of your hand, and they're very flat. They're very, very flat. 00:20:21.158 --> 00:20:26.058 I think they're probably a millimeter, two millimeters in thickness at the most. 00:20:27.818 --> 00:20:35.138 I see. And this is implemented and with the special technology stimulates a 00:20:35.138 --> 00:20:37.878 certain area, like a focal area, you called it, 00:20:38.298 --> 00:20:46.758 in the brain that then helps to reduce or maybe in the future to eliminate those seizures. 00:20:47.338 --> 00:20:56.678 Yeah, so it will stimulate to – the goal is to have a reduction versus baseline of greater than 50%. 00:20:56.678 --> 00:21:02.638 And as I mentioned, there are patients who do have a very, very high level of 00:21:02.638 --> 00:21:06.998 response and go to what we call seizure-free with the therapy. 00:21:07.018 --> 00:21:09.678 But that is not the aim. 00:21:09.858 --> 00:21:17.938 The aim is to have a significant reduction of 50% or greater in the seizures versus the baseline. 00:21:19.657 --> 00:21:24.237 Because for the people, that massively improves their life, the life quality. 00:21:24.777 --> 00:21:30.997 Exactly. And that's what we see, right? You mentioned there earlier, 00:21:31.237 --> 00:21:38.897 when you have these unpredictable episodes, it can be at a very bad time. 00:21:39.057 --> 00:21:42.557 It can be when you're walking down the stairs, when you're driving, 00:21:42.557 --> 00:21:47.357 or if you were trying to do something where you could injure yourself. 00:21:47.357 --> 00:21:53.857 Um, and it, so it, it really puts the patient in a, in a, in a position of being 00:21:53.857 --> 00:22:00.597 more isolated and, and with this type of therapy, you're, you're able to, um. 00:22:02.097 --> 00:22:07.937 You know, having fewer seizures, having fewer, uh, uh, effects get out and, 00:22:08.017 --> 00:22:12.237 and become part of society again in a way that you weren't before. 00:22:12.237 --> 00:22:21.697 The other thing is the device also has the ability for the patient to actually, 00:22:21.717 --> 00:22:24.017 if they're feeling, and some patients can do, 00:22:24.177 --> 00:22:29.517 they have this, there's an aura or some sort of a feeling prior to an epileptic episode. 00:22:29.517 --> 00:22:36.477 They can actually trigger what we call a bolus or an additional stimulation 00:22:36.477 --> 00:22:45.097 to try and cut the onset of that episode as well. 00:22:45.397 --> 00:22:56.677 So there's the automaticity and then there's the manual aspect of patient-initiated therapy as well. 00:22:57.437 --> 00:23:05.317 So many people who do have, for quite some time, epilepsy, they can feel what you call the aura, 00:23:05.757 --> 00:23:10.477 an upcoming seizure, and that's when they can stimulate in order to minimize 00:23:10.477 --> 00:23:13.037 it or to avoid it completely. Yeah. 00:23:13.477 --> 00:23:15.897 Another important thing is... 00:23:17.109 --> 00:23:23.489 This is all what we call subthreshold. So the patient actually doesn't feel the therapy at all. 00:23:24.249 --> 00:23:27.969 The only time they would feel the stimulation is after the surgery, 00:23:28.189 --> 00:23:30.429 one month after we do the initial programming. 00:23:30.929 --> 00:23:37.389 And we move the stimulation to an area where they can sense it or feel it, 00:23:37.489 --> 00:23:41.009 but then it's reduced to what we call subthreshold. 00:23:41.249 --> 00:23:50.069 And so they can't feel it at all. And so it's a completely transparent therapy in that way. 00:23:50.749 --> 00:23:52.389 You can't feel it at all. 00:23:53.129 --> 00:23:58.729 So that's also beneficial. You're not feeling a stimulation or a side effect from that. 00:23:59.529 --> 00:24:04.729 And we're really proud also of the design of this lead too, because one thing 00:24:04.729 --> 00:24:09.609 in particular for patients who have suffered from epilepsy is they may need 00:24:09.609 --> 00:24:11.689 brain scans or MRIs in the future. 00:24:11.689 --> 00:24:17.089 And this device is actually opaque in an MRI field 1.5 or 3T, 00:24:17.329 --> 00:24:25.069 you can't actually see any echo or effect in the MR scan. 00:24:25.269 --> 00:24:30.489 So it allows still for freedom for the patient to get those scans and for the 00:24:30.489 --> 00:24:33.129 physicians to use it as a diagnostic tool. 00:24:33.929 --> 00:24:36.669 It doesn't hinder future diagnostics. 00:24:37.969 --> 00:24:40.849 I see. um we've been 00:24:40.849 --> 00:24:44.029 talking about the device we've talked about the patients um 00:24:44.029 --> 00:24:47.089 actually you told me the first human clinical 00:24:47.089 --> 00:24:50.649 tries started in 2021 and you 00:24:50.649 --> 00:24:56.389 have european market approval gotten in 2022 and can you take this from there 00:24:56.389 --> 00:25:04.009 our commercial activity really kicked off uh fully in 2024 and we've been focused 00:25:04.009 --> 00:25:09.629 on our german austria switzerland markets and then And recently, 00:25:10.009 --> 00:25:17.409 halfway through last year, we we we entered a tender in the UK and are on the 00:25:17.409 --> 00:25:23.709 procurement list for for a centralized procurement list for the UK. 00:25:23.709 --> 00:25:28.709 And we'll be doing our first patients in the UK here before the end of the year. 00:25:28.849 --> 00:25:30.209 So that's really exciting. 00:25:30.449 --> 00:25:35.129 And then we also recently this fall, we started up in Portugal. 00:25:35.129 --> 00:25:36.929 That's our first distributor market. 00:25:37.569 --> 00:25:42.109 And we've done two patients there already in Portugal. 00:25:42.629 --> 00:25:46.049 But the majority of the patients are in Germany today. 00:25:47.329 --> 00:25:53.529 And that has been really ramping very nicely in key centers across Germany. 00:25:53.809 --> 00:25:57.849 I see. And what is kind of the outlook? What are you looking for? 00:25:58.029 --> 00:26:02.889 Everybody who has an understanding or key, you're based in Heidelberg. 00:26:02.889 --> 00:26:07.569 You have approval in Germany. You are an American. 00:26:07.829 --> 00:26:11.749 You work with American companies in the future. I think I could see the next step. 00:26:12.276 --> 00:26:15.336 So there's a couple of things I would add. 00:26:15.456 --> 00:26:21.796 We're very committed to expanding the science and the evidence around our products. 00:26:21.996 --> 00:26:27.996 We've initiated four different clinical projects in Europe. 00:26:27.996 --> 00:26:33.636 There are three ongoing registries. One of them is a post-market registry for 00:26:33.636 --> 00:26:37.996 our continued MDR or CE mark approval, 00:26:38.216 --> 00:26:43.076 and plus two physician-sponsored registries that are ongoing. 00:26:43.556 --> 00:26:52.256 And then we have initiated what we call an indication expansion clinical trial here in Europe. 00:26:52.356 --> 00:27:00.516 It's called Easy4U. And that study is to expand the indication from adults to 00:27:00.516 --> 00:27:04.016 teenagers, so from 12 upward. 00:27:04.416 --> 00:27:08.116 And that study is already halfway through its enrollment, 00:27:08.116 --> 00:27:13.696 and we're looking forward to the completion of that trial and being able to 00:27:13.696 --> 00:27:19.856 serve that adolescent population in the near future. 00:27:19.856 --> 00:27:27.936 Now, the biggest focus is obviously the United States from an entry standpoint. 00:27:27.936 --> 00:27:32.036 And we have a breakthrough, what we call breakthrough designation with the FDA. 00:27:32.296 --> 00:27:38.336 So we're working with them to submit our proposed what we call IDE trial, 00:27:38.516 --> 00:27:42.176 clinical trial for evaluation in the U.S. 00:27:42.396 --> 00:27:49.916 To determine, to then be able to submit for approval for use in the United States. 00:27:49.956 --> 00:27:55.596 So that trial will be our first randomized control clinical trial. 00:27:56.056 --> 00:28:00.856 And that's really exciting. So we're working on the final development of that 00:28:00.856 --> 00:28:07.216 trial and look forward to submitting that and executing that in the next year, year and a half. 00:28:08.376 --> 00:28:13.276 Especially teenagers. This has to be very important because it can be a complete... 00:28:14.112 --> 00:28:20.852 End-of-life scenario for a teenager if he or she is not invited to party and 00:28:20.852 --> 00:28:28.292 having seizures massively limits their social life and their circle of friends. 00:28:28.492 --> 00:28:33.832 I do believe that that also has a massive impact on their quality of life. It sure does. 00:28:34.072 --> 00:28:41.092 And I mean, this is a population, It's heartbreaking to see patients suffering 00:28:41.092 --> 00:28:48.512 at an early age and anything we can do to support options or choices for earlier treatment, 00:28:48.512 --> 00:28:50.792 all the better. 00:28:51.132 --> 00:28:57.672 And that's why we're doing this indication expansion trial in Europe. 00:28:57.972 --> 00:29:05.192 It's a very important underserved or unmet market at this point or need from patients. 00:29:06.052 --> 00:29:13.312 So I can already tell you have a lot of big plans going forward, especially the U.S. 00:29:13.592 --> 00:29:19.052 Increasing indications, because in my mind, there would be two important things 00:29:19.052 --> 00:29:20.252 you would need to go ahead. 00:29:20.752 --> 00:29:23.692 First, talent and second, funds. Yeah. 00:29:24.512 --> 00:29:27.692 Yeah. So we're building out the teams, right? 00:29:27.952 --> 00:29:33.632 We've expanded our team in Europe as far as sales go. We're also working to 00:29:33.632 --> 00:29:35.712 expand to other markets in Europe. 00:29:36.159 --> 00:29:42.159 We're doing that in a very thoughtful way to make sure that we're balancing 00:29:42.159 --> 00:29:47.679 supporting the existing markets, but also able to support those new market entries 00:29:47.679 --> 00:29:49.419 in a safe and meaningful way. 00:29:49.919 --> 00:29:55.339 We will work with distributors in certain markets and consider other markets to go direct. 00:29:55.559 --> 00:29:59.059 So that's work that's ongoing to expand that expertise. 00:29:59.059 --> 00:30:03.999 We have a very strong chief commercial officer in Pedro Marquez, 00:30:04.239 --> 00:30:08.079 and we have on the technology side, we have Michael Tittelbach, 00:30:08.139 --> 00:30:16.399 who's been leading for the last eight years the R&D efforts for Precisis. 00:30:16.399 --> 00:30:24.219 So, yeah, a lot of a lot of investments in in talent from also from the engineering 00:30:24.219 --> 00:30:29.659 side and the medical side and will continue to grow, grow that. 00:30:29.879 --> 00:30:38.319 I think the other the other aspects to support funding the ongoing ongoing business 00:30:38.319 --> 00:30:42.579 is going to come partially from our commercial activities, from our revenue generation. 00:30:42.579 --> 00:30:47.999 But of course, we need further investment for the big plans that we have, right? 00:30:48.159 --> 00:30:57.599 So we are looking at private alternatives as well as angel investors and VCs 00:30:57.599 --> 00:31:00.979 and different corporate partners. 00:31:01.159 --> 00:31:08.979 So we have a very strong corporate partner with Cochlear, and they are a supporter of ours. 00:31:09.859 --> 00:31:17.019 But we're looking for future investment to help us fund the next stage of our growth. I see. 00:31:19.139 --> 00:31:24.839 So only thing actually left for me to say is good luck with your endeavors. 00:31:25.079 --> 00:31:28.619 Thank you. All the investors who'd like to reach out to you down here in the 00:31:28.619 --> 00:31:33.319 show notes, we link your LinkedIn profile as well as everybody who's interested 00:31:33.319 --> 00:31:35.079 in joining you on your journey. 00:31:35.119 --> 00:31:38.199 We'll also link your career website, okay? Wonderful. 00:31:38.979 --> 00:31:41.939 It's great to talk to you. Thank you so much for the time. 00:31:42.619 --> 00:31:47.759 Totally my pleasure. So the only thing left for me is wishing you a very nice 00:31:47.759 --> 00:31:48.939 Halloween in Heidelberg. 00:31:50.159 --> 00:31:55.719 Yes. And hope to have you back with some future successful announcements. 00:31:56.059 --> 00:31:58.219 That would be great. Thank you so much. 00:31:58.799 --> 00:32:00.899 Thank you. Have a good day. Bye-bye. Bye-bye. 00:32:06.299 --> 00:32:15.479 That's all, folks. Find more news, streams, events, and interviews at www.startuprad.io. 00:32:15.779 --> 00:32:17.979 Remember, sharing is caring. 00:32:18.800 --> 00:32:31.509 Music.