Welcome to StartupRed.io, your podcast and YouTube blog covering the German startup scene with news, interviews and live events. Music. Hello and welcome everybody. This is Joe from StartupRed.io coming to you, bringing you another awesome interview, this time from a healthcare startup based in Heidelberg. But first, I'd like to welcome Carl. Hey, how you doing? Great, great. Thank you so much for the invitation and for the opportunity to share the company and what we're doing at Precises.
Appreciate it. Exactly. Talking about Precises, we'll soon get into this, but first, let's talk a little bit about you and the people who can see this, see that you are not in your 20s anymore, if I may be able to say that. Can you a little bit introduce yourself? What you've done before, including but not limited to, we talked before, staying in Singapore, doing a lot of medical stuff and even getting an MBA from the University of Chicago Booth School of Business.
Yeah. So I've been in the medical device field for the last 20 plus years. And I actually started in the medical device just after completing my executive MBA with Booth. I was at the time based in Barcelona and that then transitioned me into medical device. And I spent time with Guidant back at the time, a very well-known cardiac rhythm management company.
And did sales and field technical work, supporting implants in that, and then moved into marketing, but in the specialized area of upstream marketing. What that means is basically new product development and evaluation of new approaches to addressing disease. In this particular case, sudden cardiac death and heart failure. From there, I actually moved over to into St. Jude Medical and in that case moved at the time from the U.S.
To Belgium, where I spent 11 years within St. Jude doing a variety of different roles in both marketing and commercial, everything and also in different divisions. So I spent time in the electrophysiology division, as well as cardiac rhythm management and neuromodulation. Most of those in commercialization of new products or products entering the market in Europe.
And then with neuromodulation, a focus on the international side and not only marketing, but also then going into sales leadership and running sales for a period of time in Europe. For the entire division, but then migrating into a sales-specific role in DBS or deep brain stimulation. I then moved...
St. Jude was acquired by Abbott, and I moved from there to Singapore, as you mentioned earlier, and spent three years as the regional marketing lead for cardiac rhythm management in Singapore and for the Asia-Pacific region. And then in 2021, moved over to the U.S. To take on a global role, global downstream marketing. So responsible for all commercialization of new and novel cardiac rhythm management products.
That included new implantable cardiac monitors, as well as leadless pacemakers, both the single chamber and dual chamber leadless pacemakers, before joining Precisis this fall. So that's a little bit about my background. You have gotten around quite a bit. I've seen here Barcelona, Brussels, New Jersey, Singapore, and Austin, Texas. So did you always move around with your family? Yes. So from the very early stages, my wife and I decided we liked living and managing in different cultures.
And so we we endeavor to find positions where where we could realize that from a professional standpoint, I find it very interesting to to manage the complexity of doing business in different cultures with different health reimbursement systems, different payer systems. And so that really keeps me engaged and interested and just the aspect of living and learning in different cultures and also raising the family. To have the experience of different cultures. And I have three sons,
and two of them were born over the seas. One of them was born in the U.S. So, you know, a lot of international experience with them as well and exposure. Do they also speak French? Yeah. One of them speaks French. The other two actually speak Mandarin. Fei-Jang Hao. Very good. For me, I've also lived in many different places. and it's kind of like from every place I took some food with me from my time in China.
I know it's not really Beijing food, but the big chicken plate, Dapanji, I took some food with me from a time in Spain, from a time in the US. Is it also the same stuff for you that you have certain dishes that remind you of certain places? Yeah, absolutely. You know, in Belgium, it's the traditional brasserie food that you get, mulfrit or waterzooie, very, very traditional Belgian dishes, which we truly love. And we have our favorite brasserie that we always go to in Brussels.
In Singapore, it was chicken and rice. But because Singapore is also very multicultural and has a lot of other cuisines, we would also gravitate towards things like katsu curry, so Japanese katsu curry or even ramen, right? So and then, you know, recently in Austin, we like, of course, the barbecue in Austin is some of the best in the world. And so and we're living near a very famous barbecue restaurant.
And and so that that is also something we really enjoy. But we we always are looking for that diversity in food. And it's a big part of it's a big part of why we like being in different cultures as well. We do have a lot of European executives, entrepreneurs, founders, co-founders, company owners here. How did Precises manage? I assume first they found you through a very highly paid headhunter. But how did they convince you to take over this job?
Yeah, so I had been in discussions with them previously. And then there was about a year-long pause in the discussions. But they were moving Angela Liedler, who was the founding CEO of the organization, was looking to retire and still be involved, but in a different capacity. And she started to search for her successor. And we had continued to be in contact off and on. And we were reconnected and we decided to have a discussion around the opportunity.
And then I had been following the the move from the the early phase development to the commercialization phase with a lot of interest on on social media and watching what they were doing. And and they they seem to be gaining some really good momentum. And also their their published clinical results and their future clinical results were really, really looking quite exciting. So that got me very interested. And then for me, it's it's what are we treating and is there a patient need?
And because it really any therapy that I'm looking at, that's that's for me, first and foremost, and very important. I really feel that it's important to have an impact. And for me, what I'm doing tied to where the patient need is and what what the unmet need is and if we can address that need. We are addressing a real need in those patients who don't respond to drug therapy. And need an alternative to resection or other more interventional type procedures.
Or that might end up on another drug regime instead of getting some sort of a stimulation. So that to me was really exciting about it. The technology was exciting. And then I also was meeting the other leaders in the organization, I think, and the team, right? So we have about 35 people across the team. And the team is, you know, everyone from scientists to engineers to salespeople. And we have a cumulative knowledge and medical device of over 250 years, right?
So it's really deeply, it's deeply seated in great experience, and a lot of energy and the executive team, meeting them and making sure that there was a really good synergy between me and them was really important. And so it was very easy decision on my side to take this opportunity and run with it. I see. You've been already talking about stimulations. You've been already talking about somehow about the main idea. Can you tell us what the main product of Precises is and And what it is used for?
So it's really the world's first minimally invasive brain pacemaker to treat what we call drug refractory epilepsy, focal epilepsy. And it's called the EASY system and it stands for the Epicranial Application of Stimulation Electrodes for Epilepsy. So that's the name EASY. And the name is great because it really pays homage to how they've approached this. It's a minimally invasive procedure relative to other procedures that would be used to treat this type of indication.
And it's using novel stimulation forms or waveforms to treat or what we call reduce the excitation or the excitement of the different areas in the brain that can cause focal epilepsy. So that's really at the core what it's about. And the technology is twofold. One, it's the electrodes. So we have an electrode, what we call an electrode array. And that's a series of five electrodes in about a five centimeter ring. And those electrodes allow for a very unique stimulation pattern.
And actually, we can modulate those two different stimulation patterns. And that's where the treatment comes in. And then the control of that, the other expertise and area that we have is around the control. So the device, so the device that goes into the patient that's connected to the lead has very specialized controls to be able to do these different stimulation modes. So that's a little bit on the technical aspect behind the product.
I had to smile when you started out talking about what the product is for because for everybody without a medical background, you could have said blah, blah, shabla, blah, ding, dong. It would have had the same effect. So basically, we're talking about avoiding epilepsy here. What do you talk about or minimizing? Minimizing. So we're not curative in a sense. what we're doing is we're reducing the excitation of these focal areas, so the excitement.
And by that, we can reduce the number of seizures that a patient may have that is suffering from focal epilepsy. We have some patients who are 100% seizure-free, but that is not the primary aim. The primary aim is to reduce by 50% or more from what we call a baseline. So they take a baseline of their seizures per month. And we want to see a reduction of that greater 50% or greater to say that this therapy is effective. And so we see that in our clinical results today.
Many people out there will have never seen a seizure in real life. So it can be basically something that people just break down to really cramping. And it's not like you have a cramp in your leg and you just walk it off, you know, some motrin and walk it off. That just doesn't work. You can use completely control of your body.
It can be very dangerous. For example, if you're handling just simply in the kitchen with a knife, if you're walking up or downstairs, If you're operating machinery, if you're driving a car, something like that. So it has a massive impact on your life. And when you talked about a resection, that is basically when some neurosurgeons take out like a little piece of the brain in some areas that is possible. And that can cure those seizures.
And for some. Yeah, it can. It can be a cure. I mean, I don't think it's 100% in most cases, but it can be more of a cure. But of course, you can have side effects from any time you're opening the cranium or the skull and causing damage to or removing tissue can have other side effects as well. I was once talking to a neurosurgeon, and he said basically it's a surgery, but the effect is similar. Every neurosurgery is almost similar to have a heavy traffic accident. Yes.
Most of those what you're speaking about is any procedure that requires opening the skull. So we call it craniotomy. Our device actually goes just below the skin, below the dermis. On the surface of the skull. So it's actually not going into the brain area. We are able with our, our unique technology and our algorithms to transmit the signals or the stimulation through the skull tissue, through the skull, through the bone and, and modulate the brain in that way.
So we don't need, that's why in some ways it's, it's nice. The name is easy. It is, it is an easier procedure in the sense that you're not opening the skull in order to place the device. Um when we talked before you had some numbers about how many people do have epilepsy across the world what we look at is the in the total population so global population about one percent of of, the global population suffers from epilepsy and of that 30 percent of those.
Are drug resistant and of those drug resistant patients 70 percent of those could be candidates for a product like easy could be candidates for easy drug resistance here means usually get some drugs and the epilepsy is much less worse or completely stops. And there are some forms of epilepsy where this simply doesn't work. It doesn't show any effect. Yeah. So in some cases, and when we say drug resistant or drug refractory, we mean they're resistant or refractory to two or more drugs.
So that's what we consider to be drug resistant. And the likelihood that a third or a fourth or a fifth drug makes a significant improvement, it can make an improvement, but it doesn't make the same level of improvement. And what we would say over time is that we have an opportunity with our system to potentially give an alternative option before or potentially before trying other types of medication with those additional side effects and so on and so forth.
So our real area of focus is the drug resistant population. But today what we say is, you know, we think that around that big level of population that around 70% of them are candidates today. I see. And then what you get is basically a cut in the skin on your skull and the implementation of your, let's call it a little machine. How big is it? So the system consists of the electrode array, and that's the electrode array, so you can see the size.
And that's what goes, and it's great that I don't have much hair, so you can see it. There's an incision in the skin, and then up against the skull, you place the lead over the focal area. And then the wire is tunneled down into a location in the, depending on the side of the left or the right in the clavicular area, the clavicle. And the, what we call the pulse generator, and this is the pulse generator, is then inserted with the lead and then inserted into what we call a pocket.
A pocket is made and that's inserted similar to a pacemaker. And that's how that's how the implant is done. And and again, this is a very common procedure, this tunneling and placement of the of the pulse generator. That's very similar to a pacemaker or even a deep brain stimulation device. And the electrode, like I said, is is is very simple.
It's simply an incision. And the beauty of our system is that when or if, for example, there is no effect, if it doesn't have an impact, the entire system can be removed and you are left with the scars, but you don't have any hardware or any hardware left behind. That's not the case with other solutions or alternatives for treatment of focal epilepsy, drug resistant focal epilepsy. Since a lot of people will also listen to this, so the electrodes have fit in
the palm of your hand, and they're very flat. They're very, very flat. I think they're probably a millimeter, two millimeters in thickness at the most. I see. And this is implemented and with the special technology stimulates a certain area, like a focal area, you called it, in the brain that then helps to reduce or maybe in the future to eliminate those seizures. Yeah, so it will stimulate to – the goal is to have a reduction versus baseline of greater than 50%.
And as I mentioned, there are patients who do have a very, very high level of response and go to what we call seizure-free with the therapy. But that is not the aim. The aim is to have a significant reduction of 50% or greater in the seizures versus the baseline. Because for the people, that massively improves their life, the life quality. Exactly. And that's what we see, right? You mentioned there earlier, when you have these unpredictable episodes, it can be at a very bad time.
It can be when you're walking down the stairs, when you're driving, or if you were trying to do something where you could injure yourself. Um, and it, so it, it really puts the patient in a, in a, in a position of being more isolated and, and with this type of therapy, you're, you're able to, um. You know, having fewer seizures, having fewer, uh, uh, effects get out and, and become part of society again in a way that you weren't before.
The other thing is the device also has the ability for the patient to actually, if they're feeling, and some patients can do, they have this, there's an aura or some sort of a feeling prior to an epileptic episode. They can actually trigger what we call a bolus or an additional stimulation to try and cut the onset of that episode as well. So there's the automaticity and then there's the manual aspect of patient-initiated therapy as well.
So many people who do have, for quite some time, epilepsy, they can feel what you call the aura, an upcoming seizure, and that's when they can stimulate in order to minimize it or to avoid it completely. Yeah. Another important thing is... This is all what we call subthreshold. So the patient actually doesn't feel the therapy at all. The only time they would feel the stimulation is after the surgery, one month after we do the initial programming.
And we move the stimulation to an area where they can sense it or feel it, but then it's reduced to what we call subthreshold. And so they can't feel it at all. And so it's a completely transparent therapy in that way. You can't feel it at all. So that's also beneficial. You're not feeling a stimulation or a side effect from that.
And we're really proud also of the design of this lead too, because one thing in particular for patients who have suffered from epilepsy is they may need brain scans or MRIs in the future. And this device is actually opaque in an MRI field 1.5 or 3T, you can't actually see any echo or effect in the MR scan. So it allows still for freedom for the patient to get those scans and for the physicians to use it as a diagnostic tool. It doesn't hinder future diagnostics.
I see. um we've been talking about the device we've talked about the patients um actually you told me the first human clinical tries started in 2021 and you have european market approval gotten in 2022 and can you take this from there our commercial activity really kicked off uh fully in 2024 and we've been focused on our german austria switzerland markets and then And recently, halfway through last year, we we we entered a tender in the UK and are on the
procurement list for for a centralized procurement list for the UK. And we'll be doing our first patients in the UK here before the end of the year. So that's really exciting. And then we also recently this fall, we started up in Portugal. That's our first distributor market. And we've done two patients there already in Portugal. But the majority of the patients are in Germany today. And that has been really ramping very nicely in key centers across Germany.
I see. And what is kind of the outlook? What are you looking for? Everybody who has an understanding or key, you're based in Heidelberg. You have approval in Germany. You are an American. You work with American companies in the future. I think I could see the next step. So there's a couple of things I would add. We're very committed to expanding the science and the evidence around our products. We've initiated four different clinical projects in Europe.
There are three ongoing registries. One of them is a post-market registry for our continued MDR or CE mark approval, and plus two physician-sponsored registries that are ongoing. And then we have initiated what we call an indication expansion clinical trial here in Europe. It's called Easy4U. And that study is to expand the indication from adults to teenagers, so from 12 upward.
And that study is already halfway through its enrollment, and we're looking forward to the completion of that trial and being able to serve that adolescent population in the near future. Now, the biggest focus is obviously the United States from an entry standpoint. And we have a breakthrough, what we call breakthrough designation with the FDA. So we're working with them to submit our proposed what we call IDE trial, clinical trial for evaluation in the U.S.
To determine, to then be able to submit for approval for use in the United States. So that trial will be our first randomized control clinical trial. And that's really exciting. So we're working on the final development of that trial and look forward to submitting that and executing that in the next year, year and a half. Especially teenagers. This has to be very important because it can be a complete...
End-of-life scenario for a teenager if he or she is not invited to party and having seizures massively limits their social life and their circle of friends. I do believe that that also has a massive impact on their quality of life. It sure does. And I mean, this is a population, It's heartbreaking to see patients suffering at an early age and anything we can do to support options or choices for earlier treatment, all the better.
And that's why we're doing this indication expansion trial in Europe. It's a very important underserved or unmet market at this point or need from patients. So I can already tell you have a lot of big plans going forward, especially the U.S. Increasing indications, because in my mind, there would be two important things you would need to go ahead. First, talent and second, funds. Yeah. Yeah. So we're building out the teams, right?
We've expanded our team in Europe as far as sales go. We're also working to expand to other markets in Europe. We're doing that in a very thoughtful way to make sure that we're balancing supporting the existing markets, but also able to support those new market entries in a safe and meaningful way. We will work with distributors in certain markets and consider other markets to go direct. So that's work that's ongoing to expand that expertise.
We have a very strong chief commercial officer in Pedro Marquez, and we have on the technology side, we have Michael Tittelbach, who's been leading for the last eight years the R&D efforts for Precisis. So, yeah, a lot of a lot of investments in in talent from also from the engineering side and the medical side and will continue to grow, grow that.
I think the other the other aspects to support funding the ongoing ongoing business is going to come partially from our commercial activities, from our revenue generation. But of course, we need further investment for the big plans that we have, right? So we are looking at private alternatives as well as angel investors and VCs and different corporate partners. So we have a very strong corporate partner with Cochlear, and they are a supporter of ours.
But we're looking for future investment to help us fund the next stage of our growth. I see. So only thing actually left for me to say is good luck with your endeavors. Thank you. All the investors who'd like to reach out to you down here in the show notes, we link your LinkedIn profile as well as everybody who's interested in joining you on your journey. We'll also link your career website, okay? Wonderful. It's great to talk to you. Thank you so much for the time.
Totally my pleasure. So the only thing left for me is wishing you a very nice Halloween in Heidelberg. Yes. And hope to have you back with some future successful announcements. That would be great. Thank you so much. Thank you. Have a good day. Bye-bye. Bye-bye. That's all, folks. Find more news, streams, events, and interviews at www.startuprad.io. Remember, sharing is caring. Music.