Table of Contents
Introduction
Meet Karl Stoklosa: A Leader in Medical Device Innovation
Understanding Epilepsy and the Global Need for Solutions
The EASI System: A Revolutionary Approach to Epilepsy Treatment
Key Features of the EASI System
Benefits for Patients
Differentiating PRECISIS in the Medical Device Industry
European Market Success and Future Expansion
Early Commercialization in Europe
Strategic Growth in Key European Markets
Ambitions for U.S. Market Entry
Investment and Talent Growth Opportunities
Building the Team for Global Expansion
Funding the Future of Neuromodulation
Strategic Partnerships as Catalysts for Growth
Call to Action
Conclusion
Introduction
Welcome to another insightful feature by Startuprad.io, the authority on startups in Germany, Austria, Switzerland (DACH region), and beyond. Today, we shine the spotlight on PRECISIS, a groundbreaking healthcare startup based in Heidelberg, Germany. This innovative company is transforming epilepsy treatment with its revolutionary EASI System, the world’s first minimally invasive brain pacemaker for drug-resistant focal epilepsy.
For startup enthusiasts, executives, investors, and healthcare professionals, PRECISIS exemplifies how visionary startups can address unmet needs in the global healthcare sector. With its patient-centered approach and cutting-edge technology, PRECISIS not only saves lives but also improves the quality of life for millions worldwide.
If you are passionate about entrepreneurship, technology, and impactful healthcare solutions, this deep dive into PRECISIS' journey, leadership, and innovations will provide valuable insights into how startups are shaping the future of medical technology.
Meet Karl Stoklosa: A Leader in Medical Device Innovation
At the helm of PRECISIS is Karl Stoklosa (https://www.linkedin.com/in/karlstoklosa/), an accomplished leader with over two decades of experience in the medical device industry. His career began with an Executive MBA from the University of Chicago Booth School of Business, a program renowned for cultivating leaders with a global perspective. Karl’s subsequent journey has taken him across continents, providing him with a wealth of experience in diverse healthcare markets.
Karl’s professional portfolio includes roles at Guidance and St. Jude Medical, where he specialized in cardiac rhythm management, neuromodulation, and upstream marketing. His work focused on developing innovative solutions for critical conditions such as sudden cardiac death and heart failure. Over the years, Karl has honed his skills in both technical and commercial aspects of healthcare innovation, making him uniquely equipped to lead PRECISIS.
What sets Karl apart is his ability to merge technical expertise with entrepreneurial vision. Having lived and worked in major global hubs such as Barcelona, Singapore, and the U.S., Karl brings a nuanced understanding of the complexities involved in scaling medical technologies across markets. For C-level executives, venture capitalists, and startup investors, Karl’s leadership is a testament to the importance of strategic foresight in building impactful startups.
Understanding Epilepsy and the Global Need for Solutions
Epilepsy is one of the most common neurological disorders, affecting approximately 50 million people worldwide. Characterized by recurring seizures, epilepsy disrupts the lives of patients and their families, often creating barriers to education, employment, and social interaction. While medications are available, they are far from universally effective. About 30% of epilepsy patients are drug-resistant, meaning that traditional therapies fail to control their seizures.
This subset of patients faces significant challenges. Uncontrolled seizures not only limit daily activities but also pose serious safety risks, such as injuries from falls, burns, or car accidents. Additionally, the social stigma associated with epilepsy often leads to isolation and mental health struggles. For healthcare providers and innovators, addressing these challenges requires a shift from reactive care to proactive, personalized treatment solutions.
PRECISIS is at the forefront of this shift. By focusing on patients with drug-resistant focal epilepsy, the company is tackling one of the most pressing issues in the field. Its innovative approach not only provides an alternative to invasive surgeries but also reduces the burden on healthcare systems by offering a cost-effective solution. For healthcare investors and startups in the medical technology space, this represents a lucrative and impactful opportunity to make a difference.
The EASI System: A Revolutionary Approach to Epilepsy Treatment
Key Features of the EASI System
The EASI System is a state-of-the-art solution designed to manage focal epilepsy through minimally invasive technology. Unlike traditional treatments, which often involve extensive brain surgery or prolonged drug regimens, the EASI System uses advanced neuromodulation techniques to target the root cause of seizures.
Epicranial Electrodes: These flat, compact electrodes are placed beneath the scalp, directly on the skull. They deliver targeted electrical stimulation to brain regions associated with seizure activity, eliminating the need for invasive procedures.
Pulse Generator: This small device, implanted near the collarbone, controls the stimulation delivered by the electrodes. Its compact size and advanced programming capabilities make it a discreet yet powerful tool for managing epilepsy.
MRI Compatibility: Unlike many medical devices that interfere with imaging technologies, the EASI System is fully compatible with MRI scans, ensuring seamless diagnostics throughout a patient’s treatment journey.
Benefits for Patients
Patients who undergo treatment with the EASI System experience a significant reduction in seizure frequency, often exceeding 50%. For some, the therapy leads to complete seizure freedom. Beyond these clinical outcomes, the device offers tangible lifestyle improvements, such as the ability to return to work, drive, and participate in social activities.
Additionally, the system’s manual stimulation feature empowers patients to take control of their condition. By activating the device when they sense an impending seizure, patients can proactively manage their symptoms, further enhancing their independence.
For investors and healthcare entrepreneurs, these patient-centered benefits highlight the EASI System’s market potential and its role in transforming epilepsy care.
Differentiating PRECISIS in the Medical Device Industry
PRECISIS distinguishes itself through its focus on innovation, rigorous clinical validation, and commitment to patient outcomes. The EASI System’s minimally invasive design and cutting-edge technology position the company as a leader in the neuromodulation space. For startup founders and venture capitalists, PRECISIS offers a blueprint for how technology-driven solutions can address complex healthcare challenges while creating substantial market value.
European Market Success and Future Expansion
Early Commercialization in Europe
PRECISIS achieved European market approval in 2022, a milestone that underscored the device’s safety and efficacy. The company began its commercial rollout in late 2023, targeting key markets such as Germany, Austria, Switzerland, the UK, and Portugal.
Strategic Growth in Key European Markets
Germany, with its advanced healthcare infrastructure, has been a focal point for PRECISIS’ commercial activities. The company’s entry into the UK and Portugal further highlights its strategic approach to market penetration. By leveraging regional partnerships and tailored commercialization strategies, PRECISIS is creating a strong foothold in Europe.
Ambitions for U.S. Market Entry
PRECISIS’ ambitions extend beyond Europe. With FDA breakthrough designation, the company is preparing for its first randomized controlled trial in the U.S. This marks a significant step toward regulatory approval and entry into one of the world’s largest healthcare markets. For North American investors and stakeholders, PRECISIS represents a high-potential opportunity to invest in a proven technology with global applicability.
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Investment and Talent Growth Opportunities
Building the Team for Global Expansion
As PRECISIS scales, attracting top-tier talent across engineering, sales, and medical research remains a priority. The company’s leadership team, including experienced executives like Gabriel Marquez and Michael Tittoback, is focused on fostering a culture of innovation and operational excellence.
Funding the Future of Neuromodulation
To sustain its growth, PRECISIS is actively seeking investments from venture capital firms, angel investors, and corporate partners. Revenue generated from European commercialization efforts will also contribute to funding future initiatives, including clinical trials and market expansions.
Strategic Partnerships as Catalysts for Growth
PRECISIS’ collaboration with Cochlear, a global leader in implantable hearing solutions, exemplifies the power of strategic partnerships in driving innovation. Such alliances not only accelerate product development but also expand market access, making PRECISIS a compelling choice for investors and partners alike.
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Automated Transcript
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:00:01]:
Hello and welcome everybody. This is Joe from start up rate dot I o coming to you, bringing you another awesome interview this time from a healthcare startup based in Heidelberg. But first, I would like to welcome Carl. Hey. How you doing?
Karl Stoklosa | CEO PRECISIS [00:00:18]:
Great. Great. Thank you so much for the invitation and for the opportunity to share, the company and, what we're doing at Preciseis. Appreciate it.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:00:29]:
Exactly. Talking about Precisys, we'll soon get into this. But first, let's talk a little bit about you. The people who can see this, see that you are not in your twenties 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?
Karl Stoklosa | CEO PRECISIS [00:01:02]:
Yeah. So I've been in, the medical, device field for the last 20 plus years, And I 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 Guidance back at the time, a a very well known, cardiac rhythm management company, and did sales and, field field technical work supporting implants, in that, and then moved into, marketing, in the but in the specialized area of upstream marketing. What what that means is basically new product development and evaluation of of new new, approaches to addressing, disease, in this particular case, sudden cardiac death and and heart failure. From there, I actually moved over to, into, St. Jude Medical. And in in that case, moved at the time from the US to Belgium where I spent, 11 years within St.
Karl Stoklosa | CEO PRECISIS [00:02:18]:
Jude doing a variety of different roles, in 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 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 in Europe, for the entire division, but then migrating into a a sales specific role in DBS or deep brain stimulation. I then moved with St. Jude was acquired by Abbott, and I moved from there to Singapore as you mentioned earlier and spent 3 years as the regional marketing lead for cardiac rhythm management in Singapore, and for the Asia Pacific region. And and then, in 2021, moved over to the US to take on a global role, global downstream marketing, so responsible for all commercialization of new 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.
Karl Stoklosa | CEO PRECISIS [00:03:48]:
So that's a little bit of my background.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:03:51]:
You have gotten around quite a bit. I've I've seen here Barcelona, Brussels, New Jersey, Singapore, and Austin, Texas. So did did you did you always move around with your family?
Karl Stoklosa | CEO PRECISIS [00:04:06]:
Yes. So, from the very early stages, my wife and I decided we we liked living and and, managing in different cultures. And 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 of doing business in different cultures with different health, reimbursement systems, different, payer systems. And so that that really keeps me engaged and and interested. And and just the the aspect of of living and learning in different cultures and also raising the family to to have the experience of of different cultures. And I have I have 3 sons, and 2 of them were born over the seas. 1 of them was born in the US.
Karl Stoklosa | CEO PRECISIS [00:04:55]:
Mhmm. So, you know, a lot of a lot of international experience with them as well and exposure.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:05:01]:
Do they also speak French?
Karl Stoklosa | CEO PRECISIS [00:05:03]:
Yeah. The 2, one of them speaks French. The other 2 actually speak Mandarin.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:05:09]:
Sei Zheng Heo. Very good. Yeah. Yeah. It it it it it 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 it's it's not really Beijing food, but the big chicken plate, Dapanji, I took some food with me from from a time in Spain from the time in the US. Is it also the the same stuff for you that you have certain dishes that remind you of certain places?
Karl Stoklosa | CEO PRECISIS [00:05:38]:
Yeah. Absolutely. You know, Belgium, it's it's the traditional brasserie food that you get, mouefried or, watterzooey. Very, very, traditional Belgian dishes, which we truly love, and and we have our favorite, grocery that we always go to in in in Brussels. In in Singapore, it was chicken and rice. But because Singapore is also very multicultural, and and has a lot of other, cuisines, we would also, gravitate towards things like, katsu curry, so Japanese katsu curry or or even ramen. Right? So and then, you know, recently in Austin, we we like, of course, the barbecue, and Austin is some of the best in the world. And so and we're living near a very famous barbecue, restaurant.
Karl Stoklosa | CEO PRECISIS [00:06:29]:
And and so that that is also something we really enjoy. But we we always are looking for that diversity in food, and and it's a big part of it's a big part of why we we like being in different cultures as well.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:06:43]:
We do have a lot of European executives, entrepreneurs, founders, cofounders, company owners here. How did Precisys manage I assume first, they found you through a very highly paid headhunter, but how did they convince you to take over this job?
Karl Stoklosa | CEO PRECISIS [00:07:05]:
Yeah. So, I've 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 the founding CEO, of the organization, was looking to retire and and, you know, 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 and we were re 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 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.
Karl Stoklosa | CEO PRECISIS [00:08:22]:
I really feel that it's important to have an impact. And for me, I 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. And we have 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 the the the 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 in medical device over 250 years.
Karl Stoklosa | CEO PRECISIS [00:09:25]:
Right? So it's really deeply, it's deeply seated in 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 between me and them was really important. And so it was very easy, decision on my side to to take an take it take this opportunity and and run with it.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:09:53]:
I see. You've been already talked about stimulations. You've been already talked about, somehow about the main idea. Can you tell us what the main product of Precisis is and what it is used for?
Karl Stoklosa | CEO PRECISIS [00:10:11]:
So it's a it's really the world's first minimally invasive brain pacemaker to treat what we call drug refractory epilepsy, focal epilepsy. And it's it's called the EASI system, and it it stands for the Epicranial Application of Stimulation Electrodes for Epilepsy. So that's the the name, EASI. And the the name is great because it it really pays, homage to how it's 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. 1, it's the electrodes. So we have an electrode what we call an electrode array, and that's a a series of 5 electrodes in a in a about a a 5 centimeter ring.
Karl Stoklosa | CEO PRECISIS [00:11:35]:
And those electrodes allow for, a very unique stimulation pattern. And, actually, we can modulate those 2 the 2 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 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 on the technical aspect behind behind the product. Mhmm.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:12:11]:
I had to smile when you started out talking about, what the product is for because for everybody without a medical background, it could you could have said blah, blah, blah, blah, blah, blah, blah, blah. It would have had the same effect. Exactly. So so so so, basically, we're talking about avoiding epilepsy here. What are you talking about or, minimizing?
Karl Stoklosa | CEO PRECISIS [00:12:34]:
Minimizing. So we we're
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:12:35]:
Yep.
Karl Stoklosa | CEO PRECISIS [00:12:35]:
We're not we're not curative in a sense. We're what we're doing is we're reducing the the excitation of these focal areas, so the excitement. And by that, we can we can reduce the number of seizures that a patient may have, that is suffering from, focal epilepsy. You know, we we have we have some patients who have are a 100% seizure free, but that is not the 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 wanna see a reduction of that greater 50% or greater to say that this this therapy is effective. And so we see that in our clinical in our clinical reside in our clinical results today.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:13:30]:
Many people out there will have never seen a seizure, in real life. So it can be basically something that the people just break down to really cramping. And it's it's it's not like, you 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 or 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.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:14:22]:
And for some yep. Correct?
Karl Stoklosa | CEO PRECISIS [00:14:24]:
It can it can be a cure. I mean, it I don't think it's a 100 it's a 100% in in most cases, but it can be more of a cure. But, of course, you you can have side effects from anytime you're you're, opening the the cranium or the skull, and and causing damage to or removing tissue can be can have other side effects as well. Mhmm. I
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:14:46]:
was once talking to a neurosurgeon and he said, basically, it it it's a surgery, but the effect is similar. Every new surgery is almost similar to have a heavy traffic accident.
Karl Stoklosa | CEO PRECISIS [00:15:00]:
Yes. That's most of those what you're speaking about is any procedure that is, 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 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.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:15:51]:
Mhmm. When we talked before, you had some numbers about how many people do have epilepsy across the world?
Karl Stoklosa | CEO PRECISIS [00:16:00]:
Yeah. It's a it's a big it's a big issue. I'm gonna pause. I wanna make sure I get the numbers.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:16:06]:
Sure. No worries. We can cut this out. Mato will cut out the waiting time. Yeah. Mato is my editor.
Karl Stoklosa | CEO PRECISIS [00:16:12]:
Yeah. Oh, great. Awesome. I just wanna make sure I get you the correct two seconds. I thought I had it up my my
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:16:27]:
In my notes, I have around 1% of the global population has epilepsy, most focal, and most drug resistant.
Karl Stoklosa | CEO PRECISIS [00:16:34]:
Yes. I wanna just get the percentages here. Sorry. Give me just a second. Sure. Got too many slides. That's open.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:16:50]:
I know that I have something like 30 tabs open here.
Karl Stoklosa | CEO PRECISIS [00:16:55]:
Yeah. Yeah.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:16:56]:
Fortunately, I do have a new computer that we lovely call the beast, that has more, RAM on its graphic card than the old laptop I used to run Sono Brady on.
Karl Stoklosa | CEO PRECISIS [00:17:09]:
Oh, wow. Okay. Sorry. I'm I'm very sorry. As I've mixed it up a couple of times, I'm just wanting to make a 100% certain
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:17:56]:
Totally fine.
Karl Stoklosa | CEO PRECISIS [00:17:57]:
That we we get these numbers correct, and I'm unfortunately struggling here further.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:18:03]:
That's very German. Be precise.
Karl Stoklosa | CEO PRECISIS [00:18:06]:
Yeah. I I just don't wanna be I don't wanna be. It's loading in a little bit. Is that this is the challenge of being a new CEO and and new new stuff you you, you end up with some, here we go. Yeah. Okay. Now I'm ready.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:18:47]:
Keep going.
Karl Stoklosa | CEO PRECISIS [00:18:48]:
So, yeah, so the the, what we what we look at is the the in the total population, so global population, about 1% of of the global population suffers from epilepsy. And of that, 30% of those are drug resistant. And of those drug resistant patients, 70% of those could be candidates for a, product like Ezy could be candidates for Ezy. Mhmm.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:19:29]:
Drug resistance here means usually you 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.
Karl Stoklosa | CEO PRECISIS [00:19:45]:
Yeah. So in some cases, and when we say drug resistant or drug refractory, we mean, they're resistant or refractory to 2 or more drugs. So Mhmm. That's that's what we what we consider to be drug resistant.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:20:02]:
Mhmm.
Karl Stoklosa | CEO PRECISIS [00:20:03]:
And the the likelihood that a 3rd or a 4th or a 5th 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 we we think that around that big level of population that around 70% of them are candidates today.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:20:51]:
I see. And, then what 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 how big how big is it?
Karl Stoklosa | CEO PRECISIS [00:21:06]:
Yeah. If I would it be better if I showed?
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:21:11]:
Sure. Go ahead. But but most people most people will still listen to it by but totally fine. Show it. Show it. Show it. It's good. Yep.
Karl Stoklosa | CEO PRECISIS [00:21:18]:
2 seconds.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:21:21]:
Anu will also cut out this wait time.
Karl Stoklosa | CEO PRECISIS [00:21:39]:
So the system 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'm I don't have much hair, so you can see it. There's an incision in the in the in the skin, and then up against the the the skull, you place the lead over the focal area. And then the the wire is tunneled down into a location in the depending on the side or 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 the implant is done.
Karl Stoklosa | CEO PRECISIS [00:22:40]:
And again, this is a very common procedure, this tunneling and placement of the pulse generator that's very similar to a pacemaker or even a a deep brain stimulation device. And the electrode, like I said, is is is very simple. It's 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, it 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 for treatment of of focal epilepsy. Drug resistant focal epilepsy.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:23:28]:
Since a lot of people will also listen to this, so the electrodes, half fit in the palm of your hand, and they're very flat.
Karl Stoklosa | CEO PRECISIS [00:23:36]:
They're very, very flat. They're, I think they're probably a millimeter, 2 millimeters in thickness at the most. So Mhmm.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:23:45]:
I see.
Karl Stoklosa | CEO PRECISIS [00:23:46]:
Yeah.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:23:47]:
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?
Karl Stoklosa | CEO PRECISIS [00:24:05]:
Yeah. So it will it will 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 who do have a very, very high level of response and go to what we call seizure free with the with the therapy, but that is that is not the aim. The aim is to have a a significant reduction of 50% or greater, in in the seizures versus the baseline.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:24:37]:
Because for the people that massively improves their life, the life quality.
Karl Stoklosa | CEO PRECISIS [00:24:42]:
Exactly. And that's what we see. Right? You you you, you know, when you're when you you mentioned there earlier, when you're when you have these un 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. And it so it it really puts the patient in a in a position of being more isolated. And and with this type of therapy, you're you're able to, you know, having fewer seizures, having fewer, effects get out and and become part of society again in a way that you weren't before. The other the other thing is the the device also has the ability to for the patient to actually if they're feeling and some patients can do they they have this. There's an aura or some sort of a feeling prior to an epileptic episode.
Karl Stoklosa | CEO PRECISIS [00:25:47]:
They can actually trigger, what we call a bolus or an additional stimulation to try and, cut that, the onset of that of that, of that episode as well. So there's there's the automaticity, and then there's the the the manual aspect of patient initiated episodes or patient initiated therapy as well.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:26:14]:
Mhmm. So many people who do have, for quite some time epilepsy, they can feel what he called the aura, an upcoming seizure, and that's when they can stimulate in order to minimize it or to viticle bleeding.
Karl Stoklosa | CEO PRECISIS [00:26:30]:
Yeah. Another another important thing is that this is all what we call sub threshold. So the patient actually doesn't feel the therapy at all. The only time they would feel the stimulation is after the surgery, 1 month after we do the initial programming. And we we move the 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 it's it's a it's a completely, transparent therapy in that way. It's it's you can't feel it at all. So that's also beneficial.
Karl Stoklosa | CEO PRECISIS [00:27:12]:
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 one thing in particular for patients who 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 3 t. You can't actually see any, any echo or or, effect, in the MR scan. So it allows still for freedom, for the patient to get those scans, and for the for the physicians to use it as a diagnostic tool.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:27:51]:
Mhmm. It it it doesn't hinder future diagnostics.
Karl Stoklosa | CEO PRECISIS [00:27:54]:
Exactly. Mhmm.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:27:56]:
I see. We've been talking about the device. We've been talking about the patients. 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 us from there?
Karl Stoklosa | CEO PRECISIS [00:28:14]:
Yeah. So we, market approval, we started in late 23 with some with commercialization activities in, in Europe. And, actually, the the clinical trial results, gave us that CE mark with, which was really great. The the the hurdles or the burn or the barriers to to receive MDR or approval of our CE marking are are quite high. And there was recognition of the, of the results from our clinical trial, and and the need for such a a therapy in the marketplace. We entered into an initial, a concerted, sorry. Our commercial activity really kicked off, fully in 2024, and we've been focused on our German, Austria, Switzerland, markets. And then recently, halfway through last year, we we we entered, a tender in the UK and are on the procurement list for for kind of centralized, procurement list for the UK, and we'll be doing our first patients in the UK here, before the end of the year.
Karl Stoklosa | CEO PRECISIS [00:29:34]:
So that's really exciting. And then we also, recently, this fall, we started up in Portugal. That's our 1st distributor market, and we've done 2 patients there already, in in Portugal. But the majority of the patients are in in Germany today, and and that has been really ramping very nicely in in key centers across Germany.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:30:00]:
I see. And what is kind of the outlook? What are you looking for? Everybody who has, who has an understanding okay. 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. Yes.
Karl Stoklosa | CEO PRECISIS [00:30:19]:
So there's, there's a couple of things I would add. We're very committed to, expanding the science and the evidence, around our our products. We've, initiated, 4 4 different clinical projects in in Europe. There are 3 ongoing registries. One of them is a post market registry for our continued MDR or CE Mark approval and plus 2 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 EZ4U, 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 ed the completion of that trial and being able to serve that that that adolescent population, in in the near future.
Karl Stoklosa | CEO PRECISIS [00:31:27]:
Now the biggest focus is obviously the United States from a from an entry standpoint. And we have 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, for evaluation in the US to determine, to then be able to submit for approval for for use in the United States. So that trial will be our 1st randomized control clinical trial, and that's really exciting. So we're working on on the the final development of that trial and look forward to executing to submitting that and executing that in in the next year, year and a half.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:32:14]:
Mhmm. How especially teenagers, this has to be very important because it can be a complete end of life scenario for for a teenager if he's he or she is not invited to party. And having seizures massively limits their social life and and and their circle of friends, I do believe that that also has a massive impact on their quality of life.
Karl Stoklosa | CEO PRECISIS [00:32:42]:
It sure does. And I mean, this is a this is a, population. It's it's heartbreaking to see see patients suffering at an early age and anything we can do to to support options or choices for earlier treatment. It it all the better and that's that's where that's why we we're doing this indication expansion trial, in in Europe. It's, it's a very important, un underserved or unmet market at this point or or need from from patients.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:33:15]:
Mhmm. So I I can already tell you have a lot of big plans going forward, especially the US increasing indications. What because in my mind, there would be 2 important things you would need to go ahead. 1st, talent and second, funds.
Karl Stoklosa | CEO PRECISIS [00:33:35]:
Yeah. Yeah. So we're we're building out the teams. Right? We've 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 we're balancing supporting the existing markets, but also able to support those new market entries in a in a safe and meaningful way. We will work with distributors in certain markets and and consider other markets to go direct. So that's work that's ongoing to expand that that expertise.
Karl Stoklosa | CEO PRECISIS [00:34:11]:
We have a very strong, chief commercial officer in Gabriel Marquez, and we have, on the technology side, we have Michael Tittoback, who's been leading for the last 8 years the the r and d efforts, for, for Precisys. So, yeah, a lot of a lot of investment in in talent, from also from the engineering side and and the medical side, and we'll continue to to grow grow that. I I think the other the other aspects to support sort of funding the ongoing, ongoing, business is gonna come partially from our commercial activities, from our revenue generation. But Mhmm. Of course, we need further investment for the big plans that we have. Right? So we are we are looking at, private private private alternatives as well as angel investors and VCs and, you know, different different corporate partners. So we have we have a very strong corporate corporate partner with Cochlear, and, they are they are a supporter of ours. But, yeah, we're looking for future investment to help us fund the next stage of our growth.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:35:29]:
I see. So only thing actually left for me to say is good luck with your endeavors.
Karl Stoklosa | CEO PRECISIS [00:35:38]:
Thank you.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:35:38]:
All the investors who would like to reach out to you down here in the show notes, We link your LinkedIn profile
Karl Stoklosa | CEO PRECISIS [00:35:44]:
Great.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:35:44]:
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. Great.
Karl Stoklosa | CEO PRECISIS [00:35:53]:
Great to talk to you. Thank you so much for the time.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:35:56]:
Pauli, my pleasure. So I only thing left for me is wishing you a very nice Halloween in Heidelberg.
Karl Stoklosa | CEO PRECISIS [00:36:03]:
Yes.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:36:04]:
And hope to have you back with with, so with some future, successful announcements.
Karl Stoklosa | CEO PRECISIS [00:36:10]:
That would be great. Thank you so much.
Jörn "Joe" Menninger | CEO and Founder Startuprad.io [00:36:13]:
Thank you. Have a good day. Bye
Karl Stoklosa | CEO PRECISIS [00:36:14]:
bye. Bye.
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