Nick Talamantes 0:00
Lothar, thank you so much for joining me here at LSI Europe. Tell me a little bit about what you're doing the company you're with.
Lothar Krinke 0:07
Hi, Nick. First of all, thanks for inviting me to this interview. My name is Lothar Krinke. I'm the CEO of Newronika. I've been on board for about four months, but the company has been founded more than five years ago. And what Newronika has been doing is built the world's most advanced Deep Brain Stimulation system for the treatment of Parkinson's disease. And I'm very excited about this. If you don't know what deep brain stimulation is, I can explain this a little bit more. But you might have heard about the field of brain computer interfaces or brain device interfaces. So that's what we really have, we have a bi directional device that is implanted in the patient and can measure brain signals and deliver electricity to the human brain.
Nick Talamantes 0:55
So I do hear the term BCI brain computer interface, it's a bit of a buzzword. How is your technology different than a BCI? If it's not one?
Lothar Krinke 1:06
Well, we would argue it is a brain device interface. Now there's a computer as well. So you could call a brain computer interface. The way I would describe it as brain computer interface, or brain device interface is really a technology field that can be applied to anything from non invasive to invasive ways to monitor brain activity, and then really translate intent, for example, from the human brain into some kind of action. What we have is a bi directional device where we measure brain activity that then automatically interprets that brain activity to better treat Parkinson's disease through a system that then also then automatically delivers electricity to the human brain. At the right amount, no more, no less, minute by minute, hour by hour, day by day. So truly personalized medicine
Nick Talamantes 2:00
Neuromodulation. It's been around for a while now to treat a variety of different things from chronic pain to depression. What makes your technology sort of the next generation or next step in neuromodulation? BCI?
Lothar Krinke 2:14
Yes, so neuro tech or neuro modulation is really where cardio physiology or pacemakers were about 20 years ago, more than 20 years ago, it became clear that to make the next generation better cardiac pacemaker you have to integrate electrophysiology and activity sensors. So, a pacemaker today when ICD does not pace all the time, it paces when the heart needs it. It's the same concept for the brain, except the neurophysiology of the brain is probably a billion times more complicated than the heart. But fundamentally, it's the same idea. We integrate sensors, interpret the brain signals, and then adjust therapy based on that just like a pacemaker will only pays when the patients need been the patients need it.
Nick Talamantes 3:04
So what's sort of the unmet need that neuron HCA is addressing with its technology?
Lothar Krinke 3:09
So yeah, we're going after an existing market deep brain stimulation is a billion dollar market today with three of the major med tech companies involved in it. However, the problem is that only 15% of patients with Parkinson's that are perfect candidates for this therapy receive the therapy today. And then the other indications epilepsy, it's probably less than 1% penetrated. So why is that? It is because DBS works really well for a patient but not all the time. So the therapy effect fluctuates throughout the day. There also stimulation to do side effects just like if a pacemaker paces all the time and get heart failure. And so that's the problem we're trying to address by automate medically adjusting the stimulation to what the patient needs in that minute. We solve that problem of that fluctuation and we have clinical data that proves that the concept works. On top of that. Today, a neurologist uses trial and error to program a device which is complicated because these modern devices have 16 Soon 32 individual context so imagine you have to try them all out. Now we have a biomarker that we can measure that that predicts which stimulation context to turn on and also at what power so we really automate the workflow for the for the neurologist and make it really based on the diagnostic if you will, rather than traveling there.
Nick Talamantes 4:49
Is that biomarker proprietary to Newronika?
Lothar Krinke 4:52
No, the biomarker itself was not it has been known for a long time that this biomarker is called. You measure local field potential So in a specific band, the beta band, and you calculate the power. And it is associated with symptoms of Parkinson's, other people have known this other people have measured it. Our proprietary technology is around how we filter this brain technology, right? There's all these brain signals going on, and you stimulate, and the way that we implemented filtering technology to detect the signal that's proprietary. And then our algorithm is different than the algorithms that for example, Medtronic is using. We have a proportional control algorithm. They have a different algorithm. There's other patents as well. So the biomark itself is not it's well accepted, which in many ways is a good thing. But the way that we implementing it is proprietary.
Nick Talamantes 5:43
Tell me a little bit about what stage Newronika is at right now. Are you commercial preclinical? Where Where are you guys right now?
Lothar Krinke 5:51
Well, if anyone listens who was an investment wants to give us $30 million, or euros right now, that's all about the same. That's what we're looking for. We need $30 million to complete our US pivotal trial, we want to get FDA approval, the system today a CE mark, but in conventional mode. So this adaptive mode that I talked about. The automaticity is not a proof the sensing, yes, but not the automaticity. We are filing as we speak for CE mark, we do have clinical data, but it's really feasibility clinical data. So $30 million, and a couple of years, and we will likely going to have FDA approval we have filed for an IDE. And about a third of the 30 million will go directly to the clinical trial. Now the third to make are developing next generation technology. And the other third is for everything else that you need to run a company such as facilities, IP and that kind of stuff. But $30 million launch in Europe 2025 in the US 2027.
Nick Talamantes 6:57
What does sort of the future look like for neurotic you mentioned Parkinson's disease? Is that where you're starting?
Lothar Krinke 7:03
Yeah. So first of all, thanks for this question. Because people sometimes think, well, it's just Parkinson's not that big. By the way, Parkinson's, actually big disorder, there is more than a million Parkinson's patients in the US going to 1.6 million in the next couple of years. And in Europe, it's already over over a million. So there's probably more than 3 million Parkinson's patients in the developed world. So it's a pretty big market. And if you look at the total addressable market, it far exceeds $10 billion. Now, today, it's a billion dollar market, but it could be the other indications that are of particular interest to us are epilepsy. Other companies have DBS approved for epilepsy, even sort of a closed loop system from a company called neuro base. So our technology is perfectly suitable for epilepsy. That, of course, would require, again, additional capital investment. But technically, the the hardware is the same. It's just would be different firmware, different clinical evidence. Epilepsy would be next. And you mentioned depression earlier. Others are investing heavily right now in deep brain stimulation for depression. I just spent five years in before coming to Newronika in the psychiatric space. It's, it's hard, because not just the technology, you also have to convince psychiatrists to accept brain implants. But it's possible I I'm very hopeful that depression will be a future indication.
Nick Talamantes 8:30
So it sounds like you're here at LSI Europe to meet with investors, potentially partner strategic partners. How is that going? Do you have a bunch of meetings lined up? Is it looking promising?
Lothar Krinke 8:41
Yeah. And it looks promising. I mean, we have the round partially subscribed to but we need to, we need someone to write the big check to be the lead. For this investment. We have a lot of people that would join the Syndicate, including our existing investors. Of course, we also have some grants. So how's it going? Well, it's no secret that fundraising would have been a whole lot easier last year, given the economic situation, but I'm really optimistic that we will close a round. And we also have particular interests from some of the strategics are ready to collaborate or do a deal.
Nick Talamantes 9:19
That's exciting. I'm hopeful that you guys will be able to do so soon. Lothar, is there anything else you want to share with us about your company what you guys are doing your mission?
Lothar Krinke 9:29
I think it's a broader mission. wildbrain device interfaces are sort of a cool technology. What is always an issue when you talk about deep brain stimulation that patients don't know about it. Right? It's only 50% of patients with Parkinson's that get that therapy today. And if you ask people, What are the treatment options, they don't think about Deep Brain Stimulation. Now if someone has Cardiac Crom bradycardia everyone's getting a pacemaker, right 95% of patients with bradycardia get a pacemaker. So, you know, one challenge out there is we really need to educate patients and neurologists that this is a treatment option that has amazing results. Already conventional DBS works very well, we are making it even better, it should be really standard of care.
Nick Talamantes 10:23
You mentioned awareness is a problem is or our alternative means or standard of care also sort of creating resistance to deep brain stimulation and this type of technology.
Lothar Krinke 10:37
Yeah, so sometimes full disclosure, I also, for five years ran my tracks deep, deep brain stimulation business. You know, people always think the pharmaceutical companies are the competition, right? Because they have medication. And, of course, first, you know, before you get a brain implant, you try some medication. But to me, it's actually not the pharaseutical companies that, that that are the hurdle. It really is the inaction of neurologists that are not sufficiently educated to prescribe this therapy. So, you know, when, you know, I still think about this. And I've been saying that for the last 10 years, it's almost unconscionable, not to give patient at least the opportunity to evaluate with a good candidate for deep brain stimulation. So that's my battle cry, this is my social message, we we have the tools to help more Parkinson's patients, and we can reduce the socio economic cost of neurodegenerative diseases. The way that I'm thinking about this is that we will create direct interactions with a patient. So our device throws off or delivers personalized brain sensing data, we were integrating this with wearable data. So that actually allows us to develop a relationship with a patient. And if I learned something about having been in this space, really in the medical device space, is patients are the best ambassadors to tell other patients, that there are treatment options.
Nick Talamantes 12:17
This is all been incredible. What drives your passion at the end of the day.
Lothar Krinke 12:21
Yes, so look, what can be more intimate than studying each other's brain? Your brain is where your personality is. And that's so exciting to me. It is the frontier. It's the opportunity. It's the privilege to study how human thought works, how we interact with each other. And that big vision this, this challenge is so exciting that it overwrites all stress you might have in fundraising and all the things that happen day to day running a company. We are studying the human brain, and we'll discover a lot over the next decade.
Nick Talamantes 13:02
Lothar thank you so much for coming by for this interview and for being an innovator here at LSI Europe.
Lothar Krinke 13:07
Thank you. Thank you
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