Lothar Krinke Presents Newronika at LSI Europe '23

Newronika is developing AlphaDBS, a closed-loop deep brain neuromodulation system for the management of symptoms due to Parkinson's disease.
Lothar Krinke
Lothar Krinke
CEO, Newronika



Lothar Krinke  0:05  
I'm Lothar Krinke, I'm the CEO of Newronika. I'm here to raise the series B. This up, okay. 800 billion is cost to society of neurodegenerative diseases in the US alone. To help address this crisis and to make a small contribution, Newronika has developed the world's most advanced Deep Brain Stimulation system. What is DBS? DBS is a pacemaker for the brain instead of wires going to the heart wires go to the brain. It's used to treat Parkinson's disease with a total addressable market of $3.6 billion, or euros. Today, the market is approaching 1 billion euros. So you may ask, how do we grow this market from about 2 billion to 3.6 billion and beyond? In order to do this, we need to address the barriers of adoption. With DBS today with conventional DBS symptoms still fluctuate throughout the day, patients experienced stimulation and do side effects. And DBS systems need to be adjusted frequently, which is time consuming for the neurologist? So can technology really reduce barriers of adoption? Let's look at pacemakers. Today, 60 years in with pacemakers. If a patient requires a pacemaker, there's 100% probability that patient will have access to pacemaker. So that market is nearly 100% penetrated. How did the cardiac pacemaker business evolve that way, by addressing specific technologies, I would like you to I would like to draw your attention to adaptive rate responsive cardiac pacing, which evolves very early in the evolution of cardiac pacemakers, and I would like you to think about Remote Patient Management. Newronika was formed to exactly develop those technologies in DBS. So what is adaptive DBS? We sends brain signals through the wires that are already implanted in the in the brain of the patient. The system analyzes those brain signals, and calculates and delivers the precise amount of electricity for the patient that they need. Minute by minute, hour by hour, day by day, no more, no less. This is what our system looks like. It's a full system to treat Parkinson's disease. And I'd like to draw your attention to this little icon there. On the lower right hand side, we have built a in the cloud data management system where we can store brain data 24/7, we are already sitting on more than 40,000 hours of continuous brain recording data. By the time our pivotal trial is finished, we will have 1 million hours of brain recording data that is useful for the neurologist. So the approach is simple, which is where the pharmacokinetics come in patients with Parkinson's medication but their pharmaco kinetics is so that they fluctuate between side effects, efficacy and no symptom relief. DBS helps to reduce these fluctuations but does not eliminate them because DBS conventional DBS delivers electricity at a constant rate, no changes. In adaptive DBS, our system detects side effects and lower stimulation or detect symptoms and increase the stimulation keeping the patient in this sweet spot where they have symptom relief 24/7. Our most recent trial of 10 patients showed that nine out of 10 patients preferred adaptive DBS over conventional DBS. We know that the neurologist had to spend less time on programming or adjusting simulation settings. But what does it look like for an individual patient? This particular patient on conventional DBS sets still 4.7 hours of symptoms with adaptive DBS, this patient was symptom free for 16 hours so the entire day. What would you do with an extra four hours of quality time quality time during the day? I hope I've convinced you that these technologies can address these barriers of adoption. Unlocking 3.6 billion dollar market potential. But this is a platform technology. DBS today's in use is used in many disease areas with a total addressable market far exceeding 10 billion. So we're not the only game in town. Newronika and Medtronic have developed adaptive DBS. In fact, I was at Medtronic I was part of that team at one point. Our system like Medtronic system has now clinical data and shows that adaptive DBS is superior to conventional DBS, but the Newronika has system is technologically advanced, is slightly better than the Medtronic system. So what will happen over the next years, Medtronic and us will focus on adaptive DBS. Boston Scientific and Abbott have not invested in that space. And of course, Veronica can be acquired by either Boston Scientific or Abbott so they can catch up. But they are not the only exit option for us. Existing DBS or neuromodulation players that are not in DBS today could access the most advanced full DBS system and enter the market and become market leaders. We can also go for an IPO in 2027. So what needs what remains to be done? We already have CE mark for our conventional DBS system that actually has adaptive DBS under the hood and have submitted for MDR compliance CE mark. We expect to receive that CE mark by the by next year, which will open the first potential exit window for the US we need to finish our pivotal trial which has started and that should lead to a full approval by the end of 2026. With a second exit window in that year, for as I said already upon potential IPO. So Newronika is raising currently 30 million euros. More than 10 million of those are subscribed already. We are addressing a massive market of 3.6 billion in Parkinson's alone, over $10 billion. If you add just one or two more indications, we have proprietary patented technology that matters because we have clinical evidence that shows that we can improve the life of patients with Parkinson's disease. We offer multiple exit options as early as 2025. More likely 2027 when we can claim us approval, sell ourselves or go for an IPO. Thank you for your kind attention. And I have one minute and 20 seconds for questions. Any questions? No. If you have any please talk to me at the conference.


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