Lothar Krinke, Newronika - Neuromodulation System for Parkinson's | LSI Europe '22

Transcription

Lothar Krinke  0:03  

$800 billion. That's the socio economic cost of neurodegenerative disease in the United States. And that number is growing rapidly. To help address this issue, Newronika has developed the world's most advanced Deep Brain Stimulation system. So what is deep brain stimulation? Deep Brain Stimulation is a pacemaker for the brain. Just like a cardiac pacemaker delivers electricity to the heart. DBS systems deliver electricity to the brain to treat diseases like Parkinson's. This is an existing market with revenues of about a billion dollars. And it's growing 11% annually. Actually, it's growing faster except the folks that write reports always say it's 11%. I came from a Medtronic. I used to run that DBS business years ago and we grew it 20% A year and I'm convinced this market can grow much faster. Why? Only 15% of patients with Parkinson's that are perfect candidates with deep brain stimulation received this therapy today. So why is that? There are barriers of adoption. While almost every patient 90% of patients have a therapeutic benefit from deep brain stimulation, that benefit is not predictable. A patient with DBS will spend some hours in the perfect state on without dyskinesias. But also, the patient will spend hours throughout the days where the therapy doesn't quite work, their stimulation and do side effects. And the systems need to manage need to be adjusted many manually, frequently. And that process is time consuming for the neurologist. And these systems need to be exchanged every couple of years which adds the risk of infection and costs to the healthcare system. To address this, we close the loop on a DBS system. Now we are not the only company that has ever closed the loop neuro pace, for example to design epilepsy and of course, continuous glucose monitoring was referenced earlier today. But in adaptive DBS our design principle was we want this system that required no change in procedure for the neurosurgeon, the magic is an implant the system measures brain signals called local field potentials and automatically analyzes these systems these signals and adjust stimulation so that the patient receives the right amount of electricity minute by minute, hour by hour, day by day. This is our system and this actually CE marked in the open loop mode. So it is see marked for conventional DBS with sensing. But does it work? So now here's the question does the video play? Yes, success. Okay, so on the left you see a patient with dBs, conventional DBS that is and the patient also took a Parkinson's medication. And when this patient reads was a peak dose when there was the highest level of the Parkinson medication present in this patient, the patient develops this dyskinesia, which is the stimulation and do side effect which is these almost dance like movements. On the right, you see the same patient with adaptive dBs, the same amount of medication on board, but the system automatically adjusted to that state. And the patient. Obviously, it's obvious even if you're not a physician, this patient does have no dyskinesia. But that's a video. So when other clinical results, I have to be honest, we only have so far three long term patients. We have many, many patients with short term data, but only long term data on two patients. And three patients I should say these patients, on average, gain four additional hours of perfect on time, on a DBS versus conventional dBs, four hours, think about what you can do with an extra four hours of quality time during the day. And then we have our perfect patient, this patient unconventional DBS and what I mentioned to you earlier, six months, five hours in the day the patient was doing really well. No side effects and the therapy worked. But almost three hours during the day, the therapy didn't quite work and then stimulate enough and seven hours a day. This patient unfortunately had these side effects these dyskinesia side effects with adaptive dBs, this patient spent all day long in the perfect state. And the rest of the day the patient slept. So essentially, the patient got perfect therapy here. We also ask these patients in a blinded fashion, which of the two modes that they prefer and all of them preferred adaptive DBS. Interestingly, only one could explain why. That patient said there's a side effect stimulation induced stimulation to speech problems. The others couldn't explain it. And if you're interested in some hypothesis why that would be, I'm happy to talk about the non motor symptoms of Parkinson's disease. These are depression these are generally not feeling well, which is hard to explain. Right? Try to explain to someone what it's like to be tired. I hope I've convinced you that our technology can address several of these major hurdles. Because we are all about automaticity. The system automatically adjust to what the patient needs. It provides truly personalized deep brain stimulation. We also now have this biomarker that will allow the neurologists to quickly program patient in quite frankly, we can automatically program the patient didn't neurologist, the neurologist will spend a lot less time on adjusting systems for patients. Okay, so we're not the only game in town, I already mentioned neuro pace in a different place. Medtronic, where I was five years ago, also has adaptive DBS. They are finishing a clinical trial as we speak, we do have superior technology because we have better sensing technology and superior algorithm. But that's not my point. The exit strategy is simple. Medtronic creates the need the other guys, Boston Scientific and Abbott do not have a solution. And here we are, and can offer that solution to them. So one of our exits, of course is to sell ourselves to Boston or Abbott. There are other potential exit partners, of course, other medical device companies that are today in the neurosurgical suite, where we go and say you have the tools for the implantation, you have the nail we give you you have the hammer, we have the nail, we might as well sell our implant. But it is a platform technology. So Parkinson's is the leading indication and DBS followed by epilepsy and pain in continents and others. In fact, we are talking to a strategic about a collaboration in an indication that we're not pursuing at this moment. We need $30 million to run our clinical trial to get FDA approval. We have our IDE submitted and we're finalizing some biocompatibility testing, generally this trial has been agreed to with the FDA. So in closing, we're looking for $30 million. And for that we will deliver in 2027 a ready to go to market system to go after Parkinson's disease in the United States. We will also be able to launch in 2025 closed loop DBS in Europe. Assuming that we can convince the notified body that we can add the adaptive mode to our existing CE mark which is open loop. We have better and proprietary signal detection. And our algorithm is far exceeds the technology that others have. I showed you the clinical data. We're expanding the market. And it is a platform with a tam, greatly exceeding $10 billion. And we have a strategy to pursue multiple exit options. And I'm on the dot Thank you