Alois Hopf, Bottneuro - Non-Invasive Custom Made tES/EEG Device | LSI USA '24

Alois Hopf  0:04  
My name is Alois Hopf. I'm a neuroscientist by training, Chief Science Officer and co founder of Bottneuro. Meow mind this is our product for non invasive, personalized, non invasive brain modulation for the treatment of neurological diseases, mostly for the treatment of Alzheimer's disease. Alzheimer's disease nowadays is one of the major healthcare challenges. Globally, there are up to 50 million patients suffering right now from the disease, and up to 11,000 new patients diagnosed with Alzheimer's every single day in Europe and the US combined. So in Alzheimer's disease where we have we have actually an accumulation of neurotoxic protein, which then leads to neuronal degeneration, neuron death, disruption of brain oscillations, which then leads to a decline in cognitive function in functional capabilities of the patients. And finally at the end to the death of the patient. Till now there is no treatment, there is no satisfying treatment available for Alzheimer's disease, which shows important especially with an aging society we're living in and predicted there is going to be any regrade or GE HealthCare change in the future. So in recent years, there are a couple of non invasive neuromodulation technologies emerging, which have shown promising results in restoring neural oscillations in restoring functional capacities in restoring cognitive functions in Alzheimer patients. And finally, also to slow down the disease progression. So one study I want to highlight is from from two years ago, where we have shown that repeated application of transcranial electrical stimulation in eyes time of patients over several weeks a month actually leads to an improvement in a memory index score, so leads to an improvement in memory function. And this is also prolonged off the off the end of study. Another example, just recently, a US startup doing auditory and visual stimulation. In Alzheimer patient published they have very promising results in improving functional functional capabilities in isothermal patients. So what we're doing we have developed over the last year I will castmate Mi Mi Neuro Stimulator for more multi target electrical stimulation of, of brain regions. And what we do here and as we apply transcranial electrical currents, to very specifically enhance neural activity to entrain neural oscillation and restored therefore, the healthy brain activity. And where we start for each patient, we do start on an MRI scan with an MRI scan of the patient. And based on the MRI, we can derive the 3d anatomy. So this is why this cap fits me perfectly. And I can ensure that if available again tomorrow, or in a week, or in a month, the electro position of position exactly at the right location, it's very easy to set up, I don't need a physician who who helps me to set it up, I can have it at home, I can treat myself, I do not need to go to the hospital to get my Alzheimer treatment. And importantly, going for a personalization also the electrode locations are personalized to to ensure that we have optimal stimulation and optimal simulation in the target region. If you look here at patient two and patient three, they both receive a kind of off the shelf stimulation, or off the shelf electrode montage, they both received the exact same current applied the exact same location, they just have got the same treatment. But at the end the electric field what you see in the CoLo among those patient looks completely different. And the electric field in the target is the accuracy of Butik dosage. And this difference mean you're curious to difference in in anatomy, some patient have maybe a sick of skull, they have differences in white matter grey matter CSF compensation and electrical conductivity. So, because of death is absolutely essential that we have this person station to know what we are doing in the brain to know and to protect the actual the treatment outcome and have and reduce the variability. As I said, I mean nowadays there are some emerging technology coming on one hand we have more on the medical device side, for example transfer magnetic simulation, which is showing very promising results in treating Alzheimer's disease in phase two trials. Also in the at least in the US approved anti amyloid treatment, very criticized for effectiveness but not least the thumb thing. But both of these technology. We are we can debate how effective those are. But both of them I see have critical limitation and this is they do require in clinic assessments in, in clinic treatment, and just considering there are 11,000 new patients every single day in Europe and to us, this is just not applicable for for a broad population, every healthcare system will, will come to its limit with those with those treatments. This is why from the very beginning on we focused on designing developing device which can be used at home, which is suitable for home treatment, and which is not a burden or a huge burden for the for the healthcare system. Yeah, just very short. I mean, we have now current different approaches for going to market. And one approach where we can actually already go now at least in Switzerland and Europe to go to market, as our device was recently registered as custom made device in Europe which exist, which allows physician even without a CEO or FDA clearance to prescribe the device and for us to generate first real world data getting feedback from patients in clinical settings outside of clinical trial. So over the next years to 2728, when we actually expect to get FDA curious effective treatment, we expect that we can treat up to around 3000 patients, which is also a scope amount of devices, we as the startup can handle ourselves we can we can push we can manufacture and we can distribute. Afterwards we will have we are for global commercialization and broad market penetration, we will we have to partner up with the big companies. So this is what I meant. This is currently with the customer ID registration. We focus as this is only accessed in in Europe or Switzerland, UK and the European Union. We talk it now in Switzerland, many private clinics, small specialized clinics, mental health clinics, and private clinics through get first VR first feedback. So currently, we are expanding, looking for collaborators distributors, mainly in the UK and European Union and also saves people actually bring it to the patient. And then last a half the United States and 27 This is the more so an old slide deck. Yeah, okay. On 27 Going to the US market as a US FDA cleared de novo clearance of a therapy. So currently for this approach we are running or we just run our first in human clinical trial in Switzerland in a handful of healthy subjects just finished the tri last field intervention phase last week, and are now preparing our next trial to prove proof of concept showing first efficacy of our treatment of our therapy in actual Alzheimer patients in Switzerland. So, over the last year, we have incorporated Bottneuro SpinaFX from University of Basel, where me and my co founder posts worked out over the years we have received millions of non dilutive funding to push them to analyze and investigate mechanism faction in 2001. We have incorporated and since then, we have raised approximately 7 million US dollars for mainly the technical development of the device, getting all the technical documentation cytotoxic QMS system to actually bring it to market as custom made device and also to run our first inhuman safety and feasibility trial right now. Now, we are at a stage of pre Serie A, we are racing Serie A, to continue to push the market launch in Europe and to run our our next clinical trial. So Ashley mentioned Beckman Smalley, the co founder of Bottneuro. With me, we are currently a team of seven FTS various background science tech business. And we are backed up by I would say a very strong board. We have former CEO of Medtronic, Switzerland, former CEO of Novartis, Switzerland, in our board helping us in business development, having huge networks having the experience and know how to scale and in bringing medical devices to to to application. Also our Scientific Advisory Board having Harvard professor I mean something he and Christoph Misha to KOLs in the field of transparent authentic and simulation in ice Hymans disease. So this is what I mentioned. We are currently raising 10 million US dollar to bear to go for the market launch, to bring our device to clinical application in Europe to extend our sales team and distributors and very importantly to push for clinical development to go for a proof of concept trial and as a preparation for our pivotal stage trial. Which is comes next in the US to get FDA clearance by the end of 2027 2028 So feel free to reach out to me and happy to discuss

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