Nicolas Vachicouras, Neurosoft Bioelectronics - Minimally Invasive Brain Implants | LSI USA '24

Nicolas Vachicouras  0:03  
Thank you very much. And good afternoon, everyone. My name is Nicolas, I'm CEO and co founder of Neurosoft electronics, where we're building minimally invasive brain interfaces that can read and writes into the human brain. So think of some of the most devastating neurological disorders out there. People who suffer from epilepsy, severe tinnitus, deafness, blindness, or people who have lost the ability to move or speak due to spinal cord injury or stroke. So these are disorders that impact hundreds of billions of people worldwide. And until recently, there wasn't much that could be done for them. And so one of the big hopes for these patients is what we call brain computer interfaces. And in particular, in our space. These are implantable medical devices that can both record activity of the brain or electrically stimulate the brain. And with this, we're able to not only monitor but also treat or restore loss functions. And so this is exactly what we're doing at neuro soft. And we have developed a very unique platform technology and interface that allows us to interface with the human brain, both recording and stimulating. And these are electrodes that remain at the surface of the brain. And what's very unique about our approach is that we're using materials that are not only much thinner than what's currently available on the market, but also my software. So it's not only flexible electrodes, they're actually stretchable and elastic. And this is extremely important for three main reasons. The first reason is safety. We match the mechanical properties of the environment in which we're implanting our devices think of the brain as pannacotta, to food extremely soft. And this is critical to decrease foreign body reaction, which has been one of the big bottlenecks in the industry. But we can also reduce the risk of subdural hematomas, or brain compression. The other nice aspect of having stretchable electrodes is that we can access the full cortex. So most of the cortex is actually located in the salt chi, which are these valleys of the surface of the brain. And being able to access these regions opens up a lot more clinical indications that we can address with these technologies. The last important part, which is the most important one is that we are able to leverage our electrodes that we can fold and unfold without breaking them because they're elastic. And this opens up the possibility for minimally invasive approaches. So instead of doing a huge opening in this call, as it's currently done, we can deploy the electrodes kinematically to us more berhow leveraging the fact that we can stretch and stretch these electrodes without breaking them. Another important aspect is a lot of the current technologies on the market are using handmade prop manufacturing processes. And we're leveraging semiconductor industry manufacturing processes to manufacture devices. So we have set up a full medical grade manufacturing line with an ISO certified quality system in Geneva, Switzerland, where we're based. And one of the main impacts of using semiconductor manufacturing processes is that we can increase the resolution of these devices. So think of it as a TV screen with more pixels, we can provide much better resolution when we record but also when we stimulate with these devices. So of course, as you have more and more channels, more sensors, you have a lot more data than your Corinthia able to address. And so this is where in our industry neural interfaces, you can leverage artificial intelligence and machine learning to understand what's happening on the brain by looking at this data. So one of the particular interests leveraging these tools is to detect biomarkers in particular for epilepsy and traumatic brain injury. But we can also use it to decode brain activity, we can understand what's happening on the brain, we can understand the intentions of the patients to move or speak by looking at the brain data, leveraging AI and machine learning. So this technology has been developing for many years, we have demonstrated it in rats, pigs, and monkeys both for recording and stimulation, actually, not only from the brain, but also spinal cord and peripheral nerves. And we have more than 20 peer reviewed articles where we have demonstrated our technology. This has allowed us to build up a large IP portfolio, we have a lot of know how trade secrets but also patents 16 granted and 11 pending. And one of the very big successes last year that we're extremely proud of is that we're able to do our first in human recordings. So this was performed in Houston, Texas, with the facility in tandem, where we leveraged patients who are undergoing brain surgery due because of epilepsy or brain tumor to test our devices. And so we were able to demonstrate safety but also the ability to record high single quality from these patients. So you can see here some data from an epileptic patients and you can see the epileptic activity and these high frequency oscillations here. So, as you can imagine, interfacing with the brain opens up a lot of potential applications. So on this graph on the bottom parts, we have partnerships that are currently ongoing, where we just provide the electrodes and people are exploring typical brain computer interface applications that speech and motor but we're actually interested in something very different. So first product is an interface that is intended to be implanted for up to 30 days. This can be used for epilepsy or brain tumor surgery. What is very nice it's it's a class two medical device For five with a 510 K pathway, but we can also leverage it to explore different indications. And so one of the main indications we're interested in in terms of a treatment is severe tinnitus. So in the last three minutes, I want to tell you more about severe tinnitus and what is the link with brain computer interfaces. So this is Ken Taylor, he was the founder and CEO of Texas Roadhouse, huge food chain in the US. And he started having severe tinnitus, which is this ringing in the ear, but it was extremely severe. So think of it that that jet airplane taking off in your ears 24 hours a day, seven days a week, it was horrible, and he eventually committed suicide because of that. So tinnitus is actually a huge societal problem, about 15% of the world population suffers at some degree from tinnitus. Fortunately, most cases are mild and can be addressed with noise cancelling, or a fan or stuff like that. But for a very small portion of these patients. This is extremely debilitating. And it's still 120 million patients worldwide who suffer from severe tinnitus. So it's as bad as what can have chronic, extremely loud, no treatments this today, there's nothing that can be done for these patients. So there's a huge opportunity here. And you might wonder what is the link between a brain computer interface and the something that seems to be a problem in the ears. So what people have discovered is that in these patients, you have rewiring of the brain, abnormal brain activity, actually hyper synchronization near the auditory cortex that is causing this issue. And so we're leveraging some knowledge from the past 10 years. And in particular to studies there was a study in 50 patients who has been shown that it is possible to stimulate the brain and to completely suppress this sensation. And this was done by one of our advisors, the QP, leader in the field of tinnitus, and surgeon conference with the Heda. And more recently, we were able to do a non invasive fMRI study where we leveraged what we knew, but also be able to discover other better targets for our neuromodulation. And so leveraging this we have a clear mechanism of action. And our goal is to do a pacemaker for the brain, where instead of stimulating the heart, we're stimulating the brain with our electrodes to completely suppress or drastically reduce the sound perceived. So this is really one of the first devices really trying to treat severe tinnitus. And so of course, not everyone wants an implant, but considering only the people who are severe who fit their criteria and who would be willing to get an implant is still a multi billion dollar opportunity. So we're a team of 13 people, mostly based in Geneva. We have expertise in quality regulatory Clinical Affairs, also manufacturing r&d, and we have great advisory board that spends all the different expertise that we need for such an endeavor. So up to now we raised about $12 million. A lot of it has been so non dilutive funding, and we're currently raising $50 million. We already secured some part of it with that grant and are closing earlier this quarter. And we already have some commitments, but we're currently looking for other investors. And this will allow us to reach two big milestones. The first one is to commercialize in the US our first version of our device for up to three days. And also to do a first proof of concept study with our electrodes for severe tinnitus. So I'm happy to talk if you're around for the end of the day. I have no devices here if you want to see how they're very unique, and thank you so much for your attention.