Ana Maiques, Neuroelectrics - Cloud-Based Personalized Neuromodulation | LSI USA '24

Ana Maiques  0:04  
Today we are going to talk about Neuroelectrics which, of course, is my company. I'm the CEO and co founder. But we think it's an amazing company. Because we are taking a different look at brain diseases, we think that we can change the way we really treat diseases by approaching a neural circuit therapeutic therapy. And I'm going to talk a little bit more about that. So we are a late stage clinical company, we are in a phase three registration study. But the beauty is that we've been selling our devices worldwide in 75 countries. And we have a manufacturing capacity in the research field, and we raise 20 million in our Series A, so let me drive you to what neurologist is trying to do. So you in the audience, one out of five people is going to develop a brain disorder, either Alzheimer's depression. And I think that part of the problem while this conference is so great, is because many, many patients don't have a solution in pharmacological brand. So we think we can bring a new approach by those patients that are not responding to meds. So what are we doing at the company, and part of the reason why they invited me here is to wear my cab, which I will do in a little bit. But I think that this is a snapshot of what we are trying to do at neuroleptic. So on one side, we will map your brain via EEG, MRI or other modalities, to then build a computational neuroscience model of your brain, we call that a neuro twin a digital copy of your brain. So then we can design the best protocol for your brain for your pathology, and then provide non invasive brain stimulation at home. So as you can see, this is Novell, I don't think there is any other neuromodulation modality that can do this at home non invasively. And this is how it works. So let me wear my famous cap right now.

So now that you're looking at me, this is as you can see, this is wireless, I can move around. And it's plenty of electrodes, we have up to 32 electrodes, and any of the electrodes can monitor my brain activity, which will look like this. So this is a traditional EEG with dry electrodes. But what we are most excited about is that any of the electrodes that I'm wearing, can inject electrical currents into the brain, non invasively. So you have a platform that is capable of doing Read and Write non invasively in a wearable wireless form. So where are we going to do with this nice cap. So I think it's treating disorders at the circuit level. So when you suffer from depression or from epilepsy, we believe in your electrics that is a circuit link approach. So maybe your depression has a mood disorder, or he has an Adonia, or different symptoms, and those symptoms are related to secrets in the brain. So with this technology, we can really stimulate secrets in the brain in ways that it wasn't possible before. Based on this device, we can monitor your brain activity at home, and then build a neural twin of the patient. So we collect your EEG in real time when you're at home, we uploaded into our computational model, and we build what we call a physiological and electrophysiological model of your brain. So imagine, like flight simulators for pilots before you go into a plane, the pilots do a simulation, right? Why can we not do that in the brain? Why do we need to prescribe you a drug or our device without trying to understand you're going to respond? So this is where I think AI and specifically computational neuroscience can change the way we deal with brain diseases. So this is the snapshot of the technology. But let's see the data. So we are committed to bring this nice gap into the clinical world and our first indication is epilepsy. Why epilepsy is one of the most studied neurological diseases we understand pretty much how it works with EEG, we can identify seizures, and there are other sorts of neuro modulation like VNS or RNs, that are really on the market. So what is the problem in epilepsy? The problem is that in the United States today, there are 3.4 million patients with epilepsy. And 340,000 are not responding to medication and they have a focus. So it's pretty amazing. If you think about it, that today in the United States, out of those 340,000 patients, only 3% are getting surgery, either acronym to me, or an implanted device. That means that today 331,000 patients are having seizures without any control of meds. And let me remind you that you can die or kill yourself from a scissor. So within this is a huge treatment gap. And and we believe that with our approach, in this case, Here's what we do in epilepsy, we ask the neurologist to tell us where the seizures are coming from. Remember, this is focal epilepsy. So they do an MRI, and an EEG of the patient. And they depend in our software, where the seizures are coming from. And blue is inhibition. So we inhibit the focus. And then we build a 3d model of the brain of the patient, whether it's, you know, with the MRI, and we calculate for each patient, how many electrodes and how much current we need to inject to target that area. So fully personalized to the patient, brain and to the patient pathology. And then as you can see our copies customized only with the locations on the head that are linked to the protocol that we have designed. So this approach we did for an FDA pilot, back in 2019, at Boston Children's, and we show how, after 10 days of stimulation, 20 minutes every day, we could reduce seizures, and let me show the data. So 20 minutes, 10 days, we were at the Clinical Neurophysiology cover with the paper. And these are the results. So we got 44% Ceaser, median reduction with 10 days of stimulation over an eight week follow up period is pretty remarkable if you think that this patient's alternative is surgery, and they are not controlled with meds. So where are we doing with this data, we infer that into a pivotal registration study. So today, we are in a phase three registration study in more than 40 sites, 150 patients last patient in September or December this year. So we are very excited, we are at the doorsteps of ending our pivotal trial. And these are the US sites you may recognize close to others we have chalked but we have a number of us sites, but also European sites. And I have to say that I've been a little bit disappointed by this low recruitment pace in the US. And that's why I open Euro where he's going much faster. And I think part of the incentives to go into surgery has made it more slow in the US. But we are very committed to finalize this study to have FDA approval in September 26 and launch this new product into the market. This is the first time at transcranial current stimulation company goes through the FDA in an indication like epilepsy, so we are very excited. And we have been analyzing the pricing within this is a phenomenal business 25k for treatment, and 240,000 patients in target. So a potential big revenue of 2.6 billion so phenomenal business. And because I have one minute, I have to tell you that we will not stop in epilepsy. We also did an ID pilot study in depression with the FDA where we showed that after one month of stimulation at home every day, 30 minutes, we really reduce the Madras and improve the score of Madras patients by almost 73%. So amazing, beautiful data in depression that now we want to push into a pivotal phase as in epilepsy. And for that we are raising 40 million. That will take us through both MDD readout of the phase three as well as approval in epilepsy. So I think that we are bringing this non invasive technology to really to the clinical path. And I couldn't do this without my amazing team. Some of them are here, Anna and Kim. And I think that's one of the most beautiful things of an intrapreneur is to be able to bring a completely new technology into the world and we are very excited because we are very close to commercialization. So if you are in strategic or an investor interested in mental health and epilepsy, come and join us because I tell you we are going to be in the clinic very very soon. Thank you