Video Transcription
Ana Maiques 00:02
Hello everyone. Good morning. Thanks for being here so early. Free coffee for you all, and hope you have a nice day. So I'm Ana Maiques, founder of Neuroelectrics. Let's get started.
Ana Maiques 00:22
Hello. So you're listening to a pretty sad song, right, which is good for the beginning of the day. So what about if I tell you that this is not a sad song, it is a representation of a brain suffering from depression. So when a brain suffers from depression, it has what it calls frontal asymmetry, so the left part of the brain has less electrical activity than the right part. So with the song, with the sad song, I tried to show you how these two hemispheres are not properly talking together and therefore creating this distorted sound. So what are we trying to do at Neuroelectrics? Well, we want your brains to be healthier, and for that, we have developed this now famous, also called "Lady on the Cap" technology that I'm going to wear right away. Let me see. So, as you can see, it's wireless, it's portable, so I could be easily sitting on my couch at home, and any of the electrodes that I'm wearing can do two things. On one side, we can monitor brain activity. Now that you're listening to me, your brain has 100 billion neurons that are communicating electrically, by synapses, not only chemically. So this is about the physics of the brain, and we can collect your brain signals, also called EEG, to diagnose, but what I'm more excited about is that any of the electrodes that I'm wearing can inject little currents into the brain, electrical stimulation, like the bad press electroshocks. But let's say it's very low current, non-painful, that really gets through your scalp, and it can either excite or inhibit your neuro activity. So let's imagine that what I would do right now is you could see now my brain in real time, so blue is less activity, red is more activity. So let's say that I'm suffering from epilepsy. One of the nodes behind the electrodes may be creating a much bigger red activity, so it's hyper-excited. So what I can do with this technology is use any of the electrodes like this one to target currents into the brain to, for example, inhibit neuron activity. Just make the neurons, let's say, fire less or slower. So we don't have, for example, scissors. So this is what we are doing at the company, and it's not only about this famous cap, but it's about, you know, we've been using AI for such a long time, machine learning in neuroscience, it's just impossible to understand how the brain works without, you know, the help of machine learning and language models. So what we are doing at the company is this cap is coupled with what we call Neurotwin. Neurotwins are digital copies of your brain, our physiological and biophysical models of your brain, so digital copies. So we can in the cloud before prescribing you a treatment, we can play on what is the best amount of electrodes and how many to get you the current, so this has never been done before. We have 25 people in the company only doing brain modeling. So I think this is really important to personalize treatments. And let me tell you what we are doing on the clinical side. So we are working mainly in two pathologies. The main one is epilepsy, and the second one is depression. We have pilot data in Alzheimer's, but I would say our most advanced program is epilepsy in which we are in a phase three pivotal trial. So let me tell you why we are excited about epilepsy. When I scaled our company from beautiful Barcelona to, let's say, interesting Boston, we started to work with Boston Children's, and we discovered, which was pretty stunning, that out of the 3.4 million patients in the United States that suffer from epilepsy, 1/3 are refractory, so they don't respond to meds, and 700% have a well-identified focus. So out of those 340,000, we know that the focus where the seizures are coming from are very well identified, but only 3% of all those patients today are getting surgical. So either a craniotomy, they remove the part of the brain that is creating the seizures, or an implanted Medtronic neuro pace, Levanova, kind of. So 331,000 patients today in the United States have this huge unmet need, and this is a huge market. We are pricing our technology at $30,000, so this is almost a three-point billion market. So what are we doing in epilepsy? So we ask every neurologist in our clinical trial phase three pivotal to do an MRI and an EEG of the patient. They do anyhow, because this is, remember, focal refractory epilepsy. So they need to know where the seizures are coming from. And then they paint in our software where the seizures are coming from, and blue is inhibition. They want inhibition. So our algorithm, our Neurotrans, builds a 3D model of the brain of that patient, and then we start to compute how many electrodes and how much current do we need to inject to that particular patient with the scalp thickness, the conductivity, everything we've gotten from the MRI to really get the desired solution. So here, every patient receives in the hospital a color-coded cap with the positions and the currents that they need. So this is truly personalized. And what we are more excited about is that the FDA allowed us to bring Neurotrans into our Phase Three pivotal trial. So in our Phase Three open label, we did 20 patients at Boston Children's and Beth Israel, and we compared eight weeks of seizure tracker. Remember, these patients are refractory. After 10 days of stimulation, 20 minutes every day. So the patients were wearing our cap 20 minutes during 10 days. And then we compared the follow-up period. This was we did children and adults, so nine years and older. And this made the cover of the Journal of Clinical Neurophysiology, and this is the result. So we were very happy to have a 44% seizure reduction only after 10 days, 20 minutes of stimulation. It's pretty remarkable if you think that these patients are not responding to meds, and the only alternative is surgery, and only 3% are getting surgery. So we have three non-responders, some of them, two of them, at least, were misdiagnosed. We took focus, and we only stimulated over one focus. So these results were so good that the FDA granted us breakthrough designation. And we raised a Series A of $20 million led by Morningside in Boston and Henry Tamir Foundation. And with this Series A funding, we are now doing 40 hospitals, 150 patients, randomized control trial with the same protocol. And we have 20 sites in the US and 20 sites in Europe. And we are one year, a little bit from readout. So we are more than halfway. We are very excited, and this is the first time that this technology goes through the FDA in a new modality of non-invasive stimulation. So very, very excited. And then, of course, we also funded a new study with the FDA. This was in depression. So what we did is we sent home 35 patients during more than a month, and they self-stimulated themselves with the cap for more than 30 days at home, only with the caregiver. We had ladies in Kansas, in Florida, with only their husband, and the compliance was 88%, so we are extremely happy with the compliance. And as you can see in the results, we got an amazing, this is open label, so there is no sham arm like in our phase three, but at least you can see the drop between baseline and four weeks after in the improvement of the MADRS score. So we are very excited, and for that, we are raising a Series B to finalize epilepsy and launch into the market. So we'll be launching 27, we are very close to commercialization. We recruited a Neuro Pace commercial chief, a person we are working with reimbursement. I think we have a very good reimbursement scheme because the alternative is surgery, which is $100,000. And then, of course, if we get 20 more, we'll get the MDD phase three pivotal trial. So anyway, we have a wonderful team. I'm very happy to have almost 70 people in the company and the best investors I can have. And let me tell you that my team and my investors will keep on working very hard until every brain doesn't sound sad, but it's healthy, and it all has a happy song like this one. Thank you. Fight for that white gold. This one for them. Good.
