Attila Borbath Presents Synergia Medical at LSI Europe '23

Transcription

Attila Borbath  0:05  
So I'm Attila Borbath. I'm the CEO and co founder of Synergia Medical. And I'm going to show you how we are shedding light on neurostimulation. Indeed, Synergia Medical has developed the first ever non metal opto electronic neurostimulator for the treatment of refractory neurological disease, it's definitely a disruptive solution. And as you will understand it has multiple advantages. We have identified the market potential and because we have already one big player out there, we know that is clearly identified. And it will it is a large market potential. We have been quite successful so far after a couple of years of development. We have reached our pre preclinical study which was designed together with FDA it's a GLP study on on 40 sheep. And the results were excellent. Now we are preparing for doing the right the right thing which is implanted on a human being. So the first thing humans planned for 24. Together with an early visibility plan study in the United States. Later on, we're going to go for the pivotal trial. And I'm very proud about our IP portfolio, 55 patents that have been already granted. Obviously, as many of us are passionate and experienced team. And we are here actually I'm I'm here to raise a round of 25 million that will be used to cover or clinical studies. The beauty of our technology platform is that with one platform we can address three major markets. And as I said, these markets have been already proven by our competitor. The first one is drug resistant epilepsy. The second one is treatment resistant depression. And the third one is refractory chronic migraine. All in all, the market potential, according to our analysis is ranging from 24 billion up to 96 billion euros. So we have a first indication which will be our go to market indication. And it is epilepsy. And more specifically, those epileptic patients who are not responding to drugs, that treatment resistant, and it's called drug resistant epilepsy approximately 1/3. Obviously, Epilepsy is a major neurological disease, the fourth most common one, and its impact by not having a solution is very important in terms of quality of life. But also patients are living in the constant fear of having a seizure that can happen anytime, at work at at at school, when driving if they are authorized. But most importantly, these impact is important, even more important for children because it leads to cognitive impairments, a poor quality of life. And an increased risk of comorbidities. Good thing is that there is a treatment solution, including surgery. And within surgery we have vagus nerve stimulation, also called VNS. So as I said it's a proven therapy that is used for epileptic patients since 25 plus years now, it is an adaptation of an old technology based on pacemakers using metal implants. But it is proven it reduced seizures, it shortens the duration, the frequency, there are less severe. However, there are some limitations and important limitation when digging on this on this phenomenon. The use of metal renders the treatment difficult to perform MRIs. And there's also a risk of current leakage that leads to neck pain and voice iteration as a side effects. On top of that, the current treatment option has a battery life that actually needs to be which is limited and needs to replacement every three to four years, sometimes even every second year, which is really difficult. Strong limitation for children talking about MRI limitation. MRI and functional MRI are essential because their brain is evolving and monitoring. Still measuring brain is super important. Finally, the replacement every second or three years is a year Huge limitation for the parents who doesn't want to implant the children because of that. So, we have a new approach using optoelectronic. And as I said, we have developed a very first Neuro Stimulator implantable neurostimulator, using that technology. So that disruptive technology actually delivers the same therapy as the existing one, but allows for additional benefits, it enables nonmetallic components by biocompatible materials, there is no risk of corrosion, no current leakage, and there is no lead breakage sorry. On top of that, it also allows the use of optical sensors in order to do some analysis and closed loop stimulation. So, the name of our system is called NeoVNS. I would say it's a classical neurostimulator in a way that it has a post generator that you see here, the post generator is made out of quartz, it is a highly efficient rechargeable battery, thanks to also to optics alignment system. And this pulse generator, actually sense light through a lead, which is an optical lead, it's an optical fibers made of biocompatible polymer fibers. And at the tip of the optical fiber light is transformed back into electricity into very mild current impulses through a helical electrode that smoothly wraps around the nerve. All this has a huge advantage of being transparent to MRI. That means that obviously, there is very little artifact for the imagery. But more importantly, it is 100% safe to be used in MRI. And on top of that, we use that functionality to also have a possibility to fine tune the stimulation parameters using functional MRI. And this can be also done remotely with a remote programmer. I talked about the transparency of the casing that allows some sensors that also using light in terms of sensing biomarkers within the body. And that's obviously useful to do some closed loop therapies. When designing this device, we have thought about all the different stakeholders, not only the patient, but all the stakeholders. So we believe that we bring value for all of them. Obviously, the patients as I said, it's an improved therapy management. It reduced the number of surgeries and it leads peace of mind quality of life in terms of MRI exams. For the pediatric population. I said it's a really a showstopper because of the replacement of the device every every third second of three years, but also the maturity of the brain that needs to evolve and the comorbidities that those children have, absolutely needs to have MRI that that is very difficult to do, currently. The physicians we are discussing with we have a fantastic key opinion leader Advisory Board are super excited because actually we will open the black box of understanding by using stimulating the patient while doing functional MRI. And finally, you understand that the payers are very happy as well because you will have less replacements. Our clinical and regulatorily regulatory pathway is very clear. We finished our vnv test. We are starting our Pivotal, surreal first inhuman next year in Belgium but also early visibility in the United States. That will be followed by a pivotal trial in Europe and United States which will be a limited 111 arm study in each of these studies. We will leverage the results of livanova who is doing a huge reimbursement study on depression to run a pivotal study and later on we will be discussing with FDA we have some ideas to leverage on the result of the epilepsy to get the pivotal study for depression much faster. As a Third Indication as I mentioned, we also investigate chronic refractory migraine because VNS is showing fantastic results externally and an implantable device makes makes a lot of sense. Obviously we have a fantastic team as everybody does here. But most importantly my executive team of very experimented in medical device and we are in total 35 People at Synergia Medical. That's the wrap up. And as a conclusion, I want to say thank you. We are live, we are raising 25 million to finance all our clinical works. And last but not least, I want to leverage, highlight or awards. Two of them the European Union innovation consulting accelerator program. We won that last year. It's a 2.5 million grant plus 7.5 equity. So the next round is already partially covered. And I'm very proud to say that we want the Belgian Galeon prize we recognize the most innovative and disruptive medical device. Thank you very much.