Attila Borbath, Synergia Medical - Shedding Light on Neural Stimulation | LSI Europe '24

Attila Borbath 00:02
So I'm going to present Synergia Medical, a company that I co-founded, and I'm happy to share my slides with you this afternoon. I was going to show and explain how we revolutionize neurostimulation using light. We are shedding light on neurostimulation. So we target our first device on epilepsy, specifically drug-resistant epilepsy, which is a very important market where today there is only one big player that I will talk about. Epilepsy is a worldwide problem, particularly in the US and Europe. Altogether, 3 million people are suffering from drug-resistant epilepsy. That means that epilepsy is pharmaco-resistant; there is no other solution. The medication is not working anymore, and that represents one out of three patients, approximately 30%. As you can imagine, it's a devastating disease. Not only does it cost a lot to society, but there are also premature deaths and suicide rates that are skyrocketing. Depression is also very high. So that's a real burden. If we focus on the US, we can do the same for Europe. Obviously, the typical path for an epilepsy drug-resistant epilepsy patient to be treated is to be on medication for a couple of years, and then they are referred to an epilepsy reference center, which happens 10% annually. So that's approximately 100,000 patients that are looking for a solution. Globally, we estimate this at a 4.2 billion potential market. Once they are identified in an epilepsy reference center, they do have solutions. One of them is a company I already mentioned, LivaNova, which does vagus nerve stimulation, and it is one among other possible solutions. But you can see on the left chart that the vast majority remain on drugs. That means that the solution is not adequate for them, and you can see that currently, there are some technical limitations, whether it is the invasiveness of the solution or other constraints that we are going to tackle. The two main ones are MRI compatibility and MRI safety, and the fact that those patients need to have a replacement every X number of years, averaging three to four years.

So as I mentioned, the first big problem is MRI safety. We all know that MRI has become a standard of care. Everyone will need to undergo an MRI in their life. If you look at specific populations, like women who have breast cancer, that's a very, very important aspect. One out of eight women will unfortunately have breast cancer in their life. If we focus on epilepsy in particular, one in three patients will require regular monitoring of the brain once a year. And if you look at the importance that MRI has with other neurostimulation companies outside of epilepsy, you realize that they are all claiming conditional MRI safety, and they're all fighting, so to say, to be the best in resolving this problem.

The other problem I wanted to mention is battery longevity and the fact that you need to replace it every three to four years in the case of drug-resistant epilepsy. So there is this contradiction between replacing a battery and improving the stimulation parameters, which will consume even more battery. In some cases, our competitor needs to replace the battery after 12 months, which is kind of unbearable for the patient. So we brought a solution for that—two main aspects, and this slide summarizes all the solutions that we bring in, both for MRI compatibility and safety and for rechargeability.

We have developed a revolutionary new neurostimulator, as you can see, and as you can imagine, this is done without any metallic components. The generator at the bottom of this picture is placed in the chest, and the lead is implanted through the skin to the vagus nerve. The lead, actually, that you can see here is very particular in our case because the classical electrical wire has been replaced by an optical fiber. We still stimulate with electricity like classical neurostimulation because, at the tip, at the electrode, we convert light into electricity by the use of a solar panel that we have developed. So we solved all the problems that are currently being faced. And as you can see, all stakeholders will benefit from our solution because not only are we MRI safe, but we allow reversible surgeries, and it will definitely cost less for the payers and their investment companies.

So our strategy is to go to the market and first take market share from LivaNova. That will be easy, so to say, because the market is there, and we can capture all those patients that are desperately waiting for a decent solution. Second, we will unlock the potential, which is all those 92% that remain. The third step, what we call the referral gap, is saying that all those patients that are not referred to epilepsy reference centers. This is all marketing, sales, and awareness that we will lead.

Another aspect about MRI compatibility is changing the patient journey. As you can see here, usually patients are waiting three to six years for evaluation of their epilepsy. That's a long time. Specifically, if you take a child that has been waiting for a solution until they get a VNS implant, those three to six years are actually lost. With our system, we will be able to implant the patient directly with the VNS, and during all those years, they still have the possibility to undergo all the examinations.

In this slide, you can see our roadmap to the market. We expect to reach the market by 2028 with a PMA. Currently, we are in a clinical work phase, which means that we will switch at the end of this year or the beginning of next year to the next phase, which is the pivotal trial. These are the milestones that are shown in the user. By 2028, we will generate revenue in the US, and thanks to our cost of goods, we'll be able to generate an 85% gross margin, and we will have market traction for possible acquirers by 2029.

I'm speeding up because I see my clock is running. We have a very talented, multidisciplinary team. Robert Levy was the former President of the International Non-Regulation Society. He is heading our Advisory Board, which is a mix of academic centers and large recruiters. Jackie French is the Chief Scientific Officer of the Epilepsy Foundation, and Dr. Michael Sperling is the Editor-in-Chief of Epilepsia. They are all part of our advisory board.

So why are we here? We are raising funds. We are currently raising a round of 15 to 20 million. Why is it 15 to 20? Actually, we have a commitment from our existing shareholders for already 4 million. We have won the EIC Accelerator program from the European Union, which means that we have 7.5 million in equity that is granted. So we are looking for the other part of this equity, between 5 to 10 million, to complete this round of financing. This will lead us to the completion of the first in human and the submission to the IDE.

Just a last note about this slide: it is all about our recognition. I already mentioned the second logo, the EIC Accelerator program. The first one is the Galleon Prize that we won. It is a recognition of the most innovative medical device. We are quite proud that our technology is fully published very recently in Nature. Thank you very much. Applause.