Synergia Medical | Attila Borbath, CEO

(Transcription)

Attila Borbath  0:00  

Hi everyone, I'm Attila Borbath, co founder and CEO of Synergy Medical, we develop the Neo VNS, a new approach with up to electronic for vagus nerve stimulation in order to help epileptic patients. Epilepsy is a big, big problem in our society. And as you can imagine, 1/3 of the patient are drug resistant, that means that they don't answer to any medication. So that means that in their life, they can have a seizure at anytime, anywhere at work at home, even while driving a car. So there is a solution for for a part of them, which is brain surgery. And for the for less than 40%. The last option is neural stimulation. So there is a treatment option, but the current treatment have major limitations. The first limitation is that there is only one type of stimulation for all the patients there is no personalization. The second limitation is that there are many technical constraints. One of them is that military component doesn't allow MRI scans. And the non rechargeable battery generates multiple replacement during the lifetime of the patient. Last but not least, there is only one supplier out there for neural stimulation to treat epilepsy, drug resistant epilepsy, and it has only 14% of market penetration. So we do have a solution we have developed near VNS, the industry for excuse me Opto, electronic neurostimulator that that gives the ability to deliver targeted and personalized stimulation to the patient. And also that enables safe MRI to the patient. How do we do that we have developed optical fibers that are replacing the classic electrical wires, and a nonmetal pulse generator that allows us to deliver personalized treatment and to be safe and easy to use in MRI and functional MRI. Secondly, we developed a fast and efficient rechargeable battery less than 15 minutes every week. That means that we have able to obviously increase the device lifespan but also to divide by three to replacement surgery costs, which is very important. We are very patient centric and increase the efficacy through tunable stimulation and multiple sensing capabilities with the IPG. And finally, we improved dramatically the quality of life of the patient and the safety by developing also ultra small device user friendly remote controls and alarms. When we created the system, we thought that we would bring a value proposition for each stakeholders, obviously the patient with a optimized and personalized neurostimulation parameters, improved quality of life, the physicians, we have developed an artificial interval intelligence assisted patient treatment and monitoring. And we are able to understand the drug resistance epileptic patient through the ability to correlate neurostimulation parameters with brain activity. Of course at the hospitals there will be fewer patient left without a solution and also reduced personnel workload and surgical cost. Finally, society is has an impact as well, by removing worries, stress stigma, and also reducing the healthcare costs by circa 50%. It's a huge potential market. 65 million people affected worldwide worldwide, half a million every year diagnosed in USA and Europe is the fourth most common neurological disease worldwide. And we have estimated the serviceable obtainable market to be around 20 billion US dollar with one point 1.15 million patients it is obviously also a market that has a potential scale of opportunities. As I said, there is only one player out there and when we look at all the advantages that we bring, compared to what is existing, we definitely say that we have a disruptive technology that answers many, many problems that are around. Obviously there are other industry players like neuro pace and Medtronic but they assist them to treat epilepsy. It's much more invasive than ours. For the other players, they are not not treating epilepsy or not even treating, not even doing Vagus Nerve Stimulation. Today we have some Have strong preclinical validation. So, that means that we have done in vitro validation first, as you understand opto electronic system is quite new, it's a first ever system that will be implanted. So, we had to actually test bench test the functionality. So, with a with a photovoltaic cell converter, we are able to stimulate the nerve with electricity. Having non metallic fiber optics, replacing the electrical wires and non metallic casing we had to test the MRI safety completely that has been done also on bench test. Then we started animal studies with small animal first rats with simulating the sciatic nerve of a rat successfully with electricity. And since more than a year, one and a half year, we are now doing large animals. So we have 20 sheep that have been already implanted with our system. And we have able, we have been able to prove the safety, the implant stability, the outcome, the biocompatibility and the functionality of a new VNS system. So leveraging on all this animal data, we are now currently running a GLP study on approximately 30 Not approximately exactly 30 sheep according to FDA requirements. And and the goal is to start the first inhuman feasibility study by end of this year, that will prepare us for a pivotal study and filing the IDE with the FDA. So it will be a random controlled, random randomized controlled trial of two years that will lead us to the market approval CE marking and FDA approval by end of 25. Of course, we do have competing financials we have done we have done all sorts of homework to see if the device has been the possibility to being reimbursed. We have the code for reimbursement, and we established a pricing for USA and Europe. We will be cost effective we'll be reducing as I mentioned before, the healthcare costs by 50%. And we have a very compelling cost of goods which allows us to reach a gross margin that is very interesting. For that we will also plan to raise money we are preparing a series B of around 20 to 25 million euros. Of course there is many other opportunities. VNS is also able for depression, but for dBs, we have also Parkinson disease that is important that to understand that our technology allows us to address all those markets. We have a strong team i co founded the company with myself and Pascal Duguay who is the inventor of other implantable technologies. One of them was acquired by Intel paramedical now is livanova. We have world renowned advisors. That is the medical Medical Advisory Board is chaired by Professor Dr. Levy who is the immediate past president of the International non regulation society. And our chairman. Chairwoman. Sorry. Sophie Bhatt is the former general manager at livanova. I think it's over but that's a summary of my presentation. And I thank you very much