Tareck Raafat Presents G Life Quantum at LSI USA '24

Tareck Raafat  0:05  
It's a pleasure to be here and to present your G life quantum you have today with us. Sebastian jarelli is also the co founder. He had heart surgery pediatric and adults, and myself, I'm supporting him on the CO role. What is our technology based on? Our technology is based on the principles of photobiomodulation. Maybe I've heard about photobiomodulation, but just as a recap today, it's an it is used in the process of pain management, tissue management, damages. It's copper, extracorporeal, assessed, applied, and as it is applied extracorporeally, there are limitations, and these limitations are related to the dosimetry and the radiometry, which do not allow, at the end, to establish a standard of care protocol. You will see here, quickly on in a video, how it looks like so these photobiomodulation is already applied in the US, as you know, since about 40 years, and is classified by the FDA as class two then. But when light passes through the different layers of the skin, as you see here, what's happening. You cannot control it. There's a lot of scattering, there's a lot of absorption and reflection. So this means, despite the positive impacts and effects that you see, you cannot establish a proper standard of care protocol. So what have we been doing? We bring this to the next level. The next level means, at the end is where the whole power lies here. Because what we are talking about, we are talking about light, photo, photonic emission interacting with biological tissue, which is a very important impact, as you know, since many years. Let us show show you how it looks like we name this technology, quantum biomodulation technology. Here's our laser source, a fiber optic and a catheter to enter as here's an example in the heart muscle. What are we doing? We are we are targeting the cardiomyocytes and more particularly, the mitochondria. What's happening in this process? As we have clear focusing, we work on ATP increase, no release and ROS modulation. So at the end, it's a key mechanism of action that we are triggering is the modulation of ATP, Ross, no and others, and as such, we are driving a first epigenetic treatment approach as we are influencing the genomic expression. So what is very important about this technology, it is extremely reliable and reproducible, and we allow a dosimetry and radiometric approach extreme high precision. So this means we can establish a standard of care protocol. I will not discuss the technical parameters, because these are in line with what photobiomodulation is about, and is in line at the end what the FDA already classified, the guidance that came out beginning of 2023 and we are clear there is no any modification of biological tissue. Just to summarize, very important, we provide precise dosimetry, very high efficacy, very easy to use. Here's a percutaneous technique I will showcase you very much on our first indication and to be administered easily in different settings of care. What are we targeting as first indications? So this is just a spectrum. What you have to think about we are providing a platform technology as we are driving the mitochondria, this platform technology is agnostic to many diseases in our body. As you know, the first indications we go after are in the secondary care setting, ARDS, acute respiratory distress syndrome and acute coronal syndrome. Mortality rates for ACS around 20% and up to 40% plus for ARDS today, when you look at 30 day, readmission rate is one out of five patients within 30 days. And just for these two indications, the expenditure to the US healthcare system alone is 50 billion plus. And we are conservative here when you look at just the key initial markets, we are focusing on US and Europe five we have 2 million plus patients. You can imagine how many patients are dying these days and how many secretly we have, for example, on ARDS, when you go on mechanical ventilation. We are targeting a 10 billion estimated market size just for the six markets. So let us have a look and delve a little bit into ARDS. Our first indication to come, I will show you a little bit how it looks like. So this is how the lung is exposed to ARDS. Drastic difficulty of breathing, high mortality rates when you get put on mechanical ventilation and. We apply a very simple cell genome method to do what to introduce the fiber optic into the right atrium, and what are we triggering? We intervene at the end as a primary endpoint on the PIO two, FL two ratio, which is guiding the ARDS, we have demonstrated significant statistical improvement, and with seven days of treatment, we expect reduction of mechanical ventilation, reduction of ICU stay and 30 day readmission rates. This is improvement picture that you will observe. Where do we stand? We have completed today the pre clinical trials, 25 pigs. The results are outstanding, fully consistent. We are aiming for the human trial to start by end of this year with a class two classification and potential breakthrough designation by the FDA. We demonstrated, and this is what you reproduce on the primary endpoint, statistical significant improvement. And we have very positive trend on o2 reduction on P 50, and all of this benefit for a very strong patient recovery. Let us look at our second indication, which is about one year behind, which is acute coronary syndrome. Let us start about where we stand. So you have to keep in mind, we have about more than 500,000 patients, and you are suffering from ACS today, when you have the heart here with the ischemia lesion, what we are doing is we introduce our quantum biomodulation, either during cabbage or PCI. Here you see a cabbage, and we do this in a pre pair and post condition just for a few seconds, so it does not change the standard of care, really a few minutes that we are driving it. And you see on the left side the perfusion without our technology. On the right side, this technology. So when you do an MRI scan on this I can tell you that the lesion, number of lesion, is dramatically reduced. So we are really increasing cardiac contractility, and at the end, we are reducing hyperfusion injury. So you can imagine it's like when you have an heart attack. What's happening? About 50% of your heart cells during the perfusion process are dying, and we can reduce this tremendously. Where do we stand engaging with CFDA to secure class two, driving a breakthrough designation with human testing to start by the end of this year, whereas at the end, we believe a commercialization process happening during Age two of 2025 we are looking for a range of 15 to 30 million to do what, to continue our pre clinical trials on ACS, to Run the human trials on ARDS and to go into the sales and distribution process. So far, we have been funded to about 3.5 million by BPI France and private angel investors. The team is a very strong team about different expertise areas. You have Sebastian myself. Here today, we have a very strong Head of Technology Center driving with the cdmo, where Jabil is supporting us. We are doing our preclinical trials in house. So this means this gives us an agility, a flexibility, to be extremely fast. And as you know, for example, also in Europe, the MDI 2017, change, as we have all to do, also in Europe, in our pre clinical trials, we have this capability in house, and our Chief Commercial Officer, more than 20 years in the business, has been working on driving strong partnerships and how to drive access and uptake in the business. So we welcome you to prepare humanity for the Quantum Age of medicine. Thank you very much. Applause.