Karl Schweitzer 0:05
Good afternoon. It's my pleasure to be here I'm going to move us to the most important sense of us human beings with this vision. More importantly, I'm going to speak about continuous loss of visual field also known as glaucoma. This is the largest unmet clinical need enough technology is the leading cause for Erias blindness in the world. 80 million patients are suffering from glaucoma, that number is going to grow to 100 million within the next 15 years. So that's as if 1/3 of the US population would become blind. prevalence is 2% in the adult population, aged 14 Buff and in Asia, it's even higher to 3% of the population. Now, there is of course standard of care. Glaucoma is being addressed but it's a risk factor it's being addressed. And it is focusing on the eye which has elevated IOP intraocular pressure, which is not a good thing. So it needs to be addressed. And that is being done by the means of eyedrops surgery or minimally invasive glaucoma surgery. And even if the IOP intraocular pressures to improve down to normal limit, the problem is that loss of visual field continues. And then, as a matter of fact, 40% of all glaucoma patients worldwide do not have elevated IOP and another number 70% In Asia, so again, a much higher number in Asia 70% of all right coma patients do not have elevated IOP. So clearly, we need a paradigm shift and we need to look at more than just the eye and that is the optic nerve, there's just a camera and the CPU is the brain the cortex and in between you've got the optic nerve we need to focus on the optic nerve. Why because Glaucoma is a neuropathy disease of the optic nerve. If you look here, on the left hand side, you see the comparison between the healthy eye this is the optic nerve going into the eye and here you see the diseased or you see a thinning out of the actions you see loss of structure. And the reason we lose structure is we have oxidative stress or chronic stress on a cellular level that leads to a halt in metabolism which in turn down of course, which perceives the is perceived by the patient is loss of vision because there's no function. And if nothing is done about that, ultimately the cells will die. This is where we see it, we see a thinned out a structure of the optic nerve. Now fortunately, our central nervous system is based in electrical activity. And this is where we're playing now in ophthalmology. These are electronic stimulation gardens which have four electrodes embedded into periorbital space. It's an outpatient treatment, which you see here. And it allows us to now create an electrical field and we're stimulating from the eye through the optic nerve all the way to the center of vision into the cortex. And we know that the current arrives in the brain. Because authority patients are blindfolded by the stimulation goggles. They perceive flashlights so called phosphenes. That's a neuronal signal that travels along the optic nerve to the center of vision. We have CE mark on the therapy with the therapy is applied in 10 sessions. So 800 patients times 10 8000 sessions already done, and not a single SAE not a single serious adverse event with that therapy so far. Now, there's no magic to it. This is just neurophysiology. These are preclinical data, the mode of action behind electrical stimulation, you're counting space has widely been published. I'm just showing three examples here. Electrical current triggers a lot of activities on a neuron level, such as neurotrophic factors being set in motion but also perfusion going up, which is a very good thing. And the effects of optic nerve stimulation are threefold. We have one effect, which is called neuro protection, as to sell now gets back interests being reengaged into activity can protect itself because it nurtures itself with metabolism. Secondly, functional neuro restoration. We see on this side there's a Flatliner, the red sorry, the red frame always shows the animals that were after optic nerve injury on the sham group randomized to enter green frame show the animals that actually did get optic nerve stimulation. And you see the difference also here we see here, we do have again visually evoked potentials, we don't have any animals that have not been treated. Likewise, structurally, we see sprouting out of actions on the right hand side, we don't see any so clearly with electrical stimulation, we can accomplish those three effects in animals. Now let's look at humans. These are now one year data 101 eyes. So the treatment was given for 10 days, nothing about 350 days. And then we looked again at the Perimetry at the visual field of these eyes. And we see that in 63% 63% of all treated eyes at one year follow up. We have no further loss of visual field as a matter of fact, 59% we do see an improved vision Will field. You see this also here on the box plot? Oh, I'm sorry, on the box plot that we had on the on the, on the right hand side, the data were published 15 months 18 months ago in bioelectronic medicine and so in the public public domain, so those are patients that had elevated IOP were treated with standard of care were coming to normal level but continued to lose visual field. And with these patients then these results were obtained. And remember I talked about normal tension glaucoma patients, those who do not present with elevated intraocular pressure, or should their 12 months data we see in 69% of all treated eyes, we have an improved visual field a 12 month follow up compared to baseline. Also these data were presented last year well, glaucoma Congress, and we just got accepted yesterday for European glaucoma Congress with the latest data we're going to present in the beginning of June in Dublin. You see here again, the Perimetry is right I left I have a normal tension glaucoma patient in the red frame baseline. And again, in the right frame, you see six months and 12 months for three months and 12 months follow up. So we see a clear improvement of the visual field in these patients. The business model we are selling those codes so that a treatment cycle can be given. For 4500 to $6,000 to the eye clinics with the eye clinic gets this via email, we have zero cash, we have no inventory, we have no logistics, it's unlimited in the scalability. And then those 10 sessions can be done it needs to the code is needed to operate the system. The systems either sold or leased. If we only take 5% of Samet 26 billion we covered at 1.3 billion share of market business opportunity. Currently, as it's another technology, there's no coverage itself pay, we're going to move them to private pay through insurance companies before we move into reimbursement. On a competitive side, there's three players out there who are using electrical stimulation of technology. Two of them, Chiba University from Japan, as well as well. collisional from Germany are not addressing glaucoma, the addressing of retinitis pigmentosa it's a hereditary disease. There's only one center in Germany, the Soviet center that only in the right clinic by the founder is using electrical stimulation for a variety of indications, including glaucoma, and you see the price level down there as well. We are fundraising that's why I'm here we are fundraising for US market access for FDA trial to the tune of 12 million. We have a very strong investment case, because with the rest we have experienced from six countries in Europe, we have long term clinical data, we actually will start us clinical trials in q2 of 2024. IP with 20 patents. And again, there's a large unmet clinical need. And there's a reason why glucose which is the number one glaucoma metric company out there has a market cap of 4.3 billion actually tripled their market cap since they were launched, use of proceeds will go into the US clinical trial about half of the 12 million, then r&d, we're going to have a complementary unit that will be used for home use. That is going to complement the system has been used in the outpatient setting. And then, of course team a commercial team in Europe and most importantly also a US team. Here you see the team, very committed to the right to site for all patients. That's the mission we on. And we are very fortunate also to have an excellent team of advisors with in Europe Professor app from Berlin. And here in the United States Jeffrey, Professor Jeffrey Goldberg from Stanford University. Professor Andrew Eva comer visited yesterday from University of San Francisco. And then also Dr. Sadri, who is founder and CEO of the visionary Eye Institute in Newport Beach. With that, I invite you to come and see us contact us see me I'm here until Thursday evening. So we can make you part of the success investing as we bring neuromodulation to ophthalmology because that's at the end of day what we do. Thank you for your attention.
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