Gilad Hizkiyahu Presents ProArc Medical at LSI Europe '23

The Omega device by ProArc Medical is a minimally invasive, non-surgical procedure to restore urinary function and treat lower urinary tract symptoms (LUTS) caused by an enlarged prostate.
Gilad Hizkiyahu
Gilad Hizkiyahu
CEO, ProArc Medical



Gilad Hizkiyahu  0:05  
So before we start, I'd like to ask you to imagine something. Imagine waking up five times in the middle of the night to go to the bathroom to feel the same urging sensation to willing to pee, without being able to do so, or going over night after night after night. Imagine avoiding long flights, or when you do take a flight, you choose the worst possible seat of an airplane, the one closest to the bathroom because you know, we're going to go there often during your flight. So if you're a man, congratulations, you have a prostate. And if you have a prostate, that means you don't need to imagine those things. All you need to do is wait your turn until the prostate is big enough. So you experience those by yourself. My name is Gilad Hizkiyahu, and I'm the CEO of ProArc Medical and at ProArc we're developing a fast, easy, long lasting solution for BPH, which is enlarged prostate. So what is BPH? Basically, it's a non cancerous enlarged prostate that blocks the retrieval path preventing the from urine to flow through it, it leads to various side effects and uncomfortable symptoms such as urinary urgency, frequency, nocturia, which means waking up multiple times at night, and if untreated, may lead to irreversible damage to the urinary tract and urinary system. It is very, very, very common effect. In fact, that happens to 50% of men over 50 and 90% of men over 80. So basically, I'm developing this for myself. Now there are over 100 million men worldwide who suffer from BPH. The industry is big, and the market is constantly growing much like our prostate. So how do you treat BPH and I'm focusing on minimal invasive surgical treatments. The gold standard today is tissue tissue surgery using a procedure called T warping. Basically, it's an approach that says no prostate no problem. So you remove the prostate from within nucleate the prostate, or use some other kinds of treatments, we'll probably call this prostate tissue abuse. So you inject steam, use laser, whatever you can to harm the tissue, damage the tissue and open up the urethral block. Now those solutions lead to medium to long term relief. However, they do come with other side effects and problems such as sexual dysfunction take longer time to recover. Sometimes it's painful, and it's irreversible. Because once you have the tissue, it doesn't grow back, then entered new solutions to the market mechanical dilation of the prostate, let's call those shifting the curtains aside basically pushing the the curtains of the prostate aside and letting urine flow. So you can use stents in theory, there was a low risk fast and simple to deploy inside the prostate. The problem is that they offer short term solution and they suffer from migration, they tend to move as the prostate moves and they suffer from incrustation because exposed parts of the of the stent that are metal get in calcified over time and causes damage. So another solution a very successful solution was introduced in 2017 by a company called Neo track your lift. This solution offers sutures, also a low risk procedure for a medium term better longer term than then stents. But unfortunately, in real life data, we can see that in five years, there's about 30% return rate when using sutures. And this is not a good news, I mean, no man wants to hear is they're all just saying this was a wonderful procedure very successful. Let's do this again in a couple of years, right. So in addition, this, this solution is also not reversible and requires a long length a larger and difficult learning curve. That we're for cities is a natural evolution in the mechanical dilation of the prostate from stents through sutures to implants and we designed the world's first mechanical implant that is fully metal to be embedded inside the tissue of the prostate. So in this way, we try to find the next generation of long term solution, maintaining the low risk approach of dilating the prostate mechanically, to for long term doing a fast and simple procedure, but also having a durable metal implant. Avoid migration crustacean by having it implanted inside the tissue and having it fully reversible, and then I'll show you how. So this is our implant, we call it the Omega implant, you can guess why we intend to put it in the center of the prostate right here to open up the lateral lobes and apply constant pressure to open the lobes. And this will give us a long term solution. And what we do is we create an incision around in the prostate and we release this implant into the pocket we created inside the prostate they were that way it's anchored inside, it can't move and it's not prone to incrustation because it doesn't experience urine flow. Now I'm going to need a volunteer because I want to demonstrate on stage preferably a man over 50 No, okay, no, I'm sorry. I'm kidding. It's insurance one. Let us do that. Thank you. But let's, let's show how it works in animation. So this is delivery device, it's visually guided using a standard SR scope. You go to the center of the prostate, find the blockage area. This is our implant it's wound around in the center of the shaft. We use a balloon to inflate it and put it in place we create then an incision using a specific electrode designed for it, release the implant. It's a spring like bouncing into the pocket, and then we deflate the balloon return the sleeve in place, pull up the device the entire procedure is just Five minutes end to end. And the result, as you can see, is an implant that opens up the prostate and it's also covered inside the tissue not prone to to migration or infestations. So animation is fun, a nice anybody can draw animations. This is real results from the first mn study we had earlier this year. So on the right hand side, you can see the before imaging This is the sisters go from our first patient. You can see the lateral lobes of the prostate almost touching each other we call those kissing lobes. And this is the before inspection. And the after minute is 30 seconds after we implanted our omega implant. So this is the wide open prostate. You can even see the bladder neck right in front of you. But there are two things you can see here and I want to note and one of them is that you can see almost no bleeding. The reason is we use electrocautery so we coagulate the tissue as we perform the implantation. The second thing you can see here is the implant and this is the most impressive part because the implant is deeply embedded inside the tissue and will not suffer from crustacean. So our first event study will prove to be safe, effective, fast and simple. And we even practiced its removal of this implant. It's very easy to grab it with the grasper and pull it out because of its flat ribbon ribbon like shape. We launched a pilot study afterwards, that was a month ago, for 1212 months of follow up in four different sites. Now let's talk about the big three, regulation reimbursement and IP. In terms of regulation. The FDA approach is pretty straightforward. There are many BPH solutions out there. So fairly simply 150 to 200 patients 12 months follow up is enough to get FDA approval. And we already designed this study for next year. Dr. Jeff Dan, a reimbursement advisor was also the reimbursement advisor for your lift. He told you took one look in our device and said Listen, you guys are doing something unique, you use electrocautery. So you perform medical surgery and you embed an implant. This will entitle you a much higher reimbursement go than all other competitors, including upcoming stents and your lift. Enter. In terms of IP, we submitted over 10 different patterns in three families covering the unique implant for the prostate, which is one of its kind, delivery device and implantation methods. Some of those battens already were approved in the US and Europe. This is our team. We're seven full time employees in the north of Israel, very strong leadership team, very strong engineering management team. We do everything in house in terms of designing our our device. Half of the team is engineering. And now we're focusing more on our on QA, RA and clinical trials. We have some stellar advisors in this team. They're all very distinguished doctors, but I want to I want to point out a few. So Peter Gilling, is a well known physician, who's an expert on BPH treatments, he will be RPI in the coming pilot studies we just launched in New Zealand. We have Professor Klaus Rubin, who's the president of the benign prostate society, benign prostate disease society. From Texas. He wrote the guidelines for the American urology association of how to treat DPH is a word very well known expert in the field. And we have Dr. Dean eltromat from Canada, who's an expert in minimally invasive treatment, especially mechanical dilation of the prostate working well is 10 companies and with your religion. This is a roadmap. As I mentioned before 2023 We finished our first mn study successfully, we launched a pilot study in 2024. We intend to finish our pilot study approach, the FDA finished our vnv processes and launch our big pivotal study at the end of the year q4 24. We're now looking for $5 million investment to help us cover this part of our journey all the way through to start the US pivotal study for 15 sites 150 to 200 patients. Next on, we will finish the pivotal study and somewhere in the end towards the end of 2026. We'll apply for the FDA marketing approval getting ready for commercialization or m&a. This will require additional $20 million for the pivotal study support. So where will this bring us if you know there are three years $25 million overall to get to FDA approval. So this is what looks what it looks like. When you get to that point. Those are some recent BPH m&a acquisitions, deals in the field. So first of all, almost famous one euro lift was acquired for $1.1 billion in 2017, the first successful mechanical relation of the prostate, then you see those those deals Boston Scientific Olympus library acquired companies in the same field, the most recent one library acquisition was less than a month ago, they acquired Eurosonic for $600 million. So the ballpark for those deals for solutions for BPH is $500 million. So three years from now, we are in a position for potential m&a. And if you know another thing here, you can see the distance between the FDA approval and the acquisition so Olympus acquired a meditate with the ITIN solution a few months after FDA approval, whereas laboratory acquired one month after the approval with zero sales. So this is our potential this will be in three years from now. And we're looking for the right partners to join us in this journey. Thank you very much

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