John Wong, Fluid Biomed - Bio-Resorbable Stent for Brain Aneurysms | LSI USA '24

John Wong  0:04  
It's my pleasure to speak today at LSI. We presented here about a year ago and we've made tremendous progress since that time. We are Fluid Biomed. We're developing the world's first bar resorbable neuro vascular stent to treat brain aneurysms. cutting to the chase. We're a VC backed preclinical. I should take I take that back. We're now clinical stage pre revenue company. We're a startup based in Calgary, Canada, if you've ever had the pleasure of visiting, we have our first in human clinical trial results since last year. And we have now have an open strategic lead $20 million round for our Series A with a term sheet in hand. So the founders, myself and my co founder, we are inventors of the technology as well as Kol is in the domain. I'm co founder and CEO John    Wong. I'm a neurosurgeon at the University of Calgary also a professor there, I trained in Canada and at Yale. I also have my MBA from Wharton, my co founder, fortunate I've known this gentleman for 25 years now, he was my student, my resident, incredible human being incredibly talented, also a neurosurgeon that I helped train along the way, but where he deviated from the path was along the way, he actually became a biomedical engineer during his neurosurgery training, having achieved that degree from Harvard. And when we brought him back to Calgary, we came up with with an idea, a concept, and we've been able to iterate repeatedly in our university lab, to the product that we now have in hand in human patients. So the unmet clinical market need here is that of a brain aneurysm. An aneurysm is a bubble on a blood vessel, a weakness that's prone to bursting and causing a stroke. If there are 50 people in the room one of us have has an aneurysm that we don't know about, and and if it bursts, it's fatal and a third so it's a terrible, terrible disease. Aneurysms are silent, but they can be treated. But even nowadays, pending pain, many patients need repeated procedures to fix their aneurysms. The global and brain aneurysm device market is already pretty healthy over a billion dollars currently, and likely to double by the end of the decade. Our product is a stent, a mesh to treat a blood vessel weakness. Most people are familiar with heart stents, coronary stents, there's a lot of difference between our hearts and in our brains and Hearthstone is almost now a commodity. A bare metal stent retails for about 400 to $500. Not the case for neurovascular. A neurovascular stent retails for over $14,000 each. This very high ASP really attracts the attention of a major medical device manufacturers. How do we fix aneurysms? Well, on your left there you see coiling. That's where you go into the aneurysm from the inside. And you deposit these little Slinkys these tiny devices to plug up the aneurysm from the inside as opposed to flow diverting stents. That's what you see on your right there. That's where you go into the normal blood vessel and place a stent to divert blood flow. That's why it's called a flow divert or you don't need to go into the weakness. So that's stents are generally are faster, safer, more simple, more cost efficient, and also use less radiation. But there are problems with existing metal technologies. What is that? Well, after you put in a stent, what's less well advertised that those metal stents that we have available now don't work all the time 25 to 40% of patients that aneurysms are still alive. After that you can't remove the stent, you can't put coils into it because you're blocked off from the aneurysm. And these these deficiencies really lead to higher costs to the system and risk to the patient. So Fluid Biomed has developed resolve the world's first polymer based flow, diverting stent. This is a unique hybrid design that really takes advantages of the best of both worlds best of polymer the best of metal, and really allows for revolutionary performance from a doctor standpoint. So physicians like myself and my co founder, we go up inside of the blood vessels, under anaesthetic under X rays, and we gently float these tiny wires or in tubes into the blood vessels of the brain. There you see a cartoon of an aneurysm and then we release a stent a flow diverting stent, again diverts blood flow away from the aneurysm and causes blood to clot often heal inside of the aneurysm. Now, this process takes several months, sometimes a few years for the aneurysm to slowly go away and heal over time, as opposed to the existing metal stents. Ours is mostly Palmer allowing the aneurysm to heal leaving very little metal behind. When we look at the survey the the landscape here, our product is very familiar to physicians. Why because we use these all the time the metal stents and ours is very similar in terms of user friendliness, but that's where the differences in ours is the only polymer based product polymers softer than metal so we can actually shape percent fit our stent into many more types of aneurysms than the existing metal stents. We can also use our our stents with coils. Those are those devices we talked about before The current devices are incompatible with coils. We say that you can't go through this then ours you can. Our stent is also visible on CT scans and MRI scans. So now you don't need to do invasive imaging. And the Palmer itself is extremely conducive material for endothelial activation, that means blood vessels, blood cells, blood vessel cells that he'll onto and attach on to the stent. We've, we have extensive peer reviewed research that we publish, and over 100 animals up to like four years now. And this is all culminated in our first in human trials, we're proud to say that since LSI of last year, we have now conducted our first in human clinical trial, a feasibility study, where on your left there is the arrows pointing at an aneurysm six months later, with a 12 month study, but at six months, the aneurysms already fully healed. And our results look very promising. Two out of the two brain aneurysms have already cured and the third patient with a on a humanitarian basis, we're treating a different aneurysm. That result is still pending. Our IP and Tech Tech transposition is actually also very, very unique. We already have patents issued in Canada, Europe, and Cooley as our IP lawyer and helping us with with the USPTO. I'm a university professor at the University of Calgary we have a unique position with them. What's that, in that they own 5% Common shares in my company to look dilutable After the first million, no royalty, no licensing agreements. So this is really frees us up for conversations with the strategics. We have a great team. We've done all of this with less than a dozen people with the help of a fantastic advisory board. We've been super time and capital efficient. So before 2019, we were kind of a research project. Then we saw the project had legs. We got we we raised our pre seed round from local friends family, that university we got to our animal implantation after prototype development 2021 We raised 4.7 million from Xiang Bay capital just down the road from in Palo Alto medicine innovative in Miami. With those funds, we were able to get to our first inhuman trial two years after seed flows unheard of in our industry, overall, so super proud of the team. Where are we at now? We have a $20 million series A with a term sheet in hand, from a very large one of the most well respected, strategic strategics in the world at this point. What are we going to do with those funds? We're transitioning to the FDA, we have monthly standing meetings with the FDA to define our regulatory path. We're working with our strategic to develop a full commercial line for this very unique product. We will continue to develop our technology to smaller device sizes, grow our engineering team, again, less than a dozen people now. So I think we can do a lot more if we hire a couple more engineers, we're going to scale up our contract manufacturing. And those user funds will take us partway through our pivotal trial. What is that pivotal trial 150 patients single arm study 12 month outcome. So overall, every parent thinks their baby is the most beautiful baby in the world. I'm no different. My startup I think is special. We've levered a number of unfair advantages to continue to de risk the journey. We have a unique device that's familiar to doctors and yet innovative at the same time. We we have our first in human clinical trial data. We have a defined FDA pathway. We have existing reimbursement codes that are already very appealing to companies and and physicians and hospital systems. And again, we have a $20 million dollar series a strategic lead with a term sheet in hand and we're rounding with the syndicate. So it's my pleasure to speak to you afterwards whether at the meeting or afterwards to continue the conversation. Thank you very much.