John Wong Presents Fluid Biomed at LSI Europe '23

Transcription

John Wong  0:00  
Thanks, everyone for, for listening to my talk here. So I'm John Wong, co founder CEO of Fluid Biomed. We're developing the world's first polymer based neuro vascular stent to cure brain aneurysms. We're a VC backed medtech startup based in Calgary, Canada. We're in the midst of our first in human clinical trial or opening a 10 to 15 million Series A round. Welcome to LSI Europe. Thanks very much for attending. So the founders myself, my co founder were the inventors of the technology as well, as well as medical experts in the domain. I'm co founder and CEO. I'm a neurosurgeon academic practicing at the University of Calgary in Canada. I trained in Canada at Yale University. I also have my MBA from Wharton, my co founder is Dr. Ella Mytho, President and CTO besides also being a neurosurgeon, he's perhaps more importantly from from a company standpoint, a Harvard trained biomedical engineer, and it's his research coming from the University of Calgary research labs that were that were spinning out towards commercialization. So the unmet clinical and market need here is that of a brain aneurysm. Brain aneurysm is maybe one of the most feared diseases out there. This is a weakness on a blood vessel that's prone to bursting. brain aneurysms are not rare, they affect about one in 50 people. And I was talking to the LSI team, there's about over 700 people here at the conference. So that means about 15 people walking here at this conference probably have a brain aneurysm they don't know about. This is very serious because aneurysms are silent, but if they burst, they're fatal in a third. And many patients need repeated procedures to treat this aneurysm. From a market standpoint, the brain aneurysm device market is healthy. It's over a billion dollars currently likely to double by the end of the decade. And neurovascular products such as ours are really enjoy a very high margin specialized niche. Our product is a stent and these neurovascular stents, they retail for over $14,000 each. It's not a commodity, not like the coronary stents or the bare metal stents. So let me teach you about neurosurgery in about a minute here. This is how we fix aneurysms. Nowadays from an endovascular standpoint. On your left you see they're coiling. coiling is where we advance tiny wires and tubes all the way inside of the blood vessels of the body under X rays, and then try to pack an aneurysm with these coils, these little metal Slinkys trying to fill up the aneurysm from the inside. However, you can burst the aneurysm accidentally as a surgeon. So the other technology that's really come into play now is that of a flow, diverting stent. And this is a high density mesh stent made out of metal that you implant inside the blood vessel. So stents use less radiation, they're faster, and they're more cost effective because you're using one stent as opposed to many coils. The problems with the existing metal stents from a patient standpoint, the all of the case series and the research out there show that after you put in an all metal stent, the aneurysm still persist 25 to 40% of the time, the aneurysms are still alive despite the stent, and you can't remove the stent. So what can you do, you can put coils in you're kind of stuck as a doctor. So we just basically monitor the patient and hope that the aneurysm doesn't burst over time. From a payer standpoint, these repeated procedures and tests come at higher costs this system and risk to the patient. So what is Fluid Biomed done to to resolve these issues we created ReSolv, the world's first hybrid brainsten. This is a revolutionary polymer metal design that leads to fantastic performance. So doctors like myself and my co founder who's a procedure on a daily weekly basis, we advance tiny wires and tubes under X rays into the bloodstream under X-ray guidance in this hospital base procedure. And then we navigate these tiny wires and tubes all the way into the blood vessels of the brain and then position our stent and implant release the stent. This is a self expanding flow, diverting stent that diverts blood flow towards normal blood vessels of the brain, but slows down blood flow inside an aneurysm inside the weakness causing a clot off and then gradually heal over time. Now as opposed to of all metal stent, ours is 85% polymer first of its kind, so majority of scent disappears leaving very little footprint behind. This leads to a number of unique value propositions because we're using a very soft polymer, as opposed to all the all metal stent competition out there. Ours is again, the only polymer based solution. This makes it the most versatile aneurysm device potentially that will be on the market. We can treat basically all aneurysm types, not just a select few that the metal stents look after. And it's going to be a very familiar technology we know about that as a physician, this can be used as a standalone device, but also can be used with coils. So remember, I talked about coiling versus flow diversion versus stenting. One was cannibalizing the other that's not the case. With our technology. We're complementary to coil so this is really appealing to the strategics As well, the Polymer itself is radiolucent, visible at X-rays. So then we're not getting the artifact that shadows on CAT scans and MRI scans that we see with the metal stents. Lastly, and perhaps even more Amazingly, the Palmer is bioabsorbable over time, and that heals into the blood vessel wall as early starting as a week after implantation. So does that mean perhaps a patient doesn't need to be on strong blood thinners afterwards, perhaps this is all rooted in groundbreaking university research conducted in my co founders lab. We have we have been in stealth mode for several years. And now we're starting to release the information out in peer reviewed medical literature. And we have a very strong favorable IP position. We have a broad base patent issued in Canada. Wilson Sonsini and Cooley are our IP legal experts. We have an we have a patent issued in the US for our proprietary stent delivery system. And this is also really important, the IP is wholly controlled by the company founders, of course, have signed it over the company. But our university partner, I'm a university professor, they are a minority equity shareholder and Fluid Biomed, 5% Common shares, dilutable after their first million, no royalty agreement, no licensing agreement. So this is unheard of when you're talking about technology coming in from a lab. In terms of our pathway of execution, we've been hyper efficient here, you can see they've been working on the lab for several years, developing prototypes, testing extensively in animals, almost 100 animals now with stents in animals at the four year time point, we're really, really trying to make sure we have a strong body of evidence as we go towards regulatory bodies were at the end of the green there, and of preclinical validation. And we have already in the midst of our first in human clinical trial. This has been supported our VC backed seed round, but we need more funding, of course to conduct more pivotal trial 10 to $15 million. That's where we're targeting towards FDA approval. But we also recognize that the comparable acquisition exits along the way, all of the innovations in our space have been the result of acquisition of small startups by the strategics. They range from $150 million to over half, to almost half a billion dollars. Just recently this spring, pre FDA approval. In terms of de risking the medical device journey. We were ISO 1345 certified. We are approved for stent design and development. from a regulatory standpoint, we're closing off our first in human clinical trial, we've launched a GLP animal study, we're working with Health Canada, again, we're a Canadian based company towards potentially starting our safety study within that country. And we actually have a monthly standing meeting with the FDA. I talked to other startups this is like crazy with the FDA. I have a meeting with the FDA every month during her lunch hour, pre pre sub I look at it so we're super fortunate about that. And we talk about how we're going to navigate the the regulatory pathway for the FDA and reimbursement there's already existing favorable us CPT and DRG codes. terms of financing, we've raised on two safes. Our seed round was closed in q3 of 2021, co led by Xiang Bay capital and in Palo Alto and Metis Innovative in Miami, fantastic partners that sit on my board. We're launching a 10 to $15 million equity raise, and you can see the use of proceeds. They're all geared towards our pivotal trial and expanding our platform to a gen two device already. So Fluid Biomed is a special company. We think we have a number of unfair advantages. The founders are domain experts, are KOLs. We have a rich network and experience level, my co founder runs groundbreaking world leading research and bioabsorbable, both for neuro. We have a fantastic track tech transfer position that no one's ever conceived of when you're coming on at a university. In terms of the clinical trials, we look at that with relish why? because our center runs clinical trials for other agencies, other companies. And so and we were highlighted in New York Times a few months ago for for our research. So that is fantastic. Thanks very much for listening. Happy to answer your questions. Reach out to me on that meeting app. You can download our materials there as well. Thank you very much.