John Wong, Fluid Biomed - Bio-Resorbable Stent for Brain Aneurysms | LSI Europe '22

Transcription

John Wong  0:05  

Thank you very much, everyone. appreciate everyone listening in both here in person and online. Again, we're Fluid Biomed. We're developing the world's first ball resorbable brainstem to cure aneurysms. We're early stage preclinical startup VC backed already in launching, again, a $10 million round to initiate clinical studies. So, myself and my co founder, we are the inventors of the technology as well as medical experts in the domain. I'm a neurosurgeon, I trained in Canada and at Yale, and I received my MBA from Wharton, my co founder, President and CTO. It besides also being a neurosurgeon, he's also perhaps more importantly, a biomedical engineering having trained at Harvard, and it's his research out of the University of Calgary that we're spinning out towards commercialization. So the unmet clinical and market need here is that of a brain aneurysm a brain aneurysm is a bubble on a blood vessel a weakness, and it's prone to rupture and leakage. A brain aneurysm is not rare affects up to 5% of the population. In fact, President Biden had two aneurysms that were treated as well as Emilia Clarke from Game of Thrones, so both younger and older people. Unfortunately, 1/3 of people with a burst aneurysm will succumb and many patients need repeated procedures as well. There's a huge potential market for because of patients with undiagnosed aneurysms, the aneurysm device market is over a billion dollars already and I want to differentiate our neurovascular stent from the more common cardiac stent a cardiac stent are our hearts then, you know, they're they've been around for decades almost now a commodity retail for about 400 to $500 each. That's not the case with a neuro vascular stent, a neuro vascular flow diverting stent as it's called, retails for over $12,000 plus a very high margin product that attracts the attention of the major medical device manufacturers. So aneurysm treatment now can be sort of conceived of in terms of endovascular terms from the inside of the blood vessel as coiling versus flow diversion. coiling is where a catheter is introduced into the aneurysm weakness into the bubble. And then we deploy coils little soft those Slinkys to plug up the aneurysm from the inside. As opposed to flow diversion. This is a stenting procedure that's faster, more cost effective and uses less radiation than coils. This is where we implant a high density mesh stent to divert blood flow. The current metal stent technology does have its issues though, from a patient standpoint, what's less well known is less well known is that a metal flow diverter fails 25 to 40% of the time, meaning at one year after implantation with a metal stent, the aneurysm will still persist. And this leaves the doctor in a very difficult situation, because there are a few treatment options afterwards, except for to put in another flow diverter. From a payer standpoint, these are repeated procedures that lead to higher costs of the system, as well as risk to the patient. So Fluid Biomed has developed Resolve, which is the world's first bio resorbable flow diverter. And this is a marvel of engineering. You can see here on our highly magnified view the strands of our stent, those are polymer strands 50 microns thick, and these are then buttressed with a wire scaffold that provides radial force as well as visibility as well. Let me show you how, how the stents are implanted. So doctors like myself and my co founder can now navigate tiny wires and tubes inside of the body under X rays. And after we position our our catheters into the normal blood vessels of the brain, we can then identify the aneurysm and then release a stent, a metal flow diverter, that again, high density mesh stent that then diverts blood flow into the normal blood vessels of the brain, but slows down blood flow inside of the bubble inside of the aneurysm. Over time, the aneurysm will clot off and then heal, as opposed to a metal flow diverter that's permanent, ours is made out of a bio resorbable polymer that will then dissolve and heal into the blood vessel while leaving very little footprint behind. So let me show you in this human model, a silicone model of a human aneurysm of our technology and the stents already been partially deployed here with tiny wires and tubes. And what we can do with our sin as opposed to the metal stent is that as we're deploying this, then we can It's so soft and flexible, we can actually shape the stent to the anatomy, which is impossible to do with metal flow  diverters. And after that, we can actually do fluoroscopy or X rays, and we can visualize the stent. And if we're not happy, as opposed to metal stents and giving up we can then at that point, go into the aneurysm through the stent and deploy coils impossible to do with current technology. And this provides reassurance to the doctor and the patient that their aneurysm is more are effectively treated.So again, the construction of our stent is really leads to a number of unique value propositions there are about six metal stent competitors out there, all made by the major medical device manufacturers. Ours is the only bio resorbable technology and again, adds to revolutionary versatility in terms of performance, we can treat all types of brain aneurysms, not just a select few with the metal metal stents. This allows for more safer and more efficient treatment. From a physician and patient standpoint, we can also perform more accurate and non invasive testing afterwards. We don't have to depend on invasive angiography that subjects the patient to risk and pain, we can do non invasive CT scans and MRI scans, as well because our polymer disappears over time, there's no need for lifelong blood thinners. We look at our technology as a foundation of a platform. We've already demonstrated long term aneurysm cure in the laboratory, where brain surgeons are highly laser focused on the brain aneurysm market. There's no reason why this technology can't be leveraged to other areas of the body. In terms of timelines. We're in preclinical testing with our stent. And we're now manufacturing our stent delivery system with partners. In terms of our IP and tech transfer position, we've been issued a broad piece patent in Canada, we're responding to the USPTO with with claims through Wilson Sonsini, our legal partner, we've been issued a patent for our stent delivery system in the US, and also highlight that our IP is wholly owned by the company. Our university partner is an equity stake holder. But there is no pre existing licensing or royalty obligation to our university. We have a diverse and effective team, we have about a dozen team members there. Most of them are full time all dedicated, passionate to the mission where an engineering focus term in terms of design and quality. And our advisory board is diverse in terms of geographically as well as by sector with experts in regulatory stent science, patent law, clinical trial conduct, as well as med tech strategy as well. We have a very efficient pathway of execution. We're in the green there. And you can see we're in the middle of preclinical validation. With our seed round that was VC backed, we are engaging with strategic partners, we have a line of sight towards first inhuman data. We know that the clinical trials will require more funds, more resources moving forwards until FDA approval. But we'll again we'll point out that with the comparable technologies that are out there, they've all been the product of acquisition. And these exits, exits have ranged between 150 to $380 million, all pre FDA approval. These are some of the companies with an active interest in stent technologies. We've spoken to all of them numerous times with key executives there, and I think they're really intrigued by the underlying fundamentals of our polymer based stent. In terms of past financing, we've raised two rounds, both safe notes. Our last round was a seed round that was VC backed by Xiang Bay capital in Palo Alto, a very respected med tech, VC firm as well as Metis Innovative in Miami as well. And with those funds, we've completed long term animal studies, over 50 studies demonstrating cure of disease. We've contracted with manufacturers, both in California as well as Minneapolis, and we now have a PMA FDA regulatory strategy defined, and we were recently certified ISO 13 485 for design for medical device design. So the ask is that we are opening our Series A round $10 million equity raise. We are now in the process of undergoing due diligence by three VC firms. The use of proceeds will be geared towards this first inhuman proof of concept implantation in the near term, but it all leads to a multicenter clinical trial that you see below. So again, in summary, we are domain experts. I know this feels like the back of my hand, I've devoted decades of my life towards this we have a rich network and experience. We are the world's leading bio resorbable lab looking at in the neurovascular speed space for bowel resorbable. We have an enviable tech transfer position. And we're very comfortable with her and running clinical trials at our university. We already do so for other agencies and companies already. So thank you for listening. I really do appreciate it and if you have any questions, please reach out. Thank you