Phil Smith Presents 4D Biomaterials at LSI USA '23

Transcription

Phil Smith  0:05  

Thank you very much. And good morning, everybody. And thank you for coming to listen to my short talk. It's a great pleasure to be here in sunny California, coming from Rainy old England. When we landed, I thought we'd been flying around in circles for 10 hours because it was just like England. Cloudy and damp. But hey, ho, I think the sun's coming back tomorrow. So yeah, I'm Phil Smith. I'm the CEO and co founder of 4D Biomaterials. And over the next few minutes, I'd like to take you on a short journey to share with you how we've been starting to reimagine the world of resolvable devices. So we're gonna start off with a little riddle here, our vision is to become the global leader in a disappearing market. That sounds like a dumb thing to do. But actually, the only thing that's disappearing in this market is the products. Because if you implant a medical device to do a job, why do you really want it to stay there after the job is done. That's our premise. That's the premise of the resorbable medical device industry. But we're approaching it slightly differently with a new type of material. So and we're going to commercialize this new novel resorbable polymer in the medical device field to hopefully improve the already valuable benefits of this type of technology. As I said, this market is far from disappearing. It's already the existing market for resorbable polymers is already worth $1 billion per annum globally, it's growing at about 8%. And that translates into about $6 billion dollars of resorbable implantable medical devices as we stand. So we think that with our technology, we can grow the market for the polymers themselves fivefold, because we think we can break through a number of the constraints that's been holding this market back. And that translates ultimately into a market of $30 billion in terms of the equivalent resorbable medical devices. So why did people use resorbable polymers at all? Well, they are used in a variety of surgical medical and veterinary applications. The biggest market segment is orthopedics. And the second is drug delivery devices. So any application where ultimately you want the medical device to be resolved into the body after it's done its job, that's where this is advantageous. So some of the benefits that this approach offers include over non resorbable alternatives include restoration of the host tissue, and local homeostasis, reduction in the need for secondary device removal procedures, and reduced risk of delayed infection. Combining those things we expect oh one expects to achieve better treatment outcomes, better patient experiences, and lower treatment costs. And the ultimate premise is, if it doesn't need to be there permanently, then why not have a degradable product that resolves into the body and then once it's job's done, it's gone. Despite widespread clinical use of the incumbent materials, their inherent properties have constricted the growth of this market somewhat. And we think in our materials, there is a significant scope to extend the growth of this market. Some of those issues or limitations are clinically problematic degradation profiles and byproducts such as acids, which can accumulate and cause pain and inflammation and even cyst formation in some cases and the need for revision procedures. They have a very limited range of properties, which also can limit their their range of applications. And they are confined to manufacturing procedures such as injection molding, or filaments, 3d printing, which constrain again, the geometry and the the types of features you can include incorporate into medical device. out my co founder, Professor Andrew dove, who's one of the world's leading experts in resorbable polymers started this journey about 17 years ago, with a vision to develop a better resorbable polymer chemistry. He started that research in Warwick University, he transferred his team to Birmingham and this company was ultimately based on the results of that work the The platform is brand name 4Degra, 4DEGRA, because it's a 3d printable mesh platform, which also degrades over time in a predictable way. So the 4D is for the time element. And it's a novel, patent protected photocurable resin based on proprietary polycarbonate urethane chemistry. So there's nothing that hasn't been used before here, but it's just been packaged and assembled in a unique way, which makes it novel. And the first US patent is we've just got a letter from the US Patent and Trademark Office saying that it's going to be C to grant in about six weeks time. So that base pattern is the IP foundation of the technology and the business. This is the only route to 3d printing, very high resolution resorbable medical devices. So quick history of the company. The research, as I said started in back in the early part of the 2000s. The company was first registered in 2018, we started launching the technical grade resins for r&d projects and innovation developments in 2020. And in 23, just recently, our first mu ova and study in vivo study with a derisking product, which is an interference screw for a cruciate ligament repair has been tested in in shape, and found to be osteoconductive. And substantially equivalent to the predicate screw device that we were testing against, which obviously, for those of you that are familiar with the FDA 510 K process is is an important conclusion. So our plan is to take that that de risking product through the FDA on a 510 K basis, and then de risk the platform so that other device innovators can use these materials in other products, which ultimately will be a high very high value. I mentioned the the letter from the US Patent and Trademark Office. But the plan is to be launching a medical grade of the resin in 2024. So we're just setting up the GMP production units in the UK to be able to supply those medical grade materials. So just recapping then, 4degra is a game changing advancement in resorbable polymer technology, which is a novel custom custom designed polymer chemistry designed to do the job of making medical devices that can be reabsorbed into the body. It's very versatile technology, it works on a lot of high resolution 3d printing platforms. So there's no you're not tied into any particular 3d printing company. We do have our preferred partners, but there's a good selection to choose from. And this technology provides the design device designer with unmatched design freedoms, both from the 3d print ability, which means you can incorporate all sorts of features, porosity, detailed features, and, and things that you can't make through any other process. We've demonstrated or proven this at the all of the length scales from macro scale, to micro scale to nano scale. So you can make very small products with this technology. These are some of the concepts that we've been working on with a number of our partners and customers from dental applications, foot and ankle applications. A breast conserving lumpectomy device, and micro suture anchors, and so on. I'm looking at the time clock and moving on a bit quicker. So these are the things that we can do with this and the benefits you can offer to innovators. And these are some of the partners that we're working with currently. That's the team very experienced team including veteran startup people, medical device people, 3d printing people, polymer chemists, material specialists. The business model is ultimately to sell resin and support services to our device partners. And we are currently raising a Series A of 5 million and we have raised about $3 million of that we're looking for another two. We've already received an acquisition bid, but it's very early so we're probably going to carry on and move past that. So if you'd like to speak to us about this investment opportunity, or collaborating with us in the design of products, we'd be delighted to speak to you. Thank you.