Tony Simula, TekCyte - Biocompatible Medical Device Coatings | LSI USA '24

Tony Simula  0:00  
Tony, good afternoon, everyone. My name is Tony simula CEO of TekCyte, and we focus on High Performance Coatings for implantable devices. We're a small company. We've been around for only five years of B to B enterprise, pre clinical stage, and we, as I said, we develop medical coatings to be applied to implantable devices. We've raised about two and a half million in seed capital and about a million dollars in non dilative grant funding. Now focus is really around microbial biofilms. Hospital acquired infections account for a large, substantial amount of cost burden on the US health budget each year, up to $25 billion a year just to manage the complications from these infections, and about 25% of all h IIS involve implantable devices, whether they be an orthopedic implant or even a catheter. And where there's an infection, there's biofilm, and where there's biofilm, there's often the risk of a very long term and chronic infection, because once biofilm is formed, antibody treatments cannot remove the biofilm, and typically, the device that's affected needs to be removed. Now, where it's a catheter, that's quite simple, but where it's an orthopedic implant, that's quite a serious impact on both the patient and the cost to the healthcare. And of course, the excessive use of antibiotics to treat these conditions exacerbates the problem that we have with antimicrobial resistance, which the who has listed as a as a top global concern for the future. And so the infections, as I said, can affect a wide variety of different implants, but just take central venous catheters. For example. There are a quarter of a million infections in the US alone each year. Now these patients are often acute care conditions with comorbidities, and so the mortality rates are quite high, up to 10 to 20% as I said, the burden on the healthcare budget is quite high. The industry has tackled this problem by using antimicrobial coatings on these devices. Now there's been some limited success, but of course, the presence of some of these chemicals on these coatings can lead to local irritation where the catheter needs to be removed and replaced, and in some as I said, excessive use and exposure to antimicrobials does exacerbate the problem of antimicrobial resistance. Now, if you look at orthopedic implants, for example, antimicrobial coatings are not possible because osseointegration is so critical to the effective treatment with these implants, and if you inhibit that process using these coatings, then you fail in terms of treating patients with those implants. Again, the impact on the healthcare budget is quite high, and so we're limited by the option of what biofilm resistant coatings or anti infective coatings can be applied or used for those sorts of treatments. And we think we have a solution, and this is a drug free medical coating. It's based on a peg like structure, and it's a hydrophilic coating, which forms a barrier on the surface of your device, and it prevents the bacteria from ever adhering, and therefore you prevent the formation of biofilm. So if you don't allow the biofilm to form, the chronic infection won't won't persist, but it also prevents proteins and platelets from adhering to the surface. And there are a number of features, and I'll draw upon the first one, that is, it's very, very thin. It's five nanometers, no more, and therefore, it won't interfere with the with the with a three dimensional structure that you're trying to coat, and also the the fine topography, if there is some that you have to be aware of. And as I said, importantly, it's a drug free approach to treat this condition. Now, does it work? Well, here we have some evidence using a number of microorganisms, and we can show that we can inhibit the adhesion of microorganisms binding to the surface. Now there's a four or five log reduction that we see here. Now bear in mind, this is a non active so we're not trying to kill the bacteria. Many actives struggle to achieve even a four or five log reduction, but the FDA, those that are on the market would typically have to achieve a six log reduction. So as a non active, passive coating, that's a pretty good reduction. And of course, as you can see visually, it prevents the formation of biofilm, because you're preventing the significant number of the bacteria attached to the surface. Now, because it prevents other material from sticking to the surface, including platelets, it's also anti thrombogenic. So we've undertaken a number of studies on stents and stent grafts and shown that we can significantly reduce thrombosis. Now for something like a central venous catheter, you have the double benefit. You have this biofilm resistant coating, but also an anti thrombogenic coating to prevent clots. We've tested this using a number of human donors, and we can see a very consistent result. Now, tissue integration is very important for some devices, like orthopedic implants, dental implants. Now we haven't tested this yet to verify or validate the osteo integration. But here we show with a porous Teflon plug that was implanted into mice and left for 28 days, the bare Teflon, we show very little, if any, integration of the tissue into that plug when it was coated with bioinvisible our coating, we see. It goes from a hydrophobic environment to a hydrophilic surface, and that encourages the cells to grow into the pores. These are microscopic pores, and so to encourage tissue integration for the implant. And of course, there's another study we undertook with stents implanted into pigs, and within five days, we see normal growth of the endothelium over the bioinvisible coated stent so it doesn't interfere with normal growth of the tissue that it's that that surrounds it that's important for tissue integration. Of course, it shows that it's safe and biocompatible. We've undertaken some tests at Namsa to verify that. So we've seen some really important value propositions for bio invisible because it is drug free, you're not exposing the individual to chemicals and antimicrobial agents that can cause adverse reactions, particularly local irritation, say with catheters. Of course, if we can reduce infection in the biofilm that causes infection, end up with a better quality of life for the patient, for the manufacturer, we're able to then produce safer devices that are less likely to fail because of complications like thrombosis and infection, and we believe we can offer market differentiation for our commercial partners. From a healthcare perspective, obviously you're reducing that burden of having to treat patients with these complications, and if you reduce the excessive use of antibiotics, we can go some way to reducing the risk of antimicrobial resistance, becoming a serious problem that it already is, and becoming worse. So we're starting out with some low hanging fruit and simple targets. We've got some companies at the moment evaluating bioinvisible on their central venous catheters, and we'll move to more complicated more challenging devices, like orthopedic implants. We've already approached some orthopedic companies, and we've got some really good interests there, and we hope to engage them to evaluate bioinvisible on their implants. And as we move we can see a potential for bioinvisible to be a platform technology and be able to coat a number of different implants and treat different conditions, primarily infection, but also thrombosis, when we get to stents and stent grafts, for example. And we see a number of different revenue streams for the company, obviously the typical tech transfer and licensing model, but also an opportunity for us to coat on behalf of some of the companies, where they are not able to provide the coating or apply the coating themselves in their own facility. And we think over time we can, we can have a large chunk of that total addressable market, which is, at the moment, over $400 million and growing quite rapidly. We have an experienced executive team and a very experienced executive board, sorry, non executive board, each entrepreneurs in their own right with successful exits, and we have industry advisors who have provided insight for us and to target the appropriate markets, but also to open doors and allow us to engage with the right target companies and those individuals in those companies to make the to generate traction and interest for our technology, because we are and do require that we partner with these companies to get the product to market. So so we are seeking commercial partners. We think we have a unique coding with good IP protection, and we think we can offer our commercial partners some market differentiation, and maybe over time, if we're in enough products, we can take the Intel model and have a little tech side inside logo on many of these products. Of course, we're seeking equity capital up to $2 million that will give us a 24 month runway. Of course, we need to complete a lot of in vivo validation of our opportunities and applications. As I said, we are still very early. We're also looking to validate new opportunities we see potential for a broad range of device applications, and then also look to scale up the process to meet the regulatory and manufacturing requirements. So thank you for your time. Applause.