GLW Medical Innovation | Vadim Gurevich, CEO

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Vadim Gurevich  0:00  

Good morning. My name is Vadim Gurevich, CEO of GLW Medical Innovation. And we're here to talk about some of the technologies that my team has put together over the last five, six years, we have an experienced team that has been focused on trauma and extremities for last 20 plus years were founded in 2015. With a focused on cost effective manufacturing, combined with innovative implant materials to date, we've gotten for 510 Ks, to drive our innovation into the markets, specifically into trauma, hip fractures, and foot and ankle. We've raised $15 million since the start of the company, and we're looking to raise $20 million for Series C, moving forward in order to drive commercialization onto the market. Our core technology is a new unique blend of titanium thinwall titanium material together with P carbon fiber peak that creates an ortho loosen or radiolucent effect on visualization of on the X ray, we build up a portfolio of intellectual property around this technology. And we have executed now ortho lucent implants into a number of applications. Essentially, what we've done is we've been using additive manufacturing, 3d printing, combining it with peak carbon fiber peak, we are to our knowledge, the first company to get 510 K for mass production of 3d printed implants combined with peak and what that means is as an example, this is our brand new ankle fracture plating system that we got 510 K on last Friday. The way it works is we do 3d printed shell, edit and manufactured shell of titanium. And then we injection injection molded peek onto it, which is quite unique in all of our IP surrounds this core technology of combination of the two materials and additive manufacturing, opposed to do an edit, edit and manufacturing like almost everyone at that at this conference talking about were they doing patient specific additive manufacturing, were using additive manufacturing for scaled mass production. To that end, were able to produce implants, whether it's plates, screws, nails for orthopedic applications with a reduced cogs. So if titanium only milled process has been used for last 100 years, has had flat cost and frankly, the cost is going up because of what's going on around the world. Without process of additive manufacturing, and injection molding, were able to reduce cost of manufacturing between 40 to 60%, depending on our implant portfolio. And here's some clinical applications. To show you how it looks on an x ray. We have a cannulated screw line for specific for for an ankle and clearly an x ray. As you can see from left to right, you're able to see down to the bone. So if you're a physician, you're able to determine Did you reduce the fracture? Did you not reduce the fracture do you need to reoperate and this plays out throughout our portfolio cannulated screws now more recently, our plating portfolio and also has applications for hip fractures, fracture nailing. These are the developed systems that we've gotten 510 K and commercialized on the left is our Artemis hip fracture now it is the first next generation hip fracture now to hit the market in over 10 years, whether it be a startup or the big strategics. What's unique about this system is we have fourth generation instrumentation so opposed to having 4, 5, 6, 7 trays to go in the back table we have one trade. Sounds familiar, I think based on the conversations earlier at the same time, by combining the two materials were able to really drive cost savings on manufacturing, where we clearly are able to deliver a hip fracture nail significantly less on cost than anyone else in the world. Moving to the right, we brought to the market last year, a differentiated creed cannulated screws system that has headed and headless screws, which on the surface is a commodity because everyone has been selling titanium based screws for the last 50 60 years. But again, with our cost structure plus visualization, you're able to see what's going on and you have no downsides You don't have to learn any new procedure, you don't have to do anything different from what you've been doing as a physician for last 50 plus years. We're super excited about our Apollo ankle fracture set that we got, in fact, in K again, last week. What's unique about this is, it's a clear benefit to any physician using the plating system for ankle fractures, because they can see down to the bone. There's no downsides in using our system, the plates themselves, because as I mentioned in the previous slide, they're thin plates exactly the same that all the physicians are used to. And the physicians are used to titanium thin, thin plates. And yet, because of the combination technology, we are able to allow the physician to contour the plates. So typically, some of the other companies on the market in the United States, they've came out with peak only a carbon fiber only plates, which are great because they're radiolucent. But as a physician, you're not able to contour them at all. Without technology, you're able to come to the plate, and you're able to use it just like you always have in your practice. We've put together a rock star development teams, we focused on two segments using our technology. One is a foot nickel specific surgery advisory board. And another one is trauma specific surgery advisory board. And we're talking about who's who, in the industry, or in who's who at the institutions anything from HSS down to UCLA. Health here in California, we have a robust sales channels. We sell through two strategic organizational partnerships. One is called innovate ortho, and the other one is called no misstep, foot and ankle. One focused for foot nickel distribution, the other one is focused for trauma. Altogether, we have over 65 distributors across the country that represent 200 sales agents that is driving our core technology onto the market. Today we started using and using our technology for hip fractures. And for an ankle long term we see our technology expanding. Beyond hip fractures and for an ankle and really going into upper extremities. We see great applications for a plating technology for hand and shoulder for example. Beyond that, we have plans to establish his CMF business specific utilizing our ortho Lucent technology. So there's many many applications for our core technology, we believe we're positioned to disrupt orthopedic implant market because the implant market frankly, is increasingly is driven by cost reduction, and nothing related to innovation, we're able to bring cost reduction to the implant. Plus we are able to bring additional features and benefits to the surgeons that are not available today. So far as I said we launched four products commercially onto the market. We're looking to to do an additional eight cleared products over the next 24 months and really push this technology core technology of titanium one P carbon carbon peak on to orthopedics in general. Our financial projections are last year we did a little bit over $3 million, really with two products that we've gotten 510 k for which was our hip fracture now and our cannulated screws. This year, we're projecting to do between seven and 10 million and really drive the sales beyond that to 20 30 million. And the way we see this were development company. We have an engineering team based in New Jersey and based in Germany, we have over 10 engineers really focused on driving this technology throughout Orthopaedics. And our partnerships with a commercial teams can drive their sales up to so this is an aggressive move on our end to make sure we bring this technology to the markets in really drive innovation and cost containment, if you will. in orthopedics. We're raising $20 million for Series C. It's for acceleration of our development to clear more products from the FDA. We're looking to create an upper extremities portfolio specifically focused on our plating core technology. We would like to initiate some key clinical studies to validate that technology with the societies and inventory production. So for example, our hip fracture nailing system is very heavy on instrumentation. So cost of instruments we're looking to you utilize the proceeds from a Series C, to purchase more inventory to bring to the market. In an organizational structure. We recently announced a new designer procurement center in tullian, counting Germany, which is the world's capital of instrumentation for the folks who know about it. Thank you very much. I'm happy to take any questions off to the side and good luck to everyone else.