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Michael Finegan, Acera Surgical - Soft Tissue Repair Company | LSI USA '24

Acera Surgical is a soft tissue repair company born from research and a focus on innovation.
Speakers
Michael Finegan
Michael Finegan
, Acera Surgical

Michael Finegan  0:04  
Thank you for having me. I'm happy to introduce you to a serif surgical today. We are a platform technology company revolutionized revolutionising soft tissue repair. We're backed by 10 years of clinical and academic research. We have a platform technology with a very large intellectual property portfolio. We participate commercially in a $2 billion market. And we have strong commercial growth today with very good with a very good gross margin profile. We're investing in our commercial engine primarily along with clinical data. And we're scaling our infrastructure as well to keep up with our commercial revenue opportunity. The company was founded in St. Louis in 2013 by a guy named Matt McEwen who today is our chief technology officer that was working in his MD PhD program at Wash U. Had one year left figured out what he discovered in the lab went to Wash U licensed the technology quit his program, paths ahead and St. Louis friends and family to raise a little bit of money. And here we are 13 years later, really rocking his technology. We have three FDA cleared products, we have cavora, which is indicated for burns first and second degree burns. We have Sarah fix, which is for Dural repair. And we have rostrata, which is a family of products. And that's the one that is commercialized today. We have not commercialized sir effects, nor have we commercialized cavora. We believe we're the future of soft tissue repair. We are a non biologic, we're a non holograph. We are not xenograft we believe our technology perfects the replication of human extracellular matrix. And we with our platform technology, can design whatever tissue construct we want in a synthetic way, biodegradable resorbable. Very, very applicable to a number of different clinical indications. The base technology is called electrospinning. For those of you that are not familiar with it, you basically take liquid polymers, you can take a range of the bio resorbable polymers, you inject them into a highly charged electrical system. And the novelty of the technology is that it spits out fibers that can be collected and made into a matrix. The fibers are sub cellular. So they're their anatomy meters and scale. That is the novelty of the technology. And that's why the body reacts so well to our constructs. And why the the power of regeneration of soft tissue is so efficient, we can play with the fiber size, we can play with the way the fibers are aligned, we can play with the strength, the degradation profile, how long it stays in the body, we can put through the system, a number of different polymers, we can make these elastic, we can make them in cubes. So it's a very, very high potential for a number of different clinical applications platform technology. We have a very strong and broad product, or patent portfolio, we have two patent families that we outlay since from WashU. We continue to aggressively prosecute those families and those open applications. We have two patent families that are our own. So our our patent portfolios well outside of what we're doing commercially today, but we have broad opportunities in a number of different spaces. So again, just getting to the product portfolio. rostrata is the product we're focused on commercially. It is indicated for wound management any and all kinds of wounds, surgical wounds, traumatic wounds, full thickness wounds, we have three form factors or product types. cavora Again, for first and second degree burns, and Sarah fix for Dural repair. Again, just to remind you cavora And Sarah fix are not commercialized today. We haven't commercialized those just because of focus and scarce resources. So just talking about rostrata. The beauty of Australia is if you look at rostrata, and you compare it to human ECM under strong microscope, it looks exactly the same and that we've made it to mimic human extracellular matrix. It comes in a number of different form factors, which I'll show you in a minute. It's made from Poly poly poly diacetone fibers and PLA. So materials that are well known in med tech space, the basis for resorbable sutures. It's got some very interesting properties. I'll talk about a couple of them. One is that it is resistant to enzymatic degradation. So it's very sturdy, you can suture it, you can staple it stays in the defect, the soft tissue defect space, not affected by enzymes. It also elicits when it dissolves via hydrolysis, a slightly acidic microenvironment. So when it dissolves and it does that in the form that we have rostrata it'll dissolve in the body from two to four weeks. When it dissolves. It creates this micro environment that's slightly acidic and it doesn't because of the degradation of the material results in some slightly acidic byproducts. I'll come back to that, because that's a really important piece of the technology. Scale is everything and there and again, the reason this works so well in the body, and we're having such fantastic clinical results is the scale these fibers are 500 times smaller than a number zero absorbable suture. They're many times smaller than a human cell. And that is the novelty when you see this work. In many of the experiments we've done, not only does it look exactly like human ECM, but you can actually see the way the body reacts to it and the cells sort of transporting themselves through the matrix. Again, talking about scale, and why scale and size matter. And just to give you some perspective, on the left hand side, you see a human hair, you see a spore pollen, and in the background, that's Estrada, that is the fibers of Estrada. And on the right hand side, you see a human cell reacting to the matrix itself. I talked about this, we recently did the USP 51 benchtop test, which is the standard test for anti microbial anti microbial anti fungal it, we tested both rostrata sheets, we also tested restraunt and mini matrix against five of the most prolific bacteria and surgical wounds and two of the two of the most prolific fungi, we crushed the test three log reduction after four weeks in all of those bad guys. So it's got antimicrobial antibacterial properties. And that's, that's really important in soft tissue healing. Where we're focused today commercially, we're focused in plastic surgery, plastic surgery reconstruction, we're focused in orthopedic and trauma. That's a giant call point for us. We're also focused in ortho oncology when they're taking out big soft tissue blocks, and they need to recreate soft tissue. We're also focused vascular surgery and foot and ankle surgery. And then this is what it looks like the three different form factors. rostrata comes in a sheet format, it comes in a mesh version that expands to the one for increased coverage area. And it comes in a particular version, the particular version is new. We just launched that a few months ago, and it's doing quite well. From a clinical data perspective, we continue to invest here, we recently published our first RCT, we will continue to make strong investments here we are completely our focus. So that's our that's our call point. And that's where we continue to do most of our clinical work in the or we're headquartered, as I mentioned, in St. Louis, we have a headquarter office where we do all the admin functions, we do inventory, pick pack and ship, we have a manufacturing site down the street, where we do many matrix production, cutting, packaging, r&d, work, finishing, labeling, prototyping, etc. This is what we're focused on. Currently, we're focused on a couple of various a particular product portfolio, we still have tons of potential in a number of different spaces that we haven't even conceived of today. So we're we're working on a restaurant, a implantable version of the technology. That's that is moving nicely. And then beyond that, we've got a full r&d pipeline. And we're trying to make sure we prioritize that in the right way for growth moving forward. We've got 42 Direct reps, expect it and the year was 60. We have a hybrid sales force. We do have 50 agencies as well. And working a lot of rep productivity. We've got a great commercial leader who's done a phenomenal job. We've got broad access, we pretty much have every GPO contract we want. We've got a lot of IDN contracts don't really seem to be challenged there. We're doing quite well. And last but not least, we will invest continue to invest in our clinical data. from a commercial standpoint. We finished the year at 26 Point 3 million up from six little over 16. We are accelerating our revenue growth. We had a really strong fourth quarter, and we're looking forward to the future. from a capital perspective. We do have a friends and family cap table no institutional money. We will be looking to raise money amount to be determined. We're funded into next year but we're looking to scale the organization significantly given the opportunity we have. Thank you very much

 

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