EndoShape | Jim Kasic, CEO

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Jim Kasic  0:04  

Thank you everybody. My name is Jim Kasic. And I'm here to talk to you about Endoshape where we're experts in biocompatible, radiopaque. shape memory, plastics. That's a lot of words. But basically, we have a plastic technology that's similar to the nitinol technology in that it is shaped memory. Now, where we've chosen to use this technology first is in making embolic coils. So what is an embolic coil? Basically, it's a pipe cleaner, that we extrude out the end of a catheter, and it's used for shutting down or create an embolism in veins and arteries. So on the benchtop, you can see our coils being deployed into a small four millimeter tube. First, we deploy a framing coil that holds the device in place, and then we back that up with a packing coil that creates a nice, thick pack, which allows for a great embolization. So why did we go after embolic coils? Well, traditional embolic coils are made out of metal, they have very poor packing densities and very high recanalization rates, which means failure. In addition, they have a significant artifact when imaged under MRI or CT. So again, our solution is radiopaque shape memory, polymer, we get a very, very good coil pack density, and a significant reduction in artifact compared to traditional metal coils. Now, first, we're going after the peripheral vascular market, which is going to grow to approximately $830 million by 2028. But we also have the technology to go into the neurovascular market, it's going to grow to be over 4.5 million. So what are our results? Well, first of all, when we look at imaging artifacts, you can see that the metal coil has a very large Starburst and a huge imaging artifact. In our case. With our polymer coil, we have a very small image artifact and a head to head comparison in a GLP animal study, we compared ourselves to the Boston Scientific IDC coil which we consider to be the best coil in the market, we found that we had a much higher coil pack density, which is good. That created a faster time of occlusion which again is good. We had a much lower recanalization rate over time again better and nearly half a coil less was used in the study per site in order to create this, so we feel we have a much better product. addition, if you extrapolate our results to the rest of the market looking at the leaders include Boston Scientific penumbra, Medtronic and Terumo. On average, we've got almost a 60% Faster occlusion 30% fewer coils. And if we price our device the same price as the Boston Scientific coil, we will have an overall cost of procedure that's 50% less than the market. And in addition, we have better performance with no image artifact. Now we've successfully completed a q sub with the FDA. And we know we know we don't need any human clinical data. And we'll be submitting our 510 K in April. Only our toxicology results are necessary to complete the 510 K or biocompatibility results. Our device is compatible with the Terumo prograis, the BSC renegade as well as Medtronic rebar, which are their top delivery catheters. And we have a full range of sizes from two millimeters all the way up to cover the entire market. As I said, we'll be submitting our 510 K. And in April, we expect to have our clearance by late summer and then to be launching our product this fall. Now our cost of goods assuming that we're going to use four coils per patient is going to be about $480. And the average price in the market for selling this would be $4,000, which gives us better than 85% gross margin, we believe we're gonna be extremely competitive giving our better results. In addition, these procedures are reimbursed by known CPT codes. Now our go to market strategy is not to build out a huge sales force but we've been successful in the past using 1099 reps in order to go out and sell our devices. We plan on going to key opinion leaders which we think represents kind of the 8020 rule where 20% of people are going to be easy to go to. We already have established relationships with them. And we'll concentrate on building good significant clinical results with these groups rather than trying to go out and cover the whole market. Now, we've chose peripheral vascular as our first product because it allows us to de risked the polymer technology and then move into neurovascular products of our budget, we need about a million dollars in order to get to a design phase with neurovascular products. And we're working on that right now as time allows, along with our launch over peripheral vascular product. We've got nine issued patents, three patents pending covering both our polymer formulations as well as our device. I'm leading the team, we've got an all star cast. Our lead investors are led by volcano capital, myself, I'm a polymer scientists. I've had two exits in the medical device space, one in a Tronic. And when a striker Zimmer Biomet there's a number of strategic targets out there that are primed for acquisition of ours, we started conversations with these companies and typical exits in this space are well over $100 million, approaching $300 million in some cases. In summary, we've got a superior product, a clear 510 K route, a full product pipeline, and an experienced team. It's a big market, an ASP of $4,000 per case, with a better than 85% gross margin, raising from five to $15 million, then that will get us through FDA clearance market launch with working capital and then funds through positive positive cash flow. Thank you very much.