Video Transcription
Pasi Kankaanpaa 00:02
Hello everybody. My name is Pasi Kankaanpaa. I'm the CEO of Biomendex, a bone graft company based in Tampere, Finland. Let's talk about the bones. Did you actually know that there are 11,000 operations daily requiring bone grafts? That's a lot. In the U.S., that means seven and a half thousand operations. And of those, 1,000 operations fail and require revision surgery. There are solutions available, but the solutions are mediocre at best. They are difficult to use, and the surgeons do not trust whether the graft actually stays in the defective site. Even the gold standard autografting doesn't really tick all the boxes. It takes more time, it increases the pain for the patient, and it increases the risk of infections. Imagine the brick you have a defect in your bone. Imagine the brick that doesn't fit in. What you need to do, you can't change the brick. You have to take the Dremel and make the hole bigger. That's tedious. That takes more time. We have a solution: adapters. It's a malleable bone graft made of the same materials, so the bioactivity is the same. Safety is proven, but it's malleable, and you can really, really squeeze it into the defect, and it stays there. It doesn't drop, like most of the competing products. So that's your choice. You can use the bricks, or you can use the malleable option we are offering here, with the same bioactivity and the same safety profiles. We have done our first-in-human clinical trial, already pilot testing, and that proved the efficacy and safety. What we are claiming here is that we have the preclinical data from our vet surgeries. Already, 1,500 animals have been operated on successfully without any complaints so far. And this dental study here confirmed these findings. In addition, from the usability point of view, from the graft migration point of view, both cases were confirmed. Patients loved it, dentists loved it, and the graft actually stayed in the socket, in the tooth socket, without any coverage or any stitches. So basically, challenge solved. From the value proposition point of view, if you have something which is bioactive, which is safe, which is easy to use, and which stays in the socket in a defect, in this case, you can create or you can shorten the surgery times. You can decrease the number of revision surgeries. You can alleviate the pain for the patients, and you can lower the risk for infections altogether. We are talking about about 1 billion annual savings in the U.S. healthcare alone.
Pasi Kankaanpaa 03:53
If you look at the competitors who are out there, none of these are really, really ticking the box when it comes to usability and when it comes to how to make sure that your graft actually stays in the defect. And those two points are the major points that we have been trying to solve with adapters. And we think we have nailed it. We have the bone graft; it stays there. No matter how much I'm raising and flagging this bone here, it stays there. From the market perspectives, the commercial bone graft market is basically you can divide it into allografts and then biomaterials, but these commercial ones cover only 45% of the surgeries as we speak. The rest is still done by autografting, taking the bone graft from the patient him or herself, despite the drawbacks of autografting. So the market is more than double—double that, actually—the addressable market. Our goal is to achieve a 10% market share in the commercial sector within the next 10 years, gradually increasing the market share. But our desire is to actually go towards the autograft market. If any product can do that, adapters can do that. The vet business is where we have started the commercial operations already. It's a brilliant blue ocean market for us. It brings us some early revenue, and perhaps even more importantly, it brings us preclinical data all the time, constantly. But the North Star for us is definitely the clinical market. And there we have started on the spinal side; the 510(k) submission for spine has been submitted. We have started the preclinical study, and we anticipate doing the final 510(k) submission in spring 2025 for the other indications. What you see here are on maxillofacial extremities. We are also having the preliminary plans already in place. And there we are heavily leaning on the collaboration together with the Mayo Clinic from a market point of view. As you can see here, spine is a really, really important market segment. It covers 70% of the total commercial bone graft markets. So that's really, really highlighting that point. For the modeling purposes, basically, we have used the comparative pricing here because we are still assessing the pricing and we are still assessing reimbursement details. So we are just using the street price here for this analysis. And also, we have been mimicking, to some extent, the models of the more recent players in this field, namely BoneSupport and Kurosh, but having our own twist there. From a traction point of view, we have secured 6.5 million in investments, angel investments, and grants in order to develop the IP of this technology. And the IP is owned by the company fully. But more lately, because we are moving towards commercialization, we have been trying to build up the clinical collaboration network in the U.S., working very closely with Mayo and also with Wake Forest, North Carolina. From the roadmap point of view, we have a clear focus on U.S. markets, but also we want to extend the vet business and continue the CE mark clinical trial and the other indications that are coming on, as well as the manufacturing scale-up. We are looking for an additional 10 million in investment in two tranches in order to execute that roadmap I just showed you. In the first phase, we concentrate on 510(k) clearances of spine and oral segments, market entry, execution activities, as well as scale-up of the manufacturing and moving or doing the tech transfer to a U.S. setup. In the second phase, then concentrating more on the EU clinical trial as well as on the other indications. Yes, that's it. Let's change the bone grafting practices together. We are here with the team. So if you have any questions, please don't hesitate to come back to us, and then we can go into more depth. Thank you.
