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LSI Europe '24 Summit

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Nanochon | Ben Holmes, CEO

Speakers

Benjamin Holmes

Benjamin Holmes

CEO, Nanochon
Nanochon is applying novel materials to replicate bone and cartilage, and high-end 3D printing to create an implant which can permanently repair debilitating joint injuries.

Ben Holmes  0:00  
Hello, good afternoon, everyone. Before I get going, I just want to say that the very last trip that I took before the pandemic was in 2020, to come to this conference, so it is a true pleasure to be back here and be on the stage. And a lot of exciting things have been happening at Nanochon. So I'm looking forward to telling you all about them. But first, I need to talk about who we are. And what we're looking to address clinically. So Nanachon is developing an implantable medical device for an indication known as cartilage resurfacing, specifically looking to treat these these things called focal cartilage lesions, which essentially are like potholes that are either through an injury or just through natural degeneration developed in the cartilage surface of the knee. So they cause a problem for patients because they essentially leave the underlying bone and some of the other tissues in the knee unprotected, this causes the patient pain over time, they start to lose loss of mobility. And really, this is the dreaded disease known as osteoarthritis. So as you can imagine, patients are developing pain, they're having to give up their favorite activities, they're losing quality of life. And if these types of lesions are not addressed, really when they start to cause pain, the damage starts to spread throughout the whole joint. And this eventually leads to advanced joint disease, the treatment for which is the dreaded total knee replacement. So there is a real effort, and a devoted

subsection of surgeons in the sports medicine vertical, who are trying to treat these types of injuries much sooner when they're diagnosed. But the issue as you'll see as I give the presentation is that the options available to them do not truly reverse the disease, they really only serve to either slow down or delay the problems caused by osteoarthritis. And there also are a number of issues in terms of implementing these solutions, even though they don't work very well. So that's really where we seen the Enercon fitting in, we essentially have designed a better patch for both stabilizing these areas of degenerated cartilage mechanically, and then also providing an adequate tissue growth matrix to actually regrow true cartilage. So the technology is based on two components. One is a novel nylon based composite, which actually has a micro and nano structure, which simulates the collagen bundles that exist in cartilage. This provides similar mechanical profile to the tissue, it also allows the material to interact with fluid and in a manner similar to cartilage. And finally, this material acts as a growth substrate for stem cells. Now, we're also pairing that material with a 3D printed approach to manufacturing the implant. In our case, this has nothing to do with making a patient specific product, but rather, it allows us to to further increase the complexity of the porous environment. And what we've seen in

various animal models is that this actually greatly accelerates that interaction of stem cells with the material essentially allows us to deliver a product which does not have to be pre cultured or impregnated with drugs or live cells. So we can deliver this as a truly off the shelf packaged solution, which is great for patients because it dramatically improves their access. But also it's great for surgeons, because they can treat many more patients than than what they're currently able to do.

And so what are those solutions that they're turning to there's really three in sports medicine. The first and still most widely done is microfracture. This is a purely surgical technique, which doesn't actually regenerate healthy tissue, but it sort of fills these potholes in with a sort of a scar tissue. The big problem with that is that it just doesn't last very long. So the searchers are going to have to go and treat these patients with something else again in one to two years. In terms of other available treatments. There's categoric Aloe grafting, where a piece of bone and cartilage is taken actually from an organ donor and transplanted into these damaged areas of the joint. The problems with this are that the surgery itself is invasive, it almost looks like a knee replacement in terms of how the surgeon has to get into the joint space. But also it's very hard to source this tissue. Patients are waiting anywhere from six to 12 months just to find a donor match. And so in response to that some of the big device and pharma companies have developed cell therapies where they're sort of pre preceding or pre culturing cells on some sort of biodegrading material. And really, the big problem with this is that it has to be also done on a case by case basis. So there still is some lead, lead time and a bit of a lag. But also there are huge problems with cost, especially since they have not demonstrated better outcomes than the tissue grafting. And so really with Nanochon we want to deliver something that not only has better outcomes for patients, but also can really come in at a much more comfortable price point. And it'd be something that can be truly manufactured and used at an appropriate volume for the space.

So

to back up a little bit, how do we know that the technology works? We've really been working on this since 2015, before the company was founded technologies coming out of George Washington University, and most recently was evaluated in a large animal pilot in goats. We learned two things from this study, one, the cartilage that we're growing is of incredible quality, it is Highland cartilage, it has the appropriate composition as well as the appropriate structural and zonal arrangement, which is very critical for this type of tissue. That is really what is going to be the key to ensuring the longevity. And also we showed is that we get this regeneration in incredible speed, we saw almost complete degradation of our scaffold and replaced it with this tissue in four months. So we also believe in added benefits of the patient is just gonna be much faster recovery will now it's taking eight to 12 months. For recovery, we think it can be done in half a year or less.

To talk quickly about the market, we have zeroed in on a highly targeted patient population of around 371,000 annually in the US, this is based on both age and scope of the injury. And that equates to about a $1 billion target market opportunity annually. However, we do believe that there's a lot of potential with our technology as a platform, if you start to talk about expanding into treating both more severe iterations of these legions and legions and other joints, we think it's close to 4 billion. And then if you fold in other soft tissue applications, we think that this could really reach a $10 billion

total market annually in the US.

One of the strengths of Nanochon is that from the very beginning, we have always engaged with the clinicians and the KOLs. Even though we're years away from going to market, they have certainly validated the need for something that performs better and truly reverses the disease. But also, they've really zeroed in on a true value proposition here, which is that using those tissue grafts and using those cell products, they really just can't reach patients and do the volume of procedures that they want to do. And so, as I said at the beginning of the presentation, we really want to give the surgeons something which is going to have a better outcome, but it's going to be just much easier to use and is really going to drive procedure volume in their practices.

To quickly talk about myself and the team, I've been leading the company since 2016. I've been responsible for all of the funding to date, which includes close to half a million dollars in non dilutive funding and pre seed funding. We also just closed a series seed, which I'll discuss, my co founder is Dr. Nathan Castro, who's a very highly decorated researcher in the biomaterials and 3d printing space. He's also participated in a human clinical pilot for 3d printed implant. We also have a strong core management team, some of the top executives in therapeutics and medical devices and orthopedics, multiple exits up there and also KOL for some of our potential strategic partners. We also have a number of key partnerships both in research development, and we are a Johnson and Johnson J labs company.

We also have a team of some of the best sports medicine physicians that are knee specialists. These are some of the top docs who are team physicians for professional and collegiate teams. We also have a surgeon from the US Army. And so finally I want to talk about that series seed financing we closed in January with close to 2.4 million. This is primarily being deployed to both develop and validate the product to take it into a proper manufacturing setting and really get ready for primetime. Also, our major milestone is doing a one more really good, high powered, well designed preclinical study with a group at Colorado State. And all of this is really in service of getting ready for a 7 million series seed towards the middle of this year. That funding will be used for further r&d development starting to talk about surgical tooling. And then also the big ticket item will be the first in human clinical trial which we are planning on doing with a clinical partner in Australia.

So to summarize, we at Nanochon are very excited about the opportunities we've been afforded to really improve patients lives, we feel like we've developed a very high unmet need both for patient outcomes, but also for the surgeons treating these patients. And we feel like we're very poised for rapid growth. If everything continues at the right clip here. We'll be able to get into the clinic by early next year. We'll be looking at being market ready by 2025. And then I also just want to mention quickly that

really the strategics have gotten much more interested in this space in the last couple years and actually had a $500 million

exit of one of our competitors even before getting FDA approval so I just think that you know the future look looks very bright for Nanochon and what we're doing. So again, thank you very much everyone and I will be in the room next door if you want to come and chat

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