Gregory King Presents Fibralign at LSI USA ‘23

Transcription

Gregory King  0:07  

So Fibralign is a spin out of Stanford University. And we've part of the Start X community as well. And a few years ago, we won the MedTech Innovator Award, too. So those are some of the things we're seeing there. But above those little icons is a picture of the lymphatic system. And we're going to be talking a little bit more about that in the next couple of charts, but it's a pretty critical part of the immune system. And we're out to treat secondary lymphedema both treating and preventing it. The company is at an early commercial stage, we've had over 200 surgeries conducted outside the clinical studies of use cases of people getting treated for lymphedema. We have three ongoing clinical studies going in the US, one in Europe, and one that just started in Japan have over 30 Publications based on our technology. And we have over 33 patents in eight different patent families that we've gone forward with. Regulatory wise we have our initial 510 K clearance. We have a CE mark for surgical treatment of lymphedema as a class three device. We have ISO 1345 certification as well. And we're currently going through the process for Japan with PMDA and also for regulatory approval and Korea. If you're not familiar with lymphedema, these are some more extreme pictures of this. But this unfortunately is an outcome in Western countries most commonly after cancer surgery, where if cancer spread to the lymph nodes and lymph nodes have to be dissected and removed with radiation, it can cause a pulling in the affected limb. And that lymphatic system I showed in the first chart, about three liters of fluid that goes through that a day. And if it gets impaired, the pulling can occur in the limb itself. It can obviously these are more extreme cases, but it can cause a lot of disfigure disfigurement, heaviness of the limb fibrosis and pain and discomfort, but also compromised immune system. So there's big issues around infections and other complications from that because the lymph fluid is not getting flushed out. Worldwide, there's about 15 million cancer related cases, numbers can be higher than that as well, too. But the biggest problem right now is there's no cure for it. The most common form of treatment right now is actually using compression management. And it's a big problem, I think in women's health, because about two thirds of the cancer related cases are related to lymphedema. Unfortunately, two out of 10 women will develop breast cancer in their lifetime. Of those one out of five have developed breast cancer related lymphedema. And there's in cases where people have a higher risk of getting a later stage, cancers and such, there's even higher risk closer to one to one out of three people that develop that. As I mentioned, the compression management is really the primary care right now, which is literally pushing the fluid out of the limb itself. So some other collateral lymphatics and collect that. It's a time consuming, ongoing rest of life type of of treatment because there's only treating the symptom of the disease and not the cause of it. And often for the patient patients, it requires a lot of out of pocket expenses as well. Our product looks rather modest, but it's a threadlike scaffold that took three years of development at Stanford to optimize the nano structure to get the right performance for it. But essentially, it's an implant that promotes and directs the formation new lymphatic vessels. And it's looks like a piece of suture as far as the dimensions of the form factors. But what it has is a line nanofibrils a collagen that helps promote the direction and the formation of these scaffolds. It's a very porous structure. This is an example of the cross section of it. And what we find is endothelial cells like it, they get attached on a day long gait, and they start to form vessels along the scaffold if they do that. And after the scaffold after the vessel has been formed, the scaffolds get fully resolved in about six to nine months, so it gets implanted, and it's there just long enough to complete its function. We have two different targets that we're looking for use cases one is treating people to have lymphedema. So we're literally bridging across the damaged lymphatic vessels to form new lymphatic vessels and to really reestablish to reconnect lymphatic system. And we're looking at using as a prophylactic treatment to prevent lymphedema from developing. These are both large market opportunities. When we look at just the US and Europe as far as total addressable market, it's it's significant opportunity. The target here is really going after plastic surgeons who are doing reconstruction surgery, and with a subspecialty in micro surgery as well. And that's where we started our clinical experience. on the prevention side, just looking at breast cancer and just looking at us a Europe alone, about 700,000 new cases a year. And just for the product that total addressable market is about $2 billion per year going forward. And in this case, our goal is to become the standard of care and working with breast oncologist to use this as implantation device. So up to date, we've actually had over 200 cases to date that have been treated. The first one was in Stanford and this is a good example of the kind of experience you've seen. Right limb is about 50% larger than your left limb after breast cancer related lymphedema After the surgery reduced down to less than a 10% difference, and the skin is back to being normal and soft. And this was actually three years after the surgery still seeing the same results from this. This is what it looks like in the limb before the surgery is that there's a large amount of pooling of fluid creating a dermal backflow. That's what's causing them to be so large. In a 15 months later the same limb you've seen these new lymphatic vessels that formed right along or bioburden scaffolding. We have a lot of examples of cases where people have gotten some kind of micro surgery to address lymphedema and had some response to that. But then after putting biobridge in a second surgery, they can get down to normalize limb volumes. In fact, this has been published by Dr. Wen at Stanford and her group as far as the research they've done with a retrospective study showing complete normalization limb volumes. We have cases in lower limb as well. This is a gentleman in the 70s had melanoma that developed a lymphedema in his right leg and then after the surgery showed improvements that occurred from that we're selling this as a single sterile pack of five devices that can be used for surgery, high margin, high value opportunity. We have surgeries now conducted in 10 different countries. And we're engaging Kol throughout US and Europe as well. And right now we're the only medical device approved for surgical treatment of lymphedema. We have a clinical study that's going on right now at Stanford University Cago. I'm sorry, that's funded by the National Cancer Institute. That's about half enrolled at this point. And Stanford and MD Anderson are additional sites for that. We have a preventative study this completed enrollment in Europe with women have breast cancer, that are at risk of getting lymphedema. And we're using the biobridge as a prophylactic treatment. And we have another study this just started in January that our partner terminalis funded will be using for going through PMDA approval. One example to look at is the prevention approaches that are being used to try to prevent lymphedema, there's a very aggressive microsurgery that's been used by a lot of cancer centers, they've been to show that they can reduce lymphedema from about a 33% risk case down to about 10% doing that procedure. But it also has a lot of complications associated with that because it extends the surgery time by a lot. And we're looking at using bio Bridge, which only adds a few minutes to the surgery. It doesn't require additional surgeon to be involved in the process. And in fact, Stanford's is starting a preventative study investigating issues on their own to address that. We are located in Union City, California, we have a GMP production facility we've put in place there that's been in production for two years now at small scale. And we've now expanded to 10x production. And it's all under 1345 certification, a small team of seven full time people in the US and two part time people they've driven through this process. And with a very seasoned group of people multidisciplinary team to make this happen. I guess it really isn't advanced materials development, we've been able to do a lot of this because we have a really great network of collaborators, and advisors have been helping us through this process. So we're looking to raise 10 million, and that's going to take us to the end of 2024. And at that point, we think we'll be ready for an m&a deal. And we'll have our clinical studies completed by then. And a lot of other key points in place as well too. So that's what we're doing. We're really focused specifically on lymphedema and treating secondary lymphedema. But we're we're going to go in the future with this is quite interesting. There's been a lot of research done in the last 10 or 15 years about them and enjoy lymphatics are located in the skull, and what role they play in nerd. neurological diseases when then lymphatics get the graded, strong correlation between Alzheimer's and Parkinson's disease. And there's a lot of interest now taking our technology we're using for secondary lymphedema and see if we can help in this these modalities to address this disease. That's a quick summary. If anyone's interested in talking more. I'm available afterwards. But we feel like we're well poised to really go after this significant unmet need as a market. And we have a strong IP position in place to protect us as we go forward with that, and we're looking at additional applications we can take it forward. So thank you