Nina Tandon, Epibone - Stem Cell Technology to Grow New Bone | LSI USA '24

Nina Tandon  0:04  
First of all wonderful to meet you and so wonderful to be at LSI. It's my first one, and I've just won a really great high quality conference. So, you know, I don't need to tell you that we're sitting on a bit of a ticking time bomb as far as skeletal diseases. You know, bone is the most transplanted human material after blood. And as a society, we are replacing millions of joints per year. Oftentimes, because of just a couple millimeters of damaged cartilage. None of this would matter, except we are getting injured earlier in life and living longer and longer. For example, ACL tears have gone up 400% In the past 10 years for girls under 18. Okay, so if we're getting injured at 15, and living till 115, it's pretty clear we're going to need our implants to last as long as we do. And put this in context Young is anyone under 60. If you're 60 years old, getting a knee replaced, your median times revision surgery is under five years. Okay? That is just not sustainable. So who are we and why do we think we can do anything different? My name is Nina Tandon. I'm I'm CEO and co founder of Epibone, I started out as an electrical engineer, I thought I was gonna go into brain computer interfaces and help solve blindness. But I'm at MIT and MGH I landed in the lab and Bob Langer and found out that oh my goodness, you could use electrical signals to control amazing systems called Bio reactors that could do things like tricking stem cells into thinking they're inside a body and get them to grow new tissues outside of the body. Bob's lab is known for I don't know if you haven't heard of him, like it's mostly most famous for Maderna. But he also has some of the key patents for cancer immunotherapies, and coined the words tissue engineering around the time when I was a student 20 years ago, this is a labor of love. And when this works, it will be a 50 year overnight success. So we are the people that have brought you lots of technologies that over the years that have changed many lives. And what we're trying to do here is to pioneer a new era of regenerative medicine, using stem cells as the source. When I first started studying tissue engineering 20 years ago, it was coined in 1988. And I started in 2004, there was kind of this first wave of tissue engineering companies using what are called primary cells or terminally differentiated cells and using them to grow new tissues, say, so for example, let's biopsy your cartilage and use the cells to make new cartilage. Well, that approach has limitations because cartilage doesn't grow new cartilage very well. So what we do that's different and what the real groundbreaking innovation that we implement that's different is that we go one step up the lineage, take stem cells to make new tissue. And so we've got a platform technology to make any living bone or cartilage that's required throughout the body. And it's just like any other bone or cartilage that you were born with, except it's grown from cells in our lab. Here's how it works. It starts we start from CT scan so that we can extract the three dimensional data make a perfect puzzle piece shaped biomaterials scaffold, and perfect puzzle piece shaped by a reactor. A bioreactor is really just a fancy word, like I said a moment ago that a cell culture system that mimics the conditions of natural tissue development, and in this controlled system, delivering oxygen, nutrients and mechanical forces. So you can think of this as kind of diet and exercise. The stem cells attached to the scaffold proliferate, and most importantly, differentiate. It takes us three weeks to engineer bone, four weeks to engineer cartilage. And we have a platform technology that in theory allows us to make any bone or cartilage required throughout the body. So that's what we do, we make bone, cartilage and combinations of bone and cartilage called osteochondral tissues. The way that this works is we emulate the natural conditions for tissue development and use our robotic cell culture systems, our cell culture media, and our biomaterials all towards the in service of tricking cells into thinking they're inside a developing body. So I said in theory, because while we have a platform technology to grow any bone or cartilage like any other bone or cartilage throughout our bodies, that is not how our clinics are organized. And it's also not our regulatory bodies are organized. So it's been really important for us to tease that balance between showcasing what we can do with the platform, but also retaining laser focus, because you know, this takes a long time. And you don't want to be that CEO who you know, wants to do every bright shiny thing. So we had to choose a beachhead market where shape really matters, the treatment options are not good. And ideally we could qualify for accelerated approval pathway through the FDA. So that's why we started out with bones in the head and face. The current treatment gold standard is autographed. That means cutting bone out of your hip or your rib or moving it to your face. If you've seen botched every single episode involves someone getting a rib cut out. It's boring to see it over and over again but it just goes to show I said I'd be kind of AI design that nose we didn't need to like, you know, cut it out of a rib. So we started here, and we just completed last summer a phase one two clinical trial in bone. So happy about that. Last summer we made history again by getting our cartilage which is layered on top of that same bone scaffold approved for clinical use in the knee. Okay, we've got Scott rodeo at HSS Brian Cole and red rush ortho and Bert Mandelbaum at Cedars Sinai, one of our investors actually also signed up to our clinical trial. So top three orthopedic hospitals in the country working on this trial, our third products and injectable cartilage filler, fully funded by the Department of Defense to date. And we are looking to now map that towards the clinic in Thailand, we implanted six patients ranging in age from 18 to 59, male female for reasons ranging from trauma to congenital defect, and we've seen the same results, the bones fit perfectly, no adverse events related to our product, and perfectly integrated and vascularized. Within four to six months, we have a suite of patents that cover not just how to grow bone and cartilage, but we know that we also need to ship and implant and scalable we manufacture these kinds of products at scale so that we can eventually show some of those kind of unit economics that we just saw from the last presentation, it's really important that this not become a therapy that's only available to the privileged few. We're seeking a series B, lead investor to help us translate this, these products to the next stage, we're planning to launch a clinical trial for our knee cartilage here in the US at those hospitals. We're also planning to launch a clinical trial for our injectable in Thailand, my co founder is Thai beef between now and when we identify the series B lead, if you're really itching to get involved in invest, we can also talk about a bridge that we are opening in advance for select investors as we continue to seek the series B lead. So you know, my my goal really is to you know, when I think about our journey thus far. And it's been 10 years, this company, okay, when I look behind and I see all of that technical derisking that we did, I'm very excited because we got the FDA to make history become the first and second. And so far only stem cell based tissue products approved to go into clinic. But when I look ahead at our journey, it's important that we not just be able to prove that our technology works on the bench and works in humans, but that it works in the clinic, and that works in culture and society. And so I'm really excited to be at this juncture in our journey, please do feel free to get in touch, I should have put my cell phone number there, if you'd like to learn more. And, you know, I just hope that I've left you with with one final thought, which is that, you know, let's all scan our bodies. And imagine all of those spare parts of our bodies that we are bound to accumulate as we go through this lifetime. 95% of us are projected to accumulate a part of our body that we were not born with in this lifetime. And imagine that that spare part is made not out of metal and plastic, no offense, but out of your own cells. And that we have every intention at the bone of making that happen. Thank you very much. Enjoy your lunch.