One of the most exciting aspects of tissue engineering is its potential to address the organ donor crisis. Currently, not enough organs are available for the number of people who need them. Tissue engineering offers the possibility of creating new organs in vitro, which can be transplanted into patients. This would save countless lives and is a driving force behind the current wave of funding.
Another key area of interest for tissue engineering is accelerating drug development. By creating 3D models of human organs, researchers can test new drugs more accurately and efficiently. This speeds up the drug development process and reduces the need for animal testing.
Many technologies are being used in tissue engineering today, including various types of stem cell therapies, 3D bio printing, new types of scaffolding materials, and nano materials. One particularly exciting technology is the “heart on a chip” technology, which can be used to develop new therapies and personalized medicine.
Despite the potential of tissue engineering, there are still challenges to overcome. One of the biggest challenges is the lack of a true leader who is investing in tissue engineering as a whole. While there are some strategic investments in cartilage or soft tissue, there has yet to be a firm that has built out a diversified portfolio of tissue engineering pieces. This may change as more investors begin to see the potential of tissue engineering.
Tissue engineering investments should be cautious and focused on areas without current solutions. For example, there is currently no solution for replacing vital organs in the body for people who need organs or have failing tissues. Targeting supply chain solutions and therapies focused on areas without current solutions is a promising investment strategy.
Overall, tissue engineering is an exciting field with the potential to revolutionize healthcare. While there are challenges to overcome, the potential rewards are immense. Companies such as Patics, Epi Bone, and Prellis Biologics are developing promising technologies in tissue engineering. Investors interested in this field should consider these companies and others like them.
In conclusion, tissue engineering is a field that is seeing a lot of attention and funding, and for good reason. With the potential to address the organ donor crisis, accelerate drug development, and create new therapies for various ailments, tissue engineering is poised to revolutionize healthcare. Investors should be cautious but focused on areas with no current solutions. This deep dive is a great place to start if you want to learn more about tissue engineering.
One such macro trend is tissue engineering, a sub segment of regenerative medicine. Tissue engineering is an interdisciplinary field that applies to engineering and life sciences principles towards the development of biological substitutes that restore, maintain, or improve tissue function or an entire organ.
It has the potential to have significant impact in addressing the organ donor shortage, pharmaceutical drug development, and many other fields.
However, the advancement of many collaborative technologies are needed to bring tissue engineering to its full potential.
For this reason and many others, which we’ll cover today’s webinar, tissue engineering is of increasing interest to I Select. A few process comments.
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This presentation is being recorded and will be available to replay. And so without further ado, I am pleased to present this week’s deep dive webinar on tissue engineer?
Alright. Well, let’s kick things off. Thanks everyone for joining today.
So just to to jump into what we’re gonna, you know, cover today in sort of our our traditional format, you know, we’re we’re gonna talk about what tissue engineering is. What some of the use cases are for this technology available today. More than market opportunities live for this technology in this multidisciplinary field. What technologies are being used to achieve tissue engineering today? Where are some of the challenges that DB overcome in order for this technology to becomes a part of our everyday life, who’s at the cutting edge of the technology and solving these problems, who’s investing in tissue engineering, some of the major corporate players in the space, universities and key opinion leaders that are leading the research and some advice for internally, for where we should consider our method strategy when it comes to the tissue engineering field as a subsegment of regenerative medicine.
So that’s further ado and overview.
Physitional engineering is an interdisciplinary field that applies to principles of engineering and life sciences towards developing a biological sub to restore or maintain or improve tissue function of a whole organ. It really incorporates, you know, ideas around developmental biology and engineering and then using it in a means to either regrow tissue, reintroduce tissue to the body, potentially reintroduce entire organs into the body, and also sort of the substrate for advancing the development of pharmaceutical drug discovery.
In the sense that we can we can collect better data using nuclear tissue and organs that are provided in the laboratory.
Some of the key components essentially, there’s three key components that make up tissue on your animals, diving does a little bit more. Those include cells, obviously.
You know, recreating cells that are either specific to a certain tissue or a certain organ or complex layers of cells essentially serve as, you know, the living body of the tissue. In addition, scaffolding is equally as important. We talk about scaffolding. We’re talking about materials that are used essentially to reintroduce tissues into the body and serve as a way not only for for tissues to hold on to new tissues, but to distribute nutrients and enable blood flow in a variety of other factors.
Further there signaling molecules, essentially serve as, you know, for example, a neurotransmitter as the ability for cells to communicate between across extracellular matrices.
And so signaling molecules are incredibly important in terms of introducing a tissue ex vivo in vivo.
So there’s a really wide variety that are powering tissue engineering and making it a reality today and future. And part of this, it it makes this a really exciting admin from an investment standpoint, but also makes it a complex one. And you really have to understand a lot of the pieces that come into what really makes an entire tissue engineering solution possible and and viable.
Sydney Technologies include stem cells, bioreactors to cultivate those stem cells and non stem cells for that, should that matter. BioScapleton, what we discussed, three d bioprinting, essentially, being able to print human tissue in a three-dimensional layer, an identical tissue engineering being able to, you know, identify the excess of a of an of an implanted tissue based on magnetic, in magnetic implants, in tissue sensors to monitor how tissues are performing. Desalurization, resellerization of organs, often done with, you know, external organs. And when I’m going to say that, I mean that oftentimes, you know, pork or, you know, cow products are taken and decellularized and resellularized with human human tissue.
And then another interesting area we’ll talk about organoids, which is more relevant to tissue development for research and testing and essentially saying, you know, we don’t want to build a heart. They can go back into a human. We want to build a tiny version of a heart that we can use many, many times to test a wide variety drugs and essentially understand how that drug would interact with the heart, but at a much smaller scale in the laboratory.
And today, you know, we’re not producing complex organs in a way that they can be transplanted directly there’s a lot that goes into bringing a full organ into the human body, whether that’s the complex tissues, whether it’s growing those tissues, whether it’s having the body tick uptake them successfully. Whether it’s having them communicate with the existing native tissues or having and commonly when we talk about this challenge a little bit, the vascularization problem. Actually getting blood flow into the tissue and not suffering from necrosis is one of the biggest issues that face is bringing true organs back into the body today.
So what we’re good at right now is bruising artificial bladders, small arteries, skin grafts, cartilage tissues, tracheas and scaffolds, you know, we can there’s a number of really interesting starts working in the three d bio printing space. They’re basically working in ways that can say, you know, if we can see it, if we can image it, if we can build a cad model of it, and we and we know what cells are making up this tissue, why can’t we print it in the same way that we do these other complex issues.
So here we sort of see another look at again, these sort of three core components.
And the cells, they can be – we’re talking about cells, they can be both from our own bodies. And oftentimes, that’s what they are today. But they also can be from others. They also can be donated cells.
And they they further can be differentiated cells. There there’s companies that say they’re working on growing skin that’s taken directly from our body and then reapplying it and even a skin graft. But we can also use technology today to essentially produce induced body plan stem cells from our own body or from others in order to form other types of stem cells. This other cell types and body.
Scabbled, you know, it was really interesting trying to summarize what makes us, you know, scaffolding in and of itself. And there’s really a wide variety of factors. And in the slide, we’ll both talk about a little bit sort of what the main materials are being used today. But there’s a huge opportunity in the development of of nano material and nano filaments that that essentially enable new types of scaffolding to come into light. Some of those that are that are being used today include, you know, metals, ceramics, polymers, composites, some of them to be permanent, some of them to be reabsorbed by the body. It really depends on what the needs of the implants for the needs of the engineered tissue are.
And then secondly molecules really can vary again depending on what the needs are. And other times, we’ll talk about seating. So you’ll get cells, you’ll grow those cells in a scaffold. And before preparing those who go back into the body, you need to seed them with signaling molecules that will actually signal to the body that this tissue needs to reincorporate into the system and needs to be communicated with across an extracellular features.
And sort of here just that, you know, it’s sort of finishing our summary of what this incident can look like. Obviously, this is a really simplified you know, look at what tissue engineering can look like because, you know, tissues can come from other places and we can we can take them from animals or other people or we can do various kinds of cell proliferation or those different kinds of bioreactors that we can use. But essentially, we’re isolating cells, we’re cultivating them, or proliferating them into the cell type that we want, applying them onto a scaffold, and then essentially bringing in some type of stimulus that’s gonna allow them to operate as a functional tissue and then re implanting it to the body.
So this is our key component one.
Up here, you know, there’s essentially four types of cells that can be used three of which are shown here in order to actually grow the tissue necessary for tissue engineering to occur. Embryonic stem cells are purely undifferentiated cells derived from a blastocyst of an embryo, and they can become any cell type.
Induced pluripotent stem cells while not as omnipotent as a blastocyst, their stem cells, they’re often derived from human skin or blood cells. That have been reprogrammed back using various technologies, such as genetics, to back into an embryonic like pluripotent state, where they can differentiate into a wide variety, a wider variety of cell types than they would have been able to otherwise.
And then tissue specific progenitor cells are able to differentiate in sort of their specific cell types. You know, we talk about progenitor cells. We’re thinking about the the blood, you know, the blood cells in your bone marrow, they’re able to give rise to a wide variety of blood cell types. And so in this picture, we see you know, a neural stem cell that can give rise to a neuron and astrocyte and an oligodendrocyte.
So these are sort of the three different types we can look at And further, there’s also differentiated cells. We haven’t included here because differentiated cells are obviously just cells that exist as they are. And then so, we can we can take our skin tissue, for example, as I mentioned, and you can grow it into more skin tissue. And with the right mixture of singling molecules and scaffold. We can introduce those cells back into the body.
So key component number two is scaffolding. So, you know, materials research is really important in discovery these novel solutions. These can be natural aesthetic biodegradable or permanent, and all of these have been explored some really common materials are used today include collagen and polyester.
So some some factors they’re taking into consideration for scalp design, include their injectability, their synthetic manufacturing needs, their bio compatibility with the body, whether or not they’ll be attacked by the immune system, and and their absorption absorption rate of a sort of nutrients back to the cells.
One really hot area right now is hydrogels.
And hydrogels essentially constitute a major class of bio materials because they’re physical and chemical properties often mimic those of the native extracellular matrix tissues.
And because of this, this enables the three d stacking and destacking of human cells. And this is what’s being used in these three d bioprenters today, and our ability to really build out what a tissue actually might look like.
Now, they’re superior in biocompatibility to other compounds, but unlike these compounds listed below, they don’t have the same structural integrity. And so those are some of the challenges that face hydrogels today. Oftentimes, we need to combine with these other materials. There’s polyactic acids, polyglycolic acids, and polycaprolactone, which are sort of three major assets that have been used as the core structures of scaffolding today and that form a really solid structure, but don’t have the same kind of bioavailability.
And thirdly, we have signaling molecules. So, you know, signaling molecules really represent the ability of cells to respond to a bio material in a controllable manner And it’s really the decisive factor in, you know, successful disease treatments using engineered implant materials. Signaling molecules involve multifunctional proteins such as growth factors and cytokines as well as molecules such as neurotransmitters.
And so you know, as we move on to the next section to talk about sort of the problem and the opportunity, we look back on these three factors and the variability between the three key parts of tissue engineering. And I’ll and I’ll jump back here again. The cells, we see there’s a wide variety of cells to confuse, and and they have to be cultured, and they can be cultured in different ways. We will get scaffolding. There’s a number of different ways that you can actually, you know, incorporate a cell culture into the body. But there’s limitations of new technology and limitations of old. So there’s there’s consideration that’s to be taken into account for both.
And sort of component three, again, how do we get this tissue to interact with everything else in the body. So and and that really depends on the cell type that you’re bringing in. And when you think about bringing in a complex organ, which is not, in my opinion, kind of come on for a long time in terms of, you know, introducing a a fully synthetic organ or a thrown organ in the lab.
At a complex level. You have to consider all these different types of growth factors and transmitters that are relevant to the different cell types within them.
And so, you know, with that in mind, let’s sort of jump into some of the problems that tissue engineering can address. And I’ve highlight I’ve really highlighted two in this presentation for us to go into. So problem number one is the wait list for new organs. So we can see here that, you know, in, you know, twenty sixteen, there are approximately, you know, forty eight to fifty thousand people who received essentially transplants or donors. Whether that’s from people who passed away in order to repurpose, or people who essentially have an extra kidney and donate that kidney to someone that likely they know well. Well, we can see that from nineteen ninety one to twenty sixteen, the waiting list for the number of of people who who need organ donors is has grown substantially and exponentially.
And in another snapshot here, we can sort of see where that demand is coming from. That can sort of help us inform our investment thesis. We can see that about eighty-two point nine percent of kidney people waiting for organs or are waiting for kidneys.
Twelve point two percent for liver, and then hearts and lungs slowly falling after that.
And then so the transplants that were form and kind of in a similar order. Large number of kidney transplant, obviously.
Because we’ve got two liver transplants, hearts, lungs, following there. And so we can see, you know, if we go, you know, lung up the kidney, there’s a huge opportunity in terms of tissue engineering to potentially not in the next ten or the next twenty years to replace a liver or a kidney entirely from the lab. But in order to introduce regenerative tissue is a huge opportunity. And that’s somewhere that that we should be looking.
And then the second problem is really the drug discovery needs to makeover. We just sort of see through this timeline here, average development time for a drug to go from, you know, preclinical research to FDA drug approval, seventeen years, average cost five hundred million dollars to one billion dollars. And, you know, if we’re thinking about anywhere that needs some innovation or an increase in efficiency. This is an area that can do this.
And what tissue engineering can deliver here and help an accelerator for drug approvals. And I can do this by reducing the need for animal models you know, a recent Ted Talk, I was listening to cited that humans are not rats. And so why would we rely on a rad model? That’s like to understand how a drug works in the human body.
And if we can create, you know, tissue environments that better represent how drugs work in the human body and do it at scale, it can really it really has the potential to to drive development in an acceleration of drug discovery.
And it also helps solve a little bit of the problem, potentially in the long run, of the number of patients who are available track for trials, which is one thing that we think a lot about here at I Select in terms of more modern medicine therapeutic, strictly in a in a really busy, you know, immunotherapy space. You know, how do these how will these drugs come to market? There’s not enough people available for trials. And so if we can bring tissues in the body or even There’s even a really interesting concept of of a human on a chip, where essentially you can you would recreate the entire human body at a micro scale and introduce drug at that scale.
A tissue engineering is a really exciting field, but there’s a lot of challenge that we have yet to face. The incorporation of multiple cell types into a single structure is something that’s really complex, and that the three d printing is is a is a really hot topic right now, and it’ll be really just see how that plays out in terms of being able to truly incorporate multiple cell types and vascular structures along with the other technologies that are needed to introduce new tissue to the body.
And sort of piggybacking off that complex functional vascular structures really in the reading that I’ve done has really been shown to be a limiting factor, is getting equal blood flow to the tissues to the cells in the tissue that’s reintroduced is complex and not fully shaken out yet. There’s been some some really interesting breakthroughs in the research, but it is not fully shaken out.
Seating scaffolds with multiple cell types for a few different rates. Something I wasn’t aware of prior to this this research. But if you are a fetus, you know, if sales grow different rates, how do you plan to grow them in a way that not only makes their distribution equitable and viable but do it in a way that they grow at rates that matter. So there’s there’s a number of other factors going on there.
And there’s a difficulty in tissue fabrication of sort of four classes of difficulty.
And we can sort of, you know, from least complex to more complex, I’ve seen some, you know, some solutions. Flat issues clearly skin you know, we can we can regenerate skin tissue. Tubular organs, this is your trachea, and the like are ones that are less challenging to do as well. I think largely a lot of that’s due to simply they’re not there’s not a complex of a tissue.
Sort of more complex hollow non chamber organs, which would include your bladder, somewhere where we have seen some achievement. And, really, the final frontier that’s gonna take a lot of collaboration.
Is the full grown apart Indian levers, and then another other compact complex organs.
A couple of reoccurring.
Regenerative medicine and advanced therapy, RMAT challenges include supply chain and scalability, how to do the scale, how do we set up a supply chain to ensure that these are that these therapies are personalized, that they don’t get damaged along the way. From transportation from from laboratory and a number of other places that they need to to pull materials, and then introduction to human body payment systems for curative treatments.
We when we touched on this in gene therapies, and I’ve I’ve touched on it in the overview presentation for regenerative medicine.
You know, have it the current payment system is not set up for curative therapies, and that’s something that’s gonna have to be addressed. And then the multidisciplinary nature, of digital engineering makes it potentially really impact impactful but complex to implement.
And so when you just think about having to bring in those three factors that we talked about and the number of so we talked about, you know, cells and sort of transmitters into bioactive properties and scaffolds and bring all those together in a way that makes sense for a specific patient and for for a specific tissue, And for number of other variables can go on, it’s really challenging to to see how all that comes together in a way that scales in a commercial product.
Here I’d like to highlight two technologies. First here, three d biopreneurs. Three d bioprinting is an extension of traditional three d printing. Bioprinting can produce living tissue, bone, blood vessels, potentially entire organs for use in medical procedures training and testing. The cellular complexity of the living body has resulted in three d printing, developing more slowly than mainstream three d printing. Just a more complex area.
But it really, you know, could provide the opportunity to generate patient specific tissue. For the development of accurate targeted and completely personalized treatments. There’s still a long way to go before we can create fully functioning and viable organ containment transplant.
But bioprinting, and and being able to take hydrogel and stack them in a way that that actually mimics the structure of a of a human human organ is a step in the right direction and potentially enabling technology.
And then secondarily, I’ve mentioned this one a couple of times human organs on chips. This is really, really cool research that came out of Harvard.
Potentially, the Whiz Institute Research is in a multidisciplinary team of collaborators engineered microchips. This is to recapitulate the microarchitecture and functions of living human organs, including the lung, intestine, kidney, skin, bone marrow, and blood brain barrier. These shifts called organs on chips offer a potential alternative to traditional animal testing.
Each individual organ on chip is composed of clear flexible polymer about the size of a computer memory stick. It contains hollow hollow microfluidic channels lined by living human cells with sort of human, you know, skin lines, you know, artificial vasculature.
And then mechanical forces can be applied to mimic physical microenvironment of these living organs, including breathing motions, you know, blood flow, you know, because I mean, because they’re they’re, you know, translucent, they provide a window that interworking human organs. I think this is a really, really fascinating area. And when I think about investment opportunity, moving into, you know, the ability to, you know, accelerate drug discovery and other, you know, understand people on the individual level on how their bodies would operate at this micro scale. It seems much more scalable and a need that can be corporate without having to take into consideration what it takes to actually grow a liver and put into somebody’s body.
So from this In summary, some interesting opportunity metrics anticipate to be a four point eight billion dollars to six billion dollars market by twenty twenty two. Interestingly, in in a report that I I read about the it was the alliance for regenerative medicine. It was about nine hundred to a thousand clinical trials going on today in regenerative medicine, and that goes across gene therapy, cell therapy also includes immunotherapy.
There’s about nine hundred to one thousand that are going around those fields. For somebody with tissue engineering, there’s only twenty one today.
At least in twenty seventeen.
And so that that, you know, may speak a little bit to the complexity of tissue engineering. And it people aren’t quite sure how to bring these therapies to market yet. You know, gene therapies early as well.
But it’s also a pretty popular hot topic. And there have been four major gene therapies brought to market today, although facing a major payment crisis.
In terms of growth rate, we’re looking at, you know, seventeen point two compounding annual growth rate from twenty eighteen to twenty twenty three, which is really impressive, really exciting. I think we’ll start to see those clinical trials go up a little bit more. And I think the number of clinical trials a little skewed because tissue engineering often crosses over with cellular with cell therapy.
And so some of those trials get incorporated to that area instead.
In terms of, you know, areas to invest, If areas invest, use cases, neurology, cardiology, respiratory issues, dental, interestingly was a was a really popular area for the future of tissue engineering, orthopedics, muscular skeletal, and spine, and in drug development.
At this time, let’s address some of the key players in the financing activity and see sort of what’s going on. With both some of the legacy players, startups, and the key opinion leaders.
So in terms of, you know, legacy players, I’ll highlight a few here. We can see at the largest scale of Medtronic and Striker, Allergan, we’re particularly present in in in the research, Integra, RCI surgical. In terms of what they’re working on, Medtronic is developing tissue engineered heart valves derived derived from poor sign tissue.
And I believe they’re they’re essentially decellularizing that tissue and then resellularizing it with Integra, their surgement technology usually provides a non denatured tissue scaffold, which the body, you know, can simply repilates own cells and blood vessels too as heals. So they’re working more on the scaffolding end of things. Vericel developed their Macy technology, which somehow stands for autologous cultured chondrocyte on porcine collagen membrane.
But, essentially, it’s a tissue engineering for the re gen re generation of cartilage tissue and the knee. They’ve also developed Epicel. Which is a cultured epidermal autograft, essentially means that a culture of your own skin, and then they can reapply to your body.
And at this time, they can grow enough skin per patient to cover an entire patient’s body.
Cryolife is working on photofix, which is a decellularized bovine pericardium, for the replacement of parts in the heart. And then RTI surgical is working on sort of more on the stem cell side of things, multipotent adult progenitor cells, for for scaffolds all all allagraft scaffolds, which mean that they’re coming from.
I guess, yes, so not autographs, they’re doing all the grass scaffolding in the bone repair process. So there’s a number of large players that are developing technologies within house, across a wide variety of fields. And so they’re not to be overlooked in terms of their development potential, particularly when it comes two, when we when we sort of segment it out into the three areas of difficulty, you know, their the large players are definitely working in, you know, the easy to medium difficulty technologies.
In terms of, you know, emerging startups, there’s a lot of really interesting stuff going on in the space, couple of companies that we’ve looked at, couple of that we haven’t. Hepatics is one that we’ve looked at closely and essentially they’re repurposing out of post fat tissue and converting it into viable liver tissue. And and one thing that’s interesting about their work is that they haven’t had the same problem in their early research, in their early data collection with tumor genesys, which has been one major problem in recusing these kinds of tissues of body.
Couple of other interesting companies. Olivier, formerly Biobots, essentially a three d bioprinting company.
And they’re sort of they’re working directly to were on the the Oregon waiting list in that sense.
Epi Bone, the developer of bone reconstruction technology, intended to sort of enhance the lives of people, you know, sort of personalized bone transplants.
In terms of sort of leading startups, Humasite is one that comes up quite frequently. And they’re pretty far along here. I think they’ve got about Let’s think about it.
They’ve got about, you know, what might have it in a later slide, around two hundred fifty million dollars in funding.
And so, basically, they’re developing tissue based products and trying to develop a platform technology to sort of engineer human, extracellular matrix based tissues, that can be used on tubes, sheets, particular confirmations, a wide variety of other areas.
And then they really sort of look they really appear to be the leader in what’s pure tissue engineering.
Blue Rock therapeutic is more leading on the induced chlorine coat and stem cell side of things.
But He looks to say there’s in terms of in tissue engineering has been around, you know, the idea of it to play nice 70s or maybe the last — it did go the last thirty years since the 1970s.
And it’s developed, you know, piece by piece. And when you look at and we’ll jump in some of the exits. When you look at some of the exits, they’re not quite as engaging as you think they would be. But I think recent deal activity is leading us to sort of a new forefront of this technology being adopted.
In terms of fighting for leading investors, this was an interesting area as well, because when you think about purely tissue engineering, the idea of scaffolds and and really reintroducing engineered tissues into the body. I wouldn’t say that there’s an investment leader at time. There’s people who are, you know, there’s there’s firms that are dominating in regenerative medicine.
And I I would have been, you know, happy to shouldn’t advise anybody who would like to see the slide of who’s dummy, regenerative medicine.
But in terms of who’s going tissue engineering specific, it’s early days in terms of companies that are specializing in this field.
Because there hasn’t been a ton of exits. A couple of exits that have gone through up and does. And I’ll talk about those as well. But in terms of who’s been involved SOSV and their their accelerators in Ind bio have been engaged, particularly on the three d bioprinting side of things.
Specifically on three d bioprinting side of things. SOSV is invested in biomedic solutions, which is doing three d cell culturing. Scaled bio labs, which is essentially doing cell culturing to help solve the research bottleneck in tissue engineering, and prellis biologic, which is doing three d printing.
NEEA is involved in an investment annualized technology, which is doing soft tissue regeneration to spine. And Orbiomed is also engaged with a company called Tila Bio, working on such issue repair. Interestingly, Korea investment partners of all the the VCs I read about was the most consistently active in what I would consider tissue engineering specific investments.
And so that in terms of if we were to get engaged on an investment like that and we’re seeking out elite investor, Korean investment partners is is one who I would point to as a as a really someone who’s really engaged in that space. Makes sense to create the world capital custom x surgery. Is it really?
Make faux sense.
So in terms of you know, lead universities are a couple up here that, you know, we probably see every single week, Harvard and MIT.
Some of the, you know, lead researchers coming out of there Robert the Robert Langer lab at MIT is a is a really, you know, cutting edge leader in that research. And and doctor Jay vacanti, is frugally involved in Dr.
Mizoo, interestingly, in the work of doctor Gabor Forjax is one of the leaders in vascularization research for tissue engineering and bringing tissues to the body and essentially developing those vascular structures within tissues, which is one of the huge limiting factors. So exciting to hear that from our home state, Missouri, we’ve got some really interesting research coming from there. And then doctor Nina Tarden, who’s got some really interesting Ted talks out there. She’s the c cofounder and CEO of Epi Bone.
And she’s she’s an expert in electra stimulation for tissue engineering practices, and her company is really working to re grow bone tissue, and then regrow within within within the body. And in terms of international organizations, NIH, NIBIB, and the alliance for regenerative medicine. The alliance for regenerative medicine has some really interesting reports out. And I’d say in terms of public data available.
They have been incredibly helpful in my research in terms of understanding the scope of of where the focus is today among the sort of three main segments of regenerative medicine and sort of giving sort of this database insights into that.
So here we can see tissue engineering exits from twenty eleven to the present. Again, not a really exciting exit, you know, outlook from what we’re looking at here. And and I really I really try to keep it specific to what I consider tissue engineering companies.
Histogenics sort of at the top there with a one hundred and eighty one million dollars exit with an IPO.
They’re a developer of products to regenerate healthy cartilage, improved joint function, and to prevent degenerative disease. So since they’re working on that cartilage, development. They were one of the early ones to to to go out twenty fourteen.
There’s like so Shire regenerative medicine actually when it was – what prior to – prior to this acquisition by Shire was known as advanced bio healing.
And was originally a developer of cell based therapies for various types of damaged tissue and specifically diabetic foot ulcers.
And they there was a sort of an issue kind of What was that? What’s that company? They just got that big fraud thing.
Fair enough? Fair enough. Kind of almost like a Theranos kind of thing where essentially Shire had to end up paying back three hundred and fifty million dollars in sort of false claims over their their acquisition of of advanced bio healing. And so I think a number of these early exits haven’t, you know, haven’t proven to be at the impact of the problem. So one really interesting article that I read when I started out this research really talked about where the investment opportunity is. And really, it should be in places where we don’t currently have solutions.
And those two areas from what I’ve identified are in the organ donor crisis in our in drug development. So, you know, companies that are targeting more, you know, areas that are already addressed by sports medicine, or that can be addressed by by current medical practices aren’t going to see the kind of bring the kind of value that needs to be brought from tissue engineering, although they’re valuable. Some thoughts are sort of the other types of exits that are out there in acquisitions. There’s a lot of lot of merger that equals a lot of leverage buyouts.
Just sort of non traditional exit types in terms of what we’re looking at here.
And they – and sort of again more access to the cell therapies, gene therapies, and those enabling technologies.
And really, I mean, any type of alternative medicine, immunotherapy always gets once in, immunotherapy dominates the deck that’s in the flying activity.
And here we can sort of see a snapshot of some of the deals that we talked about in terms of, like, start ups that are coming online. Humocyte raised two hundred ninety to date. In terms of companies that I I find that are they’re pretty interesting right now, I would look at Epi Bone, Prelos Biologic, already aspects Bio Systems.
In terms of sort of what some of those companies are working on, You know, Zeltis is developing, you know, bioabsorbable cardiovascular valves and vessels.
So, essentially, pieces also hard, not the entire part. But you can see that it’s kind of stepped up from those earlier exit that we saw. Instead of just cartilage issue, they’re moving into the heart. We’re seeing kind of a new wave of of funding and a new wave of excitement around tissue engineering. But in the same token, it’s not nearly as frothy as some of these other areas.
So sort of in review of what we’ve gone over here today, we talked a little about what tissue engineering is, exactly those are the three core components the cells, the scaffolding, enter the signaling molecules.
You have the market opportunity in sort of segment into two major market opportunities we talked about the opportunity for the the Oregon donor crisis. And we talked about the opportunity for accelerating drug development. A few of the technologies that are being used to achieve type tissue engineering today, whether those are various types of stem cell therapies syntothermic technologies, whether it’s using various new kinds of culturing techniques, three d bio printing, new decellularization, resellerization technologies, new types of scaffolding materials, and nano materials, and nano filaments, we talked about the the human on a chip, the heart on a chip technology that’s coming to light that would be both useful to both development of new therapies. And personalized medicine.
In terms of who’s investing, in my opinion, there still has yet to be a true, a true stronghold leader who’s investing in tissue engineering as a whole. As a whole, I’ve seen investments in strategic investments of the, you know, cartilage or soft tissue, a couple that are focused on three d bioprinting as an enabling technology, but I haven’t seen a a firm that has built out a diversified portfolio of tissue engineering pieces. We talk about this multi disciplinary in nature. I haven’t seen anybody who’s built that out yet.
But if you know of anybody, I’d love to to learn more about what they’re working on.
The corporate players in the space, there’s a lot of technology being developed in house, sort of on more of the met device side on the, you know, easy to medium difficulty No one that I’ve identified is really close to developing a full tissue in terms of an entire organ to be reintroduced to the body. I’d have some of the the key opinion leaders on the University of driving the research.
And and here, I’d like to to jump into investment strategy, thoughts, and thesis.
So where should we invest? I like tissue engineering to plot and project discovery. It doesn’t necessarily require the overall complexity of bringing engineered organ in vitro. As tissue engineering generally, you know, implies.
I think it harnesses all the good pieces of tissue engineering. It takes away a little bit of the risk in that it’s applying a much needed benefit to its existing high market opportunity and it potentially becomes very enabling in terms of speeding up drug discovery.
Target supply chain solutions I haven’t found any startups to date. I know they’re working on solutions in regenerative medicine, supply chain solutions, but I’d like to find one.
Therapies focused on on areas where there’s not current school currently solutions. It’s a little obvious, but when we think about where tissue engineering started, it started in areas where there there were solutions. Not not necessarily end all be all solutions, but there were solutions. Right now, we don’t have a solution for speeding up drug development. Right now, we don’t have a solution for replacing vital organs in the body for people who need organs or or have failing tissues.
So neurodegeneration, spinal cord injuries, diabetes, organ transplantation shortages.
Whether these are full transplants, whether these are regenerative in nature.
These are important areas to invest and to consider investment.
And then in terms of specific on the technical side, think breakthroughs in the vascularization of engineered organs, blood flow to tissues is one of the largest limiting factors in bringing complex issues in the body. So I’d really be interested in connecting with a professor at University of Missouri.
Understand what kind of break this he’s been through. So now he began his race in the early two thousands, see more about where they are today in terms of vascularization.
And in terms of being cautious or as we should invest, be cautious of you know, if there’s piggybacking off some points I’ve already made here, areas where it’s already currently solutions, you know, the risk of investment is not just likely to have the opportunity.
I would say tissue engineering because it’s mostly just in every nature, and jumping into another point here is what is risky.
And so without having to reduction being large or if the stakeholder’s willing to be willing to buy in something potentially risky.
I wouldn’t want a dozen space like that.
Full development of hard organ production. It’s going to take a lot of time and a lot of resources and a lot of trial and error to bring that to not only to a patient, but to bring it to scale.
And so I think any any companies that are working on that right now are gonna be heavily need to be heavily capitalized.
And from our investment standpoint that make a lot of sense to get involved in an opportunity like that. And then this is one thing that’s really important to consider when investing in in tissue engineering is that these there if a therapy can’t stand alone without other enabling technologies, and you don’t a good sense of one of the other enable technology to come online might not be a good idea to invest.
So you have to think about it from standpoint of, okay.
We’ve got a really cool we’ve got a really cool scaffold that’s specific to bringing liver tissue online.
But liver tissue being liver being high quality liver tissue or full livers into the body, is a long ways away.
And so investing your time and money into that scaffolding without understanding where the development of the the state of the other technologies are would hinder your ability to come to market and to be impactful on a time frame.
Look, bring back the kind of returns you would want to get from a venture investment.
And so that’s one thing that, you know, if we’re if we wanna consider investment in the tissue engineering area, we need to understand where the what other technologies need to to be strong and which ones you become online before this technology can be adopted by the market. And then in terms of companies to consider I like to Patics, Epi Bone, have gotten some some some good traction and some good some good press, Prellis Biologics, and alleviate more on the three d bioprinting side of things.
That’s sort of sort of four companies that would be in our wheelhouse of investment timing that aren’t too far along, you know, before valuations get crazy and and we wouldn’t wouldn’t be able to to get our piece in the deal.
So with that, I wanna thank everyone for their time today. I wanna thank everyone for being on the call.
This has been sort of a a segment of regenerative medicine that we’ve been focused on prior to our webinar series of doing these. I put together a regenerative medicine presentation that was focused on sort of an overview of everything. And so in that presentation, we have a little bit more about the regulatory and insurance landscape.
We covered some of that in the gene therapy conversation today.
I have not included that in this presentation, but it’s available in the appendix if you’d like to review after the presentation.
But at this time, I’d like to to open up for questions. The audience should have any or anybody in the room would like to ask anything or or understand anything a little more depth.
David, what surprised you? Anything particularly outstanding, eye catching in your research?
I’ll try and I’ll try and touch on something that I haven’t already expressed my my excitement in.
I think I I think I was surprised at how far off we were from bringing in Oregon to the body.
I you know, I at least a complex organ. You know, a trachea is different because it’s more of a structural tissue. And if you can resell your eyes, it’s not as complex.
But in terms of bringing you know, I think in our work with hepatics, you know, I think gave me a really positive look at, you know, what it would take to bring a liver back into the body as opposed to just reintroducing liver tissue, but actually producing a complex organ like that.
Really seems like that’s kind of a ways off. And that kind of changed where I thought I would find myself in terms of what I where I thought the real opportunity was.
And that’s why I kind of shifted the like, where I think where I think the opportunity is is in a in a company that can take tissue engineering.
And first apply it in the drug discovery and be able to pivot into organ replacement when the time is right, when the technology will wind up.
But anybody who I think is going straight for the organ replacement problem right now — Yeah. — isn’t gonna be doing what they think they’re gonna be doing for a long time.
Who and our immediate selection committee, do you think we can we can we can think to to get further analysis on this? Just to learn more perhaps before we see something at the subsequent stage.
Yes. So I think that some of these are big hitters. Might be hard to get on selection committee. Jay vacanti, at the is the director of the Center for General of Medicine at at Mass General. I’m really highly regarded. Doctor Robert Langer at MITLab.
David doctor David Williams, who was the former global president of the tissue engineering, regenerative medicine, international society, a mouthful.
He had some really interesting things to say. Rodrick doctor Rodrick Pettigrew at the at an IP IV.
Also, really, really well spoken had a really interesting interview. That I read about.
Donald Inbert Harvard, Danilo tagale, who’s the associate director at the National Center for Advanced advanced translational sciences who wants to develop a body on a chip.
I think that’s really cool technology. I want to learn more about. And then gave her Fort Jack’s and who’s who’s based in Missouri, who’s in Columbia, might be our best bet. He’s really working on the vascularization issue, and which is one of the most pertinent issues in tissue engineering today.
I got a couple more here. Jeremy Mao at Columbia University, who’s working on regenerative scaffolds and bones. And then Anthony Alatte, Wake for us. He’s working on a on a skin printer and in the bioprinting space.
So there’s a list of people that we can we can reach out to. I think some of you know, I would say that vacanti and and Langor are kind of home run hitters of the of the league. Might be a little hard to get a hold of.
But and Gabor Gabor’s really highly regarded as well, but he’s you know, Missouriuzzi based in Missouri.
Dr. Nina Tandon is she’s she’s got a startup.
So I mean, we try I think she’d be at least willing to talk to us. And with that, we invested she would be a good person to to get on board.
Very well spoken as well.
Well, thank you everyone. I really appreciate everybody taking their time to be on this call today.
Again, this will be available for replay and presentation available for download with a couple of a couple of dependencies that are relevant to regenerative medicine in general.