TrueLife - Elle Edin - Biomaterials and Regenerative Medicine

Episode Date: September 21, 2023

One on One Video Call W/George https://tidycal.com/georgepmonty/60-minute-meetingSupport the show:https://www.paypal.me/Truelifepodcast?locale.x=en_US🚨🚨Curious about the future of psychedelics? Imagine if Alan Watts started a secret society with Ram Dass and Hunter S. Thompson… now open the door. Use Promocode TRUELIFE for Get 25% off monthly or 30% off the annual plan For the first yearhttps://www.district216.com/https://www.biomimir.ca/The Biomaterials AdvantageRegenerative medicine should be accessible to everyone in need of healthcare. Biomaterials are affordable, scalable, and globally deployable solutions for wound healing. They can be used immediately at point of care to kickstart the body’s healing response and improve clinical outcomes. Synthetic Biomimetics for Next Generation ResultsWe specialize in designing synthetic polymers that match and exceed the body’s natural resources for healing. It’s 2023. Everyone should have access to cutting edge technology.http://linkedin.com/in/elle-edin One on One Video call W/George https://tidycal.com/georgepmonty/60-minute-meetingSupport the show:https://www.paypal.me/Truelifepodcast?locale.x=en_USCheck out our YouTube:https://youtube.com/playlist?list=PLPzfOaFtA1hF8UhnuvOQnTgKcIYPI9Ni9&si=Jgg9ATGwzhzdmjkg

Darkness struck, a gut-punched theft, Sun ripped away, her health bereft. I roar at the void. This ain't just fate, a cosmic scam I spit my hate. The games rigged tight, shadows deal, blood on their hands, I'll never kneel. Yet in the rage, a crack ignites, occulted sparks cut through the nights. The scars my key, hermetic and stark. To see, to rise, I hunt in the dark, fumbling, fear. through ruins maze, lights my war cry, born from the blaze.

The poem is Angels with Rifles. The track, I Am Sorrow, I Am Lust by Kodak Serafini. Check out the entire song at the end of the cast. Ladies and gentlemen, welcome back to the True Life podcast. I hope everybody's having a beautiful day. I hope the sun is shining, the birds are singing, the wind is at your back. I have an incredible topic and an incredible show and an incredible guest for you today. When you listen to my voice and you hear the words,

translational, regenerative medicine, what do you think? When I think about it and the person with whom we're going to learn more about it, we're going to investigate that it is the bridge between groundbreaking scientific discoveries and real-world applications that have the potential to transform health care forever. It represents the journey from laboratory innovation to practical solutions, where scientific insights are harnessed to heal and regenerate tissues, organs, and ultimately lives. It's a fascinating area, and we are going to learn much more about it today with my guest, the one and only, Elle Eden. She's the CSO of Biomimeer, CEO of AIDAN, and we are going to get into this world of what she's up to and how she got here. Elle, thank you so much for being here today. How are you?

I'm great. Thank you for having me. It's a good day. It's a beautiful day. And it's, we're on the cusp of real revolutions in healthcare. And I was hopeful that maybe you could fill in a little bit of background about who you are and where you've got to be today. Absolutely. So, I'm originally Swedish. I went to university in Linschaping at Linschaping University. I had a stint at the Karelinska Institute in Stockholm, and I got my PhD from Uppsala University, which is very close to Stockholm. It's one of the oldest institutions in the world, and I really love my time there. I'm always spawning a bit about it. Yeah, I started out in genetics and worked sort of on that.

interface between industry and academia there. I was working on a grant that was co-sponsored by pharma. And from there, I already knew that I wanted to work in re-endell medicine. I had my site set on medical device, specifically within reanerative medicine. It just happens to be that my boss at the time. had a former coworker or someone who used to be to work with him at Harvard when he was there. So they were in the same city. So he kind of scooted me over there.

And that's how I started working in medical device and reintegrative medicine. And during that time, I worked in that group for almost a decade. and I picked up a degree in chemistry during that. So that was a lot of fun. I always wanted to do things on the industrial side. I wanted to build something big that impacted a lot of people, and it's really hard to do that in academia, especially when you have, we always work in a very large ecosystem,

a lot of groups collaborating on everything, which is great for innovation, What's not so great with that is IP assignment. It becomes very messy, especially as we were working across borders, different universities have different policies, and sometimes you get in this strange situation where one country assigns the rights to the inventor and one country assigns the rights to the university.

So we wanted to get away from that, And that is how we spawned Biummer, which is a medical device startup. But specifically, we work in what we call like the squishy parts of the medical device. So permanent implantable materials, hydrogels specifically that we use as wound fillers. And we have a product that's now going through all of the regulations. regulatory work needed to bring that to market. That's mainly focused on both sealing a wound, but also allowing it to heal and disturb. Traditional methods have constant intervention from medical health practitioners.

Our product is a one and done sort of thing where you fill the wound and it gets to be left in place and it heals over time. And the big thing that we're selling is that we do this without scarring. So there are some other products on the market that have the same sort of approach to wound healing that fills wounds and allows them to heal without intervention from nursing staff or physicians. But we have really good results and we can do this without these wounds scarring. So yeah, that's where I'm from and that's what I do. It's an amazing journey. I love the idea that you can cross over from academia into the world of startups,

because I think you get the best of both worlds that way. You really have this foundation of learning, and then you get to take that learning and apply it in real time to a field that's just beginning to emerge in ways that we're just beginning to really get our hands around. But I'm curious, when you talk about healing of the wound, Is this something that someone would get in surgery or is it something somebody would get in combat or is it both? Does it work in both particular areas? The first product that we're working with, it has collagen is often the main component in materials like this.

We also have a proprietary material that I can to talk too much about, the magic source, you know? However, collagen demands cold chain shipping, which means that it isn't very good. for field applications. It's very hard for a medic to carry around something that needs to be kept at 4 degrees Celsius, right? And also the when you apply our current product, you need to properly deprivell the wound, which like clear away any damage of that tissue and clear out any dirt from the wound. That's very hard to do in the field. So the first product will be going into the hands of physicians, both surgeons and general practitioners, emergency room physicians. Our main goal is to get this into the hands of physicians who treat hard to heal wounds,

as we call them. These are wounds that have chronic inflammation and either takes in the range of nine to 12 months to heal, and some of these would never heal. heal, this would be pressure ulcers or tunneling wounds or diabetic ulcers. However, the underlying technology that brings down anti-scarring to this product doesn't really have the same constraints when it comes to storage and shipping. So we are developing a second generation product that we have a lower price point and will be possible to deploy in the field. We're both looking at getting this into the hands of military medics.

We think that there's a great use case there. But I would also love to see this in the hands of EMTs. The second generation material also, sometimes you have a really gruesome wound, right? Especially when we're talking with trauma. inflammation tends to be bad. Inflammation leads to shock. Inflammation leads to poor healing outcomes, very severe scarring and further damage to tissue. So we're hoping to we're hoping to help avoid that and the second generation material should be possible to apply on the scene and then stabilize the patient for long

enough that a physician or surgeon can evaluate the wound and then go in and excavate that and repair it in a surgical theater if needed. So that's both. But in the short term, it's definitely a thing we want to see in the hands of physicians. It's wonderful to me. It's mind-blowing to think about all the things that you're learning in the process of it. Not only are you helping science and the medical industry move forward by developing these technologies. But it seems as a crossover too. Are there some things that you've learned while implementing this technology that you didn't think you would learn?

Like it seems like there's a lot going on there. Absolutely. I mean, coming from academia, our constraints are very different, and they get to be a little bit strange. In academia, we're cheap, but we're not. we're fine with something being a very expensive treatment per unit because we evaluate this in batch so like say three to ten maybe you can easily afford 10,000 bucks for a treatment. If you're only doing three animals or three patients, like 10,000 is a very small amount

for a ground, right? However, if we're talking about emergency room business, right? That's entirely unfeasible. So we've seen a lot. We didn't know this coming into this. It's one of the reasons why we were swapping over because we there's an incentive to push the envelope on high tech when in academia. But I have a little bit of a hard time grasping what the point is. If your high tech solution comes with a price tag that's so high that it's never going to be implemented, never going to see patients outside of your pilot clinical trial.

So that's one of the main things we've really been working on and that we've learned a lot about like what the constraints are when you go to that market, what people are willing to pay for, what they're not willing to pay for. And so all the differences between, we're mainly focused on the Canadian and US market, because of where we are located right now. We eventually want to go global and we have, we have our sites set on the EU and Asia as well, particularly India. We really want to break in there because it's a little bit of a walled garden.

It's a very hard market to break into, but it's also a very undeserved market. So I think, yeah, a lot of learnings there in what is feasible and what is not. and that's informed how we design materials. What more? We've learned a lot about wound healing and how physicians look at wound healing. Because our first year was all hunting down physicians that deals with the sort of wounds we want to treat, right?

Like these really tricky, nasty wounds, that honestly, they're extremely common. We're talking about somewhere between 20% to 50% of the total global population will have wounds like this at some point in their lifetime. But there's very little common knowledge about it, right? So we had to recruit really good medical advisors, which we've managed. We have some wonderful people here in Calgary working with others on that. We've also been in a program called Creative Destruction Lab, which we graduated this last summer. And through that, we've also gotten a lot of contacts with physicians and surgeons,

mailing Canada, but also in the US. We've definitely been surprised by some things, understanding who's an early adopter and who is. Honestly, wound care practitioners, like wound care positions and surgeons have been in, they've been extremely keen on new solutions. I think because the current standard of care is, it causes a lot of strain. It causes a lot of pain. And some of the people we thought were going to be easy to commence because we were assuming that plastics, plastic surgery, reconstructive surgery would be a good entry point because

these are people who are really keen on building a name for themselves and having the latest and greatest technology. However, I would say the population of doctors in that field is so extremely heterogeneous. Like it's so different doctor to doctor in how they're. approach medicine, who they want to treat, what volumes they're looking at, what price class they come in at. They, we've definitely gone away from that. I think that, I think our technology is really good for those people. But I think they're a very difficult market to go to first, because you really, you

basically need to sell to each individual in that case. you need to convince every single person and you never know going into a room whether or not they would be super gangho on it or entirely averse to it so it's um it feels like much more of a gang and i didn't you were asking about learnings i never thought that that would be the case i didn't think that what we sort of see as the sort of workhorse medicine right like the the ones that do the same thing every day and do massive volumes i didn't think those were going to be the ones that were easiest to sell on new technology but really because um because there are so many problems with the current standard of care they have been extremely

receptive i don't think i've had a single conversation with a wound care position or wound care nurse um which hasn't come back with when can you put this in our hands um so there's been there's been amazing honestly amazing it's been a lot of fun It's fascinating to me to get to hear, I see patterns developing. I see this pattern of you having this technology and helping wounds heal. And it also seems while that is happening, you're also creating relationships and having them heal. You know what I mean? They're almost side by side in that getting this technology to work and help wounds heal.

You have to first help the relationships between health care and people heal. Like, it's kind of synonymous in a way, right? No, definitely. There's some startups are a unique space in that also, right? Both me and Fiona, who is my wife and co-founder. We published some high-profile papers in the last few years in the field of Renewton Medicine. And my wife more than me is a name in the space, as well as both of my former supervisors are very large names in the space. So like you get a little bit of spillover fame from that.

But because of the issues I was mentioning earlier about that cutting edge of the company and what's actually sellable, You really started over from scratch in those relationships, right? If I went to a conference when I was in academia, it's enough to have the names on the poster for people who want to talk to me. And we did get invitations to talk at some of the biggest conferences in regenerative medicine in the world to be actual speakers of that, which is amazing. And going to industry, there is a lack of communication between those two ecosystems. You're either quite thorough, quite set in the academic compartment or you're quite set in the industrial compartment.

And those two systems talk less than you would expect them to. And honestly, I'm very privileged in this because the groups I come out of are more professionalized or more industrialized than most. Like they have goals that are really to make usable solutions, to make things that are viable as actual medical devices on the market. and still the knowledge on the industry side of what is the latest and greatest in academia is somewhat lacking. So it's something we're trying to help sort, help fix, but it takes time, you know. Yeah. Yeah, it's a beautiful relationship, and I think it speaks to the idea that it's not either

or it's both and when you can merge the great people in academia with the people that are starting up in real world applications. I think that that's when you begin to see real wounds start to heal and we start moving forward in ways that we didn't know of before. Yeah. I also see some of these. We were actually...

So, for everyone, except George, who doesn't know, we had to talk about this before about them. what the word regenerative medicine tends to imply. And to a lot of people who read about it in articles, like popular science articles, or even coverage in major publications like nature, they do their sort of weekly coverage of up-and-coming things. Reanerative medicine has become almost synonymous with cell therapies,

which is interesting. I think there's a lot of promise in cell therapies and I have done some work in in that feel and in that direction of Renter Medicine. However, we're very, that technology is very, very young and there is some constraints on the technology that will mean that there is a minimum price tag on anything like that because you need individual sterile handling and culture of of cells going to any given patient, right? It's very hard to scale a process like that,

especially when we're talking about the really cutting edge, the big catch for now, right, individualized medicine. And we've gotten far in individualized medicine when it comes to antibody therapies. So this can be things like HIV or viral therapies. It's the main one is for cancers, but we've also seen some development there in in autoimmune disease. But that's antibodies, right?

And individualized is still for a specific subtype of a disorder. So individualized here can still mean a hundred patients or a thousand patients. We're talking about individualized medicine and cell therapies. We're talking about one patient. And we're talking about setting apart, a part of a facility for a single patient for several weeks and having a dedicated technician going in and taking care of these cultures.

And that of course, we can only bring the price down so far for something like that, right? I think we will get there. Like I think we will get there where re-enerative cell therapy in reintegrative medicine is an absolutely gigantic part medicine but I think that that step is further away than a lot of pop science and a lot of news coverage sort of frames it I think most scientists know that most

people who work in academia in in real medicine knows this however what we do it's in material science and cell-free materials for regenerative medicine so instead of culturing cells in a dish We create materials that allow your own cells to thrive inside of them. So we're basically moving that from having that in a sterile room to having that inside of your wound. We're doing very similar things. We're taking your cells, we're expanding them in a healthy way to replace your damaged tissue. But we don't need to take, when you do this for cell therapy, right?

You often take a cell sample and then you expand that in the lab and then you put it back in. We skip that step. We do that directly in the patient instead, which it strips away here, a lot of the costly steps in this, and that will allow us to reach a much larger population, much earlier. And we've already seen revolutions in this field of reanative medicine over the last, only since the mid-90s, we've seen a lot of this. I don't have that. I don't have nice graphic that, Fiona tends to show. But we've had several generations of these materials where we had the first generation that was just what was called biopolymer. So collagen or similar materials that we just used to fill a wound. And that was it. And they work well. Then someone had the bright ID to if this works well. If this works well, if we have a more normal tissue that might work even better. So the second generation that came here with wound fillers was decelerized tissue, which is instead of

having a tissue from an animal to extract this biopolymer, collagen, you took the whole piece of tissue and you removed any cells, which minimizes risks for immune complications, and then you implant then you implant that. That was generation too. But either of these things come with a lot of risks and a lot of issues. We were always concerned about transmission of disease from animals to humans, what's called sonotic disorders. But then also, whenever you process tissue like that, you damage it. Like it's part of anything that's extracted. And the body recognizes damaged tissues.

And that causes inflammation. We consider ourselves to be part of a third generation of materials in regenerative medicine. We make deliberately designed biopolymers. And while, as I said in the beginning of this interview, we are using collagen right now. We're also developing several biopolymers. There are synthetic biopholomers that would act as a replacement for the collagen, which removes a lot of those issues. So and the right now the component in our material that isn't collagen is a synthetic,

a synthetic biomimetic polymer, as we call it. So a polymer that imitates the, the, the, the biopolymers that your body produces. So we can get the benefits without the downsides. And so yeah, we really think that for the next 20 or so years, this will be the big movement in re-enative medicine because the need is so very large. We're talking about the scale of depending on which, you know, disorders you're looking for somewhere between 20 billion US up to 147 billion

annually that could benefit from this technology which is absolutely and now we're only talking about use of materials like this in in operating theaters and and clinics this is not looking at field use at all so it's a it's a huge market but markets size correlates to the pain that this that the problem causes right the market size here comes from the unfortunate state of things right now the fact that we the fact that we know that this is how many people needs need new solutions is he's rather sad like it's a it's a rather heavy thing right as we were trying to to get there as fast as we can, but we're still very small.

We've just opened a second fundraising round. So we closed our first one early this year, and now we're raising money for this again. And for the people who, I know that you have quite a diverse audience, for those who don't know, startups, startups like ours, aren't really expected to make. money very early in the process because we have to comply with regulatory before we can do make sales so we need to raise many millions of dollars before we can make a single

cent which is a tricky place to be right like you can't you can't prove this as as you're going just by getting customers and like showing that here are customers of all this thing we need to build we need to build knowledge about the product and and we need to recruit key opinion leaders within the fields that we won't affect and that is the big the big work as a as a startup founder in in medicine in any field of medicine if it's medical device or pharma and you really need to build this profile and you need to build a community that cares about the same things that you care about because otherwise even if you can raise the money to get to market if there isn't if there isn't knowledge about what you're offering

among the um among the users and among the customers that's where it dies where it's a very strange place to being and also because this might be a long tangent but In pharma, you do not, like a pharma startup will either die very early on, like conceptualization stage. Basically, you cannot get strong enough evidence to get this approved. And in that case, your company is gone, right? Or you might be overtaken at some point a few years after your launch because someone comes up with something better. But that's quite nice for investors because once you have lab evidence that this works well,

you can be relatively certain that you will get the approval. And when you get the approval, you will get sales because pharma works that way. It wouldn't get to the market unless there was evidence enough to push that to clinics. and also the organizations like the investors on that side push those new drugs really hard. Medical device is very different. In medical devices, it's still expensive to get it to market, but when we get to market, that's when we have to prove ourselves. Medical devices are never really proven in the eyes of the physician or in the eye.

of investors until you have hit really good numbers when it comes to returning revenue. Unless you make sales, you're basically dead in the water. That's the danger zone for medical devices, which is quite unique, I will say. It's very different from both startups that scale on revenue, and it's quite different from pharma startups it's fascinating to think about and and i don't know i had no idea about that and i'm sure a lot of people listening to this have no idea how that market works and i think it sheds a lot of light on the regulations it sheds a lot of light on you can have a fantastic idea but it may die in the water and it never gets out there for people to to solve problems with yeah but this is

why we do so much work on on raising awareness about these things and what The ongoing thing, the thing we're always asked about and the thing that we're always working on is find more advocates who work within the field, especially physicians. Sometimes I'm asked about like, do you, have you convinced the customers? But it's for us, it's not necessarily customers we have to come in. In our case, we're selling to hospitals, hospital systems, clinics, right? The people who actually input the order in the system, the people who use this, it's the physicians. So it's really, we need to get the people on the ground to really want this so that they can then do our sales for us, you know, so that the people who want to use this pushes their administration to enable that. So we're trying to have a bit of a grassroots movement in that.

And honestly, it's part of the reason why I'm on here, I'm talking to you. to get ice on that and have people understand that we are at the cusp of a lot, wound care really changing how it's done and who can be helped. Yeah, I think we're very close to a major revolution in that. And I would want to see these products everywhere in the world. And with this type of technology, you can get there. You can get to the point where that price point is low enough that you can convince healthcare systems in part of the world.

It doesn't have the same resources that we do in North America. Yeah. It's beautiful to me. In some ways, I see patterns and trends. The same way you're moving from academia into the startup, So too are you moving from the top-down structure to the bottom-up structure. When you come directly and you start a community, especially a grassroots community, you're going directly to the people that are going to benefit most from of it.

Instead of trying to go through an agency and sell it all the way down, you're going right to the people and saying, this is what we have, this is what we believe we can do, here's the test. What do you guys think? I really like that model. And I hope that that trend continues in the world of health care. I think it's very beneficial. Yeah, I think so too.

I will say, though, we're not, we are not unique in that approach. As startups in this space, it is what you have to do. The top-down structure that you're talking about is only really viable if you already have the network to push that to decision-makers. but startups don't have that unless you're unless you're a startup that's actually a you know spin out from a major corporate entity you don't have that that amount of reach so you have to you have to create that reach yourself and yeah the this is what we do and and it's interesting to see I was I was never really involved in the startup community before I started a company myself but Canada has an amazing, an amazing startup community.

Like, it's very active. There's always events. There's, in the last two years, I don't think there's been a single week where I haven't had at least one, most of the weeks two events that I attend, like outside of normal workouts, like evening events or pitch events and the competitions and conferences.

It's nonstop. I think it's really cool. It's really cool to be doing this during this period where there is so much movement and so much interest. Yeah, it reminds me of there's a phrase that says, collaboration leads to innovation. And it seems whether you're in the startup field or especially in the startup field, but maybe you could speak to that idea of collaboration and innovation. Absolutely.

It actually, I think that goes a little bit. to something else we have you and I have talked about in the past which is about the intersection between different disciplines Not just not just medicine, but science in general now is becoming more data driven and And the traditional The traditional compartments in science and medicine and are working less and less well because to be able to utilize all of these amazing new tools we're developing on the IT and AI side, you have to have expertise in those things as well. And you have to build those things both with collaborations with groups who are on the other

side of things. If you come in from medicine and biology or in medicine, chemistry, whichever, you really need to find a way of integrating the other part of this. And I think it's important to both build knowledge as an individual in whatever the other side of that trench is. But you also need, of course, experts that come from the other side. I think we really need we need people who are experts in AI and computing to inform themselves or get further education in the field of medicine so that they properly understand the implications of how they analyze data and so they can critically evaluate their own results and I think that this is true from the other

side as well. If you come from medicine, you can't just trust the other side to be doing it right when it comes to how they analyze data because sometimes we have issues with translating what data actually means, right? It is a piece of data, primary data, or is it a proxy for something else and that informs how we need to analyze it. But as If these camps are entirely separated, we don't, we miss those things. We miss the ability to find those issues and to evaluate the data in an appropriate way. So I think we need to strengthen collaboration between those sides of things. But I also think that we need to culture and atmosphere where it's okay to have

people come out of the opposite cam, join groups or corporations that are traditionally of the other one. So I do think that more medical device and pharma companies need to hire AI experts. And I think that more, say, platform companies, drug development companies that come in from, that really have the technical expertise in AI, need to bring in more pure biologists or, you know, medical professionals, professionals to help them build their models, models, and understand what the data actually means. Yeah. Lydia is over here. First off, thanks Lydia for putting some comments out there. She says, I love it. Collaboration leads to innovation. Would this technology support autoimmune diseases? Definitely. So the question here, we talked about a lot of things and for the last

15 minutes, so we haven't really talked about my technology. However, the materials we're working with, these biomimetics, they're really designed to interact with the immune system in a healthy way and shift the immune response from an aggressive, fast restructuring. strategy into a slower, healthier type of tissue repair. So we're only trying to shift this away from traditional wound healing into having a scaffold that functions as a stand-in for as long as it takes a heal. And during that healing period, it doesn't really heal like traditional wound healing. Instead, it functions as tissue repair. like your normal repair of healthy tissues because like we're all made out of cells right all of us and

best turned over quite quickly um epithelium and and and uh characterized a tissue which is what everything that you can see on me right now is that type of tissue uh so my corneas are made out of that stuff um my hair is characterized tissue uh the top layer of my skin is the same and that stuff is turned over something between every 14 after every 30th day or so, that's how long it takes to entirely replace those things. So we're using that. We're using that pathway to get healthier tissue to replace damaged tissue. But of course the same thing goes for or immune disease, because older immune disease is a shift of immune responses in the opposite direction, like in the direction that we are trying to stop. And we've had a lot of thoughts on how to approach autoimmune disorders

using this family of technologies, and we will continue hunting that down. However, I'm The device classification for anything that will be used to treat or immune, because it's, we're talking about central systems, like blood circulation and these things, elevates it to a very high regulatory standard anywhere in the world. More or less, all of these ends up at the highest regulatory standard wherever you are in the world, which increases development costs. So we want to leverage these first couple of generations of these technologies to start building revenue and use then use that revenue to push products that come in at higher classifications or might even be classified as pharmaceuticals rather than medical devices or in this case it's probably going to be called combination devices. they have to basically we end up having to comply with both pharmaceutical regulation as well as medical device regulation and products like that come with a very high price tag i would say we're talking about the range of very cheap as you can end up is probably around five million u.s and that's very unlikely most of these most of these will come in at 15 million u.s or more assuming that you already have the

infrastructure to build them. That's assuming that you already have a few products under your belt and you know how to build these and you don't need a new lab or anything, we're still talking about the low tens of millions to develop a single product in that space. But I think the technology has the same promises there as it has in regenerative medicine. Because we're talking about adjusting how the body's immune system functions and like bring that from a there is a thing I tend to note about in in this specific field which is a lot of people talk about natural healing and all these things right what they forget is that modern medicine is a non thing on a non-existing thing on on evolutionary timescale Our immune systems and our repair systems were evolved on the time scale that's in the millions to tens of millions of years. There's been some shifts on the scale of like hundreds of thousands of years, but that's the quickest that we really see any large amounts of change. Like when we see population level changes, it's seldom faster than that.

100,000 years ago, the needs of the human body for repair were different from what they are today. You were unlikely to live past age of 40, which means that repair after the age of 40 didn't have strong evolutionary pressures on them. But the other thing is you didn't have antibiotics, which means that wound closure is insanely important.

Like, wound closure is more important than anything else, else for a human being living in the Stone Age, right? Because otherwise you get infection and you die. And that's where scar comes from. We work on removing scar formation. And I can see a criticism leveraged against us, which is like we're going away from natural wound healing. And this is true, we are.

I want to go away from natural wound healing because natural wound healing is not designed to function in the best interest of a human being today. It's designed to function the best interest of a human being 100,000 years ago or maybe a million years ago. These are no longer the same. We now have the ability to care of each other to make sure that wounds are continuously rebandaged or cleaned.

We have antibiotics in case people get infections. In the case of autoimmune disorders, we have steroids to bring down immune responses. So we really need to find ways of curating the responses of the human immune system to work well with modern medicine. We haven't really done this at this point. We're getting closer. As I was talking about earlier, the personalized medicine, especially in the antibody field, is very much working on this. It's looking at what goes wrong in immune response and how do we adjust this to make sure that faulty immune response doesn't kill people or cause unnew suffering. I think material science has a lot.

shot there as well and and so for the non-scientists there the reason why I'm talking about medical devices and material science in immune therapies has to do with how we deliver immunotherapies right now so a nanoparticle technology is well established now as a part of this and the nanoparticles that we use to deliver active ingredients inform how these things function. And how we design the materials and how we design particles decide where in the body and what cells and where in the cells we're sending active ingredients.

But there is an other step there that I think is very interesting, which is we know that the body reacts to surfaces and materials and chemical entities that aren't necessarily small molecules, they don't pharmaceuticals in the traditional sense, but they still affect selectivity, they still affect immune response. So the same materials that we are now using to fill wounds with in theory can make those into nanoparticles, in which case they can help create that same kind of what we call total. organic behavior on a in the whole human system like this would be delivered

done to your vascular system through your blood but that means that it will it will adjust your immune response throughout your entire body I really think there's a big promise for for polymer science and material science in that and And it is a that part of science, that part of medicine is also one of these, it's a baby, just like cell therapist. It's honestly almost younger. We've seen some great advancements in that in the last few years or maybe the last decade. And some of that honestly comes from regulators becoming more tolerant.

Of those technologies, we started with nanoparticles, mainly being delivery technology for pharmaceuticals, but because we got them into the system through that, and now use the technology in different ways to help treatments. Yeah. It's almost like a Trojan horse in a way. Like if you can introduce it, now all of a sudden you have this, it's already been in the system a little bit, and now there's all this promise for it. It's pretty amazing to think about it.

I didn't know about any of that. I mean, it's regulatory frameworks, extremely complicated and obtuse. A European Union is changing a lot of that lately also, and one of these things. None of us say out loud, but I'm going to do it now. The constant thing you hear whenever you talk to regulatory consultants or other startup founders in the space is that, Europe is such a gigantic headache right now because they're shifting so much regulation at once. And it is in exactly these things we're talking about. It's in cell therapy. And it's in medical device and it's in pharma. It's mainly in medical device and cell therapy,

I will say. So it's hard to work in the European Union at the moment because there's a lot of uncertainties. I do think that that will be coming down in the next couple of years. years and I think that we will probably come out of it better than we went in. I do think in the end, the regulators in Europe will create a framework that is in everyone's best interest. But it's been a rocky five or six years, really, it's actually more than that now. Time runs faster, the older you get. The last decade, which is the period where we have been working on this and most of that

time, honestly, we've been in, or a lot of that time. time we've been in Europe. We started a lot of these projects when we were still in in Europe and we did a lot of work there in academia and we had collaborators in industry. It was an exciting time. I'm hoping that we will soon live in less exciting times. It's, you know, there's a question that comes to mind in that you have an unusual perspective because you get to see all of this promise of what can be and actually, developing these products that are making changes, but then you're up against these regulations that are sometimes very archaic. How do you balance that? That's a very good, that's one of these,

like, really big questions when it comes to how we work and where we're at. In some cases, this archaic framework works in our passion, sorry, in our favor, because there's a lot of technologies, like the one I mentioned, right, that gets, grandfathered in and it's an actual term used by the FDA by a lot of regulators more or less we've had this thing on the market for a long time and it doesn't really fit with the regulatory framework that we're now developing however we will be we will basically let that all the approval that wouldn't really be valid on there on the current regulation still sound because we know that is safe and efficient because it's been on the market for 20 years, right?

Or in some cases, 50 years. Some of those things work in our favor, really. Our primary product, this anti-scarring wound filler I've been talking about, we will take that to the market in the United States before we do in Canada, even though the majority of our team are Canadian or live in Canada, because they have a pathway to use that part of the system. It's called a 510K, and it basically says that if you're similar enough to previous device that has been approved under a certain regulatory framework, as long as you can prove that

it is safe, you can bring it to market. And that vastly decreases our costs. It makes much easier to do product development. So in some cases it's beneficial. But I was saying, then we have the other extreme of that, which is the European Union, where a lot of these changes that happen in the United States in the 90s are happening now. And they are larger, they're more sweeping. Europe has a more complicated framework like regulatory framework to begin with because it's younger.

And it's less interconnected. And it's really, it ends up affecting this a lot. And the way it's affecting it is that Europe will be a much later market for us. We will have to go to market in the places that already have frameworks in place that allows us to go to market. And when we're on the market in one place, we can build a huge amount of data on safety and efficacy. And we can leverage that when we go to more complicated regulatory environments.

And yeah, I hope that that answers that question. Yeah, I think so. It's a whole other dimension that if you're not involved in the field or you understand, like, you know, it takes a while to wrap your mind around it. But I often wondered about that. Like, it seems like a very difficult, maybe not difficult, but a unique position to be in, to see both promise and the barriers to entry right there. It's a fascinating thing to think about. Yeah. I mean, it causes some strange.

things also right because one of the things we can see here is that some countries that have smaller GDP and smaller like overall budgets for farmer development and med device development have simpler regulatory frameworks and then they get targeted as early adopters for high tech technologies it it feels unintuitive to think that some of these places would get access to latest generation treatment before Europe does. And also the UK with Brexit also ends up in one of these sort of tricky situations when it comes to market entry. So two of the places that you would expect to be the furthest along, right, with rich geographies, with people with very high requirements for medical treatment ends up being late adopters

because of this. And I think it's a little bit unfortunate. I'm hoping that the regulators are working on simplifying their frameworks, on making good pathways for new products, because I don't think that this I don't think this current thing is in anyone's best interest and it also of course leaves a lot of money on that you know on the table when it comes to a development of cutting edge technologies because most jurisdictions invest in products that are intended for that jurisdiction but if the richest jurisdictions ends up being the latest adopters they're not the one sponsoring that development. And I think that's bad for everyone.

I think that's bad for everyone on this planet. Yeah. It speaks to the idea of ethical concerns. Like there's probably all, you're probably surrounded by them. You know, well, maybe you could talk about that a little bit. That's got to be daunting. Yeah.

I mean, it definitely is, but also some of the optics of ethics of ethics has become almost more concerns than the ethics themselves. I think that the group I'm working with, I think that are crumbling as well as all of the academic institutions I've ever worked with, have really high ethical standards. But you have to be careful not just about ethics, but the optics of ethics. Because if you enter into a situation where there's the potential for spin to be introduced by media, you can be quite certain that it's that's going to happen and I have lived through some of that

I have seen some of that in action and it's a very again it's a thing that discourages innovation it discourages development the ugliest thing in that that I've seen and I've seen for people is the idea that if you test your product first in say in India. We've seen this when we were in Sweden like criticism against about testing things in India before we're doing in Sweden because the way that the spin is put on that, right, becomes you're using poor people or exposed people who don't have a better choice. And I know that when this was happening, that that specific trial was run through, I was a run through, the World Health Organization site, the largest World Health Organization site in

ophthalmology that exists. It's a nicer site than I have ever worked at myself. And still, you have these local coverage that puts the spin on it. It's like evil Swedish people using poor Indian people, which is, it's entirely devoid of any connection to reality. So having seen that, I've gotten very cautious in how you frame things and where you go. And again, it's very unfortunate that this is how the world works

because we want to bring benefit to people as fast as possible. and in the places where it matters. I also think that that's kind of that idea that you can't have lower GDP countries be first adopters is also awful because often the need for improvement in treatment, in medical treatment is the greatest there. So yeah, you're walking a tightrope when you're trying to deal with those things and when you're communicating. about those things. Yeah.

It speaks to the idea of complexity. I wish it was as easy as good and evil or good and bad, but the complexity is just, it's probably a lot like creating medical devices. The complexity of it is mind-blowing, you know? Yeah. Medicine is a, medicine moves so very fast today. but also it's so very disparate depending on where in the world you are. Like some of the coolest medical technologies I've ever seen

are in places where you, like, honestly, there is some racism in that. There's some prejudice in that where people in North America thinks that were ahead of the curve. And then you see these sites in India. or in China or Indonesia and they have resources that are, it will be 10 years until we have them in North America.

It's a little bit ridiculous, I think. I think people need to be a little bit more open-minded when they're looking at geographies. I want to point, we are hitting time now. Yes, I know. I just love talking to you. No, say, likewise. I'm really thankful.

Before I let you go, though, maybe you can tell people where they can find you, and what you have coming up. Absolutely. The best way to connect with me is over LinkedIn. My name should be on here. And the company that I am a founder of is Bermere. I have Eden AI as well.

That one has lower levels of activity right now. We're working on restructuring that one. Yeah. Connect with me over LinkedIn, send me a message. follow Biumemir. And yeah, the things that are coming up is really, we're very active in the startup scene in both Calgary in Alberta, as well as in Montreal and Sherbrook in Quebec.

We almost always have represented visiting a local startup group called Startup TNT, which is an investment group, investment group, but they hold socials. So every Thursday, if anyone here is in Alberta, come and come and visit that. You should be able to find startup TNT on LinkedIn as well. They're great people. And yeah, we work closer with them and we're always there. Someone, someone from our camp is always there. So if you want to meet us in person, that's where to find it. Fantastic. Ladies and gentlemen, please go down to the show notes, check out everything that they're

working on. It's incredible technology. We're really moving into a world that has a lot of promise. And I'm really thankful for your time today. I'm happy to learn as much as is out there. And I really think that the technology is promising. So ladies and gentlemen, go to the show notes, check everything out. Thank you very much for your time today, Ellen. That's all we got. Ladies and gentlemen, Aloha. Thanks so much. Bye.