Episode #92 | Nanochon: Joint Repair Layer by Layer

Cartilage injuries sideline millions every year, yet current treatments often fail to restore long-term function. In this episode, Dr. Nathan Castro and Dr. Ben Holmes, co-founders of Nanochon, explain how they are tackling this challenge with a 3D-printed implant designed not only to replace damaged tissue but to help it regrow. What began as a collaboration in a graduate lab has grown into a company now preparing for its first human clinical trial.

Their journey began at George Washington University in Dr. Grace Zhong’s tissue engineering lab, where the freedom to explore outside of strict grant-funded projects encouraged bold experimentation. Nathan even purchased specialized materials with his own money to expedite early tests. That investment in curiosity became the foundation for a technology that could change how orthopedic surgeons treat cartilage damage.

Nanochon’s implant blends strength with biology. It pairs a smooth articular surface with a porous lattice that integrates directly with surrounding tissue. Traditional approaches, Nathan explains, can be “like filling a pothole with jelly.” By contrast, their device provides stability without the need for sutures or pins. Despite being less than half the thickness of conventional implants, it requires two to three times more force to dislodge, which may result in shorter recovery times for patients.

From there, the company advanced step by step. They began with small animal studies in rats, progressed to goats, and finally proved the implant’s strength and integration in horses. These results not only built regulatory confidence but also convinced investors. With Health Canada’s approval for its first-in-human trial, Nanochon stands on the edge of translating a decade of persistence into clinical impact.

Ben and Nathan also reveal the realities of building a medical device startup, including raising funds during tight markets, meeting ISO 13485 quality standards, and learning to manage external contractors. This conversation is a rare look behind the curtain of medtech entrepreneurship. It shows how innovation happens in steady layers, built one on top of another, much like 3D printing itself.

Shownotes: Check back soon

Podcast Engineer: Faith Fernandes

Chapters

• 0:00 Introducing Nanochon
• 1:57 From Lab Work to Startup Vision
• 25:22 Nanochon's Core Technology & Design
• 40:49 Clinical Advantages of 3D Printed Cartilage
• 54:45 First Human Clinical Trial in Canada
• 59:30 Startup Hustle and Entrepreneurial Advice
• 1:08:04 Episode Closing and Disclaimer

Transcript

Speaker 1: 0:01

Welcome to the pod. Today we're joined by two pioneering voices at the forefront of orthopedic innovation Dr Nathan Castro and Dr Ben Holmes, co-founders of NanoCon, a company transforming joint repair through 3D printed cartilage implants. Castro, a biomedical engineer with a PhD in tissue engineering, brings deep expertise in device design, regulatory strategy and clinical translation. As CTO, he's leading NanoCon's effort from early stage development to commercialization. Ceo Dr Ben Holmes compliments this with his leadership in company formation, fundraising and executive management. Together, their work bridges advanced biomaterial science with scalable medtech business models, pushing the limits of what's possible in regenerative orthopedics. Whether you're in healthcare, biotech or venture capital, this episode offers powerful insight into building the future of joint care, layer by layer. Enjoy. Please listen to the disclaimer at the end of this podcast. Hello, hello, welcome to the pod.

Speaker 1: 1:21

This is episode number 92, believe it or not, you wonder where the previous 90 episodes went. But anyways, welcome to the pot, ben and Nathan. Thank you so much for joining us. And as a team, I think I've never done actually a team interview before. So this is going to be exciting because we have both the CEO and CTO of NanoCom, a very exciting startup focusing on restoring cartilage using 3D printing. So with that context, I alluded that we want to talk about the origin of the company. You know the very beginning, how did you guys cross paths, and you know what was the funding story for nano con so I'm curious, jenny, do you want to do like?

Speaker 2: 2:09

uh, I'll tell my version, and then nathan tells his version and we see, uh, you know, see what reality is, or?

Speaker 1: 2:15

uh, I don't know I, I would say you know, I think, whoever wants to take a first step, um, but ben, why don't you start? And n Nathan, if there are some shocking facts that you didn't know about that you can let us know.

Speaker 2: 2:29

Sure, yeah, I mean. So Nathan and I met in the tissue engineering lab at the George Washington University, still headed by Grace Chong, I think I had a strong interest in biomaterials and regenerative medicine and basically had no real background in it other than some classes I had taken as an undergrad, and so you know it's an interesting experience too, because Nathan correct me if I'm wrong we were also the first two PhDs in the lab. I don't think anybody else was a PhD at the time.

Speaker 3: 3:07

Yeah, actually, grace started about two semesters before I joined the lab. So I joined the lab in fall of 2011. She had joined as an assistant professor tenure track, I believe in fall of 2010. Her tenure track, I believe in fall of 2010. So she had actually had one higher PhD student who, you know, for lack of a better word, didn't really pan out. So if you were to ask Grace, she would probably say the same thing that she would. You know, consider me as her first PhD student and then Ben as her second. But collectively, yeah, you know we yeah, I would say, between Ben and myself and obviously students that were supportive we really built the lab to where, to where it is now, and the Promenade started, started doing Well, that sounds like the first risk you guys took in your career.

Speaker 3: 4:06

It was, yeah, being proactive and, I dare say, entrepreneurial was kind of the culture in Grace's lab for sure you know, I'm sure Ben had to kind of think about his own personal trajectory and whether or not going back to grad school really fit. Much like myself, you know, prior to GW I was working at the University of Texas at El Paso where I did my undergrad and my master's, and I'm sure we'll get into a deeper dive into our respective backgrounds. But I think Ben and I are both cut from the same cloth in regards to being risk-takers, looking for opportunities, as well as having that inherent entrepreneurial spirit. So I think what GW afforded us was the ability to cross paths in that lab and to really set the foundation for what we built with Madam Connie.

Speaker 2: 5:18

Yeah, absolutely Very well said. And I'll say too, as long as did high quality work and got stuff published. You know, it wasn't it wasn't some material that was built into one of our grant funded projects or something that grace had brought from her, her previous um labs, it was. It was just something that seemed interesting and it was kind of, you know, it was an environment where we were encouraged to have the freedom to kind of pull on threads like that. If we ever came across something that that's, that seemed kind of cool and outside the box.

Speaker 3: 6:07

Yeah yeah, definitely, and you know that really came out from as a sort of as a product of Ben and my participation in the NSF I-Corps program. Participation in the NSF I-Corps program, so, where they really instilled the importance of customer discovery to follow that lean startup approach. So that really had me thinking that, from what I was personally involved with during my PhD, which is focused on additive manufacturing, of which is focused on additive manufacturing of soft matter materials like hydrogenolism, even complementing some of our postdocs that joined the lab in some of their work, it just didn't seem like a viable option that could translate from bench to bedside. And you know, what we were looking at into the course of both Ben's interviews and my own interviews and his stellar performance in the I-Corps program is that you know we actually had participated separately because we had two different technologies that we were trying to kind of, you know, vet through the technology transfer office.

Speaker 1: 7:26

So this was before Nanocom was funded.

Speaker 2: 7:28

Yeah, this was maybe like 2012 or 2013.

Speaker 1: 7:33

I see. So most PhD students don't have any business experience Before founding Nanocom. Did you guys have any kind of business experiences already? It sounds like you did Good. You sound like you did?

Speaker 2: 7:49

I'm happy to answer that first because it's a short answer. No, I didn't really. You know, between undergrad and grad school I worked for two and a half years in industry, but not in the medical field. I was a mechanical engineer by training and I knew I had an interest in biomedical engineering and medical devices. But after four years of undergrad I was really needing a break from school. So a lot of mechanical engineers are able to get jobs in design, build, construction, that kind of work.

Speaker 2: 8:22

So I went to work for basically a company that builds like big office buildings, office campuses, infrastructure projects, work. That is interesting and challenging. But I immediately knew it wasn't for me. So for me it was just having a real interest and a curiosity in biomedical research. But what I will say is, even though it was only a few years, that experience of working in the construction industry, I got a lot of exposure to project management and it's funny because I think a lot of what I do now, even though it's many, many years later, a lot of the stuff that I do now as the CEO of the company, are things I can trace all the way back to that short period of time where I was working in an industry not the orthopedics industry, but just any industry where it's complicated, there's a lot of regulation, it's very capital intensive. I think there's a lot of parallels in managing those types of large construction projects that are very similar to how you build a medical product.

Speaker 1: 9:30

Definitely, they're very translatable, these business skills. What about you, nathan? Did you have any lemonade selling experiences and stuff like?

Speaker 3: 9:37

that before. Yeah, yeah, I mean, actually both my paternal and my maternal grandfathers were small business owners. My maternal grandfather, after he returned from the Korean War, set up a neighborhood grocery store. So you know he catered to the wants and the needs of the local neighborhood and my paternal grandfather, as well as my father, had their own business.

Speaker 3: 10:11

So my father, when I was born, was a shoe salesman at a major department store and you know, through that experience, you know he because it was partly commission-based, he would get a lot of and we're talking back in El Paso, texas, so right on the border of the US and Mexico. So there was a lot of industry and a lot of people coming into the US to purchase goods and things of that nature. But sometimes you know, he would have a big sale and then a week later the customer would come and return the items and because it was department store policy that they couldn't reshelf and resell the shoes, that got my dad inquiring. I said, okay, well, what happens to those shoes after you know they're? You know, quote unquote used. So, long story short, he did investigative work, he found where those shoes resided and then when I, you know, as a young child, I would join him at the weekend flea markets and we would sell partially worn shoes, like designer shoes and athletic shoes and, uh, you know my that was one, one aspect of my dad's business and then my dad had a storefront where he would sell, you know, um school supplies and school uniforms to cater to the local, uh, public schools who are transitioning to a uniform-based dress code and you know that was able to sustain our family during the school year.

Speaker 3: 11:55

And then in the summers he and I would travel around the region, so Texas, New Mexico, arizona, arizona and we would do basically festivals. So each town would have like their community festival. So we would go there and we would. We would sell, like you know, toys, knickknack items, and then when, even when I would go back to elementary school, I would personally go and sell school supplies to my colleagues and my classmates.

Speaker 3: 12:29

So, yeah, I've always been exposed to entrepreneurship. I have sort of that inherent upbringing to be driven and also to be very dynamic in the product that you're trying to sell. But more directly related to Nanocon, I've suffered from knee injuries my entire childhood. So it's very personal what we're doing, because I feel like I'm addressing a need that I eventually will require, but also having the guidance from more experienced people to really help mold and direct that desire. Direct that desire, so I mean, without the network of support system and mentors that I've been able to establish throughout my life and throughout my academic and professional life, I don't think I would find myself personally where I am now. So you know, I really and it's something that I enjoy paying forward to and you know, I'm sure Ben can, you know, give examples to what I'm saying when we were in Grace's lab, you know he and I were the primary students lab.

Speaker 3: 14:03

You know he and I were the primary students and I was the de facto lab manager because I had already had experience in biomedical engineering and biomedical research, so from an earlier, from my undergrad years and throughout my master's. So I think Grace really felt comfortable handing me reins to oversee the day-to-day activities of the lab and that included mentoring students both from GW as undergraduates, and one of the papers that I published during my PhD was actually with a high school student that I mentored over the summer, that I mentored over the summer. So really wanting to share that experience of mentorship and that transfer of knowledge to younger people was, you know I think, part of my core values.

Speaker 2: 14:55

Yeah, and I think that's something that Nathan and I both really share. You know, I would say one just because I consider you know, nathan, someone who mentored me early on in the lab and really kind of got me up to speed on what this bioengineering thing is all about. But also I think that we share that same passion for kind of giving back, I think, as Nathan said, and sort of sharing the knowledge we've gained, I think, as Nathan said, and sort of sharing the knowledge we've gained but also recognizing that we have benefited tremendously from mentorship, especially going through I-Corps no-transcript.

Speaker 2: 15:57

And then he was really intrigued by what we were doing, wanted to help us basically just giving freely of his time and then eventually coming on as essentially an equity-compensated advisor. So for anybody who's listening to this just wondering, how do I even start a company, you find people like that that are, you know, knowledgeable, generous, good people. You give them a little bit of a stake in the company to kind of keep them engaged. But you know, I think what's also really great about mentorship is it can also end up coming back around. You never know how someone is going to fit into the story of your career or the story of your company if it's a startup.

Speaker 2: 16:32

We just hired our first full-time employee who's not a C-level executive or Nathan or I, so like a true employee of the company, and he's somebody that I mentored when we were in Grace's lab. He was one of the undergraduate mentors and you know we stayed in touch all through his academic career. And then you know we were needing to hire somebody because we just moved to this new manufacturing space in Baltimore and it just so happened he was graduating and looking for something. So you know, I think it's also, you know, generosity and, um, you know, just really taking a real interest in people and valuing people is how you build these networks. You know it's um, I think it really does take a human touch.

Speaker 2: 17:15

I think people really forget that. Or there's so many stories about people being successful in business because they're so ruthless or, uh, because they're so self-interested. But you know, I think that so much effort from so many different types of people, so many different types of expertise, it's just I'll. I'll quote a medical device VC that I really respect and I heard him say this on podcast this is not an industry for assholes and, generally speaking, the assholes don't actually have real, real success and I I think about that a lot actually.

Speaker 1: 17:53

Especially long-term success.

Speaker 1: 17:55

Yeah, that's right, Absolutely Now going back, just dialing back a little bit so that we can have a more concrete story of how NanoCon was. What is the conception of now? We've studied a lot about 3D printing and muscular skeleton, studied a lot about nanomaterials, and what is the moment like when you guys decided, okay, this is a great time to start a Delaware or start a company? Does it take like a year to really kind of stew on it? Or was it like overnight idea? What was that like? Or was it like overnight idea?

Speaker 3: 18:35

What was that like? I mean, I can speak to like the experimental work and the realization for me. So, as Ben mentioned earlier, you know, with Grace's lab, she gave us the flexibility to explore and expand our understanding, understanding of the of the space, intellectually. So you know, as I mentioned before, we were doing hydrogels, which I felt was a difficult hurdle to transition from bench to bedside, and so that kind of got us thinking okay, okay.

Speaker 3: 19:14

Well, you know, we're trying to address cartilage in the knee, which experiences a lot of stress and impact, and you know, an analogy that we like to use quite often is the cartilage defect is like a pothole on the street. What most people are doing is filling that pothole with jelly or jello, something soft, something that's not mechanically matched to the surrounding area, something that's not going to be very robust, not very robust. So you know that got me exploring kind of the greater commercial space and saying, okay, is there a material that one has the ability to be 3D printed which falls in line with what our lab was doing? And two, does it have the you know kind of the mechanics that we would consider appropriate? So then I found have the mechanics that we would consider appropriate. So then I found a group of Canada materials, and I purchased them on my own.

Speaker 1: 20:24

On your own money, not grant money.

Speaker 3: 20:26

Wow. It's something that I personally kind of like to. It's kind of like a behavioral thing for me, and the I guess the model that kind of encapsulates this sort of, you know, behavior is it's easier to ask for forgiveness than to ask for permission. So for me, from a research standpoint, and also from like a business standpoint, you know, the cost to purchase these materials wasn't that great, albeit, you know, a PhD salary is not that high.

Speaker 1: 21:16

So any little thing, it's like a week's of dinner. A week's meals are gone, basically.

Speaker 3: 21:25

Especially in DC where you're paying a premium. But yeah, it was essentially the way I approached. It was the best way to convince somebody that an idea works is to have empirical data to illustrate your idea. So that's what I did in Grace's lab and that's kind of what I carried over through all my multiple postdocs after, before getting fully onboarded with Nanoconon. So what I did is I purchased the materials on my own, I printed some samples and then I did the initial cellular cellular studies, like looking at adhesion, proliferation, things on nature, just to kind of see one whether or not these, whether or not cells, like the material. Because at the end of the day, right, if the cells for any implantable device, if they cause an adverse reaction, then it's, you know, it's pretty much a no-go thereafter and you need to go through a lot of other optimizations or, you know, surface treatments or things of that nature which further complicate it. Right, what I was really looking for is just the cleanest, simplest way to address the problem and thankfully, one of you know at least one of the materials that I purchased showed glimpses of that.

Speaker 3: 22:56

So then, you know, after the I-Corps program, ben and I collectively came together and said, okay, well, instead of, you know, pursuing our separate pathways. What about if we just merge? You know, come together and form a single entity and then, you know, essentially build a technology up. You know, come together and form a single entity and then, you know, essentially build a technology up. You know, together and with what I did experimentally and then with us coming together is really what established Nanocon as the entity.

Speaker 3: 23:28

And we did it, you know, fairly quickly and actually we filed some initial IP with the help of one of our other students that we had mentored in the past, who had gone on to do some legal work. So we've definitely created a network of people with different skill sets that have come through the lab and have gone their own way, always stay in contact and, you know, create this mutually beneficial symbiosis to help build up the company. So after we formed the company, you know, thankfully, ben was able to dedicate a large amount of his time, a large amount of his time at the, in the early days, to really promote the technology, really, you know, pursue some additional funding, um, whereas I had to, you know, basically sustain myself. So then I had to go to the postdoctoral route, which, you know, um exposed me to other ways of thinking in other countries like Australia.

Speaker 1: 24:40

I know they go all the way across the ocean.

Speaker 2: 24:44

Yes, yeah, but I do Nathan's, the real Mr Worldwide.

Speaker 1: 24:51

I do want to mention that you guys are very generous. Every time I introduce anybody to you guys, Ben never said no, always very generously offer his time and insights to whoever which is rare towards you guys for wanting to, and also being able to, mentor people who are in needs in this space. So thank you very much for that Now that you have founded this company but that was like almost 10 years ago, wasn't that right?

Speaker 2: 25:28

Almost yeah. Nanocon turns 10 next year.

Speaker 1: 25:32

Exactly. I mean, were you guys anticipating this long of a journey?

Speaker 2: 25:38

Yeah, so I'll answer that anecdotally. Like a lot of medtech companies, we've been through a handful of funding rounds now and we had a seed two round last year. So I actually got the chance to go back and pitch an investor that I pitched way back at the beginning of the company I think it was somebody I'd pitched at 2017. And they kind of came back around, they saw me in the news or something. They invited me back to their group and they asked me oh, can you dig up the pitch deck that you did in 2017? And make sure that your current pitch deck, you know, shows progress, which in and of itself, is almost kind of a laughable thing to request. But I did it and I believe in that pitch deck. I said we were going to be exiting the company in 2022.

Speaker 3: 26:25

Oh, is that right?

Speaker 2: 26:27

Well, but yes, but you know, at the same time, you know I said we were going to be a five, 10 K I think. I said it was going to take us maybe like $7 million to get to commercialization. I also said that we were only going to exit the company for like 50 to $60 million, which we haven't exited yet. But I think what's what's interesting is that you know one.

Speaker 2: 26:52

Yes, this has taken way longer than I think we initially thought it would. But I also think that the opportunities, the size of the market, the clinical impact that we're positioning ourselves to have are also very different, and I think that sometimes you can sell yourself short by saying, oh, I need the fastest possible path to getting to an exit. If you really think diligently about what it's going to take to create value, there can be much bigger opportunities acquisition comps from our industry and, specifically looking at our indication, other companies that have developed some type of device to address a cartilage defect in the knee. The exit range is like $400 to $500 billion. So again, it's taking a lot more work, but I also think the opportunity is much larger than we thought it was originally.

Speaker 1: 27:56

Absolutely. I think the game has changed basically for you guys over time. I mean, there are some companies who wanted a quick ROI, a quick turnaround. You know, I see dozens of implant companies that can turn out different designs and indications, you know, within three to five years. But this is I guess this is considered biologic right. This is in a biologic category in terms of Well, from a regulatory perspective, it is not.

Speaker 2: 28:18

It's actually very much considered a medical device because, even though it's a unique material and a 3D printed structure that are designed to be bioactive and work with biology, there's really nothing in it that the FDA considers a biologic or a drug, because it's not eluding a molecule, it's not facilitating some molecule binding interaction, anything that would be considered pharmacological or biologic. So I think that's also an interesting nuance that even though it's designed to have a biological effect, it's not considered biologic by the FDA, which again also really changes our path.

Speaker 1: 28:59

And since we're on the subject, I'd like to just dive a little bit deeper on the technology of NanoComm, so that people who don't know NanoComm yet can have a full understanding of what you guys are proposing.

Speaker 3: 29:21

Yeah, so our core technology revolves around a proprietary filament that is compounded of two components.

Speaker 3: 29:25

Both components are well characterized and well documented, both in the regular space as well as in literature.

Speaker 3: 29:34

But we, you know, we, as it were, developed the process to homogeneously extrude it and compound it.

Speaker 3: 29:45

As well, as you know, in addition to the material itself, we also have unique design features which leverage additive manufacturing technologies for the manufacture of our implant.

Speaker 3: 30:02

So our technology of choice is fused element fabrication or fused deposition modeling, as is more commonly known. And so, you know, with that kind of, with that mindset, you know we have the inherent relative quickness of iterative design due to the presence and the use of the rapid prototyping presence and the use of the rapid prototyping, but also we have the ability to scale and to manufacture quite quickly using that technology. So we have our material, we have our implant designs and then, subsequent to that, we also have processes that we condition the final implant to be more analogous to the native tissue in situ performance that we've seen at multiple scales, from the in vitro cellular work that initially did, to the small and medium-sized animals that Ben was able to secure funding to support, and, most recently, our large animal models, which you know regulatory consultants have said is the most extreme, worst case scenario that you can test your implant in and that has just shown, you know, I would say, spectacular results.

Speaker 1: 31:44

Yeah, and thanks for submitting that beautiful photo of your latest implantable kit. So basically, for those who don't know what the Chondrograph look like, it basically looks like a little weaved, waffle-shaped implant. It's very tiny, so I guess the surgeon has to dig a hole first in the area of your diseased cartilage and then put this little waffle in.

Speaker 3: 32:08

Yes, yeah, so our, you know, our design for the human patient population is, as you described, takes the core elements of the chondrograph that we've developed over time. There's, you know, the lattice which is, you know, apropos to the that's right. I'm sorry I went this way. Yes, we are using a lattice-like structure in our implant design.

Speaker 1: 32:37

Yeah.

Speaker 3: 32:41

But one of our other major differentiating factors is we're really, really strong proponents about tissue preservation and only removing the defective tissue or damaged tissue. So we did our third generation implant design and we coupled that with our own custom arthroscopic instrumentation. So, as you alluded to, yes, you have to prepare the defect site to essentially mirror image what the implant design is and allows for it to be self-fixing. So you know, unlike other implantable devices which require suturing, nails or pins, bioresorbables or semi-permanents, we're pretty much eliminating the need for any of that. Our implant is just a one-step process where you prepare the defect and then we essentially use a specialized tool to insert the implant into that perfectly sized and mated pocket and press fit that in.

Speaker 1: 34:00

Do you have to anchor it with anything? No, wow, so I would assume the existing procedure, which is allograft, right? So that's what we're comparing to typically for this kind of process, does that need anchoring? I mean, how do you compare with allograft?

Speaker 2: 34:20

Yeah, allograft is interesting because sometimes people will anchor it with a single dart. Sometimes people will anchor it with like a single dart or if it's purely a cartilage graft, they'll suture it. As Nathan was mentioning, most of the time it's an ostracondral sample which can be press fit. But one of the things that we did in the course of our design is we wanted to make sure we were at least matching the performance that a press fit osteochondral plug gets. Uh, and so you know, we were able to pull numbers from literature. It's been pretty thoroughly tested and then we did, you know, pull out um tests on the bench and we actually were able to show that our unique design and our material take roughly twice the force to unseat the implant um compared tosterkond or Allograft. And you know, I'll kind of turn it back over to Nathan to comment on a little bit more.

Speaker 2: 35:13

But one of the additional things that 3D printing has allowed us to do, in addition to just creating a bioactive matrix out of our material, is it's allowed us to incorporate these very fine features which kind of create like a interference when you press the implant into place. And it's not so much that it's really difficult to push the implant in, but it creates this kind of like interference fit where you get a little bit of extra force holding the implant into place, which right now, with Ostracon or Allograft or even some of the other off-the-shelf implants that are on the market, the surgeons actually have to go out of their way to ensure that there is no friction when the implant is pressed in place. But 3D printing and our material have allowed us to kind of flip that in a nuanced way to get better performance.

Speaker 3: 36:01

Yeah, so our comparator for our mechanical testing was a 10 centimeter osteochondral plug, so roughly two and a half times as deep as our implant.

Speaker 1: 36:16

That's like almost entire like. That's like half of the knee, 10 centimeter.

Speaker 3: 36:21

Sorry, 10 millimeter.

Speaker 1: 36:22

Okay.

Speaker 3: 36:24

Yeah, we don't want to take off the entire condyle, that's way bigger yeah. Okay, 10 millimeter.

Speaker 3: 36:31

Okay, all right, 10 millimeter, all right Sounds good, yeah, so the traditional OC plugs are 10 millimeter. Our implant is only four millimeters in thickness but, as Ben mentioned, we're able to produce or we illustrate that it requires roughly two to three times the amount of force to dislodge or implant it. That's amazing. And we've done both bench testing and simulated bone blocks. We've also done cadaveric work in human tissue as well as in animal tissue, and it shows consistent performance across the board. And the other caveat that we also have as part of our design is that we also are offering our implant in different size ranges, primarily in the diameter dimension, so from 10 millimeter diameter to 20 millimeter diameter. So we can really look to address not only small focal defects but larger wear abrasions that are maybe not as uniform but also can be addressed by a larger surface area implant.

Speaker 3: 37:55

And because our material, as I mentioned, is malleable, we're able to press fit it in, it's able to maintain contact around the periphery of the implant.

Speaker 3: 38:11

So what we've seen in our preclinical studies is that we have in-growth from the edges, where it's in intimate contact with the neighboring mature tissue, but also from the underside. Also from the underside where, you know, as part of our surgical preparation, we debride the cartilage, the defective cartilage, we create a you know, I would consider it a subchondral hematoma, and our implant is designed to protect that hematoma and prevent and minimize inflex and inflex of synovium, which has been shown to aid in chondrogenesis, but also give it that robustness to be able to be almost time zero, stable from a mechanical standpoint to allow for subsequent ambulation. So our end goal is that, or the, I would say the dream and most bookmakers will probably agree with this is that a patient comes into the office they get their knee scoped, or they come in already with, you know, pre-vetted, with a chondro-V-vet that's able to be addressed with our technology. They close up the joint and the patient is able to walk out right afterwards, wow. Or with, you know, limited encumbrance to mobility as they heal.

Speaker 1: 39:49

Well, that brings up yeah go ahead, ben.

Speaker 2: 39:52

All I was going to say is I think that's a really important point of what makes our Not just what makes our technology intriguing, but what really makes our product highly differentiated. It's something that can act as a replacement, but also act as that kind of biologic catalyst for, you know, regeneration. So we see this, you know, not just being a better, a better solution with better longevity, but also something that dramatically improves the patient experience, which is which is really critical.

Speaker 2: 40:23

Again, even even some of these next generation things that have come on the market can't do that, and I've had people tell me anecdotally that they've turned down those treatments because you know they can't afford to be off their knee for eight months. Yeah, you know, it's really, it's really significant. So I think, just another reason why we're really excited about the potential our product has.

Speaker 1: 40:43

Yeah, that brings up a question I have is the recovery time, because you know we're joking about. Nathan made a mistake talking about 10 centimeter versus 10 millimeter, but a 10 millimeter is pretty thick in terms of defect and so, if your product can allow for a thinner defect, have you guys ever done a comparison study of what's the I guess, theoretical recovery time difference between the traditional method and your method?

Speaker 2: 41:10

Yeah, you know that's. We're about to do our first human clinical study in.

Speaker 2: 41:15

Canada so we will be at least looking at basically planning a recovery process that looks similar to osteochondralograft.

Speaker 2: 41:23

So it typically takes six months to be considered fully recovered from an osteochondralograft, and there typically takes six months to be considered fully recovered from an osteochondralograft and there's a period of two weeks where you have protected progressive weight bearing.

Speaker 2: 41:34

So for people who are not in the orthopedics industry, that basically just means you start out in a leg brace, maybe putting a little bit of weight on your leg, and you kind of work up to full body weight over a two to three week period.

Speaker 2: 41:46

So that's kind of a conservative starting point. But one thing that we built into the protocol is that if patients are doing very well, the surgery can accelerate them and then I think, assuming that happens, that's something we'll be able to build into a more aggressive recovery protocol which we can use in the randomized trial. Uh, you know, in a year or so, which would be the larger trial that actually would be to get a step to approval. Um, but for anyone listening who's not intimately familiar, you know the standard of care is still this this surgery called microfracture, where nothing's being implanted into the, into the damaged cartilage, but the surgeon goes in, they clean out the diseased cartilage, the pothole. Essentially they make a clean hole and then they drill little holes in the bone, and so surgeons have been doing that now for about 35 years.

Speaker 2: 42:38

Right, I mean it was 25 years ago, 10 years ago but now they're still doing it. That's how fast things happen in medical fields.

Speaker 2: 42:49

Yeah, well, and what I think is interesting too is that, you know, sometimes knowledge outpaces our ability to address the problem. You know, it's still the most widely done because, frankly, it's quick and easy to do. I mean, if you have a patient who's not far, you know, not far enough along to need a knee replacement, who's not far enough along to need a knee replacement which is a tremendous amount of people, but also not even severe enough to need an osteochondralograft, because it's really hard to get that tissue they might just do a microfracture because they know, okay, I'm going to buy the patient one to two more years before they need a more invasive surgery. The problem, though, is that there's been some interesting clinical evidence published in the last three or four years that patients who did not undergo any treatment at the time of getting one of these cartilage defects diagnosed had better outcomes than microfracture patients. And the problem is that, even though microfracture temporarily alleviates the pain, it doesn't stop the spread of osteoarthritis. And I would even argue anecdotally that if people don't have pain, but they have a joint that is structurally, biologically diseased and they're doing a bunch of activity on it, that's just going to accelerate the damage.

Speaker 2: 44:06

So, um, you know, we know that microfracture, um, frankly, is doing harm to people. Uh, and if in the last couple years, at any of the sports medicine society conferences, it's all the surgeons can talk about us, we need, we need to do something else. Um, and patients? I think it's also interesting. Unlike a lot of areas of medicine, patients are very highly educated. Um, you know, about orthopedics, people will, because, again it just to put it bluntly, you know, if you have a heart attack and you need to have, like you know, one of the arteries in your heart stented, you're not going to shop around for cardiologists, probably maybe there maybe there's a small percentage of people that are going to do that, but I think most people are not going to do that.

Speaker 2: 44:52

But in orthopedics, especially in sports medicine, where, okay, my knee hurts, I can't run as much but I've got time to research what are the best sports medicine surgeons in my area. Research, you know, what are the best sports medicine surgeons you know in my area? Maybe I'm a train ride away from the next city. Who are the good sports medicine surgeons there, if I'm really willing to travel? You know these are literally stories I hear from people.

Speaker 1: 45:16

Oh, no, it makes sense. I would.

Speaker 2: 45:19

Yeah, yeah, honestly, and, like you know, friends of mine, friends of my family, have really gone out of their way to, you know, seek treatment for these types of problems. And you know we have, in addition to our email, we just have like an info at nanocom account, kind of set up as a catch-all email address. That account probably gets anywhere from like a dozen to 25 people a month emailing it asking if NanoCon is available. Yet you know, I live in this state, I live in this country.

Speaker 2: 45:50

You know, even sometimes people will, will attach their MRIs and be like, can you refer me to a doctor who does it? I just have to politely say, unfortunately we're still investigational. You know, we might, might, maybe a clinical trial might be coming in the next couple of years. That you, that you, but patients are really actively seeking new and better treatments and I think that's again that's really powerful. It creates a powerful incentive for the surgeons as well, Because in this particular segment, doing new and innovative treatments as a way to attract these patients, because they're clearly taking the time to look for them.

Speaker 1: 46:31

Absolutely. Yeah, I mean myself. I have knee problems, so maybe I'll sign up for your clinical trial when it's ready.

Speaker 3: 46:39

We'd be happy to have you. Yeah, and I'd like to add that you know, because of the proprietary nature of you know, this industry as well as analogous to other industries. There's that 20-year window where not much is publicly available being able to address what previous prior technologies or prior generations of technologies were inferior in, as well as other companies who may have encountered some adverse effects over the course of their clinical trials. They're not going to compromise their availability to go to market by publishing something that's compromising. So it's really you know, in addition to what Ben was saying with the micro-threats, you know there's just this long delay in getting publicly available data to at least leverage and to vet your technology against. So you know, I don't know exactly how that could be resolved or expedited, but yeah, I mean, there's a science, there's innovation, discovery, and there's also deployment problem, right?

Speaker 1: 48:07

So I think the startup field is where founders tackle that deployment challenge. Now, if you guys already conducted the small animal and large animal trials, preclinical trials, what did you guys learn from those preclinical data so far?

Speaker 2: 48:30

Nathan, I'll let you take it.

Speaker 3: 48:33

I mean, I think initially what we found is that, you know, the material is quite impressive, both from its original source as well as our current source. So you know, the material behaves uniformly spectacular across all species and all sizes, as well as different designs. So, our small animal, because we were doing it in a rat, we couldn't really create a lattice structure per se at the scale that would fit into a rat femur.

Speaker 1: 49:09

Yeah, I can't imagine how big of a hole you have to create or how small that hole is going to be.

Speaker 3: 49:15

Yeah, we were actually able to print a one millimeter diameter, essentially osteochondral plug equivalent.

Speaker 2: 49:22

Yeah, and this was when Nathan was in Australia. So he's like working up these STLs and then he's emailing them to me. So I'd wake up in the morning and I'd have like the day's STLs and then I'd 3d print and so, yeah, I mean to nathan's point, the implants we ended up using in this rodent study were, yeah, I think they were one millimeter in diameter and they were maybe like three or four millimeters long. They kind of looked, they kind of looked like a piece of a really fine gauge screw essentially, and they didn't really have a true lattice, but they had this kind of interesting, you know they. They ended up having a porosity, sort of as like a, like a or like a surface texture, um, as an artifact of the printing, um.

Speaker 2: 50:20

And in that first rodent study we were able to really essentially see something which is very hard to observe with these types of biomaterials is the interaction between multiple tissue types. So that original study, you know, showed integration with, with the cartilage layer, but it also showed integration with bone and this is in the same material which, which I think is, is really powerful and and significant clinically, because that's that, even even again, with things that are being developed now, that's an ongoing challenge. Can you, can you make something that integrates well with both tissues? Um so, so again, just another, another breakthrough that I think we had early on. Uh, and so that that rodent study was where we learned, okay, what is at a, a baseline, like what's the biological response to this material? Uh, and then I'll turn it back over to nathan to kind of keep talking about how we kept iterating yeah.

Speaker 3: 51:17

Then we went to to a goat model. So we were able to, you know, create a more of a, more of a structure akin to what our first and second generation implant, which was essentially a, you know, a one millimeter wafer with a lattice structure with no, no articulating top layer. So our current design just kind of break it down at a high level essentially composed of three major components One we have the joint-facing articular surface, which is near solid not 100% solid to allow for influx and deflux of synovium as well as to protect the underlying hematoma. We have the lattice, which is similar to the thickness of the cartilage, which will allow for holistic integration from the core, from the inside as well as from the perimeter. And then we have essentially a mirrored, what we like to describe as kind of like a bottle cap feature. So our instrumentation creates a negative mole image of that.

Speaker 3: 52:30

So we have, we basically create what is what we call a bone pedestal. So we go in with our custom reamer. The reamer debrides all of the entire volume down to the subchondral bone, and then it undercuts and creates a trough around a pedestal of bone. That's that's been deemed to be healthy and non-uncompromised, and then our implant sits on that. So it not only does it have circumferential pressure on the outside walls of the surrounding bone but also, through the course of creating that pedestal, we induce the bone bleeding which fills the inner volume of our implant, both the inner walls of the bone fixation aspect but also the underside of that lattice to allow for infiltration and oxidation of the marrow space milieu that goes into it. So that's the embodiment of what the human clinical implant looks like.

Speaker 3: 53:45

But it was definitely an iterative design, from the rat model to the thin wafer with no articular surface, to a wafer with an articular surface. And then when we went into the equine model, the horse model, you know, our initial pilot study was looking at depth of placement. Because we were still dealing with just a single one millimeter wafer and because it's difficult to fully immobilize a horse for any given amount of time, we had to essentially use third-party fixators to ensure that the implant, or to give us the highest probability that the implant would stay in place, that the implant, or to give us the highest probability that the implant would stay in place. So we ended up using commercially available PLA, bioreservable PIMs.

Speaker 1: 54:37

Makes sense. Now we're going to talk about the exciting news that you guys want to share, which is you are entering into your first human trial in Canada. You want to share some information about that.

Speaker 2: 54:50

Yeah, absolutely. So, you know, tremendously excited. This is the first clinical use of the device and, as we've talked about over the last 55 minutes, years and years of our lives and tremendous effort have gone into getting to this point, so we're super excited. It's going to be a small study, so really still designed to evaluate safety 10 patients. We're going to track those 10 patients, uh, for 12 months, but we're going to do interim uh check-ins at three months, six uh sorry, six weeks, three months and six months. So we'll have a nice sort of like progressive build of how people are healing.

Speaker 2: 55:32

Um, the primary way that you still evaluate clinical success is pain and function. So we're going to be literally giving people a survey to ask them how they're feeling. Uh, it's a little bit more complicated, that's just a long survey with a lot of different ways to ask that question. But we we are also doing MRIs at every checkpoint. So you wouldn't typically that's not standard of care to do so many MRIs after the procedure and even in like a large clinical trial, you might not do that, but with a small cohort of patients, you know, it adds a lot of value to be able to actually visually see how the implant's integrating and you can also if you have a powerful enough magnet.

Speaker 2: 56:10

We're doing 3T, we're mandating a 3T magnet for the MRIs so we'll be able to do Mokar scoring, which is basically a radiologist I know you know this, jenny, but for those who are not radiologists, people can look at the MRI image and actually quantitatively assess. You know how good the tissue healing is. So we'll be doing all of that. And then our hope is that you know the study goes well, we could take that to the US FDA and get approval to do that larger randomized study. You know we're hoping to treat the first patient in the next eight weeks roughly and if we can enroll pretty quickly, you know we're hoping to treat the first patient in the next eight weeks roughly and if we can enroll pretty quickly, you know we can be wrapping up this study by the end of next year and looking at starting that randomized trial, you know, in the first half of 2027.

Speaker 1: 57:00

Now, who can just quickly, who can qualify for your clinical trial? Since we're on the pot, you might as well just tell who's qualified?

Speaker 2: 57:07

you have to be canadian uh well, you don't have to be canadian, although you have to be willing to travel to the toronto metro area to have the surgery and then you'd have to go every couple months for these checkups.

Speaker 2: 57:18

So that might be difficult. But you know, if you live in like niagara falls or something you just drive across the border. Um, you know, we are restricting it on age for this first one. So 22 to 60 is the age range for this first trial. We might expand that in the in the later trial. That's what it is now.

Speaker 2: 57:38

Um, there's also something called the kelvin lawrence scale, which is how the severity of osteoarthritis in a cartilage injury is presenting. So just as an example, like if you are running and you fall or you're playing soccer, you fall, you tear something that's still considered a KL0 because at that point it's a trauma. There's no sign of degeneration, but the degeneration can progress. So it's evaluated from a scale of zero to four. Four is like your knee is so badly damaged that you absolutely need a knee replacement and then there's some nuance in between that. So in addition to the age restriction, we're also restricting it to KL zero to three. Kl zero to three.

Speaker 2: 58:29

Uh, we also have some other restrictions, like you can't have had another procedure to your knee within six months. So you know, if you had an ACL tear a month ago, you can't be in our study. But if you had an ACL tear a year ago, you can be in our study. Uh, and then, beyond that, it's just, it's the typical stuff, right, like you can't be severely overweight, you can't be diabetic, you can't be a smoker. These are things that are typical in any certainly any implant trial. I think they're things that are also very typical in drug trials. So yeah, really just just trying to make sure that the date you can cleanly see from the data what the safety and efficacy of our devices Right, you want to remove all the confounding factors.

Speaker 1: 59:06

But one big congratulations to your team, because I know how hard it was to get to this point today. So big shout out. Now I know we're kind of reaching the end of our interview, but we have so much more that I prepared. I wanted to discuss. One thing is hustling okay, because you've been hustling for almost a decade and I would say it's a success in itself that the company has survived and and prospering. Um, just if you can sum it up quickly and I know it's, it's a kind of a disservice to really sum it up quickly about this like um, tell us, just share some experience, because you, a lot of people right now, are hustling and the environment of funding and startup in medtech is not great.

Speaker 2: 59:54

Yeah, yeah, I guess I'll give my perspective as the one who does all the investor fundraising. Nathan, at this point, manages all of our non-diluted funding, so he can give a different perspective on that too. But I think A lot of people are struggling, yes, and I think that the environment has still not completely corrected since 2023. But I kind of feel like things like what we're doing and where it's an implant, it's a very new technology, it's very high risk. I mean, we always faced a lot of challenges fundraising. I mean, nobody was throwing money at you know, a PMA cartilage implant.

Speaker 1: 1:00:33

Yeah, money at a PMA cartilage implant headed by two.

Speaker 2: 1:00:35

PhD students in 2016. We really had to build value, and so I think that it's important to talk to investors early on. But I think you need to understand that not all investors are the same and you need to talk to a lot of them to understand. What do different types of investors look for, when do different types of investors want to come in and what's going to convince them to come in. And I think that by just I mean truly being willing to pitch anybody who would talk to me.

Speaker 2: 1:01:05

I was able to kind of start figuring that out and kind of figure out okay, you know, the next thing we need to do is this small animal study. No one's going to give us the money to do that. We need to target these types of grants. What do we need to do after that? What do we need to do to the product? What do we need to get surgeons to tell us to be able to put into a business plan? So it's just like those conversations with investors when you do enough of them, you'll start to learn what do I need to do to make my company investable? So I think I always tell people don't get discouraged by the no's, because you're still learning from the experience. If you're doing it right, and once you talk to enough people, you start to see those patterns.

Speaker 3: 1:01:46

Yeah, and I would say from all the lessons that Ben's learned from the technical side of things, the operational side of things, right, being very mindful of what are the most value-added experiments and data that you need, to be most efficient with the funding that you do have and also what are the milestones that people are looking for to unlock those doors for the next tranche of funding. So we've been very, very diligent and very good, both involuntarily and voluntarily, of being very lean and very mindful with what are the experiments we're going to, what data is needed, how are we going to fund it? Who are we going to work with to actually get that data in a timely fashion? Because you know we ourselves don't have a lab that I. You know that I or Ben or anybody affiliated with MediCon can just go in and do all the experimental work, as we did when we were PhD students.

Speaker 3: 1:02:52

Right Now, as we, you know you've grown into industry. Do you have to outsource it through a contract work from a service provider, or you have to develop, you know, relations with, you know, either academic institutions or private labs that want to partner with you to actually build up that data set. So you know, being able to be mindful and be diligent about what your expenditures are, and also vetting the service providers and the suppliers that you're working with is also critically important, because one misstep can put you back months, if not a couple of years. So my approach is you know, as I've engaged with various service providers for the same project is really sussing out their level of expertise, their familiarity with not only our technology but the greater scope of the indication that we're looking to address and what the lead times are to actually get the work done in a timeline that's beneficial to us with our target goals of maintaining progress towards, you know, the next funding milestone.

Speaker 1: 1:04:23

Yeah, I mean this kind of echoes what you guys said earlier, which is that this is really a human business. Human business One is you found, you guys found each other, people who has incredible amount of grit, which I can, I can say that. I can say that I cannot do what you do, ben, I see, I see you out there. I do not think I can go to all these conferences just period. I know for certain. And number two is that you do have to manage all the relationships you have with these contractors and people who are providing the service so that, like you said, you have to be really focused and effective. So it's mostly people business actually, because the technology is already there and now you just have to manage the people, which is the hardest part. For everything. We can do a whole other hour, yes.

Speaker 2: 1:05:12

Yeah, sometimes. For sure, I'm going to invite you back because we have so much more we haven't talked about. We can do a whole other hour.

Speaker 1: 1:05:15

Yes, yeah, sometimes for sure I'm going to invite you back because we have so much more we haven't talked about, so let's just wrap it up here. I asked you guys to give some advice to the next generation of founders, and maybe even students in school who are thinking about entrepreneurship. What kind of advice would you give them?

Speaker 2: 1:05:48

I'll let Ben go first get funding. You know, don't get discouraged about you know stories about the federal funding getting disrupted or drying up. You know. I think the reality is that you know if you're doing something in our field, broadly speaking, you know medicine, human health. You know those needs and those problems are not going away and they're not going to just go away because of you know an administration or because of how investors are behaving. You know the opportunities to dramatically improve human health are always going to be there and I think that you know there's always going to be customers. What really kept me going very early on?

Speaker 2: 1:06:32

was going through those customer discovery programs and talking to surgeons and just hearing over and over and over how much they wanted something like what we were proposing. So you know, I think, stay engaged with your customer, if nothing else, to kind of, you know, keep perspective and keep motivation, because ultimately that's what you're doing it for. I mean, yes, we're building this thing to get a return for our investors, but ultimately we're building something that's going to live on past the life of the company and is going to be a product that is improving patients' lives and is improving surgeons' lives.

Speaker 1: 1:07:06

That's really well said. I agree 100%. What about you, Nathan?

Speaker 3: 1:07:10

What about you, nathan? I mean, I would say from an idea perspective, don't be afraid to think outside the box, don't be afraid to, as it were, fail fast. It's better to fail fast and prove or disprove an idea rather than to be afraid of actually venturing down that path. Rather than to be afraid of actually venturing down that path, which is, you know, apropos for my way of approaching not only you know commercial potential products, but you know other aspects of my life and you know again, sometimes and I'm not advocating it, but in certain situations it's easier to ask for forgiveness than to ask for permission. So if that permission means showing your idea works and has value to someone who is a key decision maker for you to realize that end goal of starting up a company, starting anything, don't be afraid to take that initial step and to at least present somebody with your idea, as opposed to try to ask, convince somebody that your idea works. For me, data and numbers and hard facts will trump anything else.

Speaker 1: 1:08:43

Wow, amazing. And this is a good reminder for myself, because I used to be like Jenny you got to take a little bit of risk every day and I have forgotten about that over time. This is a good reminder and I want to encourage everybody to take some risk every day. I'm not breaking law, okay, and I have forgotten about that over time. This is a good reminder and I want to encourage everybody to take some risk every day. I'm not breaking law, okay. I'm not asking you to break law, but just take a little bit of risk every day.

Speaker 1: 1:09:03

Yeah, so that's a really wonderful conclusion from everybody. Thank you so much for joining our pod today and I certainly want to invite you guys back in the near future, thank you. Thank you for having me today. The technologies and procedures discussed may not be commercially available or suitable for every case. Always consult with a licensed professional.