Why Cartilage Implant Development Needs Surgeon Input

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0:00 In MedTech, the difference between a good quarter and a great one isn't always the product. It's the friction standing in the way. Broken sales cycles, misaligned teams, deals that stall at the finish line. Every leader feels it, and the best ones know how to remove it. Welcome to Zero Friction, the podcast where we go inside the minds of MedTech's top commercial leaders to uncover the real barriers they face, the decisions they make, and the systems they build to keep the revenue moving. I'm your host, Terry Coutsolioutsos. Let's remove some friction. And welcome to Zero Friction. I'm Terry Coutsolioutsos, and um I have I'm the great opportunity to have a super guest today, Nathan Castro. He's the co-founder and CTO of Nanacon. He's got a wonderful personal journey, and we'd like to highlight some of the work that his company, Nanacon, is doing in the orthopedic space. So, Nathan, I'm going to hand it over to you, and and let you kind of tell us a little bit

About yourself and the journey of Nanacon. Sure. Thank you, Terry. Thank you for the opportunity to share our story with with you and your audience. I'm definitely very excited to talk about the work that we're doing and the technology we're developing here at Nanacon. So, first and foremost, you know, our you know, our company is focused on articular joints, primarily the knee, and looking at addressing what we consider focal cartilage defects in the knee. Those that are, you know, not so much compromising the underlying bone, but really affecting the what we consider the shock-absorbing material of the joint, which is the cartilage.

So, what we've developed is a what we consider a paradigm-shifting approach to this problem, where we utilize modern manufacturing technologies like 3D printing with novel materials to create a mechanically robust implant that not only resolves and eliminates time-zero pain and discomfort, but also is mechanically robust enough to allow for quick quicker return to mobility as well as serves as a substrate and or a scaffold as most people might be familiar with the term for tissue for cellular attachment, tissue and growth, and subsequent repair. So, we're really looking to get a product that not only is a stopgap measure for younger patients who have been you know, been subject to traumatic or even to a certain extent chronic cartilage injury, they've also but are looking for a solution that's outside of the outside of the scope of total joint arthroplasty, which as as I'm sure you and your audience are well aware is a you know, very invasive as well as there's a lot of constraints with the with you know, going down that

2:45 Path. So, we we really want to you know, target the core audience. So, you know, not only your weekend warrior type athletes, but also you know, your everyday patient who but due to injury or due to chronic pain have to have lifestyle changes that may require them to forego doing activities that they once enjoyed or tempering down their strain the um extent of their activity. And we really want to provide a solution that gets them back to you know, 100% performance. That's great. Well, tell me a little about about your journey first cuz I think it's a unique one in terms of you know, becoming an entrepreneur and you know, looking at all sorts of different types of innovative ways in the in the medical technology space. So, love to learn more about that and how that ties back into Nanacon as well. Yeah. Yeah, so you know, I would say that early on I was very uh very driven to as it were be my own boss. Both my

Grandfathers and my father were small business owners. So, you would uh you would uh you know, routinely find me out in the at the swap meets on weekends helping my father sell, you know, at that time semi-worn shoes or used shoes that he would buy by the truckload from department stores and we would go out and do second hand market sales. So, you know, from from like the age of 7-8 all the way to, you know, basically till I was passing, I was always involved in in his business affairs and trying to modernize what he's doing.

Right. And that really that really, you know, set the flame or ignited the flame of my desire to, you know, as a verse serve people, but also, you know, hone my skills in being, you know, learning the nuances of of social interactions. So, you know, I I didn't really see myself, you mean, you know, continuing down that same path that my father had laid because I had, you know, other other aspirations when I was younger as most people do. You're always asked, "Oh, what do you want to be when you grow up?" At that time, I wanted to be a neurologist and a cardiologist and yeah, I wanted to go into the medical space.

And then as I I, you know, you know, matured into adolescence, I started having knee problems where I would have, you know, slight subluxations or partial dislocations of my knees and that caused a lot of pain and um resulted in me, you know, needing surgery and at a younger age. So, that that in and of itself also served as a as inspiration to look for ways by which I can kind of address my own personal uh pain points, but also, academically speaking, you know, I I I would be remiss to say that I that I've product of really, really good mentoring.

5:53 So, through my junior college years where I started going to school full-time while I was working full-time in IT, you know, I had a chance encounter with one of my biology professors who one evening after our biology lab took notice of me reading an advertisement for a Department of Energy Research Internship. Um, just that chance encounter where he, you know, mentioned to me that I he believed that I would have a good opportunity or good shot at at some, you know, successfully securing one of those internships.

That then inspired me to to apply, you know, true to his word, I did get accepted. And then that led to my that led to my first internship at the Pacific Northwest National Lab out in the southeast uh Washington state. And then then during that appointment is where I first was introduced into medical technologies. So, in that lab we were looking at chronic non-healing wounds and working in conjunction with um with the US USDA on different cotton-based dressings and seeing how pre-treating or how chemically modifying these these cotton gauzes could could uh mediate some of the biology biology that occurs in chronic non-healing wounds.

So, that led to my that led to me publishing my first paper, being invited to Washington D.C. to you know, attend a a new conference, publishing a a chapter in a book, all this, you know, during that that first uh year when the graduate. And then that really just just snowballed into opportunity after opportunity and then, you know, I you know, I I then returned to Texas. I was a recipient of an undergraduate research fellowship, which allowed me to do research in the WM Keck Center at the University of Texas at El Paso, which at that time housed the the largest number of 3D printing {slash} additive manufacturing technologies in the country. And, you know, I was part of the small group looking at biomedical applications of 3D printing.

Got it. My my master's thesis was looking at stereolithography or using a laser to cure a liquid resin into a semi-solid material, finding a base material that is biocompatible to then create 3D 3D printed scaffolds or for musculoskeletal applications. And, then, from there, I moved out to George Washington University in DC, where I did my PhD and really took all of all of that background in additive manufacturing and soft matter materials and really laid the foundation for for that that lab, as well as published 40-plus papers along, you know, as a first author and as a co-author with a lot of my colleagues, too, um looking at musculoskeletal repair.

8:59 And, then, all the while, you know, obviously the I ideation comes the other side of the coin, which is intellectual property. So, through the through the course of my studies, you know, I was able to generate a a bit of IP, which, you know, we were able to participate in and take advantage of through participating in the NSF I-Corps program. So, for those who are unaware of the I-Corps program, it's it's a nation uh uh a nationwide program supported by the National Science Foundation. And, it really allows for academics to, as it were, get their put their boots on the ground to do customer discovery and based on the lean startup approach. And during that time, my co-founder Ben Holmes and I were in the throes of a graduate work and we decided to partake to an to apply. We got accepted and then and participated in the I-Corps program. As you can as you might Is this for Is this for Nanacon sort of

Was the concept of, you know, a GW between you and Ben kind of partnering on that opportunity? Yes. Yes. So my So a lot of my IP was related to materials and and and Ben's work was really about um morphological influences of scaffolding on cell behavior and tissue repair. Um So we both participated separately at that time uh in the I-Corps program. You know, I tend to be to fall back to the scientist in me. So it's hard It's a little It was a little bit more of a difficulty for me to switch gears and speak from a from a business perspective Right.

On the technology I was developing. So needless to say, out of the the I can't remember at this time the the number of participants that were in in the cohort at but I, you know, I'll be honest. I was the lowest performing. So the goal was to have 10 10 10 customer interviews per week over 10 weeks so I have a, you know, compile a list 100 interviews. That's a lot, by the way. That's pretty That's a pretty big goal. Yeah. Yes. Yes. And, you know, I I I think I barely even not even got half of it. Ben, on the other hand, was, you know, the the star of the the cohort. He exceeded, I believe, that that goal and then, you know, and at the end of the at at the end of the program, you know, we were we were basically uh ended on a go no go decision on whether or not we felt that the idea or the IP that we had generated had commercial potential.

11:45 Right. Or was at least viable to a certain degree. Well, flying Ben and I chatted and we're like, you know, you know, I think we I think we have something. Albeit it it might not be the embodiment of what we're both pitching now, but I think we do have something. So, we decided to to combine efforts and form Nanocon. And then the last sir, that was like the I think the third third or I can't remember the fourth year of my PhD. So, I had a 5-year fellowship.

So, the last year of my fellowship I had already completed all of my all of my thesis work and everything. So, the last year of my fellowship was really, you know, an opportunity for me to explore outside of the confines of my dissertation. Right. So, that that really got me thinking into the course of not only my interviews, but Ben's interviews, of really highlighting the pain points that some of the surgeons were were describing to us. And some of those were those were, you know, as simple as logistics, you know, having a shelf stable implant that they could they can readily pull off the shelf and address a a cartilage lesion that was either undiagnosed or or they felt would be would be suitable for repair at the time of, you know, during a a primary surgery.

The other was, you know, volumes and pricing. So, a lot of the a lot of our competitors at that time and now are still cell-based and tissue-based implants. Right. Like MCOs. There is a little bit more interest in synthetics now than I think at that time, but but you know, at Nanocon we really you know, really laid the foundation for something something extremely unique and that can benefit both the patient and the and the physician as well as fit into the into the economics of And the clinical benefit and all that. So so basically, you know, versus human tissue which probably takes a little longer to get a hold of you have now have an on-the-shelf ready-to-go product that is adaptable to multiple you know, situations, sizes, that type of thing. So it's a it's a great thing.

Well, let's let's lean into Nanocon a little bit and let's talk about this revolutionary opportunity, you know, from a minimally invasive perspective and let's just talk a little bit about the technology. Let's talk about the problems that you're trying to solve for your customer, the friction points. And then, you know, if we can find some time maybe we'll we'll get some video in there so our listen our listeners and our viewers can kind of see what's what's going on there. Yep, sure. So Nanocon really um and just to to to tie up the the last conversation so, you know, to date or or up to the point where Ben and I formed the company we were really looking at kind of soft matter materials and the analogy that we like to use is if you imagine your the the cartilage on your articulating joint as a as a asphalt paved street over time and over over the course of uh you know, usage you start to wear down so you start to

15:04 Develop potholes. So these potholes are akin to these focal defects that we we eventually start to form in our knees or in other articulating joints and that's just through through wear and tear. And pretty much almost everybody will have some level of degeneration of their cartilage. So, what at Nanocon what we're doing is traditionally what would have been done and what is currently also still being done is you're filling that pothole with a material that you presume it's going to be bioactive and that's going to elicit repair and minimize pain so that can be injected injectables like steroids, it can be injectables like hydrogels that will will solidify in situ or fibrin glue bioadhesives, things of this nature.

But at the end of the day, what you end up having is a mechanical mismatch between the surrounding tissue and what you filled that pothole with. What Nanocon is is developing is actually an implant that not only fits true to size to that pothole, but it also has similar mechanical properties to the surrounding tissue. So, you don't you don't develop stress concentrations in and around the injury and you also have a mechanically robust system that allows for minimal pain, allows for better uh time to recovery and also gets you back to that more active active lifestyle, all the while providing as I mentioned before a substrate for cells to attach, tissue to infiltrate and then ultimately in ingrowth of tissue from the surrounding healthy areas and thus, you know, really really repairing the tissue as opposed to just putting a band-aid on as it were.

Yeah, so our first thing the patient and our I shall preface by saying that we're we're not FDA approved yet, but it's still investigational. So, all this is for, you know, scientific understanding. So, what we're looking to address are what is referred to as KO scores zero to three, so that's really minimal to full cartilage injury. And what makes our product unique is not only that we address one, but we can address multiple lesions in the same joint through the use of different sizing options that we have available. So, we have right now our our meniscus getting 10 to 20 mm, but we also have skews that we can, you know, fit the additional sizes.

17:48 And the unique features of our of our implant are that we have areas by which and as is illustrated here, allows for influx and influx of the milieu of the surrounding blood as well as the synovium that will penetrate into the scaffold through these pores. And as illustrated here, elicits tissue to attach itself to attach, mature, and then allows for tissue to infiltrate and grow and fill the void space. Along with the implant, we've also developed a really, really elegant instrument set that prepares the patient's joint to receive our unique design design features. So, the implant itself is does not require any third-party fixation, nor does it require any bio type of bio adhesive. It is purely mechanically fixed into the joint.

So, as is common with arthroscopic delivery, you know, prepare the injury site. We have our introducer which pushes the implant in, and then it sits just slightly recessed into the into the joint to allow for 100% contact with the surrounding neighboring tissue for tissue integration and ingrowth. That's a an amazing piece of technology and frankly, what an elegant delivery system, too. So, it really looks like a end-to-end system. You've got the right sizes, you've got the right tools to get it in there and get it secured and make sure that you have successful procedure.

So, it looks like you're you're well on your way. So, where do you stand today in terms of you know, getting this thing ready for market, getting it into the hands of physicians so patients can evident you know, someday actually take advantage of this wonderful new minimally invasive approach. Yeah, so right now, even through our website or through clinicaltrials.gov, we have a safety study that we've started in up in Canada through the Health Canada system. So, this is this is So, for those of you out there that have friends in Canada who have knee problems, I'm sure they can go to your website and find a way to find a research facility there, too. So, that would be a great thing. So, um I just wanted to add that in there real quick. Nathan, cuz I know that's a a big part of getting onto your journey is getting the right patients into these studies so that you can prove your safety, can prove your efficacy, and

20:19 Then, you know, begin your regulatory pathway here in the US. Correct. Yeah. Yeah, so we, you know, we will be doing the the safety study. So, looking at several provinces in Canada. And then, once we obtained early read out data as well as combining that with some ongoing preclinical large animal work, we'll submit to the FDA to apply for our phase one clinical trial. So, hopefully, that will occur sometime in 2027. So, looking to enroll a a larger number of larger cohort of patients, bring up multiple sites. So, you know, a lot of exciting work ongoing and very, I would say, milestone moments for us as a company because uh you know I I failed to mention the timeline that we were we were operating on. So we founded the company in 2016. Ben was really really you know instrumental in maintaining the the organization afloat while while I was overseas supporting myself through multiple post docs as well as returning domestically.

Right. But I I I was returned full-time to Nanocore in October 2020. So you know and working full-time and really really made a lot of headway and a lot of progress in the last 6 years which which I think is reflected in the success we've had been having in our fundraising efforts. You know each round of funding that we've we've opened has has always been oversubscribed and you know through the course of of these years even though I even though I'm not as intimately involved in the fundraising itself you know I I hear the the chatter of how difficult fundraising in the at least at these levels can be and that we're uh we're one of the I don't want to I don't want to say an outlier but uh you know we've been able to maintain a lot of interest from a lot of a lot of Well it certainly serves a lot of purpose right? So that's the one thing and and the alternative is something much more archaic and barbaric and you know

Implants and you know cutting the bone and you know all sorts of major major surgeries with that come with all sorts of major major complications and infection rates and you know does the implant actually you know work together with the body does the body reject the implant and all those types of things. I think that's a wonderful purpose to bring. What have been some of the frictions that you've had in terms of like bringing this thing forward along the way? Where were your friction points and you know maybe you have a friction point now. Maybe there's a friction point that you're anticipating.

23:06 Can you tell our listeners about the friction points and maybe how you've sort of overcome some some of that stuff as well? Yeah, I think kind of take taking it back to the early days, the original work that I did. So, you know, as I mentioned before, most of my work was on soft matter materials and and this you know, the the material that we're using for Nanocone is definitely not in that category. So, trying to convince, you know, you you my advisor or, you know, as we're fundraising, you know, key decision makers who have the capital to invest, really um really creating the compelling story that's data-driven. So, you know, we definitely do not want to follow the the path of Theranos and, you know, overselling and under and under-delivering it in in any sense of the word. We we definitely leverage and rely almost 100% on the data that's that we're we're gathering through, you know, both funded projects as well as other

Projects that I that I oversee. You know, that that first set of experiments, you know, that I that I did to really investigate this material, um was, you know, I purchased the material myself. You know, as opposed as a as a PhD student, you don't really get a good a healthy stipend and especially living in DC. So, so I uh I I took it upon myself because I I just wanted to I just needed to to answer my own question, like does this material is this material viable or not?

Is it legit, right? Is it is it really going to make Uh-huh. So, I took it upon myself, you know, bought materials, you know, did did the work and uh you know, true you know, told it you know we did see see some promise. Right. And then that really is what what became the core IP of NanoCon as we moved forward was this material combined with the design elements that the original design elements that that Ben was investigating as well as you know teaming up with with a spec developer in these later years to really refine the implant design and the tolerances to bring it to the to the embodiment that it is now.

I'm sure that 3D printing really yeah I'm sure it adds to the efficiency, effectiveness, keeping the cost structure in the right way. Um you know because just getting something built you know that's going to be one part, getting it approved and then and then just like anything in healthcare unfortunately you know you have to find a way to get a pathway to money. So then you know you have your healthcare facilities and your your implanters and your payment systems are all motivated to support the therapy with reimbursement. Without those pathways and that market access you know that makes it even more challenging even if it's a great product and a great outcome if the if the if the Medicare is not paying for it I'm guessing that Medicare is probably a a great proportion mix of this population that would get this type of therapy. You know you need to make sure that you get those things in mind too. But very very exciting man like I'm this is something for a guy who's been a runner for a long

26:32 Part of his life and has knee problems I know I probably worn a bunch of cartilage out of my knee. It'll be nice to know that you know down the road there'll be something there for me later that can you know kind of keep me on my way and and not push me into you know an arthroplasty or something along those lines. Mhm. One kind of we close things and wrap things up a little bit here. So, the next phase is our getting through Canada, presenting that data to the FDA, building your regulatory pathway. When do you think something like this we can actually eventually get to market in the US? So, we're in the US, we're probably looking around 2029. So, if we're able to start our enrollment of our RCT in 27, you know, we'll do a two-year follow-up.

Hopefully, we'll we'll receive So, we're pursuing a PMA route because, you know, truth be told, there are no predicates that allow us to to go through that 510(k) pathway. What has What has helped us is that, you know, we we were uh awarded a breakthrough device designation. That's awesome. It helped some time ago. So, that allows us to interact with the agency a little bit more frequent and a little more efficiently. Albeit, you know, the the uh real uh belong calls in the tent are, you know, the testing required to to prove safety and efficacy both pre-clinically and clinically. But, you know, we are looking to I don't want to say fast-track, but we're exploring options by which we can, you know, do a soft commercial launch in Canada, you know, once we get enrolled we enrolled in our safety study.

So, that may be a possibility. reps, too. That's good. That's good. That's excellent. Mhm. Well, wrapping things up, I have one question for you, and this is a surprise question, but what would Nathan Castro tell his 18-year-old self in terms of, you know, life advice? Oof.

Uh I mean, I would I would probably say tell myself to, you know, keep being fearless. And fearless in the context of, you know, not being afraid to fail. As an entrepreneur, as a scientist, you go through experimentation, you go through trials and errors, and you know, I'm sure almost all, you know, graduate students will will echo this, is that you fail 100 times more than you succeed. But what keeps you motivated are those those those successes. And that's what's kept me motivated. So, you know, not being afraid to fail, uh and and not being afraid in general, obviously within certain constraints and calculations.

29:29 Sure. So, I don't I don't want to I don't want to find one of your listeners jumping off the Golden Gate Bridge. But But as a scientist, you have to calculate something, right, Nathan? Yeah. Yes. Yes. Uh well, that's awesome. I think that's great advice. Don't let fear get in the way of tomorrow. And I think that's that's a good sentiment to take. So, Nathan Castro, I really truly appreciate your time today. What a great story personally, and you know, what a great story for Nanacon as well. I'm sure we wish you all the best and the greatest success. Thank you.

Thank you, Terry. That's a wrap on Zero Friction, the show built around one simple idea. Remove the barriers and the revenue will follow. If today's conversation was valuable, please subscribe and share it with somebody who needs to hear it. That's how we will grow this community. I'm Terry Coutsolioutsos, revenue architect powered by AI. Come find me at my website, myrevx.com, and let's talk about what friction is costing you and your organization. Until next time, keep removing the barriers and keep the revenue flowing.