Latest / Zero Friction / Removing Friction: GTM with a Transformational Orthopedic Solution
Transcript
- Terry Coutsolioutsos/RevRx AI: Welcome to Zero Friction. I'm Terry Kouchalouchis. And ⁓ I had great to have super guest today, Nathan Castro. He's the co-founder ⁓ CTO of Nanacon. He's got wonderful personal journey. ⁓ And we'd like to highlight some the work that his Nanacon, is doing in the orthopedic space. So Nathan, I'm going to hand it over to you and ⁓ let you kind of tell us a bit about yourself and the journey of Nanacon. Nathan J Castro: Sure. Thank you, Terry. Thank you for the opportunity to share our story with you and your audience. very excited to talk about the work that we're doing and the technology we're developing here at Nanocon. So and foremost, our company is focused on articular joints, primarily the and looking at addressing what we consider focal cartilage defects in the knee, those are you know, not so much compromising the underlying bone, but really affecting the, we consider the shock absorbing material of the joint, which is the cartilage. So what we've developed is a, ⁓ we consider a paradigm shifting approach to this problem, where we utilize modern technologies like ⁓ 3D with novel materials ⁓ to create mechanically robust implant. that not only and eliminates ⁓ zero pain and discomfort, but also is mechanically robust enough to allow for quicker return to mobility, as as serves as substrate and or a 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 create 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, but have also, but are looking for a solution that's outside of the, outside of the scope of total joint arthroplasty, which as I'm sure you and your audience are well aware, it's a, you know, very invasive. as well as there's a lot of constraints with going down that path. we really want to target the core audience of only weekend warrior type athletes, but also your everyday patient who, due to injury due to pain, have to have lifestyle changes that may require to ⁓ forgo doing activities that they once enjoyed or tempering down there, extent their activity. And we really want to provide a solution that gets them back to 100 % Terry Coutsolioutsos/RevRx AI: That's great. Well, tell me a little bit about your journey first, because I think it's a unique one in terms of becoming an entrepreneur and looking at all sorts of different types of innovative ways in the medical technology space. So, I'd love to learn more about that and how that ties back into Nanacon as well. Nathan J Castro: Yeah, yeah. So, you know, I would say that on, I was very, very driven to, as it were, be my own boss. Both grandfathers and my father were small business owners. So you you know, routinely find me out at the swap meets on weekends helping my father sell, you know. that time, semi worn shoes or used shoes that he would buy by the truckload from department stores. And would go out and do secondhand market sales. So, you know, from from like the age of seven, eight, the way to, you know, basically, so as passing, I was always involved in his ⁓ business affairs and trying to modernize what he's doing. ⁓ And that really that really, you know, ⁓ Terry Coutsolioutsos/RevRx AI: Right? Nathan J Castro: set the flame or ignited the flame of my desire you know, as a way to serve people, but also, you know, my skills being, you know, learning the nuances of social interactions. So, you I didn't really see myself, you know, continuing down that same path that my father had laid because I had, you know, other other aspirations when I was younger, most people do, you're always asked, ⁓ what do want to be when you grow up? At that time, I wanted to be a neurologist and a cardiologist. I to go into the medical space. Then as matured into I started having knee where I would have slight subluxations or partial dislocations of my knees and that caused a lot of pain and resulted in me needing surgery at a younger age. So that in and of itself also served as inspiration to look for ways by which I can kind of address my own personal pain points, but also academically speaking, you know, I... Terry Coutsolioutsos/RevRx AI: Mm. Nathan J Castro: I would be remiss to say that I'm a of really good mentoring. So ⁓ through junior college years where I started going to full-time while I was working full-time in IT, I had a chance encounter with one of my biology professors who one evening after our lab took notice of me. reading an advertisement for a Department of Energy research internship. just that chance encounter where he mentioned to me that he believed that I would have a good opportunity or a good shot at successfully securing one of those internships that inspired me to apply. And true to his word, I did get accepted. And then that led to my first internship at the Pacific Northwest National Lab out in the southeast of Washington state. And during that appointment is where I first was introduced into technologies. So in that lab, we were looking at chronic non-healing wounds and in conjunction with the USDA on different... cotton-based dressings and seeing how pre-treating or how chemically modifying these cotton gauzes could mediate some of the biology that occurs in chronic non-healing wounds. So that led to me publishing my first paper, being invited to Washington, DC to attend a premier conference, publishing a a chapter in a book, all this, you during that first year of undergraduate. And then that really just snowballed into opportunity after opportunity. then, you I then returned to Texas and was a recipient of an undergraduate research fellowship, which allowed me to do research in W. Center at the University of Texas at El Paso, which at that time the largest number 3D printing, so I started at manufacturing technologies in the country. I ⁓ part of the spell group looking at biomedical of 3D printing. ⁓ My master's thesis was looking at stereolithography or using laser cure a liquid resin into a semi-solid material. Terry Coutsolioutsos/RevRx AI: Got it. Nathan J Castro: finding a base material that is biocompatible to then create 3D printed scaffolds for musculoskeletal applications. And then from there, I out to George Washington University in DC where I did my PhD and really took all of that background in additive and soft matter materials and really laid foundation for that. Terry Coutsolioutsos/RevRx AI: Got it. Nathan J Castro: that lab as well as published plus papers along as first author and as a co-author with a lot of my colleagues too, ⁓ looking at repair. And then all while, obviously with ideation comes the other of the which is intellectual property. So through the course of my studies, I was able to... generate a bit of IP, we were able to ⁓ and take advantage of through participating in the NSF I-Corps program. So for those who are unaware of the I-Corps it's a nationwide program by the National Science Foundation. And it really allows for academics to, as it were, their ⁓ put their boots on the ground to do customer discovery based on the lean startup approach. during that time, my Ben Holmes I were in the throes our graduate work and we decided to take, to apply, got accepted and then in the ICO program. As you can, as you might. ⁓ Terry Coutsolioutsos/RevRx AI: ⁓ Is this for Nanocon sort of was the concept of GW between you and Ben, kind of partnering on that opportunity? ⁓ Nathan J Castro: Yes, yes. So a lot of my IP was related to materials and Ben's work was really about morphological influences of scaffolding on cell behavior and tissue repair. So we both participated separately at that time in the ICAR program. I tend 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, a business ⁓ on the technology I was developing. So needless to say out of the, I can't at this time, the, the number of participants that were in the cohort. But I, you know, be honest, I was the lowest performing. Terry Coutsolioutsos/RevRx AI: Right. Nathan J Castro: So the goal was to have 10, 10, 10 customer interviews per week over 10 weeks to have a, you know, compile a list, a hundred interviews. ⁓ Yeah. Yes. Yes. And, ⁓ I, I think I barely even, not even got half of it. Ben on the other hand was, you know, the, star of the ⁓ cohort. exceeded, I believe that that goal and then. Terry Coutsolioutsos/RevRx AI: under. That's a lot, by the way. That's a pretty big goal. Right? Nathan J Castro: You know, and at the end of the program, you know, we were basically 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, or was at least viable to a certain degree. So offline Ben and I chatted and were like, you I think we have something. Terry Coutsolioutsos/RevRx AI: Right? Nathan J Castro: Albeit it might not be the embodiment of what we're pitching now, but I think we do have something. So we decided to combine efforts and form then the ⁓ so that like the, think the third or entering the fourth year of my PhD. So I had a five-year fellowship. So the last year of my fellowship, Terry Coutsolioutsos/RevRx AI: Okay. Nathan J Castro: I had already completed all of my thesis work and everything. So the last year, my fellowship was really an opportunity for me to explore outside of the confines of my So that really me thinking and through the course of not only my interviews, but interviews of really highlighting the pain points that some of the surgeons were describing to us. Terry Coutsolioutsos/RevRx AI: Right? Nathan J Castro: And some of were, ⁓ as simple as logistics, you having a shelf stable implant that they could readily pull off the shelf and address a cartilage that was either undiagnosed or they felt be suitable for at the time of, you know, during a primary surgery. The other was, you know, volumes and pricing. Terry Coutsolioutsos/RevRx AI: Right? Nathan J Castro: So a lot of our competitors at that time and now are still cell-based and tissue-based implants like Macy, Oats. is little bit more interest in synthetics now ⁓ I at time. But at Nanocon, we really like the foundation for something ⁓ extremely unique and that can. Terry Coutsolioutsos/RevRx AI: Right. Nathan J Castro: benefit both the patient and physician as well as fit into the economics ⁓ Terry Coutsolioutsos/RevRx AI: And the clinical benefit and all that. So basically, 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 great thing. Well, let's lean into nanocon a little bit and ⁓ talk about this revolutionary opportunity, you know, from a minimally invasive perspective and Nathan J Castro: Mm-hmm. Terry Coutsolioutsos/RevRx AI: 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, know, if we can find some time, maybe we'll get some video in there so our listeners and our viewers can kind see what's going on there. Nathan J Castro: Mm-hmm. Yep, sure. So, ⁓ kind of to tie up the ⁓ last So, you know, date or to the point where Ben and I formed the company, we were really looking at kind of soft matter materials. And the analogy that like to use is if you imagine the on your articulating joints a ⁓ as a asphalt paved street over time and over the course of usage, you start to wear down. So you start to develop potholes. So these potholes are akin to these focal defects that we start to form in knees or in other articulating joints. And that's just through wear and tear. And pretty much almost everybody ⁓ will some level of degeneration of their cartilage. So at Nanocon, we're doing is traditionally what would have been done 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 ⁓ minimize So that can be injectables like steroids, can be injectables like hydrogels that solidify in C2 or and glue bioadhesive, things of this nature. But at the end of the day, what you up having is a mechanical mismatch between the surrounding tissue and what you filled that pot hole with. What NanoCon is developing is actually an implant that not only fits true to size to that pot hole, but it also has ⁓ similar mechanical properties to the surrounding tissue. So 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 time to recovery, and also gets you back to that more active lifestyle, all the while providing, as I mentioned before, a substrate for cells to attach. tissue to infiltrate and then ultimately in growth of tissue from the surrounding healthy areas and us, you know, really, really repairing the tissue as opposed to just putting a band-aid on as a word. Terry Coutsolioutsos/RevRx AI: it. Nathan J Castro: So our first thing location and our I shall preface by saying that we're not FDA approved yet. We're still investigational. So all this is for scientific understanding. So what we're looking to address are what is referred to as KL score 0 to 3. So that's minimal to full cartilage injury. And what makes our product unique is not only can 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 investigating 10 to 20 millimeter, but we also have skews that we can, you know, fit additional sizes and the unique features of our, of our, of our implant are that we have areas by which, and as is illustrated here, allows for efflux 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, so to attach, mature, and then allows for tissue to infiltrate and ingrow 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 features. So the implant itself does not require any third-party fixation, nor does it require any type of bioadhesive. It is purely mechanically fixed into the joint. as is common with arthroscopic delivery, know, prepare the injury site we ever introduced for which pushes the implant in, and then it sits just slightly recessed into the joint to allow for 100 % contact with the surrounding neighboring tissue for tissue integration and in-growth. Terry Coutsolioutsos/RevRx AI: That's 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 right tools to get it in there and get it secured and make sure that you have successful procedures. So it looks like you're well on your way. So where do you stand today in terms of getting this thing ready for market, getting it the hands of physicians so patients can evidently... Nathan J Castro: Mm-hmm. Terry Coutsolioutsos/RevRx AI: someday actually take advantage of this wonderful new mint mint invasive approach. Nathan J Castro: Right now, even through our website or through clinicaltrials.org, we have a safety study that we've started up Canada through the Health Canada system. ⁓ This is a- Terry Coutsolioutsos/RevRx AI: Okay, so for those of you out there that have friends in Canada who have knee problems, sure they can go to your website and find a way to find a research facility too. So that would be a great thing. So I just to add that in there real quick, Nathan, because I know that's 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 then ⁓ begin your pathway here in the US. Nathan J Castro: Mm-hmm. Yeah. So we, you know, we will be doing the ⁓ safety So looking several provinces in Canada, and once we obtained ⁓ early readout data, 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. that occur sometime ⁓ in So looking to a larger number, larger cohort of patients, bring up multiple sites. So a lot of exciting work ongoing and very, would say milestone for us as a company because I... failed to mention the timeline that we were operating on. So we founded the company in 2016. Ben was really, really instrumental maintaining the organization afloat while I was overseas, supporting myself through post-docs as well as returning ⁓ but I was ⁓ full time Natacron. Terry Coutsolioutsos/RevRx AI: Right. Nathan J Castro: in October of 2020. So, you know, been working full time and really, really made a lot of headway and a lot of progress in the last six years, which I think is reflected in the success we've been having in our fundraising efforts. You each round of that we've opened has been over and, you know, through the course of of these years, though I'm not as intimately involved in the fundraising itself, I hear the chatter of how difficult fundraising least at levels can be. And we're one of the, I don't want to say an outlier, but we've been able to maintain a lot of interest from a lot of Terry Coutsolioutsos/RevRx AI: Well, it certainly a lot of purpose, ⁓ So it's the one thing. And the is something much more archaic and barbaric and, you know, implants and, you know, of bone and, you know, all sorts of major, major surgeries that come with all sorts of major, major complications and rates. 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. have been some of the frictions you've had in terms of bringing this forward along the way? Where were your friction points? Maybe you have a friction now, maybe there's a friction point that you're anticipating. ⁓ Would you tell our about the friction points and maybe how you've overcome some of that stuff as well? Nathan J Castro: Mm-hmm. Mm-hmm. think kind ⁓ taking to the early days, the original that I did. you know, ⁓ as mentioned most of my work was on soft matter materials and this, you know, the material that we're using for Natakong is definitely not in that category. So trying to convince, you know, either my... my advisor or, you know, as we're fundraising, you know, decision makers who have capital to invest really, really creating the compelling story that's data driven. So, you we definitely do want to follow the ⁓ path of Theranos you know, overselling and under and under delivering it. in any sense of the word. we definitely leverage and rely almost 100 % on the data that we're gathering through both funded projects as well as other projects that I oversee. So that first set of experiments that I did to really investigate this material was I purchased the material myself as opposed to as a... As a PhD student, you don't really get a a healthy stipend, especially living in DC. So, so I, took it upon myself because I, I just wanted to, I needed to, to answer my own question. Like does this mature, is this material viable or not? So I, ⁓ yeah. So I took it upon myself, you know, black materials, you know, did. Terry Coutsolioutsos/RevRx AI: sorry. Is it legit, right? it really going to make, Nathan J Castro: did the work and, you know, truth be told, we did see promise. ⁓ then that really is what became core IP of Nanocon as moved forward was this material combined with the design elements, the original design elements that Ben was investigating, as well as, ⁓ you know, up with Terry Coutsolioutsos/RevRx AI: Right? Nathan J Castro: with a spec developer in these later years to really refine the implant design and the tolerances bring it to the embodiment that it is now. ⁓ Terry Coutsolioutsos/RevRx AI: I'm sure that 3D printing really to the efficiency effectiveness, keeping the cost structure in the right way. Because just getting something built, that's going to be one part, getting it approved. And then just anything in healthcare, unfortunately, you have to find a way to get a pathway to money. So that have your healthcare facilities and your your implanters and your Nathan J Castro: Thank you. Mm-hmm. Terry Coutsolioutsos/RevRx AI: payment systems are all motivated to support the therapy with reimbursement. Without those pathways and that market access, that makes it even more challenging. Even if it's a great product and a great outcome, if Medicare is not paying for it, I'm guessing that Medicare is probably ⁓ great proportion mix of this population that would get this type of therapy, you need to sure that you get those things in line too. Nathan J Castro: Mm-hmm. Terry Coutsolioutsos/RevRx AI: But very, very exciting, man. is something for a guy who's been runner for a long part of his life and has knee problems. I know I've probably worn a bunch of cartilage out of my knee. It'll be nice to know that down the road there'll be something there for me later that can keep me on my way and not push me into an arthroplasty or something along those lines. ⁓ Nathan J Castro: Mm-hmm. Mm-hmm. Terry Coutsolioutsos/RevRx AI: One kind of as we close things and wrap things up a little bit here. the next phases are getting Canada, presenting that to the FDA, building your regulatory pathway. When do you think something like this can actually eventually get to market in the US? Nathan J Castro: So we're in the US, we're probably looking around 2029. So if we're able to start our enrollment of our ICT in 27, you know, we'll do a two year follow-up. we'll receive. So we're pursuing a PMA route because, you know, truth be told, there are no predicates that allow us to go through the 510k pathway. What has helped us is that, you know, we were a breakthrough device designation ⁓ some time ago. So that allows us to interact the agency a little bit more frequent and a little more efficiently. Albeit, ⁓ know, real lung in tent or, you know, the testing required to prove safety and efficacy both pre-clinically and clinically. Terry Coutsolioutsos/RevRx AI: That's awesome. That helps, right? Nathan J Castro: you know, we are looking to, I don't to say fast track, but we're exploring options by which we can, you know, do a soft commercial launch in Canada, you once we fully enrolled in our safety study. there may be possibilities. ⁓ Terry Coutsolioutsos/RevRx AI: It's nice to get some other reps too. That's good. That's good. That's excellent. ⁓ Well, wrapping things up, I have one question for you and it's a surprise question, but what would Nathan Castro tell his 18 old self in terms of, you know, life advice? Nathan J Castro: Mm-hmm. Oof. ⁓ I I would probably say tell myself to Terry Coutsolioutsos/RevRx AI: You Nathan J Castro: No. 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 echo this, is that you fail a a hundred times more than you succeed. But what keeps you motivated are those successes. And that's what's kept me motivated. So, you know, not being afraid to fail and not being afraid in general, obviously within certain constraints and calculations. So I don't want to find one of your listeners jumping off the Golden Gate Bridge. But... Terry Coutsolioutsos/RevRx AI: Sure. ⁓ Well, a scientist, you have to calculate something, right, Nathan? ⁓ that's awesome. I think that's great advice. Don't fear get in the way of tomorrow. I that's a good sentiment to take. So, Nathan, Castro, really truly appreciate your time today. What a great story personally and what a great story for Nanacon as well. I'm sure Nathan J Castro: Yeah, yes, yes. Mm-hmm. Terry Coutsolioutsos/RevRx AI: wish you all the best and the greatest success. Thank you. Nathan J Castro: Thank you, Terry.