Medsider: Learn from Medtech and Healthtech Founders and CEOs - An Unorthodox Path to Medical Device Success: Interview with Cresilon CEO Joe Landolina

Episode Date: May 24, 2023

In this episode of Medsider Radio, we sat down with Joe Landolina, co-founder and CEO of Cresilon, developers of a groundbreaking technology that's pushing the boundaries of what's possible in the field of trauma care.Joe was introduced to chemical lab research at a young age, which kindled a lifelong interest in discovering responsive, nature-derived materials. Embarking on his journey as an entrepreneur and innovator at only 17, Joe invented the technology behind Vetigel, a major breakthrough in the trauma field.In this interview, Joe reveals the development process behind Vetigel, an innovative product that stops severe bleeding with remarkable speed. Joe expounds on the unorthodox paths he took to build the company and the importance of a well-rounded team that’s able to balance creative and conservative strategies.Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and health tech leaders and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.

Biology takes time and biology doesn't exactly lie. And as a result, you're going to have good days and bad days. And if you're going to lead a company like this, you have to have fun with it. Otherwise, you won't be able to continue to focus and go forward. Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey everyone, it's Scott. In this episode of Medsider, I sat down with Joe Landolina, CEO of Creselon.

Joe was introduced to chemical lab research at a young age, which kindled a lifelong interest in discovering responsive, nature-derived materials. Embarking on his journey as an entrepreneur and innovator, at the young age of 17, Joe invented the technology behind Vettigel, a major breakthrough in the field of trauma care. As the co-founder and CEO of the company, Joe continues to push MedTech frontiers with his unwavering commitment to innovation. Here for you the key things that we discussed in this conversation. First, having a solid strategy is key when exploring unorthodox approaches in the med tech space. You need to reassess the market needs and your next steps continuously. Stay vigilant to seize opportunities and be flexible to pivot when necessary. Second, the FDA regulatory process isn't always straightforward and can sometimes seem like a black box.

For that reason, make sure you nail the fundamentals before getting too creative and surround yourself with an experienced regulatory team to de-risk every step along your journey. Third, be cognizant of communicating your company's narrative in a clear, succinct fashion. To do that, decide what your ultimate mission will be and simplify the complex jargon to help your audience understand your product and the value it brings. This approach attracts not only customers, but also potential investors and partners. Before we jump into this episode, I wanted to let you know that we recently released the second volume of Medsider mentors.

which summarizes the key learnings from the most popular Medsider interviews over the last six months or so. Look, it's tough to listen or read every single Medsider interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider Mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. If you're interested in learning more, head over to MedsiderRadio.com forward slash mentors. premium members get free access to all past and future volumes. If you're not a premium member yet, you should definitely consider signing up.

In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Erica Rogers, CEO of Silk Road Medical, Dr. David Albert, founder of Alivecore, and so many others. In addition, as a premium member, you'll get to join live interviews with these incredible med tech and health tech entrepreneurs. Learn more by visiting MedsiderRadio.com forward slash mentors. Again, that's Medsiderradio.com foreign slash mentors. Joe, welcome to the program. Appreciate you coming on. Of course, Scott.

Thank you for having me. Yeah, looking forward to the conversation without a doubt. So I gave the listeners a high-level overview of your bio at the outset of this episode. But let's hear it from you. If you can give us kind of an elevator pitch or maybe an elevator summary is the better description for your professional background leading up to, co-founding Creselon. Of course.

So my name is Jill Landlina. I'm the co-founder and CEO of Creselon. And I was really lucky to have gotten a pretty early start into everything. So I invented the technology behind Betterrell that we'll be talking about at the age of 17 and started the company later on that year. And was lucky that my grandfather was a former executive of Hoffman-LaRoche, who in retirement started a vineyard. And so I was lucky enough to have had.

a chemistry lab across the street from my house led by a grandfather who'd learned lab safety in the 60s. And that meant that from the time that I learned how to walk, I also learned how to go into a lab. So I had a really early exposure to chemical lab research. My parents were not so thrilled with my grandfather's approach into chemical education. And as a result, they made a deal with me, which was to go out and learn how to do research, quote, the right way. And so as a high school student, I had the opportunity to do a summer of research in tissue engineering at Columbia University that was focused mainly on using plant-based scaffolds to differentiate stem cells into a target tissue. And that really sparked a lifelong journey of trying to find responsive

materials that come from nature to do something. And at the age of 17, I was then at that time an incoming freshman in chemical engineering at NYU 10 School of Engineering. And I discovered this material that was a blend of two polymers that come out of algae that would, if nothing else, instantly reassemble and it would stick to skin and it wouldn't let go until you wanted it to. And I had this idea, which was, what if you could inject that into an actively bleeding bullet wound, at least long enough for it to hold itself in place, stop the patient from bleeding so you can get that patient to the next level of care. And while that's not exactly what we do today, that was the initial concept for vetter gel.

and we founded Crestle on around that. Okay, that's awesome. It's just a good classic entrepreneurial story. And I love the fact that you've got like a, you see a great grandfather or was it your my mother's father. Okay, okay, your grandfather who's sounded fairly entrepreneurial is like, hey, you just got to like build things in this lab and your parents are like, whoa, wait a second. You know, you need a slow down.

Let's do this. Let's do this the right way. That's great. That's a great kickoff. So there's a ton of interesting things happening with, you mentioned, you know, scaffolding and in stem cells. a ton of interesting things happening in that space. So can you give us a little bit of an idea of like what's the differentiator here with with with with with with with,

sure. I think the key word here is brute force with better gel. And so what we do is we at the simplest level make a really good mechanical barrier. And what that translates to is that that digital allows you to stop the most traumatic bleeding you can imagine. So so so think massive pulsatrial arterial bleeding that would be. lethal otherwise. You can put this product on and in under three seconds, it instantly creates a mechanical barrier. It does not get washed away by the flow of bleeding and it stops that flow of bleeding nearly instantly. But then most importantly, it allows the patient to create their own

fibrin patch underneath. So if the gel gets removed, you actually look or see what underneath what would be similar to a healed injury. So if you have vasculature, that vascular has been partially rebuilt underneath. So it's a really fascinating concept. We're not getting into things like tissue factors or other, we're not going deep into the chemistry. We're effectively making just a really good mechanical sealant that allows us to be applied to a wide variety of hemistasis or hemistatic environments. Got it, got it. And I guess without going too far into the weeds, because I don't want to get too technical, and this is certainly not my domain expertise at all, but the mechanical kind of sealant, as you described it, is it just the sheer fact that you're stopping,

you're stopping sort of the blood flow so, so acutely that allows sort of the natural healing process to take place? Is there something about your sealant that further accelerates the natural healing process? Sure. So there are a number of things. So the first of which is that you can have the best clotting agent in the world. But if it's being washed off the wound, the clot gets washed off with it. And that's the challenge that the majority of technologies today have, where even if you take thrombin and you put it directly onto a source of injury, you're going to get a lot of fiber that's produced locally. But that'll all be washed away if you don't have something to hold it in place properly. And so with the material that we have, they're both natural polymers. They've both been used across the medical device industry. And what we're doing is we're putting them together in a form that not only allows them to work as a mechanical barrier, but it also allows.

allows them to support that formation of the clot. And to get back to the term scaffolding, it provides a scaffolding so that when the patient produces fibrin, that fibrin can be produced onto something that is not only a structure that helps it build up, but it's non-porous. So if the gel gets pulled away, and I mean, we all say this when we cut ourselves shaving, you put toilet paper on it, it stops bleeding, you pull the toilet paper off, and now there's a clot on the toilet paper and you're bleeding again, because the clot ends up forming in side of the pores of the toilet paper, with something like vettigel, you don't have any

porosity. So when that clot forms, if the gel falls off or if you pull the gel off, you end up leaving that clot behind. And as the patient breathes and moves, either just from respiration or from actually moving and running around, it's less likely for that clot to get disturbed underneath. So it's acting from both angles, but primarily as a mechanical barrier. Got it. Okay. Super helpful. So give us before we kind of sort of step inside what I'd I refer as the MedSider Time Machine and go back and learn a little bit more about the journey with Creselon and what you've learned along the way, give us a sense kind of for where you're at in terms of, you know, development, regulatory,

and commercialization. Of course. So Creselon is a little bit unorthodox in the way that we've, in the way that we've grown up in that our material is novel enough that we were unable to find a suitable contract manufacturer to do it. And so, for, the last nearly decade, our journey was building our own manufacturing. And so Cresselon's journey began as becoming what is today the only a-sept-fill-and-finish operator in the five boroughs of New York City. And so we today operated at 25,000 square feet of sterile vaccine-grade clean rooms, where we produce all of our products. We went commercial with our very first product, which is Vetterjel. It's an animal health surgical hemistatic device.

And that's now commercial not only in the United States, but in about 20 countries around the globe, but primarily between North America and Europe. We've deployed about 30,000, or we've had about 30,000 patients that have been impacted by Vettergel. So that's something that we're incredibly proud of. And we just made a major investment in the production capacity of our site. So we've increased the production capacity by about 50 times from what it was. is last year in order to continue that global launch. So Vetterjel has been an extreme commercial success, something that we're incredibly proud of.

And one of the great things about animal health is that we get to see all indications under this one product. So we're doing everything from neuro and spine surgery to massive trauma, to small nicks and scrapes and treating dogs that may have a cut on their ear or on their tails. Got it, got it. And just to set the stage, for those listening that are like, wait a second. This is for veterinary use. Like, Scott, you don't interview people that are doing stuff in the veterinary world.

You did just recently submit your 510K, and we'll get into this in more detail, but you did just recently submit your 510K for human use, correct? Exactly. So we took effectively a very similar device to Vettergeal, the exact same underlying technology, and we submitted that under the brand name, CHG, which is indicated for minor bleeding externally. We're anticipating clearance shortly. And we're also prepping to file a product from the brand named TraumaGel, which will be for moderate to severe emergency use.

So I think military use as well as EMS for big bleeds, gunshot, wounds, stabbings, and anything else that falls into that category. We have, we're just now in the final stages of prepping that submission for the agency. And so this should be a very big year from not only from the Vetterjel perspective, but being able to, expanded our mission to saving human lives. Yeah, yeah. And one of the one of the reasons I was looking forward to this interview is, is because of that kind of that, a bit unique of a model, right, where, and I'm sure there's probably some strategy behind it, right, of like, you know, going first into, you know, for commercializing first for veterinary applications, probably tons of learnings, right? Not only just in your commercial approach, but also just how does this work, right?

Like what's the feedback from, you know, from veterinary clinicians? And obviously you can use that to impact your human kind of launch and rollout. But this will be fun. I'm looking forward to the rest of this conversation to learn a little bit more about that approach. So super helpful. Before we go any further, if you're listening to this interview and you're like,

this sounds kind of cool, actually. The website's Creslawn. So C-R-E-S-I-L-O-N, C-R-E-S-I-L-N, C-R-E-S-L-N. We'll certainly link to it, as well as Joe's LinkedIn profile in the full MedSider summary article for this interview. But if you're curious now, just go to Creslawn.com.

and check it out. It's cool, cool website, for sure, with some great, great videos. Well, well done. So let's step in the, let's transition, maybe chat 20 or 30 minutes or so about kind of the journey that you've been on and kind of key, key lessons learned along the way. So thinking back, right, I mean, this has been, like you said, there's been, it's been a 10-plus year journey now almost. I think, thinking back to like those very first versions of Vetty Gel. Like now, and, you know, thinking back, is there something that you would have done, you know, differently or what would you have told yourself, you know, know back then based on your learnings kind of working on those first alpha and beta

prototypes? Sure. I mean, I think patience is key, first and foremost. But secondly, one of the biggest challenges that Cresselon has faced is actually that our solution to most of our problems has been verticalization, which is very unorthodox in life sciences. Where typically young founders are told, try to make everything as virtual as possible, keep your teams as lean as possible, try to be as capital efficient as possible, find partners for doing

testing, find partners to develop the regulatory strategy, find partners to eventually manufacture and commercialize the technology. And it turned out for us that we couldn't do most of those things outsourced for one reason or another. And a lot of it came down to just the novelty and the difficulty of handling the materials that we have. And so when we frame this as what advice I would give two entrepreneurs that are in this situation. It actually, funnily enough, is don't necessarily follow the path that we follow unless there's an absolute necessity. I have a lot of entrepreneurs that come to me and say, I have this great idea. I want to start a pharma manufacturing plant.

And my advice is unless there's a gun to your head, do not. There are far better uses of capital. We ended up having to do that out of necessity, but it caused significant delays. In fact, we had an MVP that likely could have been launched through a CMO if one could have done this in 2015. And so it delayed us to market by five years and had to raise a significant quantum of capital beyond what we would have needed to in the beginning. And now from where we sit, it's a great benefit that we now own our own manufacturing site and we have control of our destiny. But it was definitely harrowing through those for several years because there's a lot of risk. inherent when you're building a factory before you even know if the product would be commercially

viable and before you even know if you can make the technology at scale into the level of quality and efficacy required by the market. And so we got it done and we got it done by bringing in a great group of people that have done this before and have as much experience as you can in flying blind in these situations. And I'm a strong believer that Cresson is better off for it. But it definitely was a challenging path to get to where we are today. Yeah. Yeah. That, It's so interesting. He reminds me of, I was listening recently, actually just this morning to a podcast, one of my favorites. And he was, the host was explaining the scenario where when he was younger, he was invited to this Alibaba event. And it was supposed to be hosted by Jack Ma. And it was like his right-hand man that eventually hosted it. It was walking through these kind of like, three key areas that most entrepreneurials kind of think they need to align around in terms of best practices. And he, you know, he asked the question. He was like, planning. Let's talk about planning. You know, who here is actually doing the thing that they originally. planned out to do. No one raised their hand, right? And the whole, the, the, the, the, the theme was like, look, I mean, yes, you of course need to be, you know, attempting to put together some, you know,

some planning and have, have a sort of a mission and where, you know, general direction of where you want to go. But the reality is like, you got to be flexible and pivot, right? I mean, you're like, the plan is never going to go as exactly as you maybe thought, expected to, to expect it. It sounds like that was probably the case for Cresla. You're like, let's get a contract, contract manufacturer up and running, keep this lean internal team, and you're like, you struck out and had a pivot. Exactly. And in fact, animal health was even a pivot.

I mean, this was as early as 2012. And Hurricane Sandy, funnily enough, but it was that pivot point for us. I had a friend who was working at the time for the Wildlife Conservation Society, and they were having challenges where injured animals could not be treated efficiently because of the hurricane here in the Northeast. And he raised it to me that they had. had very little access to hemistatics. And the hemostatics they did have were not as advanced as the technology on the human side.

And we grabbed that opportunity at Wren with it. And that became our animal health for a strategy that has helped us generate revenue far before our human approvals come through. Yeah, interesting. Yeah. Let's use that actually as a segue. But before we do that, I wanted to get your take real quickly. I find it really interesting that this verticalization that you mentioned, because it seems

like in this world of like, you know, scaffolding and stem cells and like tissue-based engineering, there isn't, if any, like, contract manufacturers that allow you to kind of like scale up, unlike, you know, most kind of med tech and in biotech. Typically there is like some sort of contract house that you can kind of give you over your design and they can kind of run with it in the early stages. But are you still seeing that same same thing, right? There's just not not players that will allow you to kind of really, you know, you know, move, forward in that kind of traditional model. So it's difficult because it's frankly, it's not terribly lucrative from the from the CMO CDMO side in order to do this because the vast majority in

my opinion of stem cell tissue engineering scaffolding type companies are highly specialized solutions and highly specialized solutions require highly specialized manufacturing. And so if you go to a big CDMO and you ask them, hey, I'd like to make a scaffold that does X, Y, and C, they'll tell they'll tell you, okay, that's great, but it'll give me X amount of money and we'll figure it out for you. But you're effectively paying them to do the development work on the front end. And they have to learn. And there's no guarantee that at the end of the day, you're going to get to something that's manufacturable.

So from where we had to begin, it was far easier for us to, as we're learning through it. Because at the end of the day, the technology that we are selling today is not exactly what we started the process with. And if we had given the formulation of 2013 or 2014 to a CDMO and they'd spent even the same time that we had, the technology would have caught up and the manufacturing process would have needed to have been different. And I think the engineer in me enjoys having control over not only the R&D and the manufacturing, but also the clinical outreach. Because as you get clinical feedback, you can use that to modify all of the pieces of the business. And, Again, it's not for everyone.

You can only do it once you've invested it, and especially as we're looking at this funding economy that we're likely headed into, it's going to be harder and harder to get investors to part with dollars for building brick and mortar before there's a commercial concept. But we, or at the least, I consider myself lucky to be able to have had great investors that understood or at least were patient with us as we hit the roadblocks that we did. And it now allows us to get out of that challenge because it's really easy to find the CDMO for simple production processes or for things that are very common. If you have something that's unique, you're going to have a hard time.

Yeah, totally agree. It's definitely different. And with that said, let's talk a little bit about that pivot, right? You mentioned, you know, it sounds like back in, you know, 2015 Hurricane Sandy comes to visits New York and says hi. and around that time you pivoted into this veterinary approach. Now you're commercializing, right, globally for that application. It's really unique and I like it. Tell us a little bit more about the pros of this approach versus, you know, the cons and maybe frame it up around, you know, just going straight to human, for example.

Yeah, of course. I mean, so in 2012, when Sandy hit. It was 2012. Got it. Okay, got it. Yeah. I was 19 years old. The challenge that we were facing primarily there was just if we were going to dive into at the time, what our first indication was, was trauma.

It was we wanted to develop a product that can be used by the military for the largest bleeds that there are. And that's a lot to bite off, especially as at the time, a group of college students. And so what we were trying to do was find an indication that had perhaps a lower barrier to entry. And when animal health presented itself, I remember at the end of 2012, my team and I went to the AVMA, which is the American Veterinary Medical Association Conference. It was in San Diego. And it was, we spent a significant amount of money that we had on hand to. We hadn't get raised investment, but we started talking and canvassing customers. And every single vet that we spoke to said that it was a massive need and they effectively didn't have much that could do. chemistasis, and especially on the larger end of massive trauma, that there was effectively nothing that was serving that market. And every single one of them most importantly said that if we brought this to market, they would buy it. And we tabulated that information. I think we had something like 350 customers or potential customers that said that they would purchase from that.

And we used that not only to raise the first amount of capital that we raised for our business, but we realized really quickly on that animal health was unique for a handful of reasons. It was unique because the regulatory barrier to entry is lower. Not that, and just as an aside there, our strategy has always been because there are no specific veterinary device regulations in animal health, we take the human device equivalent. And so I always tell my team, I like to sleep at night. And because of that, we run the same process. We run the same design control process.

We put it through GMP manufacturing. And that's one of the reasons why it had taken us as long as it has to get to market, because we follow all of the procedures as if we were making a human medical device. But at the end of the day, we realized that this was a market where we could have severe differentiation and something like three seconds compared to 10 minutes in order to stop bleeding. in a market where there are over three million surgical procedures every single year and no biosurgery vertical today. Or at least, and even back in 2012, 2013, there was even less.

And that means that these are primarily generic products that are not, that don't involve the innovation that we've seen in biosurgery in the human space. And so it's an opportunity for us as a startup to be able to enter the market far sooner, to be able to come in as a market leader with a limited space of competition where there's severe differentiation and no one who's going to get their feathers rustled by us coming in, so we're not going to be fighting big blue chip fortune 50 companies for market share. And we can make a real difference and help real patience right out of the gate and truly change something in a market that is nothing to laugh at.

And as we've proven with Vettergel, and Cresselon this year will likely be profitable alone, just on our Vetterjil revenues. And this is before we factor in not anything on the human side, but including the spend that we expend in human R&D. That'll all be balanced out by our Vetterjil revenues. And that's a really powerful thing to realize, which is that this market, which tends to be an afterthought for a number of companies. And I mean, we had investors over the years that pointed us and say,

well, listen, jettison animal health, it doesn't matter. It's not as the TAM isn't as big as what you'll find in the human surgical space. But at the end of the day, we have an 85% conversion rate for customers that haven't heard about us into opening accounts and converting over to Vettergel. And the primary competitor that they're converting from is not a product. It's what we call pressure and a prayer. It's paying someone to hold their finger on a bleed until it stops. And it means that we've been able to really quickly get clinically. feedback and real clinical feedback at that across just about any indication that you can imagine.

We're doing orthopedic procedures. We're doing spine procedures. We're doing massive trauma. We had a gunshot wound in Brooklyn that we heard about where we saved the patient's life just last week. And it really runs the gamut of anything that you can think of, but that as engineers, it allows us to make better products for human space as we start to pivoted into those markets in a very lucrative way. Right, right. I'm sitting here nodding my head, kind of leaning in because it's like, I kind of want to invest in Dreslaon. But joking aside, though, that couldn't have been easy, right? I mean, you're having these conversations early on.

You need to raise capital. You're saying, hey, look, this is, we actually believe this is the strategy. And you've got, you know, probably pretty experienced investors saying, no, I don't, I think that's a waste of time. The market's not that big. You guys need to focus. But you decided to kind of stick to your guns. And it's played out that well.

And I just, I don't know. I'm kind of riffing a little bit here. But it just reminds me of like if you're, you clearly have a ton of domain expertise. You've gone deep in this market and you just, you trusted your instinct. And I don't, I don't know if you want to add anything to that, to that point, but I just think that's really, really powerful. And we always talk like in the world of like, you know, um, you know, startups and, and in, in the entrepreneurial circles that you got to be willing to flex and pivot. But in some instances, you got to stick to your guns and say, no, no, like, I actually know a lot about what I'm

doing here. This is the, this is the way, right? As Mandalorian would say, right? This is the, this is the path forward. So, yeah, so I don't know if you have any, any, any other thoughts there. Yeah, exactly. Again, one thing that I always tell my team is that I personally get itchy if I don't, if I go a week without spending time in an OR with a customer. And I think the thing that we did really well from the very beginning is as much time as we could, as much, whether it's time or money that we could expend, we spent time in ORs with our customers, seeing what they saw and working with them to get iterative feedback. And I think sometimes that especially since so much of life sciences starts in academia, there's this divide between what happens in an academic lab and what your customer actually wants, what the clinician actually wants with the patient, it wants to see as an outcome.

And we were lucky enough to have broken that early on. And I am not an academic by any means. I even consider myself a recovering engineer. I don't spend much time, if at all, in a lab coat, unless I'm giving a tour. But beyond that, we've spent so much of the time of the early stage of the business, and that continued spending time with our customers that it makes it really easy to ensure that what we're making is solving a problem. And when you see that problem firsthand, you understand the magnitude of the opportunity.

And if you layer that with maybe a little bit of founded delusion and naïte, you end up with enough persistence to get it done despite maybe the bulk of people telling us that it wasn't the right way to go. Yeah. Yeah. It reminds me of something Ohad Arazi said recently. He's the CEO of Clarius. And I think his comment was like you got to be blind, deaf and dumb, you know, to push forward on your startup. And that's not, he didn't mean it in the sense that you just, you don't take any feedback. But it's like, you know, you know, if you listen to everyone's responses, you just won't do anything, right? I mean, it just, you know, your startup, your bolder that you're pushing up pill will not be will not go very far. You know, so there's got to be a sort of an internal sort of

perseverance, right? And even if that means, you know, pivoting and flexing, which is certainly part, you know, par for the course, there's, there's always like a certain amount of resolve that you just, you know, this is, you know, this is, this is the way to go. So with that said, Joe, let's talk a little bit more about that five to case submission. I think you, you submitted to FDA for human use about a year ago. Is that, is this like, this is a, even though this is like a, a sort of product, right? You submit it. It is a 510K pathway then. Exactly. I mean, what I like to say is that we have medical device regulation with biotech returns. Okay. And perhaps it's a little bit too mumbo-jumbo, right? But the idea is that we're lucky that because these two polymers that make up thater gel

have been used extensively as medical devices, it's a mechanical barrier. It's regulated very strongly like a medical device. And that allows us, no matter of the indication we're talking about, fairly rapid access, a relatively rapid access to the market. But we're producing technology that's ubiquitous and that is a sector definer, a redefiner that allows the surgeon to really change the way that they do surgery. And so we ended up with best of both worlds where it's something that has very broad applicability, but regulated like a device. Yeah, got it. And so you submitted, we're recording this in early Q2 of 23. You submitted about a year ago, going, it sounds like you're pretty close. Like you've made a lot of progress with FAA, FDA.

I certainly don't expect you to disclose too many details around that. But I'm more interested in just like that, call it a year journey or so, right? And it's much longer than that because there was certainly, you know, prepping for the actual submission and the efforts leading up to that. But, you know, is there like one or two things that like, you know, when you think about, you know, when you think about that that timeframe, they're like, yeah, this is, this, these are our keys to success here. Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium

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