Medsider: Learn from Medtech and Healthtech Founders and CEOs - Balancing the Clinical-Commercial Tightrope: Interview with Mercator MedSystems CEO Trent Reutiman

Episode Date: April 17, 2024

In this episode of Medsider Radio, we had a fun chat with Trent Reutiman, CEO of Mercator MedSystems. Trent and his team have developed microinfusion devices with the unique ability to locally and directly deliver targeted therapeutics during catheter-based interventions where mechanical therapy isn’t sufficient.  Trent has 25 years of leadership experience in medtech including roles in sales, marketing, and business management with a focus on minimally invasive interventional products for companies like IDEV, ROX Medical, RITA Medical Systems, Guidant, and Cordis.In this interview, Trent talks about the importance of generating data, how to balance commercial efforts with clinical initiatives, and why meticulous management is critical for successful commercialization. Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and a curated investor database to help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume V. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Trent Reutiman.

I will say for companies with a little bit more complex clinical trial work in front of them, even if you have the opportunity to become commercial, if there's not a meaningful reimbursement, you're probably going to waste money. And you run the danger of, you know, people running out using the device for something that it wasn't, it wasn't your best shot on goal. And then you end up, you know, with out of the, the marketplace or a data set that ends up out there presented at a meeting that really doesn't behoove what you're up to. Welcome to Medsider, where you can learn from the brightest founders

and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now here's your host, Scott Nelson. Hey, everyone, it's Scott. This episode of MedSySy I sat down with Trent Ruderman, CEO of Mercator Med Systems. Trent has over 25 years of leadership experience in med tech, including roles in sales, marketing, and business development, with a focus on minimally invasive interventional products for companies like IDEV, ROCSMEDAMed Systems, Guidant, and Cordes. Here for the key things that we discussed in this conversation.

First, clinical and commercial efforts are always a balancing act. You need to demonstrate your technology's efficacy by gathering solid data for regulatory approval and reimbursement. However, you also need to constantly improve upon the design and usability of your device. Embrace the fact that the initial product may not be perfect, but if it achieves the right outcomes, you can refine it over time. Second, be willing to reassess and shift your focus, especially when facing challenging scenarios or strong competition.

Don't hesitate to reposition your product to meet emerging needs or enter less crowded markets. Embrace change as an opportunity to prove the versatility of your technology. Third, treat your product and market with care. Be selective about who you sell to, especially if your technology requires. requires a learning curve in order to preserve its efficacy. Know your position in the market and articulate it clearly. Remember a quick no is always better than a slow maybe. All right, before we jump into this episode, I wanted to let you know that the latest edition

of Medsider Mentors is now live. We just published volume 5, which summarizes the key learnings from the most popular medsider interviews over the last several months with incredible entrepreneurs like Gabriel Jones, CEO of Proprio, Kirsten Carroll, CEO of Can Do Health, Dr. David Alpert, founder of a LiveCore, Greg Bullington, CEO of Magnolia Medical, and other leaders of some of the hottest startups in our space. Look, it's tough to listen or read every interview that comes out, even the best ones. But there are so many valuable lessons you can pick up 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. To check out the latest volume, 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. You'll also be able to see all of our playbooks, which are handpicked collections of the most insightful interviews with the brightest founders and CEOs that join our program. Whether you're looking to master capital fundraising, navigate early stage

development, tackle regulatory challenges, understand reimbursement, or position your venture for a meaningful exit, MedSider Playbooks have you covered. And last, considering that fundraising can be one of the most daunting tasks for any startup, we created a meticulous database of investors right at your fingertips. Explore a wealth of VC funds, private equity firms, angel groups, and more, all eager to invest in medical device and health technology startups. Access to this database is a premium member exclusive, so don't miss out. Learn more about Medsider Mentors and our premium memberships by visiting MedsiderRadio.com forward slash mentors. All right, without further ado, let's jump into the interview. All right, Trent, welcome to Medsider Radio. Appreciate you coming on. Hey, Scott, thanks for having me.

It's a pleasure to be here. Yeah, I know we're both working on companies in similar types of arenas, so to speak. So this should be a fun conversation, and we may get a little bit more into the weeds than maybe I otherwise do. So with that said, I recorded a very brief bio, a little bit more of professional bio on your background at the outset of this interview. But I always like to start here, right? Hear it kind of from you first. If there's like sort of an elevator style pitch on kind of what you've been doing leading up to the last, gosh, over a decade now with more cater, I think. Let's start there. Well, okay, great. My background really has been a path through sales and marketing. And most of those companies, you know, have been focused on minimally invasive and then

oftentimes interventional procedures. That started for me, you know, back in the field and then carried through all the way to executive leadership. I would say, you know, about 15 years ago, I consciously made a decision, though, to try to move into a little bit earlier stage and really get involved in companies that were, you know, either needed to or wanted to generate data and some sort of outcomes around their products. It was becoming clear to me as I was looking forward. I don't think just plain market access was really just going to be enough. And so, you know, very rare now are the days of just a 510K approval gets you there. You know, we might argue that, you know, if you had a strong reimbursement path, maybe you don't need quite as much data.

but I made a conscious decision to try to get involved in projects that were building data sets and really had stuff to back the technology and the outcome up. That's good. I'm looking at some of the companies. And for those that are in the cardiovascular space, I mean, you recognize some of these names, CSI, Rocks Medical, I-Dev, obviously Mercator's been working on this for, again, for the better part of it a decade. So really kind of cool background.

Let's learn a little bit more about the bullfrog, right, and what you, You're, you know, where it's kind of position today. And then we'll go back in time and, and kind of double-click into some of these kind of functional areas that we like to cover in these interviews. But give us a sense for the Bullfrog. And maybe explain it as if, like, people listening aren't overly familiar with the interventional space, right? Like, how is this used?

What is the device? How are physicians using this device today? Well, you know, the product name is the Bullfrog. It's really a catheter-based system. and the whole concept is around micro infusion. Okay. And so micro infusion, which is what we kind of brand what we're doing, is this unique ability to locally deliver targeted therapeutics

in an aqueous form, so they're liquid, during catheter-based interventions, you know, in diseases with unresolved needs. And so, you know, not a new concept, right? It's this graduation beyond mechanical therapy, whether arterial, whether on the venous side, and certainly there's a lot of precedence. Local drug delivery, most people think about it as kind of in the coronary, it was drug-eloting stents, you know, that carried over into the peripheral space, more on a balloon platform because

less stenting was being done just due to the anatomy. you know, and now we're kind of the next natural evolution of that. And what micro infusion does for you that's different is it just provides this unique efficiency that's so different because we're not dependent on a surface-coded drug, you know, onto a stent or a balloon. And so, you know, all kinds of things like, you know, not releasing a drug until you have the catheter exactly where you want it. The dosing is much more controllable. You can add contrast to the drug and actually get a visualization and imaging of where the drug's going. You know, just those kind of things were what really attracted me to this opportunity. You know, and then it really has played

itself out and we'll get into this for a number of different reasons, you know, because we've been around for a while, but we're executing on, you know, several different applications or indications. validating the platform. Got it. And for those listening, we'll, of course, link to Mercator's website in the full summary article on MedSiter. But if you don't get to that particular piece, it's Mercatormedd.com. So M-E-R-C-A-T-O-R, MercatorMed.com is the website where you can learn a little bit more

about the technology as well as just, you know, what, you know, some of the latest, you know, clinical work that Trent and his team have been working on. And so with that, with that said, you know, Mercator, such an interesting story, right? Because typically a company that's been around for 10 years, you think what's going on? It hasn't exited yet. There's, you know, it hasn't IPO, but yet you're still cranking, right? Still producing clinical data. I'm looking at even some of the releases from, from Vaines at the kind of the Viva Vains conference this past fall. So give us a sense kind of for like where you're at now. Where's the company at now? Kind of what are you, what are you focused on maybe

over the next, you know, 12 months or so? Yeah, well, the company remains in a clinical development phase. We're having to produce data to actually secure an indication. And so, you know, that's been the state of affairs. What really changed is we were headed that way in the arterial space. We actually got a data set to publication, but we got there after drug-coded balloon. And I think the drug-coded balloon ran away so fast. You know, we were kind of thinking, do we go up against, you know, a bard who had acquired Lutonics, do we go up against Medtronic? And, you know, it just, there were a lot of physicians

who had used the product and they had taken it below the knee. And so we came to an ultimate conclusion that it made more sense, you know, to go below the knee and to jump on a newer version of the drug and get to Lymeus quickly. And so, so ironically, right, we did a first study with dexamethazone because the device is so efficient, just treating the inflammation at the site, even on the arterial side, you know, produced data that looked a lot like DCB, but we just got there, you know, about 18 or 24 months after. So then our first incremental step then on the arterial side was, well, let's deliver Linus. You know, Paclitexel wasn't working below the knee.

Nobody had made it through a successful study. And by the way, that hasn't changed. You know, I mean, nothing has made it through to approval. So, you know, kind of in the 20th, 2017, 2018, early 2019 timeframe, we did a phase two randomized study. And this will come up when we talk about regulatory path, why I call it a phase two. The drug is doing the work here. We have a device approval for delivering drug. What we're really trying to do is create a new indication for a drug that's already out there. And so, you know, interestingly enough, we did a randomized study

and we got really incredible results. We had a big differentiation between the treatment and the control, and Little Mercator was the first company to do randomized clinical trial work in the U.S. on a Lyme's solution for below-the-kne interventions. And so we were all set. Phase 2 data looked good.

We had a corporate partner that was very interested heading into early 2020. We, of course, need to do a phase three study. It would be similar to an IDE trial on the device side. and we had that all lined up and along comes COVID, right? And so COVID really put that work on hold. You know, we weren't going to enroll a 400 patient study during COVID.

People didn't want to finance that. Big companies were looking internally. And so, you know, we were really sitting there in early 2020 saying, gosh, you know, we're in a tough spot. I'm glad we don't have the money because I wouldn't have wanted to be pressed to try to make it happen. I think there were companies that started enrolling early in COVID, and their clinical data came out more challenging for that. But where we have a platform and where we were fortunate and why we remain in clinical development,

and you referenced something as early or most recent as veins, is we had a lot of users that work on both sides, on the arterial and the venous side, and came back to us and said, hey, you know, despite COVID, the venous side is cranking. You know, there's a lot going on in Venus, and we really like the work you did with the anti-inflammatory steroid, could you bring it back? And so it was an easy pivot. So we've reproduced some phase two work now on the venous side.

And really, it's probably a little bit more spot on for the drug. DVT and DTE is much more inflammation based than it is cell proliferation and scarring. And so we were able to lean on some of the early work we did with dexamethazone. out a bigger version of the device that fit better for veins. And we were up and running really quick. We had extended the 510K to cover the Venus device. And all of a sudden we found ourselves, you know, while it was in COVID, all of a sudden we were working in the hot part of the field in DBT and VTE where things were cranking along.

And so it's been fun to highlight if there was an upside to COVID and there aren't many. For us, it unlocked the real platform capability of the technology. Got it. That's super, super help of explanation and a classic story of what's required, right? And the startup is being flexible and nimble and to kind of see where the market's sort of like pulling you, in essence, right? Or pushing you. Absolutely.

To move in that direction. So just so I'm clear, is the company primarily focused on the Venus space right now? Are you kind of pushing forth clinical efforts on both or just just Venus for? for the time being. Yeah, no, I think, you know, with the backdrop in Venus, right, we're getting, we got a lot of attention, you know, being the first company to be able to bring drug delivery to the Venus space, and we're far out in front of the others now. And, you know, really, if you can't deliver the drug equitiously, you don't have a means, you're not going to be able to get enough steroid on a balloon or a stent. And so we, unlike the PAD space, we really have this

drug delivery application to ourselves. So it's garnered a lot of attention. attention and that's good. I mean, if you look at the backdrop for fundraising today, you know, it's great to have a home around and it's great that there's, you know, a lot of corporate consideration and there's been a lot of tuck-ins in Venus. So yeah, I would say right now, we're first and foremost a Venus company. That said, you know, more capital and more resources. You know, we have a phase three BTK study basically approved from the agency. It's got great data behind it. And so, you know, maybe with a little success in Venus that reopens that up, maybe somebody else who decides, okay, it's time to really get back to this kind of, you know,

is Cyrolumus the next advantage in BTK therapy? You know, clearly it was an interesting debate for a few years there about pachlactyl. And while, you know, Pachlaxil came out okay and is back on the market, there was a key component, which is it doesn't get any incremental reimbursement. And so moving to the next drug with a different way to deliver it and placing the indication on the drug itself really affords us not only a unique delivery opportunity, but a unique reimbursement opportunity too. Got it. Got it.

That's helpful. And before we kind of go back in time and learn a little bit more about the past 10 years at Mercator, just to understand that the Venus play. So I spent a little bit of time in this space, right? So like I'm just trying to think through how this is used. So a patient thrombosis, they've got a DBT, a basketball surgeon, interventional radiologist, maybe an interventional cardiologist is going to intervene.

Is the, how does this use? Is the clot removed first? And then you're using the bullfrog to sort of like, I guess help prevent further thrombosis. Is that kind of generally speaking, that sort of the idea? Yeah, there's a ton of literature and nobody really dug it up until we got going on this, you know,

showing that DVT is really associated. with inflammation and thrombus begets more inflammation. And then the intervention itself, you know, can be fairly traumatic. And so is there, you know, some inflammation associated with taking, you know, the thrombus out and opening the vein? The real, you know, what's left there, right? Because obviously there's been, you know, new age thrombectomy is cranking and those guys have done a great job and, you know, reestablish this, found a way to really capitalize on the big DRG that was sitting there and then fine-tune the technology and maybe, you know, get patients in and out of the hospital quicker and, you know, do it without ludic therapy per se.

And so, you know, but what hadn't happened is there hasn't been a lot of improvement in just, hey, if you open the vein up and the patient does fine, he does fine, but a pretty big percent still go on to have post-romotic syndrome. And we believe that's really biological in nature. You know, that's an inflammation of the vein that you're not really treating by just opening the vein. And so, you know, just like anti-perlifertives, we're stopping cell proliferation on the arterial side, you know, we're really trying to quell that inflammation associated with the initial DVT event, associated with these devices that mechanically open the vein up. And then even for patients who, you know, depart from the hospital and don't go on their anti-quagulative. therapy, you know, they're not very medical compliant. We're providing, you know, a safety net to really change and try to maintain normalcy of the vein. You know, veins have a lot of capacitance.

You know, you know, they can both fill in empty, so to speak, which becomes really paramount, you know, as you're trying to move that blood up the column, the reason the valves there is, you know, with no valve, it's, it's a heavy workload, right? And so, similarly, if the vein loses its ability to fill in empty, you know, that's really what leads to, in our minds, you know, these post-rombotic syndrome and these ailments that really go with the progression of the disease that, you know, once it's the genie is out of the bottle, it's really hard to treat. And so we're trying to maintain vein normalcy along with the DVT intervention, if that makes sense. It does. It does. And I think for those listening that aren't familiar with

post-thromotic syndrome or PTSD, it's a very, very prevalent and it can be nasty, right, to live with, you know, so. Completely debilitating, right? Yeah, yeah, 100%. It's swelling and itchiness and soreness and lack of mobility. And, you know, it's very well graded. And we've been, we've been building a data set there that shows we are making a really big dent. So we're excited about that. Yeah, no doubt. That's cool. Let's spend the next, you know, 20, 30 minutes kind of going back in time and learning a little bit, learning a learning a little bit more about your journey with Mercator and really feel for you to kind of layer in previous experiences as well. And I'd really like to kind of hone in on kind of how your

thoughts as it relates to kind of, you know, moving through early stages of development. But then also would like to kind of touch on definitely your approach to clinical, clinical studies, kind of clinical roadmap in general because clearly that's, you know, that's a wheelhouse of yours. And then I definitely want to allocate a little bit of time towards talking about fundraising, you know, because you've been, you've been around a while. and been able to kind of keep, not only keep the company flow, but yeah, it's still been, you know, it's, it's still cranking on a lot of clinical work, it sounds like. So I'm curious to kind of learn about your journey there. But let's start with, with early stage development.

Bullfrog is a great example of a platform technology, but I'm sure it looked a lot different, right, back in 2014, 15, 16 than it, than it does now. And it's off, this is, you know, very challenging for a lot of med tech entrepreneurs is like, you don't have a lot of capital. You know, you don't have endless resources, but you're trying to kind of, get to the next inflection point, get to the next milestone with your development in those early years. So when you think about kind of that process, what do you, you know, how would you coach up or how do you coach up, right? Other, other, you know, med tech founders and CEOs through those early years. Yeah, you know, I can speak to kind of our experience here. I think, like you said, it's been one that,

you know, evolved over a much longer course of the time than most people have. You know, the device has been around much longer than just the time I've been here. It was initially conceived as a coronary drug delivery device. And it came out of the Berkeley School of Engineering. The chief science and technology officer here is the founder of the company. I'm very fortunate to have him as a partner. Kirk Stewart is really, you know, super creative guy. Most people when they see the bullfrog, you know, the initial reaction is that's a very clever device. And so, you know, but it started on a, you know, it was going to be a coronary product. So it was on an 014 rapid exchange platform. I don't know if all of your listeners will go that far back, but it was really

designed for something that's completely different than now. And so as that product really migrated over to peripheral because coronary DES was so successful, there wasn't really a chance to come back at that at the time. And so, you know, you can imagine all the standard iterations that you're thinking about, right? 014 to 018 to ultimately 035 on the venous side. You know, we want to increase the needle length. We want different balloon sizes, you know, to fill different vessel sizes, you know, more push, more torque, all these things, right? And so I guess what I would say is you usually don't get everything, you know, right out of the gate. And so you constantly have this list and at the appropriate times, whether it be you're updating your 510K or whether it's a new opportunity,

you know, you try to incorporate those things along the way. So, you know, all of that I think is relatively straightforward and probably things that, you know, MedTech CEOs have their arms around and think about. You know, one thing that happened here really was the 510K approval on this device, and it's a very broad indication, right? It's for delivering, you know, diagnostic and therapeutic agents to, you know, peripheral and coronary vessels. I mean, it's almost so broad that, you know, what was the FDA, you know,

what were they doing when they issued such a broad device? And then as we work with each drug, you know, we're trying basically to get a new indication that we can fold into the device label, you know, on a specific drug. I will say that, you know, not knowing, you know, how long some of this stuff is going to take, you are kind of pitted with a, hey, what's the optimal device versus, you know, what's the optimal outcome that you're trying to show? And I do think you have to have some clarity. this will probably sound like a truism, right? But you're balancing these things off against each other. And for us, it was maybe a slightly imperfect device. A lot of times you're not focused in the device world on real ergonomics and ease of use until later in the stage.

Our goal was to get a device that we could complete the study work with and show that the drug actually did what it was supposed to do, right? it met the unmet need that's left in whatever peripheral vascular intervention we were in. And so we're spending, you know, clinical research is expensive. We've spent a lot of money, you know, building datasets. I feel like we've done a good job. They're published. They're peer reviewed. They're actually peer reviewed in the same places that the drug coded balloons are.

You know, I mean, there was a real lift there. But those are tradeoffs, right? I mean, you're trading off imperfect device for, you know, does the concept. And so there's always those balances, I think, particularly in clinical development of, you know, you might not have the end-all be-all product, but if you've got the right outcome teed up, then you'll always be able to come back and continue to refine the device. Yeah, that's a, that's really good feedback. It's something that comes up, you know, fairly often.

A lot of other, you know, experienced, you know, founders and CEOs like yourself have kind of raise this up as like when you're moving through those early stage development efforts, there's always a tendency to add on like that one more feature or those two more features, right? And the ability to kind of filter out the noise and keep that kind of that core objective in mind, like this is what we want to do at this phase. And we've got to really kind of almost eliminate everything else at this point. In retrospect, it's easy, right? But in the heat of it, it's like oftentimes really, really challenging to make those decisions. Well, if some of the things I say sound cliche, I don't mean for him to be, but you're right.

I mean, it's so hard, you know, in the heat of the battle and at the moment, to know when to step on the gas and when not to. You know, maybe an example here is we had a 510K really, really early on, and yet we've been in clinical development forever. I'm not saying I know the answer, but there's a lot of expense with maintaining a 510K and a CE mark when you're not commercially viable and you're only in clinical study. And so, you know, looking back, I haven't done the analysis, but, you know, it is interesting, right? You know, were those dollars that, you know, were spent right? And it almost sounds blasphemous because everybody wants the 510K or the CE mark when you can get it. I'm just simply pointing out that pre-commercially, they're expensive to maintain. And so those are kind of questions you wouldn't anticipate or thoughts you wouldn't anticipate, but it's really interesting.

Yeah, that's a really great topic. I'm glad you brought that up, right? Because, I mean, the natural inclination, I think, for every, you know, founder's CEO is to get to that clearance or get to that, in most cases, it's a 5-2K clearance, but, you know, in some cases, I guess, be as soon as possible. But if there's not a sort of an immediate kind of commercial kind of, I guess, roadmap, you're going to be stuck in this kind of limbo land, right, where you're having to maintain. Well, there's definitely expense associated. I can confirm that. Yeah, no, that's good. And I guess, you know, kind of circling back around these decisions, right, around early stage development and what to prioritize, etc. I guess, yes, they can sound cliche, but maybe the important message, I guess, for those listening is oftentimes they're going to be hard. I mean, it's rarely that like a decision is just super easy to make. In some instances, there will be.

But most of the time, it's going to be tradeoffs, right? And they're not going to be the easiest tradeoffs to make. And so I think that's maybe the largest take-home message that if you're in this, in this same boat, right, where you're trying to make hard decisions, just know they're going to be hard. Right. And it's not like, one day you're going to land on some aha moment where it's like, oh, this is the easiest decision in the world. It's just, it's just tough, right?

That's it. Yeah. I would say, you know, exponentially with a novel device, right? If there's not a beaten path and it's well known and very straightforward, it becomes more complicated. And, you know, you should build in a little bit more patience, a little bit more introspection, you know, and, you know, be prepared. I think it does behoove you.

If you have clarity and you know where you can be aggressive, great, be aggressive. But with novel devices, you know, there's going to be surprises along the way. There's going to be challenges along the way, you know, because those paths can take different turns. And then, you know, at the very least, people can move the goal line on you at the last moment, right? Whether it's a regulatory goal line, whether it's an acquirer's goal line or an investor's goal line, you know, the pitfall of data is once you start down a data trail, you know, more is always better, right? And so how do you make sure you've provided enough to actually close down your milestone and don't get rung out for more and more and more? Yep.

Yeah, the idea of the goalpost constantly shifting. So, so critical, right? And obviously, you need to be sort of aiming towards some sort of milestone, some sort of like goalpost. But if your plan is completely rooted and baked and there's not an, they're not optionality, there's not a plan B or plan C in the event that those goalposts shift, like maybe you want to kind of rethink, rethink that approach, because oftentimes, you know, they do shift, right? And whether it's, whether it's more clinical data or more revenue, right? I mean, it's, it's, it's, everyone wants more, right? That's, that's, that's sort of, that that should be the default reality, I think,

in, in most scenarios. Let's shift a little bit towards clinical work, right? Um, yeah. And you obviously have a lot of experience, uh, with kind of building out roadmaps strategy around, around, uh, the, the buildup of scientific evidence. Not just that at Mercator, but, you know, in previous roles as well. So with that said, it may can potentially maybe a little bit easier for you, but it's often kind of a daunting thing, you know, for most entrepreneurs to kind of stare down. It's like it's super expensive. It can be nuanced.

How does that ladder up to kind of the reg approach, et cetera? You know, are there, when you think about kind of this, you know, this kind of in general, kind of building that out, right, from scratch and thinking, you know, thinking about that clinical pathway, what are a couple, you know, pieces of advice that you oftentimes are recommending, right, to other entrepreneurs that are earlier in their careers. Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only available via our private podcast

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