Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Run Your Medtech Startup on a Budget: Interview with Syntr Health CEO Ahmed Zobi

Episode Date: March 27, 2024

In this episode of Medsider Radio, we sat down for an engaging chat with Ahmed Zobi, founder and CEO of Syntr Health Technologies, which has developed an automated microfat processing system for use in aesthetics and plastic surgery. The FDA-cleared SyntrFuge device allows clinicians to harvest patients’ adipose tissue and then reinject it as processed microfat within minutes into the desired area, eliminating the use of fillers. Ahmed has a decade of experience in the medical device industry. He advises and mentors many startups, has been recognized as a Forbes Next 1000 Honoree, and is a guest lecturer at the USC Keck School of Medicine. Ahmed also serves as a board member at various organizations, including the Wound Healing Society and the UCI Center for Innovation and Entrepreneurship.In this interview, Ahmed shares his ideas on the risks and rewards of entrepreneurship, how to operate in a lean fashion, why he puts regulatory clearance above all, and how he managed to be the youngest candidate to receive a phase 1 SBIR grant.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 Ahmed Zobi.

You hear of all these CEOs and startup founders that are so married to their idea of a product that it has to be perfect. And then you've spent five years working on an app or med tech device that isn't going to go anywhere because you're so focused on it to be so perfect. 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. In this episode of MedSider, I sat down with Ahmed Zobie, founder and CEO of Center Health Technologies, who has a decade of experience in the medical device industry. He advises and mentors many startups has been recognized as a Forbes Next 1000 Henri and is a guest lecturer at the USC Keck School of Medicine.

Ahmed also serves as a board member at various organizations, including the Wound Healing Society and the UCI Center for Innovation and Entrepreneurship. Here for you the key things that we discussed in this conversation. First, embrace a lean mentality, move forward with your available resources, and challenge every expense in the early days of your startup. Don't let the pursuit of perfection paralyze you and don't waste time and money over engineering early versions. Prototype rapidly to seek real world feedback to guide your next steps and be prepared

to pivot if necessary. Second, focus on meeting FDA's core. requirements first. Don't get bogged down trying to add extra bells and whistles to early prototypes and submit as soon as you can to kickstart a productive dialogue with the agency. Even if you don't get immediate approval, their prescriptive feedback will guide your path forward. Third, VC funding might not be an option during the early days of your startup. Explore all opportunities like grants, accelerators, and any niche programs that fit your technology. When it comes to

non-dilutive funding, submit strong applications early, even if they aren't perfect. and don't be afraid to cast a wide net across relevant NIH departments. And then when it comes time to approach VCs, research their portfolios and track their records. Show them how investing in you fits their specific goals and strategies. 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, Kirste, Kirste, Carol, CEO of Can Do Health, Dr. David Alpert, founder of AliveCorp,

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 MedSider Radio.com. board 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, Ahmed, welcome to Medsider. Appreciate you coming on. No, thank you for having. Appreciate it. Yeah, I'm looking at your background in beautiful Southern California, although it looks a little bit, little rainy after the monsoon that came through, right? Right. What's funny is that, so I wasn't born in California. I was born in Ohio. So when people freak out about rain, I'm like, if only you knew the winters in Ohio. That's right. That's right. That's right. Yeah, I'm a fellow Midwestern guy as well on the West Coast. But yeah, it looks almost like a fall day in the Midwest, you know, the end of the scenes. It honestly is. I mean, the crazy part is when California floods, it really floods, right? Like, some of the freeways are gone, kind of lose your infrastructure and stuff. But, I mean, I like that. I'm wearing my shirt and shorts, and I have no complaints whatsoever about the temperature or the weather.

Just put an umbrella up and stay dry. That's all I do. That's right. Spoken like a true Ohio native. With that said, I recorded a very short bio at the outset of this episode. But I always like to start here. If you can kind of give us a, you know, sort of an elevator pitch for your background leading up to starting the company. Let's begin there. And then we'll kind of, you know, slowly kind of go back back in time and went a little bit more about the journey. Yeah, for sure. So my name is Ahmed Zobie. I'm the CEO of Central Health Technologies. graduated out of UC Irvine's undergraduate program back in 2016. And we started this company, this project out of a new program that the biomedical engineering department was doing at

UCI called the bioengine. So sort of like a copy of the Stanford Bio Design program, right? Got IP that's dusty, sitting on a shelf, doing nothing. Let's kind of, you know, create a team around it of undergrad that can breathe some new life into it. And so my back. So my back. I did a lot of research at UCI in tissue engineering, micro and nanotechnology specifically with lab on chip microfluidics. And the rest of my team was around that area. We had an individual that was doing, one of my co-founders that was doing CD microfluidics. And ramping up to this, this was my fifth year at UCI. It took a fifth year, which I think everything happens for a reason.

And we found this project that was using lab on chip microfluidics, but it was having a lot of issues with leaking, implosions, you know, stuff getting stuck inside of it, you know, the device breaking. And we said, you know, we could do this a lot better. And that is how we formed Cinder. That's awesome. I love these stories.

I'm excited to dig in in a little bit more detail. But we're recording this in early 20, It looks like based on your LinkedIn profile, kind of scanning at it and looking at it as we talk live here. But did you kind of officially start the company in the fall of 15? So is it safe to say you've been at it almost, what, little over, you know, almost eight years now? Almost eight years. The official start date of the company itself was when we graduated. So we formed as an LLC in 2016, July of 2016.

So if you're talking about formation of the company. yes, and then we convert it to a C-Corp later on, which we'll discuss in some of the other questions that you probably have, but after we got our grant funding. Okay. But officially as a team, we started in 2015 as undergrads. Got it, got it. Okay, cool. And then, you know, without getting too far under the weeds, because, you know, we'll learn

a little bit more about the technology and kind of, you know, where you've been with it since initial kind of inception to where it's at now. But, you know, what is the centrifuge system, right? Almost kind of frame this up as if I'm a, you know, freshman in high school and I know nothing about the technology. Yeah. So the centrifuge system is a little bit of a play on words like centerfuge, right? We all know what a centerfuge does.

The centrifuge system is primarily a microfluidic channel design. So think of it as like a roller coaster ride that the tissue basically passes through. And as it's passing through these channels, whether it's big, small, tiny square, triangle, whatever, it breaks the fat cells down. So we wanted to design a technology that automates the fat processing altogether. Because doctors today are mainly manually processing fat tissue. And when we took on this project, we saw a huge unmet need to truly automate this process by literally pressing a button, walking away and coming back. So the centrifuge system at its core is a fat processing tool that allows clinicians to process both small and large volumes of fat tissue in a matter of minutes.

Got it. And most of these physicians that are doing this either manually or with the centrifuge system, they're doing this to sort of harness or, for lack of better description, stem cells, right, from antipose tissue? Not really. So the stem cells talk is mainly isolation. So under the FDA regulation, those stem cells are considered a drug. What we're doing is one step before that, right? It is breaking down these larger clusters of fat cells. So I like to explain it, like think of it as a grape on a grapevine. You're just plucking a lot of the grapes and putting them into a bowl.

Still grapes. It's just you're breaking them off from the grapevine, so to say. And that's what our process does. It's breaking these fat cells from like, you know, you can have a five, millimeter diameter down to like a 700 micron micronized diameter. So it's very, very micronized cells rather than extracting those stem cells because extracting, as I said,

is defined as a drug by the FDA. Got it. Okay. Very good. That's very helpful. And give us a sense, a high-level sense for kind of where the company's at in terms of, you know, kind of the clenorick process. Are you in full-on commercialization?

What does it look like? Yeah, so we got our FDA clearance. We just completed an aesthetics clinical trial for facial fat volume loss, so re-volumizing the face. The results will be coming out hopefully this year. We have two abstracts that we're going to be presenting. We're in the process of there's another clinical trial as well in the wound care space that we're doing. But we're starting early commercialization right now,

and then we're raising our Series A office. obviously to kind of, you know, push that up and do full commercial launch. Very, very good. And just so I understand before we get, we get any further in the, in the discussion, this technology, it's used by physicians in, in their own clinics, correct? Like this is just a, it's a better, faster, et cetera, sort of mouse trap around that processing, as you mentioned earlier. Yeah. So it works in conjunction with their current workflow. So we're not really, you know, adding too much. We're basically replacing other. fat processing techniques that are out there that are more manual and really providing an automated

solution to the clinician. So, you know, clinicians have like canisters. They have other fat processing devices by leading, you know, plastic and reconstructive surgery companies, very well known ones in the state of California. But those technologies, all they really do is mainly clean the fat. They don't really break down the fat cells. And then the breaking down process is really important, especially if you're talking about retention and take within the patient's body. You don't want to put, you know, a whole cluster of fat into an area and not be able to give it the nutrients and the blood supply that it's needed in order for it to survive. So processing the fat tissue is important. And that's where the research has been showing us that it is critical for better results as well.

Okay. Very good. All right. So I'm looking at the website before we kind of go back in time, step inside the old MedSit or Time Machine, as I like to call it. center health.com. So center is spelled s Y N-T-R, S-Y-N-T-R, S-Y-N-T-R, centerhealth.com. We'll, of course, link to it in the full write-up on Medsider for this particular interview with Ahmed, but centerhealth.com is the website if you want to, if you don't get to that full write-up and want to jump to the site, you know, during the course of this particular episode or after the fact. So with that said, first question on the docket, right? We'll spend the next 20 or 30 minutes, kind of learning a little bit more about your journey

and building the company as well as kind of just various sort of frost functional hurdles that you've been you know had to have to cross and so with that said you recently I think rolled out is it the center FPU 360 I believe maybe um okay so I'm going to make make a guess probably fair fair guess that this this uh this system this late your latest system looks far different than than you know the initial initial prototypes um so thinking back kind of to your early journey working through phases of development, you know, going from from initial prototypes to alpha to beta, you know, we're some key lessons learned along that way because this is often the most difficult thing for a lot of life sciences, startups, a lot of med tech founders that are listening

to this is like they've got, you know, you've got limited capital to work with in most scenarios and you just have to move quickly, make hard decisions, et cetera. So are there a couple things that stand out that have been either especially helpful, you know, back then that you, that you were able to execute against or maybe just, you know, key, key lessons that you, learn along the way. Yeah, no, it's capital efficiencies is critical. It's the lifeblood of a company. And, you know, they call it the lean startup methodology. I want to, after after my time at center, I'm probably going to publish a book, call it leaner startup methodology. Because you can actually go leaner. Um, you know, it's crazy because, uh, you know, you see these, these tall,

signs and stories that you hear of all these CEOs and startup founders that are so married to their idea of a product that it has to be perfect. And then you've spent five years working on an app or med tech device that isn't going to go anywhere because you're so focused on it to be so perfect. That wasn't the case at Center. The case at Center was get something done quickly, do it fast, validate it, fail. What did we fail at? How do we validate it? You know, our first prototype, I kid you not. I don't want to say this because, you know, it's crazy.

But one of us almost got like clipped by a piece of plastic because all we did is we had like this little spin chuck motor and we just surrounded it with pieces of like thick aluminum. So if it broke, the hope was to hit the aluminum and, you know, hey, we failed. Let's let's fix it. One of them we didn't tighten it enough and it just flew off, barely missed one of my co-founders by just like a hair. But we learn from that, right? Now, obviously, do everything as safely as possible, guys.

But in ideation, there's risks, right? You got to just go at it and try to make it work. So for us, our first prototype was, yeah, not an encasement, just like this motor, and we just put our thing on it. But then it evolve. You know, we got like very thin pieces of plastic, created an encasement, had that same motor. our first prototype was literally built for under, I would say, $400.

We got like a janky used motor, you know, acrylic plastic from McMastercar for like, God knows, 20 bucks and just screwed this whole thing in together and created our first box. But we were able to do it so quickly. We went through, I think, five or six prototypes within the span of about a month and a half before we got our first truly like, hey, this is gen 1 of our device. And it was done again, relatively cheaply. You know, our first centrifuge system, what is now down today as a centrifuge system, was done for like 30 bucks, just CNC plastic.

So, you know, what I tell a lot of the startups, especially the ones that I mentor through a lot of the programs that I'm a part of is, you know, especially if you're in the med tech space, get something that works out. don't focus so much on the perfection because at the end of the day, your customers are going to tell you what's wrong with your product, not you. So what we did is we mixed a little bit of that and we did a program later on, about a year later,

which was called the NSF I-Corps program. And that's where we really got out there and started talking to clinicians and talking to the users, not even the clinicians. People think, oh, go to the surgeon, they'll tell you everything about your product. Well, if the nurse doesn't like your product or the scrub tech, doesn't like your product. Your product isn't going to be used in the OR, no matter how much the surgeon loves your product. So really understanding who your users are, who your customers are,

that's critical. And that's what we did. Limited capital, we just try to get our prototypes out there as fast as possible, validate it, and then eventually push it on to whether it's federal funding or even trying to raise capital around it. Yeah. So, so important your comment around really understanding who's actually using your product, right? Because it's so easy to grab it. towards physicians. And don't get me wrong, those shouldn't be ignored, especially if you're working on a physician preference device. But, you know, if nurses are touching it, if techs are touching it, like, you need to

understand kind of what their feedback is. Yeah. We had early on, we had when we were doing usability studies, we had a nurse that was like, you know, we want to see A, B, and C feature added to it. And I was like, oh, shoot, I never thought about that because the plastic surgeons are or whomever is not thinking about that because they're doing surgery. But if the tech is looking at it's like, hey, man, you know, I need this type of feature to let me know what's going on or how many seconds are left.

Like, yeah, the ring light works, but I really want something like this. And you're just adding and stacking more features on top. That you can only get from true user understanding, not just, oh, yeah, we're in the, you know, any company could say, we're in the cardiology space. We're going to talk to cardiologists. well if your product is like tuned by the the tech before it goes to the cardiologist and you need to make sure that the product is tuned accordingly you need to start talking to to the cardiology techs not the cardiologist.

Cardiologist is implanting it. You need to talk to the dude and gal that is actually preparing it for that doctor. Yeah, 100%. No, totally agree. And your feedback around this kind of this almost like this mindset, right, of shipping as fast as possible and as lean as possible and just getting getting something out there. Right. I actually did a presentation earlier this morning kind of under the skies of like, you know,

startups are like, it's like March badness. Survive in advance, right? Meaning, you know, survival meaning do as much as you can with as least amount of capital as possible to just advance to the next milestone, the next inflection, right, in a life cycle. But that mindset, you know, it sounds like you're fairly bent towards kind of, you know, startups and in an entrepreneurial kind of ecosystem. But it can be very hard, right?

for someone that maybe grew up in big companies and strategic, it just feels uncomfortable, you know, that they're... It is. And I've seen it for both, you know, like I've... The biggest thing that I try to do is I try to teach young entrepreneurs that,

that kind of mindset you need to shift away from that. And with regards to older individuals that have been in industry, moving to a startup, like people, like, you know, you see all these jokes online, like, oh, quote unquote, what is an operator, you know, I'm an operator. And it's like, a person that's been in industry for 30 years but has never actually started or run a startup. It's completely different. The path of an entrepreneur is really, really, really difficult.

But in my opinion, I feel of it as it's being worth it to do what I do. But it's difficult and people need to understand that you can only make it more difficult by how you set your mindset, right? If you're on this path that I'm going to make this perfect, it's either going to fail, by the time it's, quote, perfect to you, or it's going to fail because you're going to run out of money. And that, again, is the lifeblood of company. And even with, you know, low, limited capital, right, you have to think, how can I double my runway? You know, if you got your first, you know, let's say you got into YC or any of these incubators, you got your first 150. And, you know, the initial 150 is supposed to last six months. You better make sure that it lasts you at least a year, right?

And again, that's capital efficiency. And a lot of people just don't understand that. You know, I've seen companies raise, you know, 10 times more than what we've raised, right? And they still haven't received FDA clearance or they still haven't had successful clinical trials. It takes a different type to truly sit back and understand like, hey, we need to look at this in a different way. And I think that, you know, the listeners and also the people that I mentor too can respect that because it makes them understand. that there is no rush to spending money, there's a rush to making meaningful milestones. And I think that's great.

Yeah, that's a great line that you just used. There's no rush to spending money, but there is a rush to get to the next sort of inflection point, right? Whether it's development related, whether it's, you know, Clin Reg related, et cetera. And this is a quote I often share. It feels like it's been a while since I mentioned it. But, you know, Darmeshaw is the founder of HubSpot, one of the founders of HubSpot. I remember hearing him on a podcast, you know, I got several months, several months ago now.

He mentioned a quote around the fact that the best CEOs, right, that he's encountered or that he works with, et cetera, their decision machines, right? They can make decisions decisively quickly and move on. I think that's one of the, one of, I would echo that same sentiment, right? 100%. Yeah, DeMarre's a lot more successful than me, but it really resonates, right? I mean, in a startup, you have to be surrounded by a group of people that, are okay with making decisions when it feels uncomfortable, right? And you just got to go.

You got to go. So with that said, Ahmed, you mentioned the fact that you got FDA clearance a couple years ago, 2021 to be more specific. Then you're working on it sounds like a couple clinical publications. When you think about, you know, the last handful of years as you've kind of navigated, you know, the ups and downs of like the regulatory landscape, you know, how much to, how much budget to allocate towards clinical efforts, et cetera. And what stands out to you? How do you coach up other entrepreneurs that are kind of going to the same the same battles i i think my situation is a little bit different so with with respect to what i would have liked as an optimal situation it was covid you know we it was the first year of coven 20 20 we had not going to say

the amount of money left bank account but not as much and we had to make a decision clinical trials fda clearance or payroll we cut ourselves off and we put the money towards our regulatory and our clinicals. Now, the clinicals took time. As you know, a lot of the states were not allowing any clinical trials unless maybe it was like COVID related. So it took, you know, a couple of years to get that set up and going. But we basically put, you know, we pulled an Elon, you know, SpaceX or Tesla, we did

both and we focused our efforts there. So that situation now, if you were a founder during that time and you had to make that, you know, I respect everything. and we both share, you know, a common event. Now, for other founders in a different situation, you know, it's definitely, there's a lot of people that would say go for clinical trial data and then go for regulatory. Now, for our specific FDA clearance pathway, we didn't need any clinical data. It was based on predicate, 510K class 2, relatively simple.

We had some things that we had to do for the FDA, and we sent that. and we got our clearance relatively quickly, but again, it was during COVID. So, you know, EUA authorizations kind of slowed down all the other FDA clearance pathways timelines. So what would have taken three months to get, you probably were rating six months, right? So with regards to that, you know, navigating the clinical and regulatory, I think ultimately falls upon being able to push for, you know, the balance that you really need. And the balance is really focused around, you know, especially on the regulatory side, really looking at what tests you need to be, you know, to finish what, you know, reports you need to have for the FDA, the timelines, the worst case scenarios. Whereas with clinical trials, it's more on who you're working with.

You know, so ultimately it's like, you know, which CRO are you using, you know, who's the staff members that are going to be, you know, helping you out. clinical trials are expensive. Don't get me wrong. You know, they can range in the billions. So personally for me, taking a couple step back, if you have a quick pathway through the regulatory market, my advice, this is me, obviously talk with your team and your board, right? My advice is always to just put whatever you have, complete all the studies and stuff that the FDA requires of your product.

don't add more things than is asked of you, right? And then put it up because at the end of the day, you're locking in the FDA into a bona fide agreement, so to say. There's a contractual obligation now that the FDA has to respond to you within a certain period of time if your application didn't get rejected straight through the door. But if it actually made it through, which thankfully ours went through the first try, you know, you're going to get a couple of responses back.

You're going to get questions. You're going to get your deficiency letters, et cetera. That's now, you know, that's your pathway. Now some people might say, hey, I'm Ed, you think I should do, you know, a pre-submission. If it's a 510K based on predicate, again, my personal thoughts. There's no point. Just go and submit. You know, you have a predicate.

You do all the tests the predicates did. Submit it to the FDA and see what else they want from you right then and there. But, you know, it's definitely something. for companies to talk with their team and their regulatory advisor for sure about whether it's worth it to go down the pre-submission pathway. Personally, for me, I'm just, as we've discussed, just chuck it in, see what happens. And, you know, there is no, there will never be a true best foot forward, so to say, because the FDA can tell you something in the pre-sub, and they can still ask for more things after you've submitted. You know, it's not a guarantee. The pre-subs are

never guaranteed. It's just, hey, thank you for sharing. This is what we want to see. The reviewer could end up saying, I don't like any of this or I don't know the internal workings, but they could say I still want to see some more stuff, right? But once you get your regulatory clearance, then maybe you can start doing, you know, again, there was no clinical trials required, right, for ours and maybe a majority of other companies. But then you could start working with doctors on maybe doing like case studies or an open label study, right? Now you could just, garner a little bit more real-world data. I personally like real-world data versus, you know,

the expensive clinical trial because the real-world data is what doctors are going to go out there and, you know, go talk about at conferences. Yes, in certain levels of conferences, there's going to be like a scientific merit, sorry, that you're going to need to meet. But, you know, at least your startup that's getting out there. You're getting your voices, you know, your product heard, your product spoken about. And then you can raise the capital really needed to if you do need to go back and do like a comparative study against another product to show superiority to it or whatever. Then that's how you do it.

Right. Now again, if you're a well-funded startup, do both and good luck. You know what I mean? But for startups that are struggling to raise, you have to pick what gets you to generating revenue the fastest. Yep. Yep. And by getting in market, you're able to, most likely.

opportunities will sort of present themselves, right? Exactly. Yeah, yeah. Your product could be the secret sauce that another product in the same field, right, not maybe the same exact product that you're trying to compete against, but that product might need you to sell their products, right? So distribution networks might say, hey, we're going to lump these two products into one, you know,

buy one, get one kind of offer or whatever combination. And they sell it to doctors and say, hey, yeah, I know. So this product will do this for your patients. And then you can attach the second product to do this after your surgery or whatever it might be. You don't see that, you know, that happening if you just have the clinic. But if you have the regulatory approval, you're out there, you're working, you're hustling in the market. And you know, you're expanding your network to distribution partners. You know, we've been approached by several that say, hey, yeah, we'd love to put your product with, you know, these product lines that we're already selling, whether it's skin cream or neurotoxins or whatever.

because we're already selling those packages to doctors, adding this one product on, it's not going to do them, you know, it's not going to be crazier than what they're already purchasing, right? So these complementary product lines is really critical for also successful, you know, commercialization. Yeah, no doubt. And your point about presubs, I think, is spot on because so many kind of purists, I guess, within the med tech space will automatically default to a pre-sup, right? We need to do it. We have to do it. We have to do it. We have to do. to go down the pre-sup pathway and you're dead on. I mean, not that that you shouldn't consider it, right? I mean, I think it should be on the table, but it doesn't necessarily mean you have to do it.

And that bind, that feedback from FDA is not binding, right? So even if there are key questions that you really want feedback from FDA around and it makes all the sense in the world to do a pre-sub, just keep in mind, you know, that, again, that feedback is not binding, right? I mean, you're only going to really know until you submit that package. You know, it's the same thing with patents, right? You won't really know until you submit your patent. It's not like you're going to have meetings with the USPTO and be like, hey, what do you think about my claim number one through? No, it's.

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