US Market Access: Considerations and Strategies for OUS Companies | LSI Europe '24

George Lewis  00:04  
George, welcome. I'm George Lewis. I represent Arena, a PTC Business. For those of you that want to know a little bit about us, we do EQMS, which is electronic quality management for Life Sciences organizations that have complex devices. So typically, if you're trying to, if you're in Series B, C, somewhere in that range, that's oftentimes when organizations would look at using an EQMS solution. If you have any questions, come see us; happy to talk. So with that, let's kick off the session. We've got a really exciting and diverse group of individuals here, from venture capital and funding to folks in OEMs and startups, as well as consultancies. So before we get into the list of questions here, why don't we go through a quick introduction? Folks, I ask for two or three sentences from each of you. Christophe, start with you.

Christophe Sibillin  00:55  
Yeah. Thank you. I'm Christophe Sibillin, the CFO of a French startup company called Quantum Surgical that has put to market a device called Appian. Appian is a robotic platform helping interventional radiologists to perform percutaneous procedures. We are raising our B round, and that's also one reason why I'm here—to meet with investors.

Alessio Beverina  01:19  
I'm Alessio Beverina, I'm the founder of Panakes Partners, a VC fund based in Milan, investing in medical devices and biotech all over Europe and the United States. We're stage agnostic, focusing on various pathologies, and that's it.

Robert Hornby  01:42  
I'm Rob Hornby, Director of Mercia Asset Management. We're a UK-based VC firm. We manage about 2 billion AUM, investing from Seed through to Series B, agnostic in terms of what we look at. So medical devices, therapeutics, R&D tools, you know, we look at most things if it works for us.

Angela Paterson  02:04  
I'm Angela Paterson. I'm a Principal Consultant at Compliance Solutions. We are a quality regulatory and clinical consultancy. We're based in the UK, with offices in the US and also in Ireland. We mostly work with startups and spinouts to help them get to market with whatever limited funding they have.

George Lewis  02:30  
Excellent. Well, first off, let me thank everybody for joining us here for the panel. I mean, it's a really exciting group of folks to talk and dig in a little bit more. I think everybody here in the room can learn a little bit. And so with that, why don't we jump right in with the first question here? So the first question is, what approaches have you seen succeed in taking products commercial in the US market? Does anybody want to jump in on that first softball?

Alessio Beverina  02:52  
I can start easily. Well, I think that there is no recipe for success, other than making revenue and building a commercial force. Now, let's say that, you know, we have more than 20 companies in our portfolio since 10 years now. And you know, we have seen a lot of companies going from clinical and regulatory product development to entering into commercial. And you know, when you enter into commercial, you make a big, big change in any company, right? So I think that the best approach is, first of all, probably to tweak a little bit the team because most of the time, the first team that was able to build up a fantastic product, demonstrate it clinically, and then, you know, get the right approvals are not the best one mentality-wise to build up the commercial force. Engineers don't know what sales is, right? Essentially, I may make a little bit of a joke; engineers believe that this product is so good that it sells by itself. It's not like that. So the first thing, for me, the first step when you move into the commercial stage post-FDA, post-C mark, is to figure out if internally in your team you have the right resources, also in the CEO role, other than VP sales and VP marketing. 

Second point. Now, if I look at my companies and the six or seven that have been starting commercialization, both in Europe and the United States, we have been trying different things, right? We have been trying to use distributors. We have been trying to build up our own local commercial force, probably not everywhere in the United States, probably just in Florida, New York State, and California. We have been using 1099s, so a lot of different solutions. And also, you know, we have examples of companies that have partnered with big corporates that are the world leaders in that particular sector. They know they pay nice money, upfront payments, potentially minimum guarantees, etc., and they say, "I'm going to do the sales for you." So what, at the end of the day, out of this, for example, that I just did, which one is the most successful? Frankly, I don't know yet because the distribution with the big corporates may be good or may be wrong. And having seen lots of pitches on top of my portfolio comments, I can tell you that distribution with the big guys is complicated most of the time. 

Second, the 1099 distributors, unless you have very, very good ones that believe in your product, it's very tough because the distributor, most of the time, uses your fantastic new technology to open up the door of the hospital or the center to sell the standard stuff. So, you know, at the end of the day, probably the best one is to build up your own commercial force, localized. You see, if you don't have money or go big time, but you know, in particular, if you go FDA, post-FDA commercial in the States, well, you know that the sales price of a sales guy at that stage is pretty high, so you need to have enough resources. You need to raise the 5100, whatever, 50, depending on the kind of technology that you have and what is the target that you may have in a number of hospitals there. So there is not a recipe, sure, probably, unfortunately, because of the statistics that have been dated during the last days in this conference where, you know, 10 years ago, 50% of the companies were acquired pre-commercial; nowadays, it's 8%. Essentially, cardiovascular, if I summarize a little bit too much. So we need to go commercial. So probably you need to raise tons of money to do the commercialization, which is boring for the investor, in particular the Series A, the Series B, and also for the founder because they get diluted all the time.

George Lewis  07:37  
Alessio, thank you. So Robert, I see you smiling.

Robert Hornby  07:41  
I think he said it all. He summed it up. Good read. Yeah, exactly. Let's go. No, I'd agree. I mean, from our portfolio, there's no one recipe for success. I think we've seen lots of different things work. And I think it's that balance between the amount of capital you've got and the control over the process. And I think it depends on the technology you've got. Something that is really, really novel that the market has not seen before, or trusting a big distributor to go and do that for you. It might work, but it might not work, and we've seen it not work quite a lot of times because the salespeople don't understand how to sell the technology. It's too hard. They've got other products they can sell that are a much easier sell. So we've seen that fail quite badly. So then, you know, in scenarios like that, maybe there's a case to go and hire people, have your own sales force, have control over that process, but with that comes the cost of those people. How do you manage those people? Is there a choice? You know, a lot of our companies are, you know, UK born and bred. Does the CEO need to move to the US and be there, you know, permanently? If that's the choice, you know, it's a big move, and you've got to be committed to that. You can't kind of do half measures because we've seen, again, some companies try that, not commit to it. You spend a load of money, you don't get any traction, and then you have to pull back. And I think it just sets the wrong tone in the market. So again, I think it's just understanding where your technology fits in the market, how novel it is, how different it is. Is there a really credible reason why you use a big player? You know, does it fit in their basket? Is it an easy sell for them? In which case, why not do that? But if it isn't, then perhaps go yourself. But yeah, I would just say a bit of a cop-out because there's no, you know, I'm not saying there's a right answer, but I don't think there is.

George Lewis  09:21  
Thank you, Christophe. Angela, anything to add?

Angela Paterson  09:25  
I think we've well,

Alessio Beverina  09:25  
maybe, in addition to the fact that I agree with pretty much what has been said on Quantum and our previous venture at Med Tech Surgical, we went direct. But what we've learned over 15 years of presence between those two companies in the US is that really you need to make whatever it takes to be seen as a US company and to fit the local culture needs, and really to be reactive and to hear what the market wants. So to do that, you need definitely people who have that experience, but you also, you know, our CEO moved to the US, for example, in both ventures, at least for two years, to set up and manage the setup of the commercial team and service team.

George Lewis  10:12  
Yep, no, excellent. I think, as you've said, you can't tackle all of the US all at once, and it's a huge mistake that people in Europe make because they think they can tackle all of the US, all states, all at once. That just burns money. They fail. So it's all about key opinion leaders. Find them, get them to use the product, get them to promote the product. And then from there, you can, after you've done lots and lots of air miles coming back and forth in Europe yourself, then you can maybe afford that expensive US salesperson, but a lot of companies, the biggest error they make in failing to succeed is trying to do it all at once.

Angela Paterson  10:55  
Yeah, that makes sense. I know in a lot of our conversations, we talked about, you think state by state because UL is required in some states and not others. So it gets complicated really quick. All right, so let's move on to the next question. What strategies have you found effective in navigating the regulatory landscape in the US?

Robert Hornby  11:16  
Angela, let's take it. I mean, regulatory reimbursement was a great reimbursement landscape.

Angela Paterson  11:24  
Thank you, Alessio.

Robert Hornby  11:28  
Let's prepare. Yeah, better prepare the team. It's part of our due diligence process, I guess, up front for the companies before we invest. We can't go in with some sort of hope and a prayer that someone's going to get paid for us, whether that's existing codes that they can get paid right that route, or they've done a piece of work where there's, you know, some kind of precedent that suggests that it is possible to get paid. Yeah, I guess when we're plugging numbers into a financial model, really, which is what we do when we're sort of thinking, is this going to make a return for us? There needs to be some validity to that revenue line. And so there has to be some thought behind it, whether that's engaging an expert as part of that process up front or just something credible. But it needs to be something that the company has really thought about in some depth. It can't just be, "We've got a great technology and it's going to change the world." It's got to be, you know, great technology that's commercially viable as well, sure.

Alessio Beverina  12:19  
Well, if I may add, probably on the reimbursement, you know, first of all, most of the time the company thinks about it a little bit late, right? Probably one day before the FDA, right? They have fixed the price. They have done the market assessment, understanding who works on the patient, the doctor, etc. But they, you know, they say, "Well, you know, the trial is useful. Blah, blah, blah." So I think that if you have the chance and the time and the money, probably starting earlier to identify how you can get the right reimbursement in terms of existing codes or how to apply for new codes, which is always a long-lasting time, is very useful. So my suggestion to an entrepreneur out there is, don't wait until the last minute to know how to go for reimbursement. Try to think about existing codes in the states; there are many. So try to find one or try to also, in order to prepare for the reimbursement, to find the right KOL, the right association of patients that are the most demanding ones for having your therapy or company therapy out there in the events of the doctor, in order to be supplied to the patient. So work with the right KOLs with this sort of influence on the payer; try to work out on the patient associations. In particular, in the States, they are super strong, right? So, don't forget about that. 

Finally, there is another thing that there are technologies that do not necessarily get reimbursement. There are no codes, and there is always the out-of-pocket. So we have, for example, one of our portfolio companies, which is making serious revenue, first hearing in the States out of pocket, but because the patient needed it, and they are willing to pay 3,000 to 5,000 euros for such a procedure in order to do it right. So they will pay the money and make an example. We have a particular sector that very few people know about; it says lymphedema, when you post-cancer culture, then most of the time you have the arm or leg a little bit bigger. So patients perform 50,000 procedures a year which are not reimbursed out of pocket. They go for liposuction, and they do it three to four times a year, or they go for a major surgery like LVA, lymphovenous anastomosis, which costs in the States 70,000, but since these people are desperate about their condition, which is not just an aesthetic problem but also a life-threatening problem, they are happy to pay out of pocket seven times. So if you are able to identify this kind of early adopter that is happy to pay, go for it while waiting for the reimbursement code to come on board.

George Lewis  15:43  
Great insights. So I'm going to move us forward to the next question in the interest of time here. What is the rate? How does the regulatory landscape in the US differ from that in Europe, and what impact does it have on the market entry strategy? Angela, do you have any thoughts there?

Angela Paterson  15:59  
So the first thing really is that we always say US first now because under MDR regulations in Europe, gaining a CE mark is significantly more expensive than it was under the Medical Device Directive, and it's also significantly more expensive than filing for a 510(k). So I've got some numbers here. So if you can apply to be a small business and get a small business decision from the FDA, then your fees reduce dramatically. I'm going to say small business; it's less than $100 million, so it's not really small at all. But that's the rule. So a 510(k), for example, if you have the small business decision, is $5,440 versus $21,760, which, for startups, is a huge amount of money. PMA, and this is really quite critical for PMA, if you're a startup and have a small business decision, and this is your first PMA, it's free, so you're saving yourself almost $121,000 by going through the pain of getting the small business decision, because it is a pain, but it gets you that first PMA for free. And the FDA has timelines, you know, 90 days, 180 days. They don't generally meet it, but it's their target. So they do try. In Europe, one technical file currently is 200,000 euros for one file, and it will take them, depending on what the product is, anything from three months to 26 months to get through a notified body. So it makes absolute sense to go US first. The other thing which has changed is the IVDR for in vitro diagnostics in Europe. It used to be that 90% of in vitro diagnostics were self-certified. The rules have now changed, and now 90% will be certified. So they've gone from a cost of approximately $400 to a cost of $120,000 for one IVD, so again, US first makes sense.

George Lewis  18:31  
Excellent. Chris, I saw you shaking your head. Anything to add there?

Christophe Sibillin  18:34  
No, I mean, we've made the decision to, when we set up the company back in 2017, to opt for the MDR regulation first, and we were one of the first companies to receive a CE mark under the new regulation, even though it took our notified body about eight months from the final audit to issue the certificate, and that was just administrative burden. I like more the idea of the FDA, where you can—it's predictable, so you know what to do. And in addition, we usually do a Q-sub, so we have the occasion to talk with FDA teams to really get the file prepared in the best way possible.

Alessio Beverina  19:17  
I think this is probably the reason why you need to go to the FDA, other than the fact that the FDA is the American market, which is the largest market, blah, blah. And then they say that reason in the States, because they are more innovative, blah, blah, blah. I know they see the FDA stuff. It's the most important part. You have a discussion, and you can do how many Q-subs you want, right? You know, you try while you discuss it. Oh, no. Then while with the notified body, it's just submission. There is not the consultancy piece, which is extremely useful, particularly in small startups where, you know, everything is unknown, or we need to do this kind of study on animal or biocompatibility, blah, blah. So this is the reason why I think. Think that compared to 20 years ago, where companies from the States were coming to Europe, versus now, you know, all my companies that started, you know, all the companies come to my desk and say, "I have a plan to CE mark and start revenue generation in Europe," okay, the world of FDA. And some of them, when I invested, we canceled completing the CE mark, and we go to the States because, at the end of the day, our job is to get money back selling the company. And instead, you know, big corporates are becoming even later than before in terms of acquisition. And they don't care if you have 10 million in revenue in Europe; they want to have 10 million plus in the States. So better you do. Probably spend more in the States to get the FDA instead of CE mark. But the return on investment, I think, is much better.

Robert Hornby  21:01  
Yeah. I agree. I mean, we, I suppose, advise all our portfolio against the US first. I think it's a matter of time and capital constraints. And if you go to the EU, it's going to take you a lot longer, and there's less certainty through the process, so you don't really know what you're aiming for. So that, say, iteration being able to speak to people that you know, they're not going to tell you exactly what you need to do, but they can tell you if your plan looks a bit off. And it's just a lot quicker; it's just a no-brainer for me, really.

George Lewis  21:29  
Excellent. So we've talked about regulatory a little bit. Let's pivot to economics a little bit. What are some of the differences you see between the US market and the European market? And we've touched on a little bit so far, but anything you want to jump in there on?

Robert Hornby  21:43  
Well, I think, I mean, for our portfolio, a lot of our focus is on the UK. So we're dealing with the NHS. We're dealing with cost pressures, a system that doesn't really work that well at the moment, sadly. So the mindset you're going in with when you're trying to sell is, how can we bring costs down? How can we sort of bring the administrative burden down? How can we, you know, make things more efficient? And the mindset, you know, when we send companies to the US is almost the reversal of that, of, you know, how can we make more money? How can we sort of generate revenue? It's more commercial, you know, from what we see, which makes sense. It's very logical. But I think when you come from the mindset of dealing with the NHS, which is a very different system, flipping an entrepreneur's mindset from that to going, "No, this is actually about making money," it's not about sort of improving a process or critical outcomes still matter, but it's not the only thing that matters. So it's a mindset change, which I think is not easy sometimes for our portfolio.

Alessio Beverina  22:50  
Anyone jump in and add?

Christophe Sibillin  22:52  
No, no.

Alessio Beverina  22:52  
I can add a few things still; there is a mentality difference between Americans and Europeans. Americans are more open to innovation. I'm not talking about the doctors. Don't take me wrong. European doctors are amazing. So they like to test new things, to try new things, etc. I'm talking about the chief purchasing officers at the hospital level and all the management at the hospital level, which is private or public, who cares? They are more willing to buy new things and take the risk on new things because the KOLs stress them so much, and they need to buy. So this innovation mindset allows for revenue to grow faster. So I had one of my portfolio companies that for two years tried to make revenue in Europe. After two years, they made 1 million; then we got FDA in less than nine months, and we went to 10. Okay, this, you know, answers your question. We had six people in Europe running; we have six people running the States. So it's not a question of people that you put there; it's a mindset. People are active. 

Second, I think that, you know, coming back to Rob's point of view, you know, our healthcare system in Italy, in France, in the UK, and in other countries is easily broken on the public sector. So everything is priced down. Now try to sell a robot in any of these countries. Well, you know, good luck. Where do you find the 4 million, the 2 million, the 1 million, the cost of the robot? Gee. So, you need to be a little bit more inventive there. So in the United States, they are so flexible. First, there is tons of cash available, foundations, many different endowments, you know, lots of money that gives to the hospital to buy new things to treat the patient. Remember, the objective is to make money on the hospital side, but also to treat the patient and make everybody happy. So I think that in the United States, there is this advantage. I would like to say that probably in the States, American companies in our portfolio that are targeting American markets have been smart enough to find models, right? Okay, you need to sell; what's your cost of your robot? 1 million. Let's say 1 million. It's not true, right? It's open. Less, yeah, price, this is 1.1 million. Okay, 1.1 million. And so what you need to find in the budget, 1.1 million, right? And you are fighting with the Da Vinci 5, which is entering now in the market that, you know, everybody wants because it's the iPhone 16, right, of the surgical robotic. So you need to find a way to find this money; the hospital may not have it. So you need to find an economic model in order to find this money at the place of the hospital. So I'm sure you know better than me because you are a CFO and you're selling a robot. So I'm sure the epitome we have Rent To Buy Lease, and we keep the hospital already the lease, right? We have paper procedure; you need to be smart enough in order to solve the issue. And in the States, they get it right. They say, at the first meeting, "I don't have the money till Q1 next year." They say, "Well, why? If we do something different, let the lease or rent to buy 90 days trials, whatever, in order to make it happen." So you may find in Europe, "Oh, it's capital equipment. I don't have the money." Ah, we do a lease. Ah, wanna.

Robert Hornby  26:56  
Yeah, go ahead.

Alessio Beverina  26:59  
But conversely to what I've just said before, some of our portfolio companies, what they found is the UK and parts of Europe are actually very good on innovation budgets. They're not very good at commercializing in the long term. But there are pots of capital out there when they're in your regulatory route, where actually it's really good to sort of trial your products. It's great sort of, you know, some good clinicians out there go and test it. Go and make the mistakes in that market, you know, let surgeons break it, fix it, and then go to the US and commercialize properly because you don't want to make those mistakes there because that's where you kill your products. I think there are good things about, you know, this side of the Atlantic, but it is definitely more challenging kind of in the long-term commercial.

George Lewis  27:42  
Excellent. Let's move on to the next question. So how should an organization approach staffing for the US market? Angela, I know you're thinking about this now. I think, do you think to kick us off?

Angela Paterson  27:55  
Initially, for startups coming from Europe, they usually try to do everything themselves. Sure, for the simple reason that employment in the US is expensive compared to in the UK and Europe. So they will try to succeed by themselves for as long as they possibly can, like I said before, racking up their miles backwards and forwards for sometimes years. And then once they get some traction, they start to employ US people and then open a US office. I've seen it done the other way, where people try and open up a US office first, and then it's just an address with no one in it because they can't afford to put anyone in it. But that's how I've always seen it done. That seems to work pretty well.

Christophe Sibillin  28:37  
Yes, why in both, you know, for the US market, we twice went the direction to get industry veterans coming from big corporations. It was still the appetite for innovation. And that was definitely expensive. But what else? That was definitely more expensive than we already planned, but it paid off. It paid off in the sense that we had, you know, a quicker access to the market, and we were lucky enough to find a good person; that's not always the case. We had good and bad experiences, but overall speaking, we were successful.

Alessio Beverina  29:24  
Great. I think that the key is to either find the right first guy in the States. Because if you are the first, let's say the CEO of the United States, if your company is European, and potentially one with the commercial mentality, you know. And if you choose the right guy, the first one, you know, he has probably the network or the capacity to identify additional people on his team that works below him in order to make all the start in my robotic company, you know. We are an American CEO. As soon as the product was ready to commercialize, at least in Europe, was an American individual. Spent two years in Italy enjoying Tuscany. It's the worst place to stand an American. As soon as we were almost ready there to get the FDA, let's say six months, the guy decided to go to the States. We opened up. We even moved the headquarters there. We opened up the office, the facility where we have a demo lab, etc. And we built up 50 people in the States with Clinical Affairs, a clinical specialist, CEO, VP marketing, because, frankly, VP marketing in Italy is not as good as VP marketing in the States. The VP sales coming from Italy, even if we are super good sellers, we can sell everything; the American mentality towards American target clients is completely different. So, better you choose and go big time, and unfortunately, as you say, it's expensive. I think it's worth it. It's right if you choose the right people. But you know, I think the team is fundamental, even in the other my company that I told before that went rapidly from zero to 10 in less than nine months, right? We had an amazing CEO that was in the business forever, and in this particular segment, he knows everyone. So, bam, bam, bam, seven people like that, without using a headhunter because he knew all of these people, right? So, and now his clients are the previous clients that he was selling to. So it's extremely easy. You don't want to beat up from Europe, everything from scratch, or even sending your fantastic Italian or French or British CEO to the States because they don't defend him, right? It's a different kind of mentality, right?

Robert Hornby  32:37  
Yeah, I mean, I think I agree. I mean, we've seen it work with, you know, I guess UK CEOs going over there, European CEOs going over. I think there's a balance. You know, those individuals might have had a track record of having done something in the US before, but I think they're equally, they're very bought into the idea. So I think if you're going to hire someone to represent your company in the US or lead that company, they've got to be incentivized in the right way because, you know, it can't be something that's a very transactional relationship where they, you know, find it hard to sell it, and they disappear the next day. So I think it's, you know, it's the right approach for the company. But I think that whoever goes there, whether it be the founding CEO or someone you hire, they need to be bought into the idea. But I think you need a presence there because it's not going to happen on its own. But I think the way we approach things more generally is the board has to change as you expand to the US. I think the mentality shift is, you know, you start thinking about, I guess, exit. You know, who are those relationships that you need to build to sort of secure that strategic exit? Is your fundraising journey going to change? Is it going to be a different set of funders that come on board at that point? You know, are we the right funders to fund the US growth round? Probably not. So bring those people on board that kind of have the network and start sort of changing the people around the table, but you can kind of do it gradually over time, but that's more like non-exec positions. But I think it's not just the execs that need to change; it needs to be just a wholesale shift in kind of who sits around that team.

George Lewis  34:04  
That's great. Those are great insights, folks. Wonderful. So we don't have that much time, or maybe you want to make sure we have a little bit of time for the final question, so then it kind of wraps things up a little bit. And so, you know, what are your thoughts on what organizations need to accomplish to achieve a successful exit in the US? Big, wide-open question. Chris, let's start with you.

Christophe Sibillin  34:25  
Say what you're going to do. Do what you say you will be doing. Be crystal clear and sharp on execution. Talk to corporates. Make them aware of the progress you make in the US market. And you know, let people know the good things you're doing.

Angela Paterson  34:44  
Excellent. Angela, what have you seen?

Angela Paterson  34:46  
I think the KOLs are absolutely critical. You get the right KOLs, they start to talk on your behalf. They go on podiums. They talk about your product, the industry. Some other people also buy your product, and that's how I've seen traction gained quickly is from that. The other side is you get some young surgeons who are really interested and are desperate to get on podiums, desperate to talk. Sometimes those guys are almost as good. They might not have the name, but they're willing to work for you. And those are the ways that I've seen products really gain traction and get the interest of the bigger med dev companies that would be the people that would buy you out.

Robert Hornby  35:37  
I think for me, it's that continual clarification of what are you aiming for? What is that exit point? Because I think the thing we've seen with our portfolio is that those goalposts have massively shifted, you know, not only at exit but later stage funding rounds. And you sort of the assumption you went in with in terms of, you know, maybe when you raise a big growth round, when you get off the boat, they've shifted back by five years or something like that. So that, I think you need to be having those conversations on an ongoing basis just to recalibrate where you are. And it can't be a surprise that, you know, suddenly you go and speak to someone that you spoke to five years ago, and they're like, "I know we only invest now when you've got 20 million of revenue instead of, you know, free revenue or something like that." So just keep those conversations going. Alessio, you want to bring it home for us?

Alessio Beverina  36:18  
So unfortunately, as the data shown by Sam Bankerlali say, that 10 years ago, 50% of the companies were acquired pre-commercial, and now it's 8%. So there is just one recipe to get an exit in most of the sectors in med tech: to go and grow revenue. Okay, top-line revenue demonstrated that there is usability of your device in different hospitals, not necessarily capital. In the case of a robot, you may place 10 robots and demonstrate that these 10 robots are used every day, two, three, four times a day. If it's possible adoption, it's a question of utilization rate. That then depends, you know, the KOL point is very important because we all know that big guys listen to the younger or relatively older KOLs, and they use them as a reference, so be sure that the right KOLs that are embedded with the big corporates know about you. Okay, this is a very good point. But again, you know, you need to grow revenue top-line and be sure that your stuff is not just acquired by a hospital, but actually, you know, there are many companies that sold devices that are sitting in the corridor. So be sure that, you know, because at the end of the day, when the acquirer is looking at it, it is looking at revenue structure, technology, if I may, at one point, try to make a pain for these corporates. If you are, you know, even with 20 million revenue, and if you're grabbing market share from them, good point. If all the KOLs are talking about the new kids on the block and not about their old basic technology, it's a good point. So try to make a pain point on the corporate, and if the pain is larger, you take them potentially. You start in California, you get 10% of market share on their own market. They will notice, right? This is a pain point. So they will say, "Oh, what is this company? What are they doing?" So be sure that you tackle a platform. Second point, remember, when discussing with them, the corporates, as Rob was saying, be sure that you have a complementary product to their portfolio or an alternative that is much better than they know. Remember, a corporate that has a product that is making money, you know, it has been, it's a cash cow, as they call it, right? So they don't give up their cash cow just because you have a fancy new stuff. So be sure that it's better, it's complementary, something similar, but not the replacement of their product. Otherwise, they will buy you and close you down, which has happened.

George Lewis  39:40  
Folks, thank you. Thank you. We're already out of time. That's amazing that 45 minutes or so, maybe just 40 minutes, went by so quickly. There's a lot of wisdom packed into a small amount of space there. So thanks to each of you for spending your time with all of us here today. And with that, let's give a round of applause.