Medsider: Learn from MedTech and HealthTech Experts

Essential Tips for First-Time Medtech CEOs: Interview with Dan Rose, CEO of LimFlow

March 12, 2020 Scott Nelson
Medsider: Learn from MedTech and HealthTech Experts
Essential Tips for First-Time Medtech CEOs: Interview with Dan Rose, CEO of LimFlow
Chapters
Medsider: Learn from MedTech and HealthTech Experts
Essential Tips for First-Time Medtech CEOs: Interview with Dan Rose, CEO of LimFlow
Mar 12, 2020
Scott Nelson

I recently had the opportunity to interview Dan Rose, CEO of the French-based medtech company LimFlow. Founded in 2012, LimFlow transformed the peripheral vasculature space by providing a lifesaving option for end-stage critical limb-threatening ischemia (CLTI) patients facing amputation. LimFlow is designed to restore blood flow to the ischemic foot via deep vein arterialization, thereby preventing major amputation, resolving pain, and promoting wound healing. 

Prior to assuming the role of CEO at LimFlow in August 2016, Dan had more than 16 years of leadership experience in the medical device and venture capital/startup sectors. Most recently, he was VP and General Manager EMEA for Direct Flow Medical, and VP of Commercial Operations and a Member of the Board at Sequana Medical, a Swiss medical device company. 

Norbert Juist, an executive recruiter who specializes in medical device sales and marketing, also joined me for this interview with Dan Rose. Norbert brings a unique perspective to this discussion, having worked as a sales rep and consultant in medtech for nearly 20 years prior to transitioning to executive recruiting.

Here are a few of the topics we discuss in this episode:

  • How LimFlow used a concept that’s been in existence since 1912 and transformed it into a modern therapy that multidisciplinary clinicians can reproduce.
  • How Med Start played an instrumental role in the launch and ultimate success of LimFlow.
  • Why it’s essential to find a physician champion willing to invest time and energy in your tech.
  • Overcoming the challenges presented by an ever-evolving MDR landscape, both in the EU and US.
  • Key factors you can’t ignore if you want to succeed as a first-time CEO.
  • Why investing in independent market research is well worth the cost.
  • Why the FDA Breakthrough Devices Program has been a game changer in the US.

See more...

Show Notes Transcript

I recently had the opportunity to interview Dan Rose, CEO of the French-based medtech company LimFlow. Founded in 2012, LimFlow transformed the peripheral vasculature space by providing a lifesaving option for end-stage critical limb-threatening ischemia (CLTI) patients facing amputation. LimFlow is designed to restore blood flow to the ischemic foot via deep vein arterialization, thereby preventing major amputation, resolving pain, and promoting wound healing. 

Prior to assuming the role of CEO at LimFlow in August 2016, Dan had more than 16 years of leadership experience in the medical device and venture capital/startup sectors. Most recently, he was VP and General Manager EMEA for Direct Flow Medical, and VP of Commercial Operations and a Member of the Board at Sequana Medical, a Swiss medical device company. 

Norbert Juist, an executive recruiter who specializes in medical device sales and marketing, also joined me for this interview with Dan Rose. Norbert brings a unique perspective to this discussion, having worked as a sales rep and consultant in medtech for nearly 20 years prior to transitioning to executive recruiting.

Here are a few of the topics we discuss in this episode:

  • How LimFlow used a concept that’s been in existence since 1912 and transformed it into a modern therapy that multidisciplinary clinicians can reproduce.
  • How Med Start played an instrumental role in the launch and ultimate success of LimFlow.
  • Why it’s essential to find a physician champion willing to invest time and energy in your tech.
  • Overcoming the challenges presented by an ever-evolving MDR landscape, both in the EU and US.
  • Key factors you can’t ignore if you want to succeed as a first-time CEO.
  • Why investing in independent market research is well worth the cost.
  • Why the FDA Breakthrough Devices Program has been a game changer in the US.

See more...

Scott Nelson:   0:01
We just pulled in a 15 million Series B and build a team that was the right team that I wanted. And that's the first time Theo there a bunch of things that are critical and one of them is funding, and to them is the right team setting. And three is just the right technology. And I felt like all three of those things were there because, you know, I mean the first time CEO, by definition, you don't always know what you're doing and factors you could put your favor, but really, it was the opportunity to change and deliver value space. And that's what motivates our whole team every day is the fact that we're taking the patients who are headed for a terrible, terrible medical out and, you know, saving limb saving lives. And that's what we're trying. Welcome to Med Cider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now here's your host, Scott Nelson. I recently had the opportunity to interview Dan Rose, the CEO of the French based med tech company Lymph Flow. Founded in 2012 lymph flow has transformed the peripheral vascular space by providing a lifesaving option. Two patients suffering from C. L. T. I. Otherwise known as critical limit threatening ischemia. Lymph Flow offers a minimally invasive technology designed to restore blood flow to the foot, thereby preventing major amputation, resolving pain and promoting wound healing. Prior to assuming the role of CEO at Lim Flow in August of 2016 Dan at more than 16 years of leadership experience in the medical device and venture capital startup arenas. Most recently, he was V. P and general manager of the Mayor Region for Direct Flow Medical Review. The topics we discuss in this interview with Dan How Lymph Flow used, a concept that's been in existence since 1912 and transformed it into a modern therapy that clinicians can reproduce. How the incubator MedStar played an instrumental role in the launch and ultimate success of lymph flow. Whites essential to find a physician champion willing to invest time and energy into your technology. Overcoming the regulatory challenges presented by an ever evolving MDR landscape, reasons that convinced Dan to assume his first ever CEO role. Lymph flow. Importance of ongoing R and D and innovation to a company's success and sustained relevance. Why the FDA Breakthrough Devices program has been a game changer here in the US, the importance of having a mentor and why Dan would not give advice to his 30 year old self. There's a lot more recover in this wide ranging discussion with Dan, but I wanted to call it a few things before we get started with the interview first. Joining me on this episode is a special guest host is Norbert Juiced? Norbert and I go way back, in fact, used to sell vascular devices into the same Cath labs, and now he runs sales performance. Resource is and specializes in recruiting for medical device sales and marketing positions. He's quite good at it. No, but not really brings a ton of industry experience to the table. But he's one of the most honest, genuine and personable people I know, and he's definitely not paying me to record this. So if you're looking for a new gig or need help recruiting for some open positions, Norbert is your guy. In the show notes for this episode, you'll find a link to learn more about Over and his background. Second after about a two year hiatus. I've recently started a recording published Med Center interviews again, and there's a good reason for that. I've been knee deep in my own startup, a Jew That's J O V V, and we manufacture light therapy devices, which is technically referred to US Photo bio modulation in the world of academia. It's a really interesting space because of products or class to medical devices, but we're following a more traditional or classic director consumer online commercialization model. It's been a fun ride over the last 3 to 4 years, and I've definitely learned a ton. So if you follow these meds side or interviews, I'll be sharing quite a bit about my experiences. So keep listening and again. If you want to check out Jude, go to juvie dot com. It's J o v v dot com. Third, if you're new to these meds, set our interviews and I wanna be updated. When the next interview goes live, head on over to med cider dot com and enter your email address. Rest assured, you won't be spammed. In fact, the only time well you'll likely hear from us is when a new conversation goes live against Super Simple. Just visit med cider dot com, and right there on the home page, you'll see the opportunity to enter your email address. And lastly, as a reminder, if you continue to enjoy these interviews, please give us a rating in your podcast app. Just open the reviews tab and click on the old five stars. Thanks again. It really helps out already. Let's get to the interview with Dan. All right, Dan, welcome to the program. Really appreciate you coming on, especially considering it's ah, late on a Friday evening, Your time,

Dan Rose:   4:07
player. Thank you. Problem

Scott Nelson:   4:09
in Norbert's you're in your captain's chair. I imagine they're in Ah, in Phoenix. You ready to rock?

Dan Rose:   4:14
I am ready to go

Scott Nelson:   4:15
as the listers. No, provided a kind of an intro to your very impressive background, but to help sort of contextualize everyone for what you're doing now with Lynn Flow, can you give us an idea of the technology, that product and maybe just walk us through like what? A typical who a typical patient is in what limitless technology is helping to solve for

Dan Rose:   4:34
sure, sure, absolutely so. I mean, one flow is working in the you know the peripheral vascular space and so you know, outside the heart but in the vasculature and primarily focused on critical Misty Mia What everybody's calling now. Critic. Chronic limb threatening ischemia. Sophie L. T. I Rather cli, but essentially you're dealing with patients who have compromised arterial vasculature, or either from arterial sclerosis and also from long term experience of diabetes, and are really at risk of losing their and lived close. Focus not only on these difficult in stage patients, but truly on the end of the end stage patient. And I think the best analogy for this is if we think about where tabby started or tavern and working with the extreme risk patient population where you know surgery, waas off limit and the same is true for our patients were specifically focusing on a population of patients who have what what we term. No options. So they have no further endovascular or surgical bypass possibility. So they're essentially being consigned amputation major lower limb amputation, which is, you know, kind of the scourge of one of the scourges of modern era. I mean, this is, uh, there. Soon, many patients out there roughly 100 and 25,000 major reputation in the US It's you know it's becoming a bigger and bigger problem because patients, of course, are living longer with their diabetes cardiovascular disease, and the prevalence is going up with both as well. So and if you survive long enough, you know the arteries and your legs are not going to be able to provide it up. What floats your feet? And if you have diabetes, developing an ulcer is quite easy to do and you'll end up with an ulcer, a wound on your foot that can't be healed. And so, uh, we're trying to keep those patients from getting a motor major limb amputation, and this still remains kind of, uh, you know, the morbidity immortality is extraordinary. I mean, it's listed doing the donor medicine published Major will run meditation Is this or in the top five most most dangerous procedures surgical procedures in the U. S. Average morbidity mortality defending a little bit on above the knee or below the knee, but is roughly 10% in hospital falling a major William amputation. So something to be avoided? Absolutely, and mortality is very high in the first year, even if you do get out of the hospital. So what we're doing is what a wimp lo patient is a patient who is based with the really all of our patients so far treated, are indicated for amputation. And what we're trying to do is use the Venus system as a pathway to reap refused to patients. So if you think about the arterial system and energy sclerosis, I mean, you have a lot of councilman plaque blocking the vessel of the arteries Don't foot. And the best analogy is to think about driving the airport and get stuck in traffic. And, you know, way starts to tell. You're gonna get there tomorrow and not today. And you look across the media and you realize that that road, the other side of the road, goes where you want to go, and it may not allow you drive as fast as you want to go. It may not be ideal, but it certainly goes to the airport, and that's what we're doing. So we're creating a connection between the artery and the vein in the lower leg and then knocking out the vowels in the veins, going down to the foot and in the foot and then using covered steps to channel blood from the arterial side in the tibial arteries into the veins and driving it down into the distant distal people area and then healing wounds, which is the real goal because if you can heal wound, you can normally keep the leg on. So that's the concept. It's a concept has been around for surgically reported in 1912 but with a lot of morbidity and mortality. And what we've done is essentially take the principle of that and turn it into a purely perk. You teii gnaeus reproducible, morbidity, teachable, adoptable therapy that can be deployed, you know, by whether their interest radiologists, vascular surgeons and cardiologists and geologists anyone working in the lower leg can do this procedure. And so that's that's what That's what we're trying.

Scott Nelson:   8:54
It's super fascinating. Think that helps create a little bit of context for the rest of the conversation because really curious to learn a little bit more about what attracted you to lymph flow, especially considering your experience, but also how you think about the early stages of bringing you know this technology to life. But before we go there. Let's talk a little bit more about the technology. You said. It's been around since, like the early 20th century. This stuff always fascinates me because it's like, Why are we not seeing this until today? And so can you help us? You kind of go back in time a little bit and understand how this concept, you know, went from something that was seen in textbook to like applying actual perky Tania's techniques and making this somewhat of a reality.

Dan Rose:   9:30
Yeah, so I mean, what happened is that this this has occurred in many different areas of medicine. So the principle someone prove the principle of dog, in fact. And then people have done small surgical theories. Vascular surgeon here, a vascular surgeon there as kind of a bailout, trying to save legs at the last step, you know, really, after patients of failed multiple interventions. But no one had ever really done taking a look at one how to do it for continuously. But to really look at it in a structure of methodical way. And they're a bunch of reasons why it's very difficult to do surgically in one big reason, which is that you create a large surgical wound. And when you create a large surgical wound in a patient that already has trouble healing ones, you tend to lose the lag because of the surgical room. So there are a lot of reasons why it has not been done for spontaneously. But ultimately what happened was that position very well known cardiologists Martin Rothman in the UK, who ultimately became the chief medical officer for Medtronic Vascular and who has always been an entrepreneur, noted that people were trying this in the cardiac setting, and some patients were doing very well. But some patients were not. Obviously, if you fail in the cardiac setting, the price of failure is very high. But he thought, Well, maybe this is something that we could do and prove out in the leg and being a super busy guy, he went to a ninja Bater called MD Start in Europe, which was founded by Medtronic and Providian and Soren and Sophie Nova. Ventures and Person ventures as a kind of way to take position, ideas and, uh, system, and ultimately take them, incubate them if they could. You know, they looked promising, so that's where the experience and history came together to try and start this perk. You. Tania's approach acquired some i p from the old trans vascular business. It was acquired by Medtronic and founded by Josh Mack Our Day and started to build prototypes and a business around that partner attendee store Timlin a ham, his incredible guy. He really took the lead on founding the business in 2012 and I joined in 2016. So there was a kind of a four year period where they were developing prototypes and doing first and man in Singapore before ultimately, you know, moving into, uh, see marking face. You know, when I was reporters, we had that out back reentry catheter, and that's kind of what this reminds me of, that I could just picture this doctor who's almost like a mechanical engineer in their mind tryingto re invent a better way to do this. And they probably saw the reentry catheters that are out there and, you know, tried to come up with a better way to try and save these patients lives. Well, that's exactly what happened. So, you know, when they were trying to do the first procedures, you know, they really were taking technology that was off the shelf and starting the work and then realizing as they went forward, what technologies needed to develop internally to optimize the procedure to perfect. And there's several pieces of it that we're not available off the show. And so what? One fluid today is kind of a suite of technologies. It's, ah, ultrasound based crossing system, you know, with the needle on arterial send catheter. If you think about that way from ultrasound and a Venus receive catheter, it's a value a toma reverse or push value. Atonement allows us in a very elegant way, knock out the valve in the veins and then, ah, conical covered stent so that we can match the diameter of the artery. And the vein is that the diameters vein and then our own covered stent platform that allows us to really channel the blood from the crossing all the way down to the foot. And we have a bunch of other further innovations in progress. So it's been experience of doing exactly that, taking what they're and learning as you go. And I think that's something that anyone has been involved in early innovation. The MedTech space can really understand.

Scott Nelson:   13:35
And in terms of a timeline, Dan, can you help us understand that a little bit more? I know you mission you joined in 2016. When did Dr Rothman first bring this concept to indie start?

Dan Rose:   13:45
I think it was around 2011. And

Scott Nelson:   13:47
then they founded

Dan Rose:   13:48
the company 2012 and, uh, did first and man in Singapore through basically being introduced Thio vascular surgeon named Steven Kume, who was very interested in the space and willing to take on the kind of project from a medical clinical point of view of just you know, you always have to find that tradition who's willing to invest their energies and passion in tow, figuring out something like this and go through the ups and downs. And so there was a series of patients. I think it was seven patients done in the first in man series in Singapore, and that really proved the concept of lead, the raising of the Series A and the doing of a small city marking study, and on the back of that, being able to raise serious B and really take the company and hire a full time CEO which was myself because Jim was working on several projects the same time. So, uh, I mean, nd start is a fantastic concept because what you end up with a startup that have been incubated by a person, a CEO with tremendous passion, belts of dimensional knowledge about how to do it. Well, ah, lot of first time CEOs don't know howto put together I p portfolio. They don't know howto put together regulatory strategy. They don't know how to do a lot of the different work that needs to be done to really create a strong foundation for a growth company because they're doing it the first time. If you have somebody that is doing it for their sixth or seventh time and has had tremendous success doing it, then I think, uh, you're gonna end up with a higher likelihood of success of the long term.

Scott Nelson:   15:20
Got it? And so, uh, go ahead and over.

Dan Rose:   15:23
I was gonna say, What determines then, you know, with envy. Start Doctor Rothman's a British, you know, physician, do they? What? Makesem. Decide whether you guys start up in Europe or, you know, go from C e mark or whether you come to the U. S. And go for FDA approval. Well, I mean, that's a great question, because it touches on some of the dynamics that have changed over time, right? I mean, with MDR and a lot of other things that have happened in the space ultimately, you know, and he start was based in Switzerland. Back then, they think Mark Rothman was living in the U. S. One hand was based in the Czech Republic, but they ultimately founded the company in Germany and did a lot of the engineering work with Contract Medical International Bear and had the I p there this tremendous amount of medical engineering consultancy talent in Germany and sub suppliers. So So ultimately it was set there because Andy Start was European based, and at that time, I think the C e mark process was certainly it was a whole lot easier and more predictable than it is today. And I hope I don't have spent too much time talking about NDR because I'll just get more and more upset as we go. But then that was the real milestone that a startup could could aim for right getting Seymour generates of value of the company generating on the back of that C E mark further funding, which is the lifeblood of the start up. And so that was kind of how they structured it. I think people now are looking much more of the F s early feasibility program in the U. S. Which we've completed 2 32 patients. The F s pretty familiar with how that works as a pathway than on billings revealed CT marking, you know, But we're we're European company were based in Paris and about half of our employees in our in Europe and then half for Lim floor actually, in us so and our leadership team is actually split between Europe and the US were truly international organization.

Scott Nelson:   17:16
There's two things that really stand out kind of listening to your answer there. Dan and I don't want to spend too much on Indy are, but I would like to spend a little bit of time, so I want to go to end of the week because it's something that we're dealing with with Ju you know that the company that I'm involved with it started phenomena bald with and trying to navigate those waters is get really complex, like really quick and anonymous seems really unnecessarily complex. And so can you just, like, speak to Maybe what the challenges are with EMDR really within the context of what other entrepreneur med tech entrepreneurs should be thinking about.

Dan Rose:   17:46
Yeah. I mean, I think it means a lot of men. PR means a lot of different things to a lot of different people, right? And groups. I mean, if you're, ah, Class one device, I mean, you know, you may be asked to generate clinical data on things that it's very difficult generate clinical data on right. It's difficult to do a clinical trial on the scalp, you know, I mean

Scott Nelson:   18:05
some of

Dan Rose:   18:05
the things that are being asked to re certify our just difficult practically to do, especially when you have hundreds of different products. You're right. It's not incredibly difficult for offset lymph flow because, you know, we are generating a lot of clinical data. We're already, you know, Class three system. And so a lot of what FDR is requiring is not necessarily things, and we're already active with the FDA. So for us, it's an inconvenience because it's causing systemic disruption with the notify bodies, right? You can't get things push through because they're so busy trying to figure out the NPR, and they're not sure what exactly the requirements are. So the whole system is kind of overwhelmed, as it were. And so as a start up, you have to really try, and I understand. Can you understand and determine well in advance what the notified body is goingto want from you to get approval? And I'm not sure they can clearly tell you today, if you came in fresh to are you going to be able to get their attention, or will they even take you as a client today, which is another challenge and then three? What did your timeline going to be? Because our timelines that I won't share who are notified body is or what what the time under. But they're very long and very unpredictable. And if you're trying to, for example, you see the mark as a milestone for funding, Well, how do you know how much funding you need? It could be six months for a response or 18 months for a response, right? So I think it's become really challenging tohave a predictable system which and it's created, I think, just a higher bar overall, which in some ways is in a bad thing. But in other ways is making Europe last attractive is a place to start. And I do think that some people are certainly either choosing Teoh go to the U. S. First we're staying in the U. S. And even looking at the U. S. And China or China first. And it's very easy for Europe to become the third or fourth place you go to regulatory approval rather than first. And as the Americans lived in Europe for 20 years, I'm a big promoter of the European system. I mean, this is where I've spent a lot of my professional career, and it's disappointing to see the shift.

Scott Nelson:   20:24
Yeah, it's really interesting because that used to be such a trend is too commercialized in Europe first, primarily from a regulatory standpoint, because FDA was, you know, maybe more onerous from a timeline perspective. But it seems like those winds are changing.

Dan Rose:   20:36
They are, and it will be some time before with the best will in the world. And I think you know, the parties are trying to do their best

Scott Nelson:   20:43
but it's a real challenge. Got it. The other thing that is interesting. That and I don't think we maybe necessarily need t talk a lot about it. But I was unaware that there's a strong MedTech ecosystem in Germany, and I know specific to what we're doing at Juve as an example. It's amazing to see what's happening. You know, the things that are happening in in Malaysia and how many other companies are pulling out of you notions and as an example, But Germany? I didn't I didn't know that was a hotbed for Med Tech.

Dan Rose:   21:08
Sure, there's always been a strong MedTech presence in Germany. I mean, think about bio tronic, which is a you know. I mean, you don't hear about it much in the US but is a massive, multibillion dollar family owned but huge presence and a lot of engineering talent out of there, you know, the abbey omit technology came out of Germany, you know, go down, go down the list. If you get to include Switzerland in there than you, you know you've got some mentis. You've got Anna valve. I mean, there's there's a lift after let yo Med, acquired by CryoLife recently. I mean, just, you know, story after story after story of large MedTech presence in Germany. And remember, Germany in Europe is the place you commercialize first, if you can get reimbursement. Mean, tabby adoption was very much driven by Germany and that drove the whole global expansion of that therapy. Because being able to see how quickly and explosively this could be adopted by the community meant that, you know, you could invest in the space and you could drive towards US approval and have data from Germany to do so. It, sir, a great place to be. We're now in the French ecosystem, which is also a good and ecosystem, but, you know, not not truly comparable to the Silicon Valley. Your Minneapolis, I mean, those are those are kind of a different in order of magnitude, different in terms of you know what's going on.

Scott Nelson:   22:29
Sure, Norbert, if you're have anything else to add, I I'd loved it. Like use this as a transition point to talk a little bit of more about Dan. What? You what? Judy Lynn flow and kind of how you begin to think about taking the technology and commercializing it whether it's in Europe or maybe, you know, future plans of commercializing in the U. S as well. But I know I know we'll get to this later on in the in the discussion about maybe some of the learnings you took away from your experience that direct flow. But you know, what was the appeal toe lymph flow. You know, back in 15 4016 when you when you joined the team as the CEO

Dan Rose:   23:01
I had known could want a hand for some time and he'd actually talked to me about wouldn't blow a couple years before actually took this job. But I was very clear. I'm like that. That's not really my stage. The early prototype stage and first and man. I may not have been involved with it, but I was I was really looking forward. Thio, you know, the time when the technology could be what the risk? Because, you know, you're CEO, you're here and taking on any startup job. I mean, you're really investing yourself in completely in the technology, but I had looked at it, then subtract it and I could see the potential. I mean, ah, lot of what we do in Med Tech, for better or for worse, is you know it orations or improvements on current technologies. You know, a new flavor of stent, and I've done that. I mean, I lead marketing for corn, a vascular from a tronic and the droll Drug league stent business, et cetera. And and that was gratifying. But I was looking for an opportunity where we could really deliver a transformative kind of value to a space. And the more I looked at the seal I R L T I space, and the more I understood that would slow the clearer it was that this was a tremendous opportunity. And also to do that, you only have to know that the only two categories of products approved to treat critical misty me in United States. But the FDA are plain old balloon angioplasty, and I think one single after rectum e indication. So this is one of the hardest absolute erotic situations and cardiovascular situation to deal with, and it's a nice to a gunfight, right? And the opportunity to make a huge impact on that space is what drew me. And also, I mean, one slow was a clean slate at that point, so there were no employees. Everything was done by consultants, and so I was able to come in to a well funded situation. We just pulled him a 15 million Siri's B and build a team that was the right team that I wanted. And that's the first time CEO. You know, they're a bunch of things that are critical, and one of them is funding, and two of them is the right team setting and three is just the right technology. And I felt like all three of those things was there because, you know, I mean, is the first time CEO. By definition, you don't always know what you're doing and or factors you could put in your favor the better. But really, it was the opportunity to change and deliver value of space. And that's what motivates our whole team. Every day is the fact that we're taking these patients who are headed for a terrible, terrible medical outcome and, you know, saving limbs of saving lives. And that's what we're trying to

Scott Nelson:   25:37
God. It's certainly it's it's It's pretty easy to understand, sir, the compelling nature of the technology to do something kind of truly disruptive to that segments of the patient population, for sure. But on that note, when you think about there's this whole other animal right, which is the business side of med tech. And so when you walked into this situation, which sounds pretty appealing, right, the clean slate, well funded opportunity Billy filled out your own team. What were your early thoughts about actually making this a real thing in Europe, maybe, and really, maybe more within the context of coverage and reimbursement? How do you actually get players to pay for this technology?

Dan Rose:   26:10
Well, I think it goes back to, you know, some of the issues we talked about before with the market. I mean, we achieve see Mark with a relatively small study and, uh, even though, and we've done a lot of work in this basement I joined. But even though the health economics of lymph flow are, I mean just tremendous, I mean, you really can't ask for a better health economic value generative story because you're standing right next to an extremely expensive, extremely who are out comfort stations. And if you can avoid that, which is what we do, you know you're gonna deliver Ah, lot of value for the technology of providing. But ultimately you need a lot of data to prove that to a reimbursement authority. So and that's true for France. It's true for Germany. It's true everywhere. And so what? We decided pretty early on his we're not going to commercialize in Europe. Now we're gonna focus on building a global data set part that's gonna be done through an early feasibility study in the US and then a little trial. And once we do that, then we're gonna be able to come back and get the reimbursement we need to deliver maximum amount for the for the company. And so we've done a bunch of different things that are different from maybe what start ups to. But one of them was just saying, OK, we may be in Europe, and it may be obvious to try and start commercializing, but it's a very expensive process. And if you can't get formal reimbursement, you're gonna be swimming upstream in a very difficult situation for the foreseeable future and probably wasting a lot of money that you could be spending on other things like generation for the clinical data and further R and D. And this is one thing I'd like to stress. I mean, if I have learned anything over my time and multiple startups is that you can never stop innovating.

Scott Nelson:   27:58
You

Dan Rose:   27:58
can't think that you have solved the problem because, you know, as you go forward, you should be learning from all your experience And if you are in a competitive space and this harkens back to a little bit what you alluded to, which was the direct for medical experience. If you're in a space where you may have the right solution, an advantage over what others have today, including the strategic, everybody's innovating and they will catch up. And if you don't continue to keep your lead or advance your technology, ultimately you'll lose relatives. I think that's one of things that we're doing it lymphoma. I mean, we are just about to launch our second generation system. Third generation system is in development, were deeply involved in a generation and making sure that our knowledge and the experience we've gained is gonna be value for the company, and it's gonna be translated the better products for people. So that's not easy because R and D costs a lot for a start up. But I think we if you've got the right board and you've got there is strategy, you need to continue to do that because, you know, you know you have to be executing on your five year plan, not your one year plan. And the five year plan has to be updated every year. So I think those are Those are different, different ways that we have thought about it specifically of reimbursement, though for the US we've benefited, and I wish I could claim responsibility for this, but it had nothing to do with me. We achieved what was called back in the day the expedited access designation for the FDA, which became the Breakthrough Technologies information and Summer CMS Medicare in the U. S. Published guidance that that indicated that, you know, Breakthrough Technologies would be eligible upon FDA approval for if they met certain certain requirements for on end. And this is a tremendous advantage to the U. S. System. Now is if you get breakthrough. Ah, if you get a break your technology indication, you have a very high likelihood of having reimbursement when you launch in the U. S. And I think that changes the game. I wish that were true in Europe, but it's not. So we're very focused on that, because we can We can now move forward with confidence that when we deliver the data we're gonna deliver, we can immediately start delivering the device to the community that wants it

Scott Nelson:   30:20
on that note. Did Dink We spend a little bit a little bit of time talking about that breakthrough technology in your experience, what is? And I know you're a regulatory expert, per se, but I have a feeling you know enough to be pretty dangerous there. What's the likelihood of a technology be accepted into that program with FDA? Well,

Dan Rose:   30:37
we've seen a raft of them. I mean, if you track it, I mean, it seems like one every week has been getting Ah, the dramatics got one just a couple days ago. I mean, ultimately, you have to be focused on an area clear unmet need for the U. S. Healthcare

Scott Nelson:   30:51
system or

Dan Rose:   30:52
population. So you have to be. And, you know, it's obvious when you look at us, right? We're serving a no option patient population that is causing a massive healthcare expense and massive healthcare crisis so patients can't be treated any other way by definition, according to our protocols. So we are a breakthrough solution, and I think the very wise you of the authorities in the U. S. Has been well, okay, if this is truly breaks your solution, we need to make sure that there's this interim reimbursement so that people could actually use this when it's available. And I think you have to look closely at the program. But this is a game changer. There's, you know, there's always been talking about this Valley of Death in the US, where you know you get approval, but you can't really sell because

Scott Nelson:   31:37
you're

Dan Rose:   31:37
waiting for his arm. But you don't get in touch, and this really does change the game. I'd like to just mention one other warning because you asked about it, which is something that a lot of starts don't do. But and I didn't do in one start up where I really wish I had. But in lymph flow we did it, which is we spent a fair amount of money on market research, and I think if you're doing something that is new and is in a space that is relatively unstudied. I think there are a lot of medical areas that are relatively on studied in terms of market research. I mean, if they're selling stents into it, if they're selling hips into it, obviously they're gonna be great market reports. But if you want to find out how many no option patients, there are very difficult to do. A back in the day with Tavern. If you wanted to find out how many extreme risk patients there were very difficult to do because nobody treated right, nobody referred them and of a tree.

Scott Nelson:   32:30
So

Dan Rose:   32:30
we invested in the large independent research and we found out that there are just a ton of them out there and we can prove it. And I think that allows us one to raise money because people can really say Okay, when you get there, there's gonna be a market for you and it's gonna be a big market and it's gonna be your market and I think you know, if I raise money once without the market data and then got the market data and it's just so clear if you've got it in your hand and independent, you can answer one of the questions that's quite difficult to answer sometimes for people doing totally so on the business side of things. One of the things that I I wonder if you talked on the mortality rate of things that I know that like the five year mortality rates in these patients, is horrendous. And this is a product that I think I read somewhere, maybe on your US part of your website, that there's 270,000 patients you know, give somebody who's driving the car listening to this podcast right now. Some perspective is 270,000. Is that just the U. S. I mean, is there a business here for a standalone company? Or is this something that you know would sit well in an athletic to me Cos Portfolio? Because once they've tried after ectomy, you know, Medtronics tries that, and it doesn't work. Now they've got something else to go toe. Say this patient's life essentially, Yeah. I mean, I think there are a couple questions in there. I mean, one is as a standalone company we're talking about in just the no option. Patient population. About 88,000 essential procedures a year only in the U. S. About 350 globally and major market. You're talking about a $1.3 billion opportunity in the US alone, and so can it be an independent company? Absolutely. I mean, it is a huge opportunity, and we are positioned to unlike the other parts of peripheral vascular where you know you're competing with somebody else's stands or somebody else's balloon or somebody else's catheter. This is a limb flow market, and so we anticipate, you know, ah, true ability to build a franchise here. Now our technology is technology that is well understood by any sales rep, a clinical specialists in the space. And therefore, would it be a fit with any number of major strategic Salesforce's absolute zone? And I think it is a bit of business. That's how we're thinking about it today. We're driving to that. But ultimately, can it be part of the bag of another company? Absolutely. And you know, I think the more and more were out there, the more that limp was talked about. And, you know, when I started, people were telling me there are no option patients don't exist. Now you goto any major peripheral conference. There are separate sessions on D V. A divan actually should not sponsored by us. And this is becoming part of the lexicon of how people understand how to treat these patients. And it will only go. It will only increase as we go forward. And just next week, we're gonna We're in the late breaking trial that viva, you'll see more data. I mean, this is the beginning of a big, big story.

Scott Nelson:   35:39
And then I want to circle back around to something you said earlier it with respect to market research because it's sort of ties into your answer there in terms of defeat, trying to define the traditional tams and Sam's. I think that's super interesting that you call that out. So I wouldn't have expected you to mention that. So you're in essence if I'm understanding you correctly, you're saying, don't simply rely on off the shelf reports and in some instances, allocate the necessary funds to go study a market independently to determine like riel actual numbers. Because that I don't like that may not only confirmed kind of your suspicions about a market size but also be a really good data point in terms of raising funding to which is obviously needed for any any med tech startup.

Dan Rose:   36:16
I mean, the easiest way to break it down is at the board. Should we spend 30,000,050 million, 20 million euros to develop a product for a market that we don't understand very well? And the answer is obvious.

Scott Nelson:   36:30
Yes,

Dan Rose:   36:31
just spend a couple $100,000.100,000 dollars. You know, we're in engineering led space, and that's the engineering medical, and that's absolutely right. But ultimately, you really better understand if there's gonna be someone there to buy your product and what the dynamics are before you blow Tana money going down the wrong way,

Scott Nelson:   36:52
right?

Dan Rose:   36:52
Not understanding the needs of the market and understanding how many people are really out there for it. So I think it's it's something you know. Money is precious for every startup. But if you're not doing this work, I think if you're in a space where ill understood and there are those spaces right where it's still understood, then you do have to go out there and do the work yourself. Don't try and triangulate yourself. I think the VC see right through it. But you can say, Look, here's independent. You know, we have 51 our interviews with experts in this space that we didn't do, and they're not only telling us that our market is bigger than we thought it is, but they're telling us they're all these other applications for a technology that we didn't think about. I mean, imagine what kind of response you get and how much easier it is to proceed on almost every level with the confidence that if you get there, there's gonna be someone who wants to buy what you're selling again. It's a takeaway. I didn't do it at the beginning, but I would I would never not. You

Scott Nelson:   37:50
got it? Yeah, super interesting that that's that's something that really stands out. Good key takeaway there for myself. I know for sure, and I'm sure for other listeners as well. I want to be cognizant of time here, Dan. But one other follow question to something you mentioned earlier about clinical studies and really doubling down on the collection of clinical data. Is there anything that stands out or that would be good for others to learn from. In terms of your approach to where you're doing and where you're you're sponsoring and rolling on study center, you mentioned Singapore was one a year was sort of the launching pad largely because you had an engaged physician there outside of that, within your approach toe win and where you're starting these clinical studies. Yeah.

Dan Rose:   38:26
I mean, there's a lot of you have a lot of discussions with other CEOs about this because people always trying to figure out what the fastest way and what the best regulatory place to do it where you can collect good data depends a little bit on whether you need long term data or acute data. You know, all these are big factors. I think a couple things that I would just say our critical more than where you do it. And that is excellence in what you do. But it's in pre clinical, right, and in first and man in terms of data collection, in terms of structure is you're gonna live with that data for a long time. I mean, the FDA is gonna want to see everything you ever did right Ultimately, if you're successful and you have to think about that if we are successful, ultimately we're gonna want you didn't get the part of our pack. So do it right if you can and you get If you have the right money, try and do it right, make it fast is great. But just remember somebody's gonna look at that later on, and you need to be cognizant of that from the very beginning. You gotta find a great advocate, great position supporter, someone who is willing to invest the time to really learn with you. So there are a lot of factors and basically you have to get lucky in many ways, I think as well. But I think more important in place is just how you are thinking about what you're doing. Because a lot of times people are doing things quick and dirty. I'm nothing. You can't do certain things that way. Just figure out what's working, what's not. But just remember, everything kind of counts. And if you do it poorly at the beginning or make some mistakes in your assumptions, it will catch up with you, that's for sure.

Scott Nelson:   40:07
Good stuff, Norbert, If you're it. If you're cool with kind of moving on, I'd love to kind of kind of summarized maybe some of this. Some of this discussion through a couple questions in regards to your previous experiences. Dan, what Both direct flow medical as well as some time you spend at the High Plains, which is, Ah, boutique venture capital firm, Thinking about like those experiences there. And I know you've kind of covered a few a few of the kind of key learning points or things that you do differently. But is there like one or two other things that air pieces of advice that that you've learned from in those experiences that you, you know, you you'd offer up to other med tech entrepreneurs or people that are better at med tech start ups?

Dan Rose:   40:43
I think there are a few things I mentioned some of them. One is about just never stopping or indeed, you know, I mean, I think I think that's continuing to innovate. Week startups do innovation so well, in a way, the big companies can't do it, and that these are advantage in a way right were nimble, and we can learn and we can move fast, so keep doing it right and be responsive to what you see out there. Don't just believe you built this perfect little thing and everybody should come in. Love it right. I think there's never been a medical technology that couldn't be improved, and sometimes it's not your technology, but sometimes it's no look. I don't need to keep harping on about Taber, but truthful inflow certainly is. A lot of the innovations and improvements and outcomes came from imaging, For example, you know, understanding how to prepare for a procedure, how to use imaging during a procedure for a lot of interventional things. These air key. So it's not just about your technology is about setting it's in and making sure that you're tracking that. And I think the only other thing I would say is you've gotta have a Plan B. Things go wrong. I mean, if there's one rule, if things go wrong and it's usually things that you don't want to go wrong, go wrong. So if you can have a fallback strategy, make sure your board knows that it can go wrong and knows that you have a fallback strategy. I mean, I think you should all be in the same boat together. And so don't fall in love with single pathway. Have a Plan B and that saved me in a number of settings, and it seems like extra money. But we all buy insurance in our private lives. So trying to understand that

Scott Nelson:   42:23
if you

Dan Rose:   42:24
don't solve it that way, there is another way and you're already working on in the background. I think there's a real takeaways. Ah, hard earned, painful

Scott Nelson:   42:36
lessons learned by fire. Well,

Dan Rose:   42:38
in one thing that I have heard of companies that have done that midstream and what has prevented them from making maybe some new alterations or changes is the approval process that they have gotten their hands slapped because they made a change without then putting it back through FDA trials. So, you know, I found that interesting when you had mentioned that you guys had already well, on your third generation or improvement, I wondered, Do you have to then go back and re submit and, you know, does that cost an additional money to go through those trials again? Well, you know, that's a great point because everything needs to be done in the context of the regulatory strategy, right? And you need You need tremendous regulatory capability in house. One thing I didn't win flow very early on. We had a great consultant who helped us get the expedited access pathway and was doing a great job. But we're moving into starting an early feasibility study, and I said, Look, this is great, but I cannot go around telling people that our main goal is the companies to get FDA approval and not have complete ownership of our regulatory interaction with authorities in our strategy. And so I invested in just a fantastic Zachary Woodson is, is an incredible regulatory guy, ex Medtronic and correct Medical and Connor and I mean down the road and just amazing person difficult, expensive toe Have a full time resource. You know, you've got to do. You're already in the context of what can we change? What can we do without restarting right? For Can we do use this in this trial and then, in the next trial, be ready to swat in the improvement? So these are not easy things to navigate. So I think investing in regulatory ownership of the process, I think, is key. And, you know, I decided very early on the higher American to do that because I felt that I wouldn't hire an American to manage French regulatory process, right? So I figured I should have an American Thio higher run an American process and not a French person. So I think I think culture also matters that doesn't create too many, uh, angry listeners out there. But I think culture does matter some of these things as well with regulatory authorities. And until he made that investment and it's paying off because you can't consider or Andy and Cycles without really knowing what you can and can't do.

Scott Nelson:   45:07
That's good stuff. So I know we're short on time here, so let's go and get to the rapid fire questions. Dan, if you're if you're okay with that,

Dan Rose:   45:15
Yeah, sure

Scott Nelson:   45:17
sounds sounds good. So, 1st 1 what's your favorite business book?

Dan Rose:   45:20
You did. You did let me think about this beforehand, but the answer was to me, it was so obvious right up, right right off the bat. It's not a business book, but I think I thought immediately about endurance. The story of the book. After landing Lansing's book about Shackleton and

Scott Nelson:   45:36
going

Dan Rose:   45:36
to the south trying across the South Pole. I mean, this is you want inspiration for being in a start up a medical device startup. I mean, I think I think looking at someone who set out to do one thing and survived a lot of different unanticipated challenges in an amazing way, I think for me is you know, I look at that and say, You know, this is an adventure alone, and we can't pretend to know what's gonna happen. We can try, but but life surprises you, and it's all about how you respond and how you carry forward. If you really pressed me, I have to go back to Bill George and authentic leadership and kind of a tronic reference, but haven't been trying for years. But yeah, shackleton and endurance have to go with that.

Scott Nelson:   46:18
All right, Cool. Still, it's still bleeding. Still bleeding a little blue. It sounds like on that note. 2nd 2nd rapid fire question is, is there a business leader or mentor that you most admire? One that stands out in your career?

Dan Rose:   46:32
Well, I mean, you know, then then now you've asked me to be a slightly heretical because, you know, I'm a huge fan of ah Micro Solomon Edwards. You know, I mean, I think this whole tat Taber you know how it's been developed the whole story of how they manage comprehensively the, you know, the innovation side, the clinical data generation side, the reimbursement side, the market development side, kind of a trust, fear of ferocious competitors on the commercial end. I mean, I just It's a really, really cool story. I saw him speak in a very small group one time, and and you know that that's a story. I think we can all welcome say, that was done, right?

Scott Nelson:   47:15
Yeah, There's no doubt every time I'm based here in Southern California and I mean, I drive by the Edwards H Q. Fairly, often, maybe like once, once a week or once every couple weeks, and I every time I look at that, those big buildings, it's always just impressive what what they've been able to do with with that space for sure. So last rapid fire question before we go Ah and conclude the interview. What one thing would you tell your 30 year old self?

Dan Rose:   47:42
Well, you know, at some level. You know, I wouldn't want to spoil the story, right? You know,

Scott Nelson:   47:47
uh, um blood.

Dan Rose:   47:52
But I would say, you know, I spent a lot of time, especially my day's big company worrying about politics and whether I was inner out or what was gonna happen and many things that didn't have any control over. Right. And, uh and I think I would have had, Ah, lighter, many, many more hours of sleep and and and, ah, lighter experience overall, if I just realized that you can't sweat the politics, you know, you gotta just focus on building teams, working with people, getting things done and that everything else just fix itself. Over time, it's arrived, and it's gonna be ups and downs, but it's been just fantastic. And I'm really looking forward to seeing what's next.

Scott Nelson:   48:32
Yeah, that's such such good. Nice certainly resonates with me for sure. So, Norm, or anything else to add before we go in wrap wrap this up?

Dan Rose:   48:39
No, no, I just want to thank Dan for his time. That was really interesting, insightful stuff.

Scott Nelson:   48:46
There's no doubt, Dan, Thanks. Thanks a ton. For your time. I mean, I always feel like in a conversation like this. It's hard, almost to like, you know, concluded just cause there's so there's so many other things that we could dive dive deep rod. But ah, you know, maybe maybe we'll do, Ah, different version of a podcast some point where we'll do that. That the Tim Phares three hour interviews, you know. But, uh, that's that's right.

Dan Rose:   49:09
Maybe you could make Maybe you can have me back one day when, when, uh, you know and I'll tell the wind flow story in full

Scott Nelson:   49:17
there. There we go, There we go. I always love the part, the part Two stories. We can kind of come here and look at what you guys accomplished. You cannot fire. That's right. That's right. If you want to go Maura and learn, learn a little bit more about Lim flow. I I encourage you to go to the website Lymph flow. L I m f l o w dot com will include that in the show. Notes for this interview at med cider dot com. Again, Thanks for everyone for listening in Lynn Flo's Got it, Dan in his story, and what they're doing when Flo is is very compelling and it will be really interesting to see See what the what you guys accomplished. So thanks everyone for listening in until the next episode of Med Cider radio.