Medsider: Learn from Medtech and Healthtech Founders and CEOs - Essential Tips for First-Time Medtech CEOs: Interview with Dan Rose, CEO of LimFlow

Episode Date: March 12, 2020

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...

We just pulled in a 15 million Series B and built a team that was the right team that I wanted. And that's as a first-time CEO, you know, there are 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, as a first-time CEO, by definition, you don't always know what you're doing. And the more factors you can put in your favor, the better. But really it was the opportunity to change and deliver value in the 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 is saving lives. And that's what we're trying to do. Welcome to MedSider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host. I recently had the opportunity to interview Dan Rose, the CEO of the French-based med tech company Limflow. Founded in 2012, Limflow has transformed the peripheral vascular space

by providing a life-saving option to patients suffering from CLTI, otherwise known as critical limb-threatening ischemia. Limflow 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 Limflow in August of 2016, Dan had more than 16 years of leadership experience in the medical device and venture capital startup arenas. Most recently, he was VP in general manager of the IMEA region for direct flow medical. Here are a few of the topics we discuss in this interview with Dan, how Limflow used a concept that's been in existence since 1912 and then 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 Limflow, why it's essential to find a physician champion willing to invest time and energy into your technology, overcoming the regular, challenge is presented by an ever-evolving MDR landscape. Reasons that convinced Dan to assume his first-ever CEO role at Limflow, the importance of ongoing R&D and innovation to accompany success and sustained relevance, why the FDA Breakthrough Devices program has been a game changer here in the U.S. The importance of having a mentor and why Dan would not give advice to his 30-year-old self.

There's a lot more we cover in this wide-ranging discussion with Dan, but I wanted to call out a few things before we get started with the interview. First, joining me on this episode as a special guest host is Norbert Juiced. Norbert and I go way back. In fact, we used to sell vascular devices into the same cath labs. Now he runs sales, performance resources, and specializes in recruiting for medical device sales and marketing positions. And he's quite good at it. Norbert not only 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 Norbert and his background. Second, after about a two-year hiatus, I've recently started to record and published MedSighter interviews again. And there's a good reason for that. I've been knee-deep in my own startup at Juve. That's J-O-O-O-V-V. And we manufacture light therapy devices, which is technically referred to as photo-biomodulation in the world of academia. It's a really interesting space because our products are class two medical devices,

but we're following a more traditional or classic direct-to-consumer online commercialization model. It's been a fun ride over the last three to four years and I've definitely learned a ton. So if you follow these MedSider interviews, I'll be sharing quite a bit about my experience. So keep listening. And again, if you want to check out juve, go to juv.com. That's j-o-o-ovv.com. Third, if you're new to these Medsider interviews and want to be updated when the next interview goes live, head on over to medsider.com and enter your email address. Rest assured, you won't be spammed. In fact, the only time you'll likely hear from us is when a new conversation goes live. Again, it's super simple. Just visit medsider.com. And right there on the homepage, 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. All right. Let's get to the interview with Dan. All right, Dan, welcome to the program. Really appreciate you coming on, especially considering it's late on a Friday evening your time. Oh, it's a pleasure. Thank you for having me. And Norbert, you're in your captain's chair, I imagine there in Phoenix. You ready to rock? I am ready to go. As the listeners know, Dan, I provided kind of an intro to your very impressive background, but to help sort of contextualize everyone for what you're doing now with lymph flow,

can you give us an idea of the technology, the product, and maybe just walk us through, like, what a typical, who a typical patient is and what lymph flow's technology is helping to solve for? Sure, sure, absolutely. So, I mean, windflow is working in the, you know, in the peripheral vascular space. And so, you know, outside the heart, but in the vascular, and primarily focused on critical limb ischemia, what everybody is calling now chronic limb-threatening ischemia, so CLTI rather than CLI. But essentially, you're dealing with patients who, you know, have compromised arterial

vascular, or either from arteral sclerosis and also from the long-term experience of diabetes and are really at risk of losing their limb. And lymph flow is focused not only on these difficult end-stage patients, but truly on the end-stage patient. And I think the best analogy for this is if we think about where Tabi started or Taver and working with the extreme risk patient population where, you know, surgery was off limits. And the same is true for our patients. We're specifically focusing on a population of patients who have what we term no options. So they have no further endovascular or surgical bypass possibility. So they're essentially being consigned to 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, I mean, there's so many patients out there, you know, roughly 125,000 major lower limb amputations in the U.S. It's, you know, it's becoming a bigger and bigger problem because patients, of course, are living longer with their diabetes and cardiovascular disease, and the prevalence is going up with both as well. So, and if you survive, long, enough, you know, the arteries in your legs are not going to be able to provide enough blood flow to 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 we're trying to keep those patients

from getting a major limb amputation. And this still remains kind of, you know, the morbidity and mortality is extraordinary. I mean, it's listed, New England Journal of Medicine published major low or limb amputation is the fifth or in the top five most most dangerous procedures surgical procedures in the u.s you know average morbidity mortality depending a little bit on above the knee or below the knee but it's roughly 10 percent in hospital following a major lowly amputation so something to be avoided absolutely and mortality is is very high in the first year even if you do get out of the hospital so what we're doing is what a lympho patient is is a thing who is faced with the really all of our patients so far treated are indicated for

amputation and what we're trying to do is use the venous system as a pathway to reperfuse the patient so if you think about the arterial system and arterial sclerosis I mean you have a lot of calcium and plaques blocking the vessel the arteries down into the foot and the best analogy is to think about driving the airport and you get stuck in traffic and you know ways starts to tell you're gonna get there tomorrow and not today, and you look across the median, and you realize that that road, the other side of the road, goes where you want to go. And it may not allow you to 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 valves in the veins going down to the foot and in the foot. and then using covered stents to channel blood from the arterial side in the tibial arteries into the veins and driving it down into the distal, distal petal area, and then healing wounds, which is the real goal, because if you can heal a wound, you can normally keep the leg on. So that's the concept. It's a concept that's been around first 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 percutaneous, reproducible, low morbidity, teachable, adoptable therapy that can be deployed, you know, by whether they're interracial radiologists, vascular surgeons, individual cardiologists, angiologists, anyone working in the lower leg can do this procedure.

And so that's what we're trying to do. It's super fascinating. I think that helps create a little bit of context for the rest of the. the conversation because really curious to learn a little bit more about what attracted you to limb 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 know, kind of go back in time a little bit and understand like how this concept, you know, went from something that was seen in textbook to like applying actual percutaneous techniques and making this somewhat of a reality. Yeah. So, I mean, what had happened is that this has occurred in many different areas of medicine. So the principle, you know, someone proved the principle in a dog, in fact. And then people had done small surgical series, 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 have failed multiple interventions. But no one had ever really done, you know, taking a look at one, how to do it percontaneously, but two, really look at it in a structured methodical way. And there are a bunch of reasons why it's very difficult to do surgically. And 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 wounds, you tend to lose the lag because of the surgical wound. So there are a lot of reasons why it had not been done percontaneously.

But ultimately, what happened was that physician, very well-known cardiologist, Martin Rossman from the UK, who ultimately became the chief medical officer for metronic 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. And 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 can do and prove out in the leg. And being a super busy guy, he went to an incubator called MD Start in Europe, which was founded by Medtronic and Corvidian and Soren and Sofinova Ventures and Versant Ventures as a kind of way to take physician ideas and system and ultimately take them and incubate them if they

could, you know, if they looked promising. So that's where the experience and history came together to try and start this percutaneous approach, acquired some IP from the old transvae. business that was acquired by Metronic and founded by Josh Mackauer at NDA and started to build prototypes and a business around that partner at MD Start, Tim Lennahan, who's an incredible guy. He really took the lead on founding the business in 2012 and I joined in 2016. So there was a kind of four-year period where they were developing the prototypes and doing first in man in Singapore before ultimately, you know, moving into the CE marking phase. You know, when I was with Cordes, we had that outback reentry catheter.

And that's kind of what this reminds me of that I can just picture this doctor who's almost like a mechanical engineer in their mind trying to reinvent 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 we needed to develop internally to optimize the procedure to perfect it. And there's several pieces of it that were not available off the shelf.

And so what windflow is today is kind of a suite of technologies. It's an ultrasound-based crossing system with a needle on an arterial send catheter, if you think about that way from ultrasound and a venous receive catheter. It's a valvulatome, a reverse or push valbulatome that allows us to, in a very elegant way, knock out the valve in the veins. And then a conical covered stent so that we can match the diameter of the artery with the vein, with the diameter of the vein, and then cut 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 an experience of doing exactly that, taking what's there and learning as you go. And I think that's something that anyone who's been involved in early innovation, the med tech space, can really understand. And in terms of a timeline, Dan, can you help us understand that a little bit more? I know you mentioned you joined in 2016. When did Dr. Rothman first bring this concept to MD Start? I think it was around 2011. And then they founded the company in 2012. And it did first in man in Singapore through basically being introduced to a masculine surgeon named Stephen Coombe, 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 physician who's willing to invest their energies and passion into 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 led to the raising of the series A and the doing of a small CE marking study. And on the back of that, being able to raise a series B and really take the company and hire a full-time CEO, which was myself, because Tim was working on several projects at the same time. So, I mean,

MD Start is a fantastic concept because what you end up with is a startup that has, has been incubated by a person, a CEO with tremendous amount of passion, but also a tremendous knowledge about how to do it well. A lot of first-time CEOs don't know how to put together IP portfolio. They don't know how to 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 for the first time. If you have somebody that's doing it for their sixth or seventh time and has had tremendous success doing it, then I think you're going to end up with a higher likelihood of success over the long term.

Got it. And so, oh, go ahead, Norbert. I was just going to say, what determines then, you know, with MD start, Dr. Rossman's a British, you know, physician, do they, what makes them decide whether you guys start up in Europe or, you know, go for the 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, MD Start was based in Switzerland back then. They think Martin Rothman was

living in the U.S. Tim Linhan 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 there, and I had the IP there. There's a tremendous amount of medical engineering consultancy talent in Germany and sub-suppliers. So ultimately, it was a very important. was set there because MD Start was European-based. And at that time, I think the CE-Mark process was certainly, it was a whole lot easier and more predictable than it is today. And I hope I don't have to spend 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 aim for, right? Getting C-E-Mark, generating

the value of the company, generating on the back of that CE-Mark further funding, which is the life-full out of a startup. And so that was kind of how they structured it. I think people now are looking much more at the EFS, you know, early feasibility program in the U.S., which we've completed a 32 patient EFS, so I'm pretty familiar with how that works as a pathway than going through the old CE marking. You know, but we're European company. We're based in Paris, and about half of our employees now are in Europe, and then half for Wimflow are actually in the U.S. So, and our leadership team is actually split between Europe and the U.S. We're truly international organization.

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 MDR, but I would like to spend a little bit of time. So I don't want to go too into the weeds because it's something that we're dealing with with Juve, you know, the company that I'm involved with, it's a startup that I'm involved with. And trying to navigate those waters can get really complex, like really quick. And it almost seems really unnecessarily complex. And so can you just like speak to maybe what the challenges are with MDR? really within the context of what other entrepreneur,

MedTech entrepreneurs should be thinking about. Yeah, I mean, I think it means a lot of, MDR means a lot of different things to a lot of different people, right, in groups. I mean, if you're a Class 1 device, I mean, you know, you may be asked to generate clinical data on things that are very difficult to generate clinical data on, right? It's difficult to do a clinical trial on a scalpel, you know. I mean, some of the things that are being asked to recertify are just difficult,

practically to do, especially when you have hundreds of different products you're saying, right? It's not incredibly difficult for us at Limflow because, you know, we are generating a lot of clinical data. We're already, you know, a class three system. And so a lot of what MDR 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 notified bodies, right? You can't get things push through because they're so busy trying to figure out the MDR 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 startup, you have to really try and understand, can you understand and determine well in advance

what the notified body is going to want from you to get approval? And I'm not sure they can clearly tell you today if you came in fresh. Two, 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 is your timeline going to be? Because our timelines, and I won't share who our notified body is or what the timelines are, but they're very long and very unpredictable. And if you're trying to, for example, use CE mark as a milestone for funding, well, how do you know how much funding you need if it could be six months for a response

or 18 months for a response, right? So I think it's become really challenging to have a predictable system, which, and it's created, I think, just a higher bar overall, which in some ways isn't a bad thing, but in other ways is making Europe less attractive as a place to start. And I do think that some people are certainly either choosing to go to the U.S. first or 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 for regulatory approval rather than first. And as 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 this shift happen. Yeah, it's really interesting because that used to be such a trend is to commercialize 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 wins are changing. They are, and it will be sometime before with the best will in the world. And I think, you know, the parties are trying to do their best, but it's a real challenge. I can say that. Got it. The other thing that is interesting that, and I don't think we maybe necessarily need to talk a lot about it, but I was unaware that there's a strong med tech 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 Malaysia and how many other companies are pulling out of, you know, Shenzhen as an example. But Germany, I didn't know that was a hotbed for med tech. Sure, there's always been a strong med tech presence in Germany. I mean, think about biotronic, which is a, you know, I mean, you don't hear about it much in the U.S., but is a massive multibillion-dollar family-owned, but huge presence. And a lot of engineering talent out of there, you know, the Abiodi-Med technology came out of Germany.

You know, I mean, go down the list. If you include Switzerland in there, then, you know, you've got Semetis, you've got Yanval. I mean, there's just a list after YoMed. acquired by CryoLife recently. I mean, just, you know, story after story after story of large med tech presence in Germany. And remember, Germany in Europe is the place you commercialized first. If you can get reimbursement, I mean, Tavi 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 U.S. approval and have data from Germany to do so. So it's a great place to be. We're now in the French ecosystem, which is also a good ecosystem, but, you know, not truly comparable to Silicon Valley or Minneapolis. I mean, those are kind of a different, you know, an order of magnitude different in terms of, you know, what's going on. Sure. Norbert, if you're, if you don't have anything else to add, I'd love to, like, use this as a transition point to talk a little bit more about, Dan, what you, what jury did

Limflow 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 discussion about maybe some of the learnings you took away from your experience at Direct Flow. But, you know, what was the appeal to Limflow, you know, back in, you know, 2015, 2016, when you joined the team as the CEO? I had known Tim Huanahan for some time, and he'd actually talked to me about Winfell a couple years before I actually took this job. But I was very clear. I'm like, that's not really my stage, the early prototype stage and first in man.

I mean, I've been involved with it. But I was really looking forward to, you know, the time when the technology could be somewhat de-risk because, you know, you're as a CEO. You're taking on any startup job. I mean, you're really investing yourself in completely. in the technology, but I had looked at it and tracked it, and I could see the potential. I mean, a lot of what we do in MedTech, for better or for worse, is, you know, iterations or improvements on current technologies, you know, a new flavor of stent. And I'd done that.

I mean, I led marketing for coronary vascular for Medtronic and the druggling stent business, etc. 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 CLI or CLTI space, and the more I understood about windflow, 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 amistemia in the United States for the FDA are plain old balloon angioplasty and I think one single atherectomy indication. So this is one of the hardest astelosclerotic situations and cardiovascular

situations to deal with, and it's a knife to a gunfight, right? And the opportunity to make a huge impact on that space is what drew me in. Also, I mean, Linflow 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 in a 15 million Series B and build a team that was the right team that I wanted. And that's as a first time CEO, you know, there are 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, as a first time CEO, by definition, you don't always know what you're doing. And the more

factors you could put in your favor, the better. But really, it was the opposite. And the opportunity. opportunity to change and deliver value in the 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, it's saving lives. And that's what we're trying to do. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider premium members. If you're not a premium member yet, you should definitely consider signing up. You'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Renee Ryan, CEO of

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