Medsider: Learn from Medtech and Healthtech Founders and CEOs - The Power of Networking in Medtech, Challenges in Developing the Renal Denervation Market, and the Value of Cross-Functional Experience: Interview with Shaun Bagai, CEO of RenovoRx

Episode Date: January 22, 2017

Shaun Bagai is the CEO of RenovoRx.  He has over 16 years of medtech experience across multiple functional areas like clinical research, sales, marketing, and market development. He was instrumental in developing the European market for renal denervation, which led to the acquisition of the first renal denervation company, Ardian, by Medtronic in 2011. Most...[read more]Related StoriesWhy Intersect ENT is an Example of Hope for the Medtech IndustryAre Medical Device Models the Key to Building a Lean Medtech Startup?Substantial and Sustainable – 2 Words That Medtech Companies Should Get Used To 

Welcome to Medsider, where you can learn from experienced medical device and med tech experts through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey there, ladies and gents. Welcome to another edition of Medsider Radio, brought you from the WCG Studios here in Minneapolis. If you're new to the program, MedSider Radio is where we learn from MedTech and other healthcare thought leaders through uncut and unedited. reviews. Just a few quick messages before we get started. First, I send out a free email newsletter about once per month highlighting my favorite med tech and or health care related stories, the ones that I personally get a lot of value from. I don't send the newsletter out very often,

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they're giving it to our first 15 listeners for free, So go to reachfiredigital.com, forge slash medsider. Again, that's reachfiredigital.com forward slash medsider. Grab that blueprint. Okay, on to the episode. Hey, everyone. On today's program, we've got Sean Begai, who is the CEO of Renovo RX. He has over 16 years of med tech experience across multiple functional areas like

clinical research, sales, marketing, and market development. He was instrumental in developing the European market for renal de-unervation, which led to the ultimate acquisition of the first renal de-inervation company, Ardian, by Medtronic in 2011. Most recently, Sean led global market development for Heartflow, which included directing Japanese market research, regulatory payer collaboration, and key opinion leader development to create value resulting in a company investment to form what is now Heartflow Japan. Here are some of the things we're going to cover in this interview.

Sean's reaction to Medtronic's acquisition of Ardian back in 2011. The power of mentorship and networking and their impact on Sean's career. How Sean landed in MedTech with Transvascular before it was purchased by Medtronic in the early 2000s, how Sean's experience in a field-based sales capacity has helped him throughout his Medtech career. Sean's transition from Medtronic to Ardian and the biggest challenges he faced while developing the market for renal de-innovation. Sean's cross-functional experiences while helping to build Heartflow Japan. What Sean and his team are building at Renovo RX and what lies ahead for the company. And lastly, Sean's favorite business book, the CEO that inspires him and what he would tell

his 25-year-old self. So without further ado, let's get to the interview with Sean Begui. Sean, welcome to the program. I appreciate you coming on. Thank you, Scott. I appreciate the opportunity. Before we talk about RenovorRX, the company that you're currently CEO of, let's start with Ardian and take us back to the time when Metronic acquired Ardian in November of 2010. What were you doing for them at the time? So November 2010, I maybe rewind the clock a little bit more. I was pulled into Ardian to kind of help wrap up their existing clinical study that had a very positive result, given both my clinical research to my sales background, and then transition them more into market development and sales.

So back in that time frame, we had launched in Europe, kind of a pilot launch. And my role was mostly European market development. Germany being the biggest market. I really spent most of my time in Germany. In fact, I was flying it almost every week to get the product off the ground. So my job or my role was training physicians and became one of the lead trainers at Ardian, market development work and sales work. Got it. I wanted to start there because I think most of my audience will be familiar with Ardian considering the size of the acquisition by Medtronic. And on that note, it was a very sizable acquisition considering the size of Ardine at the time. I know Reno DeNorvation was a very, very sexy sort of therapy. I say was sort of in the past tense because, you know, I don't know how many companies are, you know, are still developing products for Reno de Innovation. But on that note, did the large acquisition surprise you, just as much as it did a lot of people kind of from an outsider's perspective. You know, to be honest, it didn't surprise me all that much, given the market potential there,

we've all living through my days of Medtronic or many years at Medtronic in the stent wars, so to speak, we were basically creating a market and hypertension that's four times the stent size as far as market size goes. And it was really creating a brand new market for something that hadn't really been paid attention to. A lot of the drugs that you know of for hypertension or treating downstream effects of the core issue, and Ardian really found a way to, I wouldn't say cure, but to potentially treat the core of the disease and the market potential is huge. I think the potential definitely was there. As you probably know, I think there were about 70 companies that had started to embark down a road of development in that same space soon after the acquisition. And to date, there are still,

I think a lot of companies were wiped out, a lot of the funds right up, but including Medtronic, there are a lot of companies that are trying to revamp the technology, take the learnings, both from the positives and the mistakes that were made previously on study design and even technology to some small degree and make that successful. So I don't think it was very surprising. I think the results of the next clinical study were the most shocking to most, especially for people on the inside. We all worked very closely with the physicians firsthand, and we've seen patients that really were able to reduce a lot of the medications and increased quality of life and potentially life extension as well from the treatment. So I think the technology definitely does work. I think the

studies need to be designed better, and that's what I believe metronic has restarted the next study with the next generation of device as well. So surprising acquisition, not so much. Surprising results from the next clinical study, absolutely. Yeah, it's a good point. I know Medtronic is still enrolling patients, I think, and I think it's HTN3, their U.S. trial right now. And I believe Boston Scientific still in the game. I think St. Jude might be as well. I don't recall the list of companies off the top of my head, but you're right. I mean, you mentioned coronary or stent wars, I should say. I mean, it seemed like there was, renal de-inervation wars, you know, at the time of, you know, at the time or shortly thereafter, you know, Medtronic acquired Ardian. Before, I want to definitely get into what

you're doing now as well as kind of your career in med tech, because I think there's going to be a lot of interesting antidotes for a lot of people to learn from. But before we go there, your general thoughts on renal de-inervation considering, you know, the initial results of the trial back in I think was that 2012-ish, something like that, maybe, early 2013. And then seemed like, you know, based on those results, a lot of people exited the game. Are you still, you know, even though you're not necessarily involved in that space anymore, are you still, you know, hopeful that, you know, renal de-irvation will become a therapy that most that patients will have access to at some point in the future? Absolutely. I'm actually very bullish in the technology. It's something that I was able to, and that's one thing I love about being in this type of career, is I get to dive in the science very deeply. Deenervating the sympathetic nervous system definitely made sense. If you looked at the early studies that Ardian did, we actually denervated one kidney at a time and we showed a reduction of hormones that were then caused by the cascade of the sympathetic nervous system. So we did definitely improve concept. The science was working and definitely made sense. I think the aftermath is really clinical study design.

patient selection could become a primary player in this. And as far as treatment goes, I'm not sure if ablating each renal artery with RF energy X number of times is the most optimal. I think whether it's RF ablation or cryoblation or some other way of attacking the sympathetic nervous system that's hyperactive or overactive, given lifestyle choices and kind of the diet that people take makes sense. So I'm not sure what the end result will look like, but I think some level of denervation for hypertension is going to be a major treatment option sometime in the future. having a crystal ball, I'm not sure if it's a few years away or many more than that. And it seems like I still, you know, converse with, as you do probably as well, you know,

people that that are still, you know, active in that space or loosely affiliated with their de-inervation space. And it seems like they all kind of think along the same lines, you know, those that you included as well as others that were closely involved with the, you know, with the early trials are still very bullish and very positive on what that may eventually look like. So cool, just wanted to kind of get your brief take on that. So before we go, you know, kind of rewind the clock all the way back to your early days at transvascular. Let's level set the audience. I provided, you know, your bio, of course, in the intro, but tell us a little bit more about what you're doing at Renova RX, the product that you will eventually commercialize in the

general sort of therapy or disease state that you're after. Of course. So Renovar RX has developed a delivery system, if you will. It's a dual balloon catheter that provides a lot of flexibility and adjustability on delivering therapeutic to the peripheral vascular. The advantage here is we're able to stop blood flow to a segmented part of the artery and deliver at high volume, high doses of therapies. Initially, the catheter has been used in gonatal veins sclerosis, been used for liver treatments. We're doing a couple of studies right now in the pancreatic cancer space, given the large unmet need for pancreatic cancer. One of the biggest issues with pancreatic cancer treatments to date is that the drugs simply do not get in the tumors. The tumors, unlike other solid

tumors, using liver as comparison, are relatively avascular or hypovascular, meaning that there aren't a lot of feeders feeding the tumor, so there's not an easy target to deliver localized therapy too. It also poses a problem when you give systemic chemotherapy. The systemic chemotherapy favors going everywhere except for the pancreatic tumor because of the lack of blood supply. So this catheter, the renovo calf, is able to isolate segments of their artery that feed the tumors and we're able to give high doses of chemotherapy. And we've been studying this now in a post-market registry study to date. So really the first focal point from a clinical research standpoint is pancreatic cancer where there's a large unmet clinical need.

Thanks for the overview there. I appreciate it. And you did receive a CE mark back in late 2015, correct? Correct. In fact, we're CE mark and subsequent FDA clearance. We're cleared back in late 2014 for the broad indication of delivering therapeutics for peripheral vascular. If you look at the space of kind of localized targeted delivery, most catheters in the space, including interventional oncology, have a broad indication. It's very difficult to get a drug device combo cleared, as you can imagine or know of. So in this space, it's very common to have kind of a broader indication, let physicians decide which vessels would make most sense to treat and what therapeutics to deliver. Got it. Very good. All right, cool. So I definitely want to dive more into your experiences

at Renova RX and kind of what the lessons that you've been able to take throughout your career and how you're applying them to what you're doing now. But let's take the next few minutes and kind of dive a little bit deeper into your background and your career. So you started as a clinical research manager at Transvascular. I don't have the date in front of me, but this was, I think, correct me if I'm wrong, but your first foray into the world of med tech. So tell us a little bit about that experience and what got you into the medical device space. No, it's funny. Sometimes careers happen by luck. I met transvasol, even to rewind the clock a little bit further. I met transvascular back in 97 when I was doing a summer internship at the Stanford Animal Lab. And the clinical research manager at the time said, hey,

if you ever need a summer job or maybe even a winter break job, we'd love to, and we've got research associates. If you want to come join us, that'd be great. When I was applying to med school, I had a year off basically between what would have been university and med school, and I called up and said, how about a job for a year as opposed to a summer? And they had just someone similar as a research associate departing from med school who was helping with preclinical research and different clinical research aspect. And after a few short interviews, I was able to secure that. So I spent a year at transvascular more as a research assistant or research associate, or at least that was the plan and then go off to med school. I was very lucky to then gain Josh Mackar,

as you, Dr. Josh Mackor, as you probably well know, as a mentor. who over the course of months steered me to maybe consider different options than going to med school. So I started off taking pictures of pig hearts and packing catheters for animal studies and was quickly able to get in a position of doing more physician training, more animal work, and then eventually taking over the clinical research activities at transvascular. Once, and this is kind of the funny story is Josh came up to me and closed the door and I kept questioning Josh or peppering Josh with questions on why he didn't practice medicine as an MD given that I was med school bound. And he finally said, look, I think you'd be great in the industry,

given what you've done in transvascular so far. Why don't you tell your boss you're not going to med school? And then when you get into med school, make it a more difficult choice, because by then your career should have taken off and you'll probably do something more than just taking pictures of pig hearts. From there, I did just that and said, look, med school may be an option, but I want to see where my career can take me in the meantime. And by the time I got into Temple med school in Philadelphia, by the time I came off the waiting list and got my acceptance, I was already managing clinical research, taking over kind of the three clinical projects we had at transvascular, primarily in Europe.

And by then, I could definitely see a pathway forward in the industry. One of the things that resonated with me most, and this is why Josh has been such a great mentor to me, is that one is that I love diving into technology and then shifting. And I think my career has shown that where I've been able to dive in the science of different technologies. I'm not sure if you call it ADD or just having fun with different areas of medicine. The other thing you recognize, and this is something that he was very passionate about, is that as an entrepreneur, he's been able to, affect many more patients through different companies that he started and helped build. And that really instilled a lot upon me when I decided not to go to med school is that I can affect many more patients by helping build companies and helping do things. And this will kind of play into the

Ardian story and why I went to Ardian as we can talk about that later. But that's really how I got my start in med tech and fell in love with both the device side, the medical technology, the science behind medicine and then kind of layering the business pieces as my career grew from there. Got it. And before we, I think that was the early 2000s. If my my research here is correct. And then you, you know, you transitioned on to Medtronic in a very commercial capacity. But before we go there, what do you think, you know, Josh or Dr. Macauer saw in your early days that sort of caused him to say, encourage you to pursue more of an industry track, you know, than versus the medicine route? You know, it's funny you ask because there

was one thing that always resided with me. And it was that whenever I was given something to do, and this is what I recommend any kind of young person getting started in any career for that matter is I devoured whatever that project was. I try to do it the best I possibly could, no matter how small the task and learn the most I could during that time period and take on as much as possible. I think being naive and hungry, I think it was month three in the company, I asked Josh if I could attend one of the board meetings to learn. Being a CEO now, I know that's definitely not something that a research assistant does is pop into a board meeting. In fact, my older colleague made fun of me for the question, but in retrospect, I think that was just my

personality. I wanted to learn as much as I possibly could. I think the other piece that he saw that he mentioned to me is I like driving things to completion. And I think that's something that he saw on trying to get things done and projects done. There are so many different things and tasks need to be done in the industry at any position that having the ability and the skill set and desire to drive things to completion would probably suit me well if I stayed in that course, if that makes sense. I know it does a lot and it makes perfect sense. I mean, it's like two two characteristics, I guess, that maybe are easy to understand, yet a lot more rare, I guess, to experience firsthand, you know, someone that's really ambitious, but at the same time, you know,

wants to execute and wants to see something, you know, go from start to finish. So very cool. Now, that's a good story. Dr. McHour's name keeps coming up, I think, in these conversations. I recently interviewed Ted Lamson, who you're probably familiar with at Neotrack. You know, obviously he's colleagues with Dr. McHour, they go back to their acclareate days and even before for that at ExploreMed. So let's, uh, and you, the small fact, you probably know this as well. So Ted was the, I think he was the R&D manager or director at Transfascular.

Oh, no, too. So he, yeah, so I worked very closely with Ted. In fact, we had some great trips to Europe together doing First and Man. In fact, I don't know if you get a chance to talk to Ted, you know, he's, I've got about four or five mentors and Ted was the one who was not my direct boss, but he really helped guide and shape my early career by being kind of the mentor and the voice. In fact, he is a doctor by PhD to Dr. Lamson, but he knew more about what we were doing than any clinician we ever met. So he was the one who taught me how to train physicians. And I think you really helped shape my lead part of my career as well.

Yeah, that's good. Now, that interview, if you want to, for those listening that want to go back and listen to it, it's fairly recent, maybe published a month or two ago with Ted Lamson, who's the founder of NeoTracked. And it's great. I mean, obviously he's very bright, very articulate, tells their story really well. But I think one of the big takeaways I had from our conversation was just, I mean, he's so down to earth, you know, and willing to share what he's learned along the way. So I just was very appreciative of that conversation. So definitely a good one if you want to go back and listen to it. That's good to know. What a small world. I mean, what a small world. I mean, especially if you live in Northern California, no kidding, right? I mean, I think everyone that's been in a while, you know, agrees that MetTech is a small. But it's like, you know, these types of discussions where it's like, wow, it really is, it really is small. So, well, especially if you live in in Northern California where you're at. But let's transition on to your move over to Medtronic coming out of transvasculary. You spent about six years in a field-based capacity, both, you know, as a clinical, you know, marketing rep as well as a kind of a pure play sales rep as well. It seems like, you know, quite a bit different than what you were doing at transvascular. So talk to us a little bit about that.

And what I really want to hone in on is your experience in the trenches with physicians and how that's translated into some of your other moves at, you know, at Rien, heartwear and you know now Renovar X. It's a valid question because and again I can't I can't emphasize enough how important mentors are in building one's career and I'll take you back to two you know exact things that push me towards Medtronic are three for that or three people if you will one is is as I decided not to become a physician my goal did I think of the age of 24 25 at that point was to someday be able to help build medical device companies just as Dr. Macauer was doing with transvascular at the time as CEO and founder

And he said, look, Sean, if you want to do this at some point, knowing inherently how products are sold and exactly like you said, being in the trenches, getting the sales experience is paramount to success as an executive down the road. Both coming from Dr. Josh Makar and also Dr. Rayneau Vermani, who is a relative of mine, who's very famous in the cardiac world, she said exactly the same thing. If you're not going to med school, go do sales. And being acquired by Medtronic with such a stellar sales channel, having the opportunity to get my foot in the door. And in fact, I've tried to guide younger people on how to get a job at Medtronic and Sales. And it is very difficult to get that level of sales position.

That would have been an invaluable experience. So I did just that. And the goal there, I think Alan Milanozzo, you're probably familiar with as well, I think he was head of sales around that time. And he basically said, look, come on board. If you can be a marketing manager and train all of their sales reps and sales trainers and physicians on the technology acquired by transvascular, given that I was one of the third. position trainers, then that might be a good transition after a year or so into a sales position. It sounded like a perfect fit and opportunity, given where my mentors were guiding me.

Coincidentally, it took about two years, I think, before a sales territory opened up where I had to manage or take a chance on someone with no sales experience in that position. After a year of training sales reps, I actually went back to Ted Lamson, who has remained a mentor of mine, and said, look, I've been training sales reps. Does that count? Can I go get my next job yet? Do I have to actually do sales? And, you know, and as a good mentor, Woody said, absolutely not. You know, carrying a number is very different than carrying a bag in the sense that you really learn what sales reps have to do, what the mindset is, how you really incentivize the correct behaviors. And I think getting the sales experience besides learning how to work with physicians, learning how to train physicians was done. But really carrying a number helps one get that perspective of how to build and run companies.

at that. Yeah, no, it's such great advice. And as you can probably imagine, I listen to a fair number of of other podcasts, too, especially in the early stage kind of like tech space, if you want to call it that. And I can always tell when a founding, you know, a founder or a CEO of an early stage company has, has had sales experience because their interviews are always that much better. They just, like, it's just, it's, they intuitively get, like, what actually works, you know, and what, what is really going to resonate with their, ideal audience. And it seems like that's always the case. And it's, it's interesting that you see that. Because I myself went, you know, spent my early career in a, in a, largely in a sales-based,

you know, field-based sales capacity in MedTech. And when I first came into marketing, I was really just surprised at how, how little folks that had spent their entire careers internally inside a, inside a large company, how little they sort of grasp what really, you know, what really works. You know, what kind of messages resonate with, you know, whether it's physician audience or, you know, another health care provider. So, I mean, I can completely relate to what you're talking about. And really, to be, to be fair, you know, vice versa, you know, a sales rep that thinks they can run, run a company without spending time, you know, internally, you know, dealing with sometimes, you know, the bureaucracy and layers and whatnot probably doesn't have a true appreciation for

kind of the full circle of a med tech company. But I saw that on your, and, you know, kind of looking at your background. And I wanted to definitely talk about your sales experience and what that, how that's translated to some of these, some of these other experiences in your career. You know, that's actually, you bring up a very good point because it's not, it goes both ways. And I think having that marketing kind of stint at Medtronic for the first couple years gave me more appreciation for what went on in-house. And as I trained sales reps from the country, when I became more of a sales trainer in certain product clients in Metronic, I definitely felt the frustrations of the sales reps with the end-unquote in-house people. Marketing and manager never get it, whereas sales reps, of course, are omniscient, is the way the sales reps usually think. Yeah.

It was actually great to be able to translate that, you know, knowing the regulatory hurdles that had to be overcome, knowing the, you know, the internal politics that had to be overcome to make things happen, you know, having that perspective on both sides of that line was definitely helpful. So I think you definitely appreciate the breadth of experience necessary to certain things. Yeah, yeah, no doubt. Well, for the sake of time, let's move on to your previous two experiences before Renovo ARA, the first one being at Ardeen, I know we already touched on this, but I am curious, how did you end up transitioning from, you know, your role as a as a coronary sales rep to your time at Ardian.

So I can't mention enough about how mentors play a role in my career. At the time, Andrew Cleland was a good friend of mine. I think we probably started drinking beers together through very close friends. I am early 20s, and over the years, he was kind of a more of a life mentor to me on which direction I should be taking my career, whether or not I should break up with my girlfriend, things like that. And so I think over multiple conversations with Andrew about what I'm doing with my life in general, he started to see a fit as already in transition from or was planning on it

transition from a clinical company to a commercial company, given my clinical research background and my sales background. And he introduced me to Greg Bacon, who was head of sales and marketing at the time. And this was very premature for a med company or a tech company to hire a salesperson. And it was basically a bunch of fun, either happy hours, breakfasts, and lunches with Greg Bacon on him asking me, And this is someone who had extensive market development and marketing experience, but zero sales experience on how I would approach the market with the RDian technology.

And until after a few months of this kind of free advice and getting to know, Greg, it made sense for me to come on board and to kind of take over and help with market development. We're working with Greg and Mike Welch, who was the director of market development at the time. So it was almost an ongoing dialogue that made an easy fit. I don't think I actually had a formal interview through that entire process. It was more of a no-brainer by that point. That's kind of the getting into Ardian part. I guess, you know, as far as the exiting Medtronic piece, it was an interesting time

because my goal was to go into sales, learn it and get out. I spent about five years in sales, and I really hadn't seen a technology that was going to change medicine as much as Ardian. So I think it was a perfect fit for me and perfect timing where I was looking for something to then do more than just sales, if that makes sense. And the opportunity to Ardian was a perfect combination of my previous experiences from an intellectual stimulation standpoint, I got to work with animal studies. I was there with early technology.

I got to train physicians. I was helping with clinical research and then helping with market development and sales. So it was basically everything I'd done before with that piece of me that didn't go to med school that thought someday I want to change medicine. And given that we're opening a new market for hypertension, this was my first chance at more of a kind of a management level to have an effect on health care. Got it. And at first blush, it looked like the move from from your role at Medtronic as a

cornerary sales rep to what you were doing at Ardian, it seemed like a pretty big stretch. But I guess, you know, hearing you describe your background at not only transvascular, but especially, you know, early, your early days with, you know, transitioning under the metronic umbrella. It seems like that that did make a lot of sense. And it's interesting hearing you describe how sort of you made that move into Ardian. I mean, geez, talk about the power of mentorship and networking. You know, I think most people would have loved to be in that role at that time.

But on that note, it certainly probably wasn't all, you know, all roses. So was there, do you recall one of the more challenging aspects of your time at Ardian and sort of what you learned from that experience? I think one of the most challenging, and I, you know, I look up to mentors and people have taught me a lot. I think the most challenging piece was we're trying to figure out how to commercialize the technologies. We were going from a clinical company to a commercial company. We were going back and forth on pricing. There was a piece of capital equipment. They're disposable catheters.

we were deciding what the sales footprint should look like. We were a few kind of market development managers, which were a blend of clinical and or salespeople, mostly in Europe. And I think the most challenging period is when we weren't hitting the enrollment numbers or I guess sales numbers right off the bat. And it was a matter of, and this helped teach me a little more strategy as well, as a matter of we don't have enough resources for this. And Greg Bacon kind of barked at us, well, you know, if that's the issue, let's get more resources. I never want to hear that excuse ever again. Let's strategize on how we're going to attack this market. And if it's more resources, or resources there, but I never want to hear that excuse

if you say we don't need it. So I think that was, you know, a big learning experience for me is that people can always make excuses why things don't happen, but it's really important to step back and put plans in place to actually gain success. Coming off of that, we restrategize how to enter the market, which physicians we should be talking to what the barriers were and we overcame them. And, you know, we really blew it out from a sales perspective with that early market adoption in Europe after that. Yeah, it's a great sort of best practice in that there's some challenges that if you're knee-deep, I think they're sort of, you know, they're going to be extremely difficult to cross, but, you know, taking a step back and sort of looking at things from a fresh lens, you know,

you get the sense that, you know, there's always some sort of solution for that, you know, for that underlying challenge. I should say there's an underlying solution to that challenge that's sort of waiting to be found if you're, you know, if you can kind of take fresh look at things. So it's a good story there. So let's move on to Heartflow. I want to ask you a few questions about your experience at Heartflow before we get to Renovil RX here. But at Heartflow, you built a foundation for what now is Heartflow Japan. And Heartflow, another company that was acquired by Medtronic. You've got sort of a trend going on here. All the companies you're at are eventually acquired by

Medtronic. So talk to us a little bit about what you built for, you know, what eventually became Heartflow Japan, especially in regards to sort of the cross-functional experience that you had, dealing with, you know, regulatory and payer collaboration, KOL development, clinical research, et cetera. So, Hartford was interesting because this is something, I've been in the med device space, my whole career, and this was a diagnostic, even a software as a service, a diagnostic for assessing cardiac disease. And I was brought in to help commercialize, primarily in Europe was the initial plan.

Soon after, I think I was the first kind of sales person after the VP of sales there was hired, they failed the primary endpoint of the study, which was completely. comparing the Hartflow technology to an invasive diagnostic approach. And the VP of sales subsequently left the company and I was working directly with the CEO for quite a while. So given that the primary endpoint failed commercialization efforts pretty much went down the tubes as well as you can imagine. So I actually helped run the next study that put Hartflow back on the map.

So my role at Hartflow actually almost reverted to a clinical research position where I ran a clinical study like a salesperson would on how do you increase enrollment, how do you increase quality of enrollment. I was training physicians as well. The fun part for me was I was able to utilize, and this is just moving the company strategically, I was able to utilize different people from different divisions in the company to, and that's why I say cross-functionally, to help run each site. So we had a marketing person, for example, cover a couple of sites in London. We had more of kind of a research-driven person cover sites in Australia, let's say, with different backgrounds. So it was a good experience on trying to find skill sets within people that isn't their core skill set, if that makes sense.

So it's in a startup environment, it's good to kind of, many people have to do different things. So it was a good way to kind of find skill sets and match those up. So during that year or two at Hartflow, it was a matter of running the study. And at the same time, we're looking into Japan. And the reason why Japan was of interest is because they, the value problem, physicians make a lot more sense for what heart flow is doing. A, they utilize CT technology to assess heart disease, which is what heart flow is based on. Two, is the physicians are salaried, so there's not an incentive to do more diagnostic testing and put more stents in. So the first few trips were

assessing the market there. Pretty soon thereafter, we use a couple of their sites as our clinical research sites. So I was able to both drive the clinical research process and see if there's potential business there. So from that point, I was able to, you know, very lucky to pull in a few good resources. And I think my biggest mentor there became Campbell Rogers, who came in and take over his chief medical officer. And he had a lot of connections with physicians in Japan from his coronary days and was able to open a lot of doors that I was able to go back in and make connections with kind of the top physicians to form advisory boards, work with local consultants to get us in front of their version of the FDA, which is called the PMDA, and their version of CMS, if you will,

which is called MHLW. So it was really kind of having those initial meetings to prove out the value propositions in the country, start the initial dialogues, get the process going. That eventually became the basis for what's now Hartflow of Japan. Towards the end of my tenure, they actually hired a general manager based in Japan and now have a whole team that are building that market. it, they just did receive PMDA clearance or approval and reimbursements soon to follow. So I think that's as far as a revenue source, that's going to be the biggest revenue stream for Hartflow in the very near future is in Japan. Got it.

And I think I misspoke. I said Heartflow was acquired by Medtronic. I'm not sure why I had that in my notes, to be honest. I had my notes here, this trend of companies being acquired by Medtronic. And I'm not sure why I thought that. That's my fault. So Hartflow was not acquired by Medtronic. But on that note, you know, let's kind of springboard into into your time now at Renova RX.

And I think you landed there in 2014, right, at Renovo? Yeah, okay. Before we jump right into the current time, are there a couple, you know, experiences, you know, maybe one or two that you can think of at Heartflow that you sort of, you find yourself kind of going back to that have, you know, sort of either key learning points or just things that you've been able to use now at Renovo RX? Yeah, I think one of the things that, and this actually was, Resonated, both came true because of Ardian and Rovorex.

Sorry, this came true with Ardian and heartflow, is that more and more, I think, there are certain medical technologies that cross different specialties of medicine. And I'll kind of rewind a little bit to talk about that with Ardian. As much as this was, the technology was to be used by interventional radiologists, interventional cardiologists, the patients were really controlled by the hypertension specialist and nephrologists. So the sales aspect or the market entry aspect was kind of twofold. How do you get the users and the physicians who like to use the technology to use it,

but more importantly, how do you overcome the barriers of their opposition of the nephrologist and hypertension specialists that want to hold on to the patients? Heartflow is the same thing. It was a matter of we have CT physicians and radiologists who want to maybe send patients for heart flow exams, but the interventional cardiologists control the patients, and they'd rather put the patient at the table and do an intervention, you know, and or an invasive diagnostic. Renova is very simple. With Renova are very similar. With Renovar RX, it's a matter of overcoming the barriers of the medical oncologists who deliver chemotherapy systemically, and we're looking at more targeted

approach. So I think the lessons learn from, in fact, both of those companies have really helped a lot with Renovar X, is making sure that you don't ignore specialties when there's a, when there's a disease state or a patient-based that is really cross-functional or cross-specialty. Yeah, that makes a ton of sense, really understanding that patient pathway and who controls the patient, who influences the patient decision the most along that journey. I have to think, it's just a hunch, but I have to think your experience in a field-based sales capacity has really probably helped you sort of, that probably, I would imagine that probably comes naturally to you now. Is that a safe, safe guess? I think it does, but I think a lot of it is really paying attention,

you know, getting out in the field and talking to physicians to really make sure the market's there. And that's something that I think is one of the most gratifying parts of my job is actually being, you know, front and center, and that's something being in a small company and being a CEO of a small company I get to do is to get out in the field, work with physicians, be in the operating room, and really see exactly like you said, you know, how does the patient pathway work? And I think that definitely helps to be successful in different areas of medicine. Okay. Yeah, makes a ton of sense. So let's talk a little bit more about Renova X. I know you kind of gave us a, you know, a high level overview, but you said CE marked in what was in late 2015, but FDA cleared in, what was it, was it, was

it late 2014? Late 2014. Okay. So kind of, you mentioned that you're currently enrolling patients right now in a U.S. trial. Is that right? Correct. We have a post-market registry study in the U.S. that's ongoing.

Prior to that, we actually just finished a safety study in pancreatic cancer patients in the U.S. as well. So we're tracking patients right now to see how they do in kind of the general population, if that makes sense. Sure, sure. And so when you were at heartflow, how did you end up getting to Renovo RX? Was another story of just your connections and your networks sort of brought you here? Exactly.

It seemed like at that point the U.S. launch was not imminent given both the FDA and reimbursement. I think they, in fact, I just saw a lot of close friends there. I think I had a bet with who's going to get FDA clearance first, Heartflow or Renova RX, and I think we won by a couple weeks. Okay. You know, so there was some headwinds in the U.S. Heartflow Japan was getting off the ground. The founder of Renova RX, Dr. Ramton Aga, from El Camino Hospital, was,

coincidentally a customer mind when I was at Medtronic many years ago. One of the things I've always tried to do is keep in touch with everybody that I can. And so he approached me a while back about the fact that their CEO has stepped down for family reasons. They're looking for replacement. And I, to be honest, thought it wasn't ready for a CEO role yet. I feel like I still had some more things to learn. And then months later, timing worked out where the previous potential CEO candidate had dropped out of the race and they were interviewing a few candidates. And he said, look, come meet the board, I think this is right for you, given your experiences and backgrounds. And he had me come interview with the board of directors, the rest of history. Got it. That's cool. So where are you at now

in terms of like the lifecycle of the product? You've got regulatory approvals in Europe and the U.S. You're enrolling patients in a post-market registry. So do you envision commercializing this at some point in your future? I do potentially. So maybe to rewind a little bit as far as how, you know, the timing of when I came on board, we had just applied to the FDA. And this is one of the reasons I think why Dr. Agha thought this would be good for me and why I think for me was a good fit, is that they were just applied to the FDA, designed for manufacturing was done for the most part. We've begun manufacturing. The next stage of the company, or since I took over, we've gotten FDA clearance,

we've gotten our device patents issued. We've done our first in human, you know, in a few different disease states. We finished our safety study in the pancreas. We're the next phase for the company is to finish off a post-market registry. The data is looking phenomenal where at least pancreatic cancer. cancer patients are living longer with the less side effects that they would see from systemic chemotherapy. As far as where this is going, that's all the double-edged sword for every small device company is do you raise funding and hire a sales force or is this actually a great tuck-in

for one of the larger companies? And that's yet to be determined. The great thing about the markets we're looking into is that there are very concentrated hospitals that do these types of procedures. So one could attack the market with a small sales force, but I could definitely see this as a fit with a larger company down the road. Got it. It makes a ton of sense, especially as more and more large strategic start to get into the interventional oncology space, I think, it seems like when you look at that, that IOS space, there's a lot of large strategics that aren't in it. It seems like that maybe that are sort of just on the cusp of maybe getting into it. So it seems like it makes sense from an MNAIS standpoint.

But I also couldn't agree with you more in regards to, you know, have, you know, rolling out a very targeted Salesforce to that select number of, you know, to call them the select number of hospitals and IDNs that do these types of procedures. So cool. So I know you've raised a little bit of money and kind of the last question, I guess, before we get to these last three rapid fire questions. Do you have plans to raise additional rounds of financing in the future? I think that's one thing I've learned as a CEO, is you're always fundraising. Right. So, you know, I think this has been an interesting exercise for me. This is probably the least

funding company I've worked with and being small and nimble and having very dedicated founders giving a lot of time to the company. We've been extremely capital efficient. But I could foresee, in the next few months we're trying to put together strategic plans for next couple years. I could see a round potentially coming up. Right now we're talking to strategics to see what other milestones would be necessary for some type of a partnership and trying to lay those plans up. But I wouldn't be surprised if we're looking into funding in the not too distant future. Yeah, very good.

I think it'd be fun to do round two of this conversation, maybe sometime next year to kind of get an update on where you guys are at and what you've learned since then. So anything else you want to share before we get to these last three rapid-fire questions? John? I think, you know, one of the things that I get asked a lot is, especially now, we were involved. I'm much sure familiar with the Stanford Star-Ex program. Yeah, loosely. Yep. So it's kind of an incubator. It's been fun, you know, given how many mentors have kind of shaped my career, it's been fun kind of giving back a little bit mentoring younger, younger entrepreneurs, younger CEOs. I think one of the, you know, if I could give a couple pieces of advice, you know, one is always do what you say you're going to do. I found it very interesting how, as you go through, especially different, groups of medical device professions sales marketing, business training that a lot of people promise things they don't deliver on. I think that's one thing I learned very early in my mentors is definitely deliver what your promises are.

And keeping in touch with people has been invaluable. I think, Scott, given what you've done with your site, you've probably seen that more often than not, that people kind of fall off the radar, but keeping in touch with people. And, you know, I've connected with physicians across different companies. And it's amazing. There are a couple doctors in Germany that I've worked with through different companies and just, you know, an email now and then. I'm not a big Facebook fan, to be honest,

but an email or phone call here and there definitely goes a long way for to serve you in the future. Yeah. No, I mean, it's such good advice. You're right. I mean, I've certainly experienced that. I wouldn't say I'm a master at that by no means. I certainly could do a lot better. But yeah, just a simple phone call, text message, you know, a short two-sentence email. I mean, it does wonders for sure. But very good stuff. So I want to be, you know, sensitive to your schedule, Sean. So let's get these last three rapid fire questions. The rapid fire in nature, you don't necessarily have to answer, answer the questions, and that sort of theme. Let's start with the first one. What's your favorite business book? You know, this is something that's come to me recently, and it's been,

it's proved invaluable for this job. I don't know if you're sure, if you've heard a book called The Hard Thing About Hard Things by Ben Horowitz. Yeah. It's been almost a Bible about how to try to sleep better at night when you're, when you're trying to run a company, especially the first being a CEO, I think the advice in there and seeing running and building a company through someone else's eyes when you don't have a lot of people to talk to about it who have vested interest in different part of your business has been very helpful. Yeah, that's a good one. So is there a CEO that you're following or one that has really inspires you in the past? You know, honestly, I think I've mentioned two so far that have really been a big part of my career growth. And it's, you know,

Dr. Josh Mackar and Andrew Cleland have been two through very different stages of my career that have definitely helped me out a lot on what I should be doing, what it should be thinking about. Very good. I had a feeling that you were going to go to go to those two guys. But last one, if you had a chance to rewind the clock, what would you tell your 25-year-old self? You know, I think my career was taking off. And I think the biggest thing, looking back at 25, is maybe tell myself to be more humble, if that makes sense. Sure, sure.

You know, I think there, you know, certainly success comes with an arrogance that you might ignore miscues that would definitely help your growth. And, you know, if I could turn back the clock, that's probably the one piece of advice to give myself. Yeah. Good way to in the conversation, because I think it's healthy advice for anyone, for sure. So, Sean, thanks a ton for your willingness to do this conversation. I'll have you hold on the line real quick as we wrap this up.

But again, just thanks again for taking the time out of your day. And for those listening that want to learn more about Renovo RX, I'll link to that in the show notes. But just Google Renovo RX and you'll probably find it. But again, you can find those links in the show notes to this episode. But Sean, thanks a time for doing this. Thank you for time, Scott. I appreciate it. All right, everyone.

Until the next episode of MedSider, take care. Thanks again, ladies and gents for listening. This episode has been brought to you from the WCG. studios here in Minneapolis. And don't forget to grab your panoptic stacking blueprint by visiting reachfiredigital.com for slash medsider. Again, that's reachfiredigital.com forward slash medsider. Okay, bye for now.