Medsider: Learn from Medtech and Healthtech Founders and CEOs - Conquering the Coverage and Reimbursement Landscape: Interview with Bruce Shook, President of Intact Vascular

Episode Date: February 21, 2017

Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression. Previously...[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 

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a highly experienced medical device executive with more than 30 years of industry experience. Bruce was previously co-founder, director, president, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression. Previously, Shook was co-founder, director, president, and CEO at Neuron Theory. therapeutics, a venture-back company developing a drug device product for the treatment of CNS disorders. Before that, he served as president of AbilMed, where he successfully obtained a PMA approval for the first FDA-approved ventricular assist device. Bruce developed cardiac pacing and anti-arhythmia products

at Cordes Corporation as well. Bruce holds advanced degrees in biomedical engineering from Columbia University and business administration from the MIT Sloan School of Management, and he earned a BS degree in chemical engineering from Penn State University. Here are some of the things we're going to learn in this interview with Bruce. After a storied med tech career, the device that Bruce is most proud of. The origin story for the tact into vascular system and how it's different than current peripheral vascular stents. Bruce's transition from cordis to abiomed and what he learned both personally and professionally. How Bruce and his team at Neuron Therapeutics responded after their failed clinical trial.

The lessons Bruce learned while trying to gain insurance coverage and reimbursement for the TMS device with neuronetics. Bruce's advice for other MedTech entrepreneurs that need to raise money beyond the friends and family round. And lastly, Bruce's favorite business book, the CEO he most admires and the advice he'd give to his 25-year-old self. So without further ado, let's get to the conversation with Bruce. Hey, Bruce, welcome to the program. We appreciate you coming on. Thanks. Great to be here.

All right. So let's start out with just kind of almost like a summary of your career, right? Because it's been a pretty fascinating ride, you know, from your early days at Cordes, you know, through your, you know, close to 10 years of experience at abiomed, you know, another 10 plus years at neuronetics, now where you're at intact vascular, you know, joining back in mid-2014. You know, it's probably like asking, you know, a parent, you know, who's your favorite child? But I'll ask you the question nonetheless. Do you have a favorite medical device or one that really stands out looking back at sort of the

entirety of your Mentech career? Well, you know, you asked me which one had the most profound effects on people's lives. I'd have to say it was the Neurostar system that we developed at Neuronetics. Major depressive disorder is really a ubiquitous disease, and it's incredibly debilitating. I didn't really fully appreciate that when we started that company, but as we get into it, I was really shocked at how debilitating it is. And we developed an entirely new way to treat that disease at Neuronetics, and it really is highly effective. So I'm really incredibly pleased and proud that it helps so many people with depressants.

I think the entire team at Neuronetics has made a fantastic contribution to the mental health field. If you ask me which technology resulted in the largest business opportunity, I'd have to say it was a ventricular assist device we developed at Abbey, and that product was the very first bad ever FDA approved, and it really formed a cornerstone of sports for what has become a very successful business. Yeah, it's good to get your thoughts on that. I'm sure it's probably hard to decide or I have a definitive answer to that question. But to be quite honest, I was loosely familiar with Neuronetics and Neurostar. But then, of course, leading up to our conversation here, I did a fair amount of research.

And it seemed like a pretty impressive journey over the course of about 10 years, which I, you know, we'll have the opportunity to get into. But anxious to get your thoughts on some of those aspects along the way. But before we go there, let's sort of level set things for the audience. In the intro to this conversation, I mentioned your, you know, your storied career. And after founding Neuronetics back in 2003, you then left to become president and CEO of Intact Vascular back in, I think, June or July of 2014. So can you provide sort of an overview of intact vascular as we see it today? And then also as a follow-up question, how does your device work and what does it treat?

Sure. Intact is a company that is completely focused on developing endovascular innovations in the peripheral vascular space. Our flagship technology is called the TACC endovascular system. And this is a purpose-designed system for the repair of arterial dissections that occur following angioplasty. They're essentially flaps that peel off the vessel wall as a function of balloon angioplasty. And the technology itself consists of implants. We call them TAC, which are small self-expanding nitinol devices. They're just about 6 millimeters long, so they're quite small.

and a novel delivery system, of course, to deliver them into the arteries. The delivery system houses multiple tacks and allows very targeted repair of the vessel right after the angioplasty procedures complete. And some of the advantages of the tack versus denting is that it's really designed to leave much less metal in the artery, 70 to 80 percent less metal. and is a very attractive idea, particularly the drug-coated balloon users. Drug-coated balloon users are a very rapidly growing segment of the marketplace. So this is really kind of a modern-day take on vessel repair following angiplac. Got it. And the idea for this tacking or this ability to tack a dissected portion of the artery,

that came, that early idea came from an experience that Dr. Schneider had. during a Christmas, correct? Years back? That is true. It's a funny story. Peter was hanging Christmas lights on his house with a staple gun. It occurred to him that he routinely encountered this same type of a problem inside arteries when he was in the cath lab performing angioplasty.

And he wondered, you know, why couldn't I just tack up these dissections or these flaps that get created by the angioplasty balloons instead of stenting the entire lesion, which was is a commonplace practice still is today. This is a so-called full metal jacket approach. And it's really overkill in many situations. So he came up with this minimal metal solution to the problem. And we literally called the devices, as I said, tax today. Got it. Such a, such a cool story, especially considering where you're at in the sort of the life cycle of the product. But give us an idea of where intact vascular is in terms of of clinical data and the regulatory approval process?

Well, we've completed three OUS trials. There was a first in man trial that Dr. Schneider completed in Paraguay, a very small initial study. And then we completed TOBA, TOBA, which is just shorthand for TAC-optimized balloon angioplasty, completed that trial, which was our first large scale above the knee trial in Europe, 138 patients, and the 12-month results were recently published in the Journal of Vascular Surgery. And then we've also completed a TOBA BTK, shorthand for below-the-k, which is our first trial in that segment of the population, 35 patients.

And the 12-month data were recently presented at Sky, which is a major cardiology conference. We have CE mark for our above-the-knees system. We will soon have CE-Mark for our below-the-knees system. And then in terms of what's happening now, we're nearing completely. of a very large pivotal trial called tova-2 for our above-the-kne indication, I expect we'll complete enrollment toward the end of Q1, and that will be followed, of course, with a PMA submission once we have 12-month data. And we are set to begin enrollment in our pivotal below-the-k trial, tova-2 BTK. We should commence enrollment in that trial in Q1 as well.

Okay, very cool. Especially the below-the-knee application. You know, I'm acutely familiar with the peripheral vascular space. Just, just, that's where I've spent most of my time in med tech. But for those listening that want to, you know, kind of get a better understanding is that that below the knee, treatment options below the knee are for arteries that are disease below the knee are, I mean, there's pretty limited treatment options. And so, you know, in looking at, you know, the animations that you've got, you guys have on your, on your website and learning a little bit more about your technology, it seems like that would be,

not to discount, you know, you're above the knee applications, but the below the knee is, I bet it's pretty easy to generate interest from a lot of interventional cardiologists and vascular surgeons for below-the-kneed applications. Oh, absolutely. You know, you correctly point out that there were very few approved tools to treat that disease. And in fact, there are no approved dent in the U.S. to treat below-the-kneed disease. And this is the very first, you know, large multi-site pivotal trial that FDA has ever

approved for a vascular implant below the knee. So I think, you know, we are well positioned. to really bring the very first vascular implant to the market for this disease. So it's very exciting. Absolutely. I don't think I fully realize or I realize the sort of the full scope of those trials, especially the above the knee and the below the knee trial. So that's very cool. And just one last question about those trials. In terms of the structure, are you comparing to drug-coated balloons or help me understand the involvement with DCBs? Because I do recall reading something about that aspect of your clinical trials. Yeah. We're not comparing to DCB.

these in a contemporaneous way. These are not randomized trials. You know, the tradition with sense in the legs is that they're typically single arm trials, and the comparator is an objective performance goal that's derived from the literature. But what we do do is we are using our technology as an adjunct to drug-coded balloon angioplasty, at least above the name. For example, in our Artova-2 trial, there are two groups in that trial. In one group, we're using our product to improve the results of plain balloon angioplasty,

and in the other group, we're using it to improve the results of drug-coded balloon angioplasty, and in each case, we're comparing to a relevant literature comparator. Below the knee, we can't really use a drug-coded balloon because there are no drug-coded balloons the FDA approved, so we're really, at this point anyway, forced to use plain balloons below the knee. Sure. Okay. That helps. That makes sense. So let's take a pause there. We'll circle back around to intact vascular and learn a little bit about, you know, the progress that you've made since joining in mid-2014. But let's use this opportunity to sort of rewind the clock and go back in time and understand your career a little bit, a little bit better. So, you know, I want to ask you a few questions about AbiaMed and then we'll kind of quickly transition to neuron therapeutics and then, you know, the eventual formation of neuronetics. But talk to us a little bit about your experience at Aboumet. You spent 10. 10 years there eventually became president of the company. I think most people that are listening are probably familiar with Abilomet as it is today. So let's, I guess the first question would be, why did you make the move from Quartis to AbioMed? Well, this goes back in time of ways, but when I

worked for Quartas, it was first and foremost a pacemaker company. It was actually the number two pacemaker company in the world, and it was the dominant part of the business, you know, long predates J&J's acquisition of the company. The division I worked for, the Implanable, products division ran into some very significant recall issues. It really kind of collapsed the business. The division got sold and the acquiring entity started to dismember it. So, you know, the writing was on the wall in terms of it being time to move on. And along the way, I'd become very excited about the idea of getting into the startup world, you know, medical device startups were really, you know, blossoming at that point in time. And an opportunity came

my way to join this little company in Danvers, Mass, called Abumet. They, they, had this ventricular assist device and it had not been used in humans at that point and they needed somebody to create a clinical research group and to interact with the FDA. So they hired me to do that. That's where I started. I was one of the very early employees at AbilMed. Got it. And you eventually, I think, you know, going back to, you were there about 10 years. I think you ended up leaving in 97, if my research is correct here on my end. So you eventually rose up and became president of that company. So before we kind of, you know, move on to your next move after that, you know, I'm asking you to go back in time quite, you know, quite a few years. But do you recall it,

you know, a few specific challenges, you know, that, that, that, that you had to overcome and maybe what that meant to you either professionally or personally? Oh, sure. I mean, there were, there were lots of challenges along the way. You know, we were doing really groundbreaking work in those days at Abumet. Ventricular assist devices were really kind of scientific toys. They were not products at that point in time. Nothing was FDA approved, nor had anything been through the kind of rigorous, you know, multi-psych clinical trial that we would all expect today. And we blazed that trail for the VAD world at Aboumed. We did a lot of things for the first time. And anytime, you know, you're bringing a truly first-of-a-kind technology through the FDA approval process, you know, there's going to be

lots of twists and turns. And that experience really taught me how to navigate that process, how to effectively interact with an agency that is naturally apprehensive about this new thing and how to survive the inevitable surprises. And then the other thing we did for the first time as a company was to build a sales and marketing from scratch. We had to transition that company from being an entirely R&D-based organization to one that was now marketing a very new and complicated product. And those transitions are tough. I learned a great deal from that experience.

That is interesting that you mentioned that. I have in my head this company that was largely built on, you know, innovative technology and you finally get to a point where you actually need to start selling it and commercializing it. I bet that would be a pretty major shift in sort of the life cycle for any company. It's a huge psychological change for the company because literally, you know, over the span of, you know, maybe six, nine months, you go from an organization that is completely dominated by technical people to an organization where, you know, a third of your employees might be sales and marketing staff, right? That's pretty wrenching, you know, change for people to go through. Oh, I bet. I bet that's a very interesting fact. So after your time at Abilomed, you spent, I think, about four years at neuron therapeutics. But before we go there, I noticed that you did end up getting

your MBA from MIT in the late 90s. It was probably around the time that you ended up leaving Abilamad. So I saw that in looking at your background. I thought it stood out to me because certainly by that at that point in your career, you had a BS, you know, in kind of Chemical engineering from Penn State and a master's in bioengineering from Columbia, obviously very good schools. You had a ton of business experience. And I got to think there's a lot of people, you know, in the audience listening to this and are thinking, you know, should I go back and get my MBA? I've got 10 years of experience. Is it worth it? So I wanted to get, wanted to get your take on that before we kind of move on to neuron therapeutics and neuronetics. Sure. You know, at the time,

I really felt that I had risen into a position at Abumet that I hadn't been done. fully trained for. I had no training in finance whatsoever, nor did I really know anything about raising money. You know, Abiyomed had gone public in the late 80s, which was something that the then CEO had handled. I didn't, I wasn't involved in that. And we really lived off those IPO funds. So there was really no need to raise money. And I thought that corporate finance was an area where I really had to deepen my knowledge if I was going to lead my own startups, which is something that I was very focused on doing at that point in my career. I was very anxious to run my own show.

And, you know, Sloan was just a great fit for what I needed. And it's an amazing place that I ended up learning much more than him. So it also was sort of a springboard. It allowed me to work my way into the startup world. I started my first company right after graduating, which was neurone therapeutic. Got it. Well, let's use that this has an opportunity to talk about neuron therapeutic. So what, you know, first maybe addressed the problem that you were trying to solve. And then I want to ask a follow-up question about, you know, the clinical trial, you know, failure, I guess is probably the best way to call that, that you experienced and sort of what you did in response to that.

Well, I started neuron therapeutics with some neuroscientists from Thomas Jefferson University in Philly. and we were working on an entirely new approach to treating ischemic and hemorrhagic stroke. We developed a synthetic form of cerebral spinal fluid that could carry enormous amounts of oxygen and could be circulated in the subarachnoid spaces around the brain. The whole idea was to oxygenate ischemic brain tissue independent of the diseased vasculature. So we were kind of going in the back door, so to speak. It was really a very radical idea. And there was some great animal data supporting the effectiveness of the idea.

But as you correctly point out, we get into clinical trials and it just didn't work in humans. I think we didn't anticipate how difficult it would be to get acute stroke patients into the hospital quickly enough. And we didn't really appreciate that the complexity of the procedure itself that we had created would cause biosephysm. vital delays. And with stroke, you know, you can't waste a minute. So the experience really taught me the importance of creating technology that is simple for the user. The technology itself may be complex, but you really need to work to make things simple for the user. And when you sort of got the thumbs down from the FDA, you know, I think you spent about four years at neuron therapeutics.

I'm curious to find out or learn a little bit more about how your team responded. And I'm curious to get your take on this because I wonder if it's any different than a conversation I recently had with Kevin Seidow, who's with the CEO of Moxymet. And they went through a period with their device where the panel gave them a thumbs down. It almost forced them to become a little bit smarter and a little bit leaner. And it forced them actually into profitability and led them to kind of iterate and pivot. it. I mean, it obviously wasn't good news. It wasn't the news anyone wanted to hear at that point, but it did sort of allow them to sort of shed some weight and then move on and springboard them

and put them in a better position moving forward. So how did you deal with that thumbs down from the FDA? And then how did your group kind of, you know, turn the corner? Well, actually, FDA had nothing to do with it. We had IDE approval to do this study. It was a relatively small study, a pilot study. And it was us looking at the day. looking at the results, we concluded that, you know, it just did not work the way we thought it would. And we really didn't think that there was anything that we could do to make it work the way it needed to work.

So that was a decision that, you know, our team made in conjunction with the board, of course, and we ended up selling the IP off and that was that. The team actually, much of the team hung together and we all went on to form neuronetics about nine months later. Got it. Okay. So it wasn't the F panel decision. It was your own sort of internal analysis.

At neuron therapeutics, this was an early stage clinical trial. You know, we just concluded once we looked at the results that wasn't viable. Got it. Okay. So that, but that team did stay together for the most part, and that's what allowed you to kind of make the transition and end up forming neuronetics. Is that right? Exactly.

Yeah. Got it. And speaking of neuronetics, you know, when you look at the technology, now. It's been featured on, you know, The Daily Show, you know, Dr. Oz, you know, pretty well-known publications, you know, across the, across the U.S., if not across the world, with pretty, I think, at least based on what I've read, is pretty broad utilization. But it certainly, it certainly wasn't all rosy. It certainly wasn't easy along your journey. And I think that's, maybe that's where I sort of got the two mixed up. That's your TMS device.

That's the one that actually had, you know, got the thumbs down from the FDA advisory panel. Is that right? Yeah, it was a controversial panel meeting. Let's put it that way. Okay. Yeah, so talk to us a little bit about that. That was, I think that panel meeting was maybe early 2007, right? Yeah, it sounds about right.

Got it. So mid-2007s, and so here you are with this technology, and the FDA, you know, gives you the thumbs down for something that you strongly feel, you know, is working and is proven. So, you know, walk us through that time and you're, you know, how your team. sort of worked through that experience? Right. Yeah, well, first of all, we were thoroughly convinced we had something that worked. It is true we missed our primary endpoint by a minuscule amount, I think 7,000th of a p-value point. It was really kind of a trivial miss on the primary endpoint. And we had multiple pre-specified secondary measures of efficacy that were very positive. And when you add to that, the fact that, you know, the safety profile, of the Neurostar technology is actually far superior to drug therapy. It seemed ridiculous to us to not have this therapy out there and available to the appropriate patients. Treatment options at the time for depression were limited to just drugs and shock therapy, and we clearly felt that,

you know, we had something really unique to add to that mix. So we pressed that case with FDA relentlessly, And we did dozens of analyses demonstrating the effectiveness of the treatment. We brought some of the most accomplished people in psychiatry into the discussion who were very supportive. We ultimately refiled the application after the panel meeting as a de novo 510K application, something that FDA wanted us to do. And ultimately, you know, the FDA decided to reconvene some of their own psychiatric experts to look at the data and some of the analytical work we had done. And that was enough to win the day and move us to clearance. So when you think about, you know, that context, and I know, granted, it was probably

about 10 years ago now or, you know, eight or nine years at least, you know, looking back of that experience, would you have done, would you do anything differently? You know, let's, not to say that you'll get into that scenario with intact vascular at all, but let's say, you know, at a hypothetical company and you ran into that same scenario where, you know, the FDA or a regulatory body was just, being overly difficult, would you, what advice would you give to other maybe founders that are in that early stage entrepreneurs that are in that same scenario? Well, I think, you know, the first bit of advice I would give anybody is that, you know,

stability matters, no matter how difficult the discussion may get. There's absolutely no point in getting angry and getting emotional about it. You know, the discussion should be based on the scientific facts and you need to focus it on the scientific facts. I also think that, you know, bringing really credible, skilled, knowledgeable clinicians who are in no way conflicted into the discussion is very, very helpful. I think, you know, you really just need to understand the true source of whatever the agency is uncomfortable about. They're smart people and they have a job to do just like all of us do. And typically, if you can marshal database arguments that make sense and they're valid, you know, you can convince people.

So I think you keep it focused on the data and the risk benefit profile of the technology and you do the best you can and make your case. I love your response with respect to not getting emotional about any sort of decision that comes down. I think it's easier said than done, but definitely a good reminder, I think, for anyone in a similar scenario on that at the end of the day, you know, to your point, civility and then, you know, the science will win, maybe with a little bit of persistence, you know, the science and the data will hopefully win the day. But good point nonetheless. So before we kind of circle back to your experience at intact vascular so far, I want to quickly hone in on the whole coverage and reimbursement

aspect to neuronetics and kind of what you accomplished there, because, you know, know, like I mentioned earlier, it seems like there's definitely some better insurance coverage with respect to, you know, TMS therapy now that obviously wasn't the case. So can you talk to us a little bit more about your approach to not only gaining coverage, but also, you know, getting, getting reimbursement for that particular therapy? Reimbursement was, I think, one of the toughest obstacles we had to overcome. You know, Neuronetics is now at or were very near full reimbursement for the technology, but it took six or seven years of really hard work to get there. We had to secure new CPD1 codes, which is a very difficult

and political process. We had to work with every insurer in the land to secure coverage policies. And then once you have policies in place, you have to frequently do battle over the payment amount. So I would say that reimbursement for first-of-a-kind technology is a substantially higher hurdle than FDA approval, partly because you have to deal with so many players simultaneously. So if I were to give advice to other people, I think we all have to be extremely thoughtful about the reimbursement hurdles any new technology presents as part of your upfront diligence process. For example, a technology that demands new CPT-1 codes is going to consume much more time

and money than one other than one that can leverage existing codes. So if you do go down that road, you have to be willing and able to invest in a really broad clinical development program, something that's going to generate really compelling, randomized data, and you have to have the right people working reimbursement for you. It is definitely a skill position, and I give a great deal of credit for the reimbursement success at Nournetics to Mary Haley, who ran a reimbursement team. She did an extraordinary job. with respect to reimbursement. My hunch is that you're treating your TMS therapy is, you know, it is probably for a patient's, you know, a cohort of patients that is covered by private, private insurers. Is that accurate? It's covered by private insurers and by Medicare as well. I think, I don't know off the top of my head of every single Medicare intermediary covers it today,

but I think the vast majority do. Yeah. Well, I mean, to your point about, I guess where my, where I was going with that question is to your point about, you know, know, so many stakeholders being involved, this question comes up again, or this topic, I should say, comes up again and again in the sense that, you know, reimbursement or coverage of reimbursement is becoming, you know, the biggest hurdle with respect to, you know, the evolution of a certain medical device technology. And, you know, especially when you're dealing with, you know, private payers, because there's so many of them. And it's just a, it's just a different beast overall. And so I got to think that you probably, you probably learned quite a bit during, during that

process dealing with so many different private payers with the TMS therapy. Yeah, you can't underestimate the difficulty of winning that war, and I don't think you can underestimate the time and money required to wage that war either. Got it. Before we go to Intact Vascular, because I am curious to learn a little bit more about why you made that transition and what brought you to Intact Vascular. But, you know, looking back over your 10 years at Neuronetics, is there anything else that you think is worthy of mentioning or something that you look back and think, wow, I'm really

proud that we did this and didn't go in that certain direction? Well, I think that, you know, the fact that we invested so much effort and so much money in clinical development early on at Neuronetics really ultimately saved us, particularly when it came to reimbursement. We ended up with two large randomized controlled trials, one that we exclusively funded as a company and then the other that NIH funded and we supplied equipment. And I think having those two trials really allowed us to ultimately develop all the reimbursement that's in place today.

It's absolutely pivotal. It took a long time and it took a lot of cash, but it was money very well spent. That's good to note. And I think to your point earlier about even getting a CPT category one code, the level of evidence or the amount of clinical evidence that's needed. You know, if one has to potentially go in that direction, better to make sure that you allocate the proper budget for the clinical trials up front.

So let's kind of move on to Intact vascular. I'm curious to learn a little bit more. You're transitioning out of Neuronetics. So what brought you there in the first place? Yeah, I was recruited into Intech by Cheryl Neff from Quaker partners. Cheryl's one of Intax, early investors and board members. He was also a longtime investor in board member at Nurenetics. and the company is local actually just down the road from neuronetics.

So it's very easy to meet the employees here and the other directors. I thought the technology was absolutely fascinating, and it was a wonderful fit for what is happening in the peripheral vascular space. And the team was very skilled. So the company needed leadership and cash, and I was quite confident that I could supply both of those things. It's been a great fit. Got it. And I think at that point, intact vascular, the company had raised, I think, a Series A back in 2012, I think, and then you came on board about a year later or so,

you raised a pretty hefty Series B. I think 38 million was the correct number. And that was led by NEA. Is that right? Right. I brought NIA and Justin Klein into the investing syndicate. And they were joined by Quaker and HIG BioVentures, both of whom had participated in the A round. Got it. So, I mean, if that was one of the reasons that intact vascular was interested in bringing you on board, is to help lead those fundraising efforts. What advice would you give to other med tech entrepreneurs out there that are at a stage, you know, their companies at a stage where they've raised maybe some angel money. And maybe earlier on they raised some friends, you know, some friends and family rounds,

but are ready for that next step, whether they need to raise a bigger, you know, a larger syndicate through angels or they need, you know, traditional kind of venture capital money. Do you have any best practices or what's your general thought process to that? Yeah, I can offer a few thoughts. One is that you need a very clear message on everything from the market and the customers you're going to serve to the clinical trials. You plan to run, to projected cogs to health economics and everything in between. You can't cut corners on preparation before you're in front of investors that really matter. And if you need to find experts who can help you in areas where you're not strong. You know, nobody knows everything. So I think

you need to supplement yourself with people that really, for example, would have depth in health economics, if that's something that's new to you. Second thing I would suggest is that you test drive what you're going to present with people who are not going to invest, but can and will be critical of you. You really want to present to people who can rough you up. before you're ever in front of a prospective investor that really matters. I found that to be very, very helpful in refining the pitch and figuring out, you know, where the soft spots are. Another thing I think that's really helpful is if you can find warm introductions to investors,

you are much, much more likely to get an audience with that investor than if you're trying to go in a cold, particularly if you're relatively new to the money raising game and people don't really know you well. And then lastly, this is a mistake I've seen other people make a lot. You have to really minimize the amount of time that you're talking. If you have 60 minutes with an investor, you ought to be able to tell your story in 20 minutes. Now they're going to ask questions and you're going to fill that hour. But I think people sometimes are so anxious to tell their stories. and all their glory that they drone on for the full hour. And I think that's a very big mistake.

You have to hone the pitch such that it's concise and fits in roughly, I'd say, a 20-minute time span. Yeah. That's good advice. I mean, four really solid points. I think that would be valuable for anyone listening that's in a similar situation, especially with respect to your point about, you know, bringing actively seeking out those experts, you know, that need to help you craft, you know, craft a certain story. I had a conversation earlier this week with Dr. Bob Smouth, Bob Smouse, who's the practicing interventional radiologist, but is with one of the founders of Brightwater Medical. And it's a therapy that's really close to home for him, a device that's really close to him. But he actively sought out, you know, other people that, you know, that had had that domain

expertise that he clearly didn't have, which I completely respect, you know. It's, again, one of those things that's probably a little bit easier said than done, especially if your knee-deep with the device in the business and the technology. Yeah, you have to tell a multifaceted story, you know, get all the help you can with each facet. Yeah, absolutely. As we kind of look to wrap up this particular conversation, what I, you know, I asked you a little bit more about, you know, your clinical trial. And I think if my notes here on mine were correct, you expect to submit your PMA to FDA in Q1 of 2017. Is that right? Well, we're actually are already in the midst of the PMA submission process.

Oh, you are. Okay. We're following a modular approach. But the real sort of trigger for the final submission to FDA will be 12-month data, which we would get in early 18. Okay, early 18. Okay. Very good.

And then in terms of what's next for intact vascular outside of the clinical data, can you speak to that? Sure. Well, you know, the next big milestone for us will be startup of Tobitou BTK. this pivotal below the knee trial that we talked about earlier, and we'll be enrolling that trial for roughly the next 24 months. So that really kind of will take us out into 2019 between the the pivotal below the knee trial enrollment and the completion of our above-the-need pivotal trial and prosecution of our PMA.

Got it. And we'll get to these last three rapid-fire questions. here in a second. But with respect to Intac vascular, you've been there, you know, since 2000, mid-2014, about two and a half years now, you know, looking back over that time, is there anything else that you think would be valuable for the audience to know or understand? Well, you know, I think we have a really unique opportunity step here at Intact. We're bringing a very differentiated technology to a very well-established market with our above-the-kne offering. And we're a first mover in a nation. market with our below-the-kneed offerings. So in many ways, it's kind of the best of all the world. I think it's a very unique opportunity.

All right. Very good. So on that note, speaking of unique, we'll get to maybe some more unique questions to this particular conversation anyway. We'll end our discussion with the last three rapid-fire questions. The rapid-fire questions, but they don't necessarily have to be rapid-fire answers. So feel free to expound a little bit. But Bruce, what's your favorite business book? That's a very tough question. I think I would have to, if I had to pick one, I would pick Crossing the Casm by Jeffrey Moore. I think it's a seminal work on the topic of new technology adoption, any new technology adoption. I would say it's a must read for any entrepreneur who's interested in bringing truly new products to the market. And I read it very early in my career and found it fascinating. And it's really, it taught me how to think it differently about new product introduction. Very good.

So question number two, is there a CEO that you're following right now or maybe one that's inspired you in the past? You know, I've really been impressed with what Scott Ward has done at Spectronetics. He and Schar Matan, his B.O. I think it's done really a phenomenal job with that company. They turned around a difficult situation. And they made, I think, a very smart acquisition with their purchase of the Stellar X drug Code of Balloon technology from Cavidian.

Yep. So that's definitely a company to watch. I think that they've really done some great work there. Yeah, it seems like they're pretty well positioned, especially with some of the recent acquisitions that they made with Angioscore. And then obviously that was a steel picking up the Stellarex technology from Cavendion after the Medtronic acquisition for sure. I could, I wholeheartedly agree.

And isn't Spectranic? Are they based there in Pennsylvania as well? No, Colorado. Oh, Colorado. That's right. That's right. Yeah. I forgot about that. Very good. I knew it wasn't your traditional like med tech hubs, but cool to see a company out of Colorado doing well. So last question, Bruce, is if you had a chance to jump in a time machine and rewind the clock, you know, what would you tell your 30-year-old self?

Oh, I think I'd probably say sell everything you own and buy that Apple stock the first time you see the Apple II computer. I wish I had done that. Beyond that, I guess I would tell myself that you have more influence than you really appreciate and you should use it. Good stuff. Good way to end the discussion. So Bruce, I'll have you hold on the line, but thanks again for your willingness to hop on, spend some time with us on Medsider Radio. Oh, sure. I enjoyed it. All right. I'll have you hold on the line like I said before. But for those listening in the audience, thanks again for your attention, as always. And until the next episode of Medsider Radio, everyone, 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.