Medsider: Learn from MedTech and HealthTech Experts

Conquering the Coverage and Reimbursement Landscape: Interview with Bruce Shook, President of Intact Vascular

February 21, 2017 Scott Nelson
Medsider: Learn from MedTech and HealthTech Experts
Conquering the Coverage and Reimbursement Landscape: Interview with Bruce Shook, President of Intact Vascular
Medsider: Learn from MedTech and HealthTech Experts
Conquering the Coverage and Reimbursement Landscape: Interview with Bruce Shook, President of Intact Vascular
Feb 21, 2017
Scott Nelson

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]

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Show Notes Transcript

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]

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Scott Nelson:   0:08
Welcome to Med Cider, 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 Med Cider Radio brought you from the W. C. G studios here in Minneapolis. If you're new to the program, Med Side of radio is where we learn from med Tech and other health care thought leaders through uncut and unedited interviews. Just a few quick messages before we get started. First, I sent out a free email newsletter about once per month, highlighting my favorite med tech and or health care related stories, the one that I personally get a lot of value from. I don't send the newsletter out very often, but when I do, I really try to make sure it's valuable. So if you're interested, head on over to met cider dot com and enter your email address as a bonus, I'll send you a free e book on the strategies I personally used to make connections at conferences. 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Digital dot com Ford slash med cider again US. Reach fire digital dot com Ford Flash Med cider Grab that blueprint okay onto the upset on today's program, we have Bruce Shook, who 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 Neuro Net IX, which is a privately held a medical device company that mark is a noninvasive brain stimulation technology for the treatment of depression. Previously, Shook was co founder, director, president and CEO at Neuron Therapeutics, a venture back company developing a drug device product for the treatment of CNS disorders. Before that, he service president of Abby Ahmed, where he successfully obtained a P M E approval for the first FDA approved ventricular assist device. Bruce developed cardiac pacing, an anti arrhythmia products at Cortez Corporation as well. Bruce holds advanced degrees in biomedical engineering from Columbia University and Business Administration from the M. I. T. Sloan School of Management, and he earned a B s degree in chemical engineering from Penn State University. Here are some of the things we're gonna learn in this interview with Bruce after a storied meta career at the device that Bruce is most proud of. The origin story for the tact in the vascular system and how it's different than current peripheral vascular stents. Bruce's transition from Courtis tab you meant 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 in reimbursement for the TMS device with neuro Net IX. Bruce's advice for other med tech 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.

Bruce Shook:   4:26
Thanks. Great to be here.

Scott Nelson:   4:27
All right, so let's start with with just kind of almost like a summary of your career, right, cause it's been it's been a pretty fascinating ride, you know, from your early days at Courtis, you know, through your close to 10 years of experience at Abbey Ahmed, another 10 plus years at Neuro Net IX now where you're at and intact vascular joining back in mid 2014. You know, it's probably like asking you no apparent you who's your favorite child. But I'll ask you the question. Then the less you have a ah favorite medical device or one that really stands out. Looking back at that sort of the entirety of your men take career.

Bruce Shook:   5:01
But you know, you asked me which one had the most profound effects on people watch. I have to say it was the nurse star system that we developed in our genetics. Major depressive disorder is really a ubiquitous disease on. 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 shock. Have debilitating it. ISS and we developed an entirely new way to treat that disease at genetics, and it really is highly effective. So I'm really, incredibly pleased and proud that it helps so many people that depression, thank the entire team in Marinette IX has made it a fantastic contribution to the mental health field. If you ask me which technology resulted in the largest business opportunity, I have to. It was a ventricular assist device. We developed it Abby, and that that product was very first bad ever FDA approved, and it really formed a cornerstone of sports for what has become a very successful of this

Scott Nelson:   6:02
Good. Good to get your thoughts on that. I'm sure it's probably hard to hard to decide or have a definitive answer, that question, but you know, to be to be quite honest. I had loose. I was loosely familiar with neuron ethics and Eurostar. But then, of course, leading up to our conversation here, I did a fair amount of research. And, you know, it's what seemed like a pretty, pretty impressive journey over the course of about 10 years, which I I would love the opportunity to get into but anxious to get your thoughts on 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 In the intro to this conversation I mentioned your you know, your storied career, and after founding your own ethics back in 2003 you didn't left to become president and CEO of Intact Vascular Back. And I think June or July of 2014 so can you provide sort of an overview of intact vascular as we see it today on, but also as a follow up question. How does your device work and what is it treat

Bruce Shook:   6:54
intact? Company is completely focused on developing and vascular innovations in the peripheral vascular space. Our flagship technology is called attack and the vascular system of this is purpose designed system for the repair of arterial dissection that a car following angioplasty there essentially flaps that peel off the vessel wall function, balloon angioplasty and the technology itself consists of implants. We call them tax, which are small, self expanding Knighton Hall devices. They're just about six millimeters long. There's quite small and a novel delivery system, of course. Thio deliver them into the arteries delivery system, houses multiple tax and allows very targeted repair the vessel right after the angioplasty procedures complete. And some of the advantages of the attack versus attendings that it's really designed to leave much less metal in the artery 70 to 80% last metal and is a very attractive idea, particularly drug coated balloon users. Drug hooded balloon users are a very rapidly growing segment of the market place, so this is really kind of a modern day tape on vessel repair following angioplasty.

Scott Nelson:   8:12
Got it and the the idea for this this this tacking or this this ability to attack a dissected portion of the artery that came that that early idea came from an experience that Dr Schneider had during a ah, Christmas correct years, years back

Bruce Shook:   8:27
that that is true. It's the funny story that Peter was hanging Christmas lights on his house with a staple gun. It occurred to him that he routinely encountered the same type of 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 sections of these flaps that get created by the engine plastic balloons that extending the entire lesions, which would become place practice still is that this is the so called full metal jacket approach. It's really overkill in many situations. So he came up with this minimal metal solution to the problem, and and we literally called the devices. As I said, Tax to that

Scott Nelson:   9:10
got such a such a such a cool story, especially considering you know where you're at in the life cycle of the product. But give us an idea of where intact vascular is in terms of of clinical data and regulatory. The regulatory approval process.

Bruce Shook:   9:24
Well, we've completed 30 US trials. It was a first in man trial that Dr Schneider completed in Paraguay I of her small initial study, and then we completed TOBA T o B A, which is just shorthand for Tak optimized balloon angioplasty completed that trial of the first large scale above the knee drop in Europe, 138 patients and the 12 months results were recently published in the Journal of Vascular Surgery. And then we've also completed TOBA bgk shorthand for below the knee, which is our first trial in that segment of the population. 35 patients. The data were recently presented. It Sky, which is a major cardiology conference we have the mark for, are above the system. We will soon have the mark for a below the knee system and then, in terms of, you know what's happening now. We're nearing completion of ah, very large Tim. It'll trial call Toby to for our above the knee indication, I expect will complete enrollment toward

Scott Nelson:   10:28

Bruce Shook:   10:28
end of Q one. And that will be followed, of course, with the PM a submission. Once we had 12 month data and we are set to begin enrollment in our pivotal below the knee trial over to B T. K. We should commence enrollment in that trial in Q one as well.

Scott Nelson:   10:45
Okay, very cool. Especially the below the knee applications. You know, I'm acutely familiar with the peripheral vascular space. Just just that's where I've spent most of my time and in med Tech. But for those listening that want ah, you know, kind of get a better understanding is that below the knee treatment options below the knee, or for for our arteries that are disease below the knee? I mean, there's pretty limited treatment options. And so, you know, and 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, ah, not to discount your above the knee applications, but the blow the knee is is Ah, but it's pretty easy to generate interest from a lot of interventional cardiologists vascular surgeons for below the knee applications.

Bruce Shook:   11:24
Oh, absolutely. You correctly point out that there are very few approved tools to treat that disease and that there were no approved dents in the U. S. To treat below the needed. These and this is the very first, you know, large multi site, pivotal trial that FDA has ever approved for a vascular implant below the day. So I think we're well positioned to really bring the very first vascular implant. The market is very

Scott Nelson:   11:52
absolutely. I don't think I fully realize I I realized that sort of the full scope of those trials, especially the above the knee and the blow the knee trial said. That's very cool. In just one last question about those trials, you're in terms of the structure. Are you comparing to drug coated balloons or help me understand that the involvement with with D. C. B? Because I do recall reading something about that aspect of your clinical trials.

Bruce Shook:   12:15
Yeah, we're not comparing to DT bees in a contemporaneous way. These air, not randomized trials in the tradition with dense in the legs is that they're typically thing Lauren files, and the Comparator is an objective performance goal that's derived from from the literature. What we do dio is we are using our technology as an adjunct, the drug coated balloon angioplasty, at least above that, for example, in our art over to trial. There are two groups in that trial. In one group, we're using our products to improve the results of playing balloon angioplasty and then the other group were using it to improve the results of drug coated balloon angioplasty and in each case were comparing to a relevant literature. Comparator, beloved in the We can really use a drug coated balloon because there are no drug coated balloons the FDA approved. So we're really, at this point anyway, forced to use plain below.

Scott Nelson:   13:16
Sure, okay, that helps. That makes sense. So let's 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 it asking a few questions about Abby, um, it And then we'll kind of quickly transition toe neuron therapeutics and then the You know, the eventual formation of your own ethics, but talked us a little bit about your experience. An album that you spent 10 years there eventually became president of the company. I think most people that are listening are probably familiar with Abby Amanda's, as it is today. So let's I guess the first question would be Why? Why did you make the move from Courtis to to add vehement?

Bruce Shook:   13:59
Well, this goes back in time away. But when I worked for quarters, it was first and foremost. A pacemaker company was actually number two pacemaker company in the world, and it was the dominant part of the business. Long predates game. Jay's acquisition of the company, the division I work for the Implant products division, ran into some very significant recall ish. Is it really kind of collapsed? The business. The division got sold and the acquiring, and he started to dismember it. So you know, the writing's on the wall in terms of being time to move on. And along the way, I've become very excited about the idea of getting into the start up world medical device. Start ups were really blossoming at that point, and an opportunity came my way to join this little company in Danvers, Mass. Called Ahab. You meds. 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 in tow, interact with the FDA, so they hired me to do that. That's where I started. I was one of the very early boy. I

Scott Nelson:   15:03
gotta And you eventually I think, you know, going back to you were there about 10 years. I think, you know, leaving in 97. If money, my researches, is correct here on my end eventually eventually rose up on became president of that company. So before we kind of, you know, move on, tow your next move. After that, I'm asking you to three. Go back in time, you know, quite a few years. But do you recall it? You know, a few specific challenges, you know, that that that you had to overcome and maybe what that meant to you, either professionally or personally.

Bruce Shook:   15:33
Oh, sure. I mean, there were There were lots of challenges along the way. Way we're doing really groundbreaking work in those days. It, Abby, amid ventricular assist devices were were really kind of scientific toys. They were not product. At that point in time, nothing was FDA approved nor at anything been through the kind of rigorous multi site clinical trial that we would all expect today. And we blaze that trail for the bad world at have you met? We did a lot of things for the first time, and any time you know you're bringing it truly first of a kind technology through the FDA approval process, it was gonna be a lot 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 is, uh, for the first time in the company was to build a sales and marketing scratch. We had a transition that company from being an entirely R and D based organization toe one that was now marketing a very doing, complicated product. And the

Scott Nelson:   16:43

Bruce Shook:   16:44
are tough. I learned a great deal from that experience.

Scott Nelson:   16:47
That is interesting that you mention that you know this. Ah, I have in my head this 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. And I bet that would be a pretty major shift in the in the inside of the life cycle for any company.

Bruce Shook:   17:04
It's a huge psychological change for the company

Scott Nelson:   17:08

Bruce Shook:   17:08
literally, you know, over the span of, you know, maybe sticks nine months. Do you go from an organization that is completely dominated by technical people to an organization where, you know, 1/3 of your employees might be sales and marketing step right. That's pretty wrenching. It

Scott Nelson:   17:26
changed for people

Bruce Shook:   17:27
to go through.

Scott Nelson:   17:28
I bet that that's ah, very interesting fact. So after, after your time in Abou Ahmed, you spent, I think about four years at Neuron Therapeutics. But before we go there, I noticed that that you did. You did end up getting your MBA from from in by M M I t. In the late nineties. It was probably around the time that you ended up leaving Abby. Um, Ed. So I saw that on, You know, in looking at your background, I thought it stood out to me because, you know, certainly by that, at that point, your career you had a B s, you know, from in chemical engineering from Penn State and masters in Bioengineering from Colombia. Obviously very good schools. You had a ton of business experience, and I got to think there's a lot. There's a lot, a lot of people in the audience listening to this and 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 your own ethics.

Bruce Shook:   18:21
You know, at the time, I really felt that I had risen into a position in ab you meant that I haven't been fully trained for. I have no training in finance whatsoever, nor did I really know anything about raising money. You know, Have you met had gone public in the late eighties, which was something that then CEO had handled. I did. I wasn't involved in that. And we really lived off his I p o fun. So there was really no need toe raise money on. I thought that corporate finance was an area where I really had deep in my knowledge, if I was gonna leave my own starts, 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, Sloane was just a great fit for for what I needed. And it it's an amazing place that I ended up learning much more than so. It also was sort of a springboard. It allowed me to work my way into the start up world. I started my first company right after graduating, which was No.

Scott Nelson:   19:26
Yeah, well, let's use that that this as an opportunity to talk about near on Therapeutic. So what, you know first maybe addressed the problem that you were trying to solve. And then and then I you know, I want to ask a follow up question about, you know, the the clinical trial, you know, Failure, I guess, is probably the best way to call that that you experienced in sort of what you did. In response to that,

Bruce Shook:   19:44
what I started Neuron Therapeutics with some neuroscientists from Thomas Jefferson University. Billy and we were working on an entirely new approach to treating scheming and hemorrhagic stroke. We developed a synthetic form of cerebral spinal fluid that could carry enormous amounts of oxygen and could be served circulated in the subarachnoid space is 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 human. I think way 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 because vital delays and would stroke you know, you can't waste a minute. So the experience really taught me the importance of creating technologies that is simple for the user of the technology itself may be complex, but you really need thio work to make things simple for the user.

Scott Nelson:   21:10
And when you sort of got the thumbs down from the F. D. A and I, I think you spend about four years at Neuron Therapeutics. Now I'm curious to find out or learn a little bit more about how your team responded and, you know, the I'm curious to get your take on this because I wonder if it's any different than ah, in a conversation I recently had with with Kevin side out, who's with you know, the CEO of Moxie Mad. And they went through appeared with their device where, you know, the panel gave them a thumbs down and almost forced them to become a little bit smarter and a little bit leaner. And it forced him actually in the profitability and lead them to kind of iterating pivot and obviously wasn't wasn't good. Knew that wasn't wasn't the news anyone wanted to hear at that point. But it did sort of like, allow them thio sort of shed some, 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 how did your group kind of you turn the corner?

Bruce Shook:   22:02
Well, actually, FDA had nothing to do with it. We had i d approval to do this study. It was a relatively small studies, a pilot study, and it was us looking at the data. Looking at the results, we concluded that, you know, it just did not work.

Scott Nelson:   22:18
But I say

Bruce Shook:   22:18
we 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 a decision that, you know, our team made in conjunction with the board, of course. And we ended up selling the I pee off, and that was that. The team, actually, much of the team hung together, and we all went on to form their own ethics. About nine months later,

Scott Nelson:   22:44
I got it. Okay, so it was It wasn't the f panel decision. It was your own sort of internal analysis and run

Bruce Shook:   22:49
at Neuron Therapeutics. This was an early stage, clinical trop. You know, we just concluded once we looked at the results that wasn't viable.

Scott Nelson:   22:58
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 your own ethics. Is that right? I got it. And speaking of, of near on, ethics, you know, when you when you get the technology now it's It's been featured on, you know, the Daily Show. You know, Dr Oz, you know, pretty pretty well known publication across the across the U. S. If not across the world with pretty, I think, at least based on what I what I have read is is pretty broad utilization, but it's certainly it certainly wasn't all rosy. Certainly wasn't easy along your journey. And I think that's maybe that's where I I sort of got the two mixed up. That's your TMS device. That's the one that actually have, you know, got the thumbs down from the FDA advisory panel. Is that right?

Bruce Shook:   23:43
Yeah, it was It was a controversial pound meeting.

Scott Nelson:   23:48
Yes. So talk to us a little bit about that. That was I think that panel meeting was maybe early 2007 right?

Bruce Shook:   23:55
Yeah, I

Scott Nelson:   23:57
got it. So So mid 2000 seven's. And so here you are with this technology and the FDA gives you the thumbs down for something that you strongly feel is working and is proven. So you know what? Walk us through that time, and you're how your team sort of work through that experience,

Bruce Shook:   24:14
right? Yeah, well, first of all, we were thoroughly convinced we had something that worked. It is true we missed our primary M point by a minuscule amount, I think 71 thousands of a P value point. It was really kind of Ah, trivial Ms. On the primary m point, we had multiple pre specified secondary measures of advocacy that were very positive. And when you add to that, the fact that you know the safety profile of the North Star technology is actually far superior to drug therapy. It seemed ridiculous. Tow us do not have this therapy out there and available to the to the appropriate patient's 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 a unique to add to that mix. So we press that case with FDA relentlessly, and we did dozens of analyses demonstrating the effect of the effectiveness of the treatment. We brought some of the most accomplished people in psychiatry into the discussion who were very supportive. We ultimately re filed the application after the panel meeting as a de novo 5 10 k applications 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 and move us to clearance.

Scott Nelson:   25:46
So when you think about, you know that that context and I know granted it was probably about 10 years ago now are you know, eight or nine years at least you know, looking back, that experience, would you would you have done? Would you do anything differently? You know, let's let's pretend not to say that you'll get into that scenario with intact vascular at all. But let's let's say you had a hypothetical company and you ran into that same scenario where you know the FDA or a regulatory body was just being over overly difficult. Would you? What? What advice would you give the other maybe founder, that are in that early stage entrepreneurs that are in that in that same scenario?

Bruce Shook:   26:18
Well, I think you know, the first bit of advice I would give anybody is that you have 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 focuses 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 their smart people and they have a job to do, just like all of us do. And typically, if you can, you know, Marshall database arguments that makes sense. Then 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 technology, and you do the best you can and make your case.

Scott Nelson:   27:24
I love your your response with respect to not getting emotional about any sort of decision that comes down. I think it's, ah, easier, 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 stability and then you know that the science will win. Maybe with a little bit of persistence. You know, the science and the dad I will. Well, hopefully when the win the day, but good point in the last before we cut a circle back toe your experience that at intact vascular so far I want to quickly ah, hone in on the whole coverage in reimbursement aspect to neuro Net IX and kind of what you accomplished there. Because, you know, like I mentioned earlier, seems like there's there's some definitely some better insurance coverage with respecto, you know, TMS therapy. Now that obviously wasn't the case. So can you talk to us a little bit more about your approach? Thio not only gaining coverage, but also, you know, getting getting reimbursement for for that particular therapy

Bruce Shook:   28:18
reimbursement was, I think, one of the toughest obstacles we had to overcome, you know, you're in attics is now at her. We're 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 cpt one codes, which is a very difficult and political process. We had toe work with every insurer in the land to secure coverage policies. And then once you have policies in place, you have to have frequently do battle over the payment amount. So I would say that reimbursement for First of a kind technologies is, ah, substantially iron girdle on FDA approval, partly because you have to deal with so many players simultaneously. So if

Scott Nelson:   29:03
I were

Bruce Shook:   29:03
to give advice to other people, you know, I think we all have to be extremely thoughtful about the reimbursement

Scott Nelson:   29:10
hurdles any

Bruce Shook:   29:11
technology presents as part of your upfront villages process. For example, a technology that demands new CBD one coaches going consume much more time and money that one other than one that can leverage existing code. 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 gonna generate really compelling randomized data, and you have to have the right people. Working reimbursement for you is is definitely a skill position, and I give a great deal of credit for the reimbursement success Internet IX Thio, Mary Hayley Randall reimbursement team. She didn't extraordinary job

Scott Nelson:   29:54
on that note with respect to reimbursement. My hunch is that you're treating or TMS therapy is, you know is probably for, ah, patients. You know, cohort. A cohort of patients that is covered by private private insurers. Is that accurate?

Bruce Shook:   30:07
It's covered by private insurers and by Medicare as well, I think I don't know, top. My head of every single Medicare intermediary covers it today, but I think the vast majority do.

Scott Nelson:   30:19
Yeah, well, I mean to your to your point about, I guess, where where I was going with that question is to your point of the hut, you know, so many stakeholders being involved. This question comes up again with this topic, I should say comes up again and again and in the sense that reimbursement our coverage of reimbursement is becoming no, the biggest hurdle with respect. Oh, 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 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 failures with the the TMS therapy.

Bruce Shook:   30:55
You can't underestimate the difficulty of winning that war can.

Scott Nelson:   31:00
I don't

Bruce Shook:   31:00
think you can underestimate the time and money required to wage that war either.

Scott Nelson:   31:06
Got it? You know, before we go to intact vascular cause I am curious to learn a little bit more about why you made that transition and what brought you tow intact, vascular. But looking back over your you know, your 10 years at Neuron X is there anything else that you think is worthy of mentioning or or something that you you look back and think, Wow, I'm really proud that we did this and didn't go in that certain direction.

Bruce Shook:   31:27
Well, I think that, you know, the fact that we invested so much effort and so much money in clinical development early on that norrin eh, ticks really ultimately saved us, particularly when

Scott Nelson:   31:39

Bruce Shook:   31:40
came to reimbursement. We ended up with two large randomized controlled trials, one that we elusively funded as a company and then the other that n i h 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. Absolutely pivotal. Took a long time, and it took a lot of cash, but it was money very well spent.

Scott Nelson:   32:10
That's good to note. And I think to your point earlier about even getting a a c p t Category one code, the level of evidence for the amount of clinical evidence that's needed. You know, if you 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 toe intact. Vascular. I'm curious to learn a little bit more. You're transitioning out of neuro net IQ. So what brought you there in the first place?

Bruce Shook:   32:36
Yeah, I was recruited into intact by Cheryl Nap from Quaker Partners, Cheryl's one of Intacs early investors and board members. He was also a long time investor and board member and aromatics, and the company is is local. Actually, just down the road from your genetics is 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 basket with space and the team was very skilled. So the company needed leadership in cash. And, you know, I was quite confident that I could fly both of those things. It's been a great fit

Scott Nelson:   33:13
God. And I think that at that point, you know, intact vascular the company had raised I think, Ah, Siri's A back in back in 2012 I think. And then, you know, you came on board about a year later, or so you raised a pretty hefty Siri's being 38 million. Was that with the correct number, and that was that was led by any a Is that right?

Bruce Shook:   33:30
Right. I brought any A and just inclined into the investing signal. Then the

Scott Nelson:   33:35

Bruce Shook:   33:35
And they were joined by Quaker and an H I G bio ventures, both of whom had participated in the air around,

Scott Nelson:   33:41
got it. So I mean, if that was one of the reasons that intact vascular was was interested in bringing you on board is to help help lead those those fundraising efforts. What advice would you give to other other med tech entrepreneurs out there that are at a stage? You know, their companies had a stage where they've raised maybe some some angel money and maybe earlier on they raised him. Some friends, you know, some friends and family rounds, but are all ready for that next step. Whether they need to raise a bigger, you know, larger syndicate through three angels or they or they need, you know, traditional kind of, ah, adventure of venture capital money. Do you have any best practices are What's your general thought process to that?

Bruce Shook:   34:16
Yeah, I can offer a few thought. One is that you need a very clear message on everything from the market and the customers you're gonna serve to the clinical trials. You plan to run to projected cog toe health, economics and everything in between. You can't cut corners on preparation before you're in front of you know, 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 nobody knows everything. So I think you need to supplement yourself with people that really, for example, would have depth and healthy economics. Is that something that's that's new to you? Second thing I would suggest is that you test drive what you're gonna 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

Scott Nelson:   35:17

Bruce Shook:   35:18
matters. I've 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 cold, particularly if you're relatively new to the money raising game on. 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 know you ought to be able to tell your story in 20 minutes.

Scott Nelson:   36:02

Bruce Shook:   36:03
they're gonna ask questions, and it's gonna you're gonna fill that our But I think people sometimes you're so anxious to tell their stories in all their glory that they drone on for the full hour, and I think that's a very big mistake. You have toe home the pitch. Such such that it sze concise and fits in roughly 20 minutes.

Scott Nelson:   36:23
Yeah, that's good advice. I mean, 44 really solid points. I think that would be valuable for anyone listening. That's in. That's in a similar situation, especially with respect. Thio point about, you know, bringing actively seeking out those experts. You know that they need to help you craft craft a certain story. And I had a conversation earlier this week with Dr Bob's mouth. Bob Smiles, who's the practicing interventional radiologist but is with that one of the founders of Bright Water Medical. And no, it's a therapy that's really close to home for him and of Isis really close to him. But he he actively sought out, you know, other people that 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 is probably a little bit easier said than done, especially if you're you know you're knee deep in the you know, with the devices in the business in the technology

Bruce Shook:   37:13
Yeah. You have to tell a multifaceted story. You know, get all the help you can with each fast.

Scott Nelson:   37:20
Yep. Absolutely. As we look to wrap up this this particular conversation. What I you know, I ask you a little bit more about, you know, your clinical trial. And I think if my notes here on my and were correct, you expect to submit your p m 82 to FDA in Q one of 2017. Is that right?

Bruce Shook:   37:35
Well, where we actually are already in the midst of the PM. A submission process.

Scott Nelson:   37:41
Oh, you are. Okay.

Bruce Shook:   37:42
We're following a modular approach, but the rial sort of trigger for the final submission, the FDA will be 12 month data, which we would get in early. 18.

Scott Nelson:   37:53
Okay. Early 18 Oka. Very good. And then, in terms of what? What's next for intact vascular? Outside of clinical data. Can you speak to that?

Bruce Shook:   38:03
Sure. Well, you know, the next big milestone for us will be startup of Toby to B t. K. This pivotal below the knee trial that we talked about earlier earlier. And we'll be enrolling that trial for, you know, roughly the next 24 months, so that really kind of will take us out into 2019. Between the pivotal below the knee trial enrollment and the completion of our above any civil trial and prosecution of R P M. Aye,

Scott Nelson:   38:35
got. And we'll get to these last three rapid fire questions here in a second. But with respect to intact Vascular, you've been there, you know, since since 2000 and 2014 about about 2.5 years now. You know, looking back over that over that time, is there anything else that you think would be valuable for the audience toe know or understand?

Bruce Shook:   38:53
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 knee offering. And we're first mover in a nascent market with are below the knee offering, though in many ways it's kind of the best of all worlds that I think very unique opportunity.

Scott Nelson:   39:18
All right, very good. So Well, on that note. Speaking of unique, we'll get to some maybe some more unique questions to this particular conversation anyway. Well, in the 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 expand a little bit. But Bruce, what's your favorite business book?

Bruce Shook:   39:36
That's a very tough question. I think I would have had to pick one. I would pick. Crossing THE Chasm By Jeffrey Moore

Scott Nelson:   39:44

Bruce Shook:   39:44
think it's 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. I found it fascinating, and it's really it taught me how to think differently about new product introductions.

Scott Nelson:   40:08
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

Bruce Shook:   40:14
know, I've really been impressed with what Scott Ward has done at Spectra in Attics

Scott Nelson:   40:21
E and

Bruce Shook:   40:22
Shar Matt 10 his b 00 I think I'm gonna don't 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 Stella Rex drug coated balloon technology from comedian.

Scott Nelson:   40:38

Bruce Shook:   40:38
that's definitely a company Tow watch. I think that they really done some great work there.

Scott Nelson:   40:43
Yeah, it seems like they're pretty well positioned, especially with some of the recent acquisitions that they made with angio score. And then, obviously, that was That was a steel picking up the Stella Rex technology from committing after the Medtronic acquisition. For sure, I I could. I hold hardly wholeheartedly agree and isn't Isn't Spectra Nick? Are they based? Their in Pennsylvania's? Well,

Bruce Shook:   41:03
no. Colorado.

Scott Nelson:   41:04
Colorado? That's right. That's right. Yeah, I forgot about that. Very good. I knew. I knew it was It wasn't your traditional, like med tech hubs, but cool to see a company 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?

Bruce Shook:   41:20
Oh, I think I'd probably say sell everything you own. And by that apple stock, the first time you

Scott Nelson:   41:25
leave the way that

Bruce Shook:   41:29
beyond. Beyond that, I guess I would tell myself that you have more influence, then you really appreciate. And you should use it.

Scott Nelson:   41:38
Good stuff. Good way to end the discussion. So, Bruce, I'll have you hold on the line. But thanks again for willing your willingness toe hop on. Spend some time with us on Made med side of radio.

Bruce Shook:   41:48
Oh, sure, I enjoyed it.

Scott Nelson:   41:50
All right. I'll have a hold on the line, Like like I said before. But for those listening in the audience, Thanks again for your attention, as always. And until the next episode of med cider radio, everyone take care. Thanks again, ladies and gents, for listening. This episode has been brought to you from the W C. G studios here in Minneapolis. And don't forget to grab your pan optic stacking blueprint by visiting reach. Fire digital dot com for slash met cider Again. That's reached fire digital dot com forward slash met cider. Okay, bye. For now.