In this two-part interview, I was lucky enough to sit down with Erica Rogers, CEO of Silk Road Medical. We first spoke a few years ago and then again much more recently to catch up on what had changed at Silk Road since our first conversation.

During our catch up, we discussed how Erica led her team at Silk Road through PMA approval, successful insurance coverage and reimbursement strategy, which led to a very rewarding public offering for Silk Road, opening at $20 a share. This resulted in the opportunity to continue the company’s goal, which is to change the standard of care in carotid artery disease with their TCAR procedure.

Much of our first conversation was about Erica’s career trajectory and how she was able to successfully, and gracefully, exit multiple medtech companies. Her lengthy career and insight as a medtech thought leader is just as interesting today as it was when we recorded our conversation.

Before leading Silk Road, Erica was the COO of Medicines360, a nonprofit pharmaceutical company developing drugs and devices for women. Erica was the founder and CEO of Allux Medical as well as the cofounder of Visiogen, which was acquired by Abbott Medical Optics in 2009.

Prior to that, Erica spent over 12 years at Boston Scientific in a variety of sales and marketing positions. She began her career in pharmaceutical sales after receiving a B.S. in Zoology from San Diego State University. Erica holds five issued and 15 pending US patents for medical devices in nanotechnology.

Scott Nelson: Erica, welcome to the program. I appreciate your coming on. 

Erica Rogers: Well, thanks for having me, Scott.

Scott Nelson: All right, let's start with Visiogen. You co-founded that company back in 2000, I believe the 2000 timeframe if my notes are correct here on my end. Then you left in 2004 to start Allux Medical. So, let's go back. I want to set the stage here for when Abbott finally purchased Visiogen back in 2009. So, I think that was about five years after you initially left. So, with that in mind, you know, any thoughts as to where you were in time, and what you're mindset was when Abbott pulled the trigger on Visiogen after building, that company back in the early 2000s.

Erica Rogers: Yeah, well, I was absolutely overjoyed for a number of reasons. First of all, obviously, as the founder or co-founder of that company, I had an extraordinary, vested interest in seeing that technology come to fruition and to the market. We were taking on a massively huge challenge there at Visiogen which was to create a true, accommodating, intraocular lens, one that would provide more accommodation power than any lens prior to that time. The structure of that lens is very, very complicated. It was a huge validation of the bet that I had placed in my career to do Visiogen in the first place which began with starting at Three Arch Partners as entrepreneur residents and [06:09 inaudible] out of that. 

So, it validated the whole decision-making process around the unmet need there, around the technology, and all of that. Also, as a founder, I still had a reasonable position in the company. So, economically it was good for me as well. In terms of was it bittersweet? Yes, of course, you'd love to be there at the exit end. It's never the end, the technology lives on and all of that. But yeah, it would have been great to be there for that kind of victory lap. Also, what I learned in hindsight many years later is that because it wasn't there when the company actually exited I didn't really get credit for the exit, even though I was one of the first. So, that was a little bit of a bittersweet pill for sure. But the reasons for leaving in the first place were kind of twofold. 

One was the company was heading into what was going to be a very long, protracted process with the FDA and by the time I left, I was at that time running marketing. So as the co-founder originally I was doing a bunch of things, wearing a lot of hats, clinical, regulatory, and marketing, and some office R&D thrown in and office management on the side. Then you narrowed the role obviously, over the years to marketing. So, it was both a personal decision around geography, just needing to be back in the Bay Area and then, secondly, wanting to place another bet because I knew it was going to be long and drawn out at Visiogen. I thought, well, I want to go do another startup and place another bet and not have all of my equity eggs in one basket if you know what I mean.

Scott Nelson: Sure, yeah, that's a good anecdote. I want to ask you a few more questions here later on in the conversation about Allux Medical and your decision to place another bet after founding Visiogen. Let's go and set the stage for the audience. I provided an intro and your bio at the beginning of this discussion, but you joined Silk Road Medical as President/CEO in 2012. We're recording this conversation in early 2017, it's about five years ago, four to five years ago. So, can you provide us an overview of the device you're commercializing now at Silk Road and really, how it's different than carotid stenting or carotid endarterectomy? Then give us a little bit of a take, and I want, a little bit of a long-winded question. But give us a little bit of a take on where you're at in terms of commercialization both here in the US and abroad.

Erica Rogers: Sure, feel free to interrupt if I'm going long on either of those multiple parts of that question. Really Scott, it all starts, the Silk Road story really all-stars with stroke and stroke is, as you know, a devastating and often fatal disease and carotid artery disease is responsible for about 1/3 of all strokes in the United States. So, unfortunately, one of the downsides of performing a procedure to fix that carotid lesion and prevent the future stroke that it could cause is in the process of fixing it, you can cause a stroke during or in the periprocedural period. So, today, carotid artery disease is typically treated with an invasive surgery called carotid endarterectomy or CEA. 

CEA is super good at protecting the brain, preventing future strokes and strokes during the procedure but it's pretty invasive. It's a long incision down the neck, meticular surgical dissection, collateral damage, cranial nerve injury, and heart attacks, and room complications and things like that go along with invasive surgery. So, to your point over the last call at 15-plus years industry has attempted to solve for that morbidity around this invasive procedure called CEA. 

We did that with a minimally invasive catheter-based approach called CAS, carotid artery stenting. That is from the trans-femoral route. The problem is, as it turned out, CAS actually increased the procedure-related stroke risk relative to CEA due to inherent design and technology flaws and in particular, starting from the groin. So, surgeons and peers weren't willing to make that trade-off of excess stroke risk in and around the procedure just to get the minimally invasive benefits. 

So, Silk Road has been able to go to school on 15 years of trial and error around carotid stenting and really honing in on where the shortcomings lie. It's really all about delivering the stent safely. So, TCAR which is Trans Carotid Artery Revascularization which is the procedure we do. It starts in the neck. It's direct access to the common carotid artery. We set up a flow reversal shunt that's outside the body, returns blood into the femoral veins and we place a stent under that flow reversal so that any debris that's rendered is captured and never, ever had a chance to hit the brain.

So, we published our first results from a big US trial in the Journal of Vascular Surgery in 2015 and showed a 1.4% stroke rate in all patients, which was the lowest published stroke rate of any modality, whether it be surgery or carotid artery stenting up until then. So, that's what really put Silk Road on the map, got everybody's attention, and last year we got a very favorable Carver's decision, which we can talk about later if you want to. We commercialized the device last year really in earnest in April and had a phenomenal first year with each of our territory annualizing it over a $1,000,000. So. we're off to the races.

Scott Nelson: Really cool success story for sure, especially for watching an early stage medtech company actually commercialize a technology here in the US without having to be acquired by a larger strategic for sure. So, it's cool to see what you and your team have done up to this state so far. So, we're going to circle back around and talk about some of those more specifics. But let's take this opportunity now to go back in time a little and learn a little bit more about your career and some of the challenges that you faced over the time as well as some of the lessons learned that have brought you and forged a path where you're at now with Silk Road. So, let's go back to your days at Boston Scientific. I know you were there from, like, the mid-90s to around the 2000 timeframe. So, what first brought you into the medtech space, and what was your role like at Boston Scientific over the span of those five years?

Erica Rogers: So, I'm going to tell you the true answer, which is I had spent the early part of my career in the pharmaceutical industry. So, I was out in hospitals and physician offices and things like that, and every time I would pull up to a hospital in my Ford Taurus and I would park next to somebody who would get out of their BMW, and I would ask that person what did they do? They would say, well, you know, I sell medical devices. Back in the day was pacemakers and so it became really clear to me early on the cool jobs were over in the medtech space. So, that's the honest answer to the question that why did I start paying attention to that area of medicine in the first place? So, I started Boston Scientific as a sales rep, literally carrying the bag. I was super drawn to that role and that company. 

It was a company called MEDITECH at the time. It was before it was even called Boston Scientific and before the IPO. Now you should understand I was a child prodigy. I was really only 12 years old when all this happened. So, if anyone is doing the math on how old I am it's really embarrassing. So, I was around when Boston Scientific went public, and I have one of the very first shares still framed in my office. So, what drew me there was obviously interventional medicine was just getting started and it was obvious this was going to change the world. The whole vascular bed was poised for from the big open surgical procedures to these minimally invasive things. It started with a really simple angioplasty of iliac arteries and obviously, history speaks for itself. That's what really drew me into Boston Scientific. This was the beginning of something really, really big.

Scott Nelson: Glad that you mentioned that. That's the point about being in the pharmaceutical space and seeing your colleagues in the device base just leading a much better quality of life in terms of income. I'm sure a lot of those people, including myself, that are listening to this interview can absolutely appreciate that perspective. The roles that you had at Boston Scientific leading up to when you left in 2000. So, I presume you eventually went in-house.

Erica Rogers: Yeah, sort of. That's a complicated story, so I did work up through the ranks in the sales organization and sales training in particular and ended up in leadership roles there. But there was a need for me to move physically to Boston, and I was unable to do that for personal reasons. So, I kind of maxed out in what I could do at Boston which is why I ended up in Target Therapeutics and I crossed over into Target did market development at the very, very early days of aneurysm coiling. Literally, I started at Target Therapeutics within days of the 510(k) clearance on the first aneurysm coils. 

My role there was market development. So, it was figuring out how to go from the five doctors in the world who could coil an aneurysm to taking over all of the intracranial aneurysm therapy and what were all the things that we were going to need to do to solve that puzzle and it was everything. Everything from reimbursement to additional data to randomized trials against aneurysm clipping. It's just a giant puzzle that had to be solved on the market development front at Target Therapeutics. So, when I think about my Boston Scientific years, I lump them all together because I left Boston Scientific and went to Target Therapeutics and within about 90 days of me going there Target was acquired by Boston Scientific. So, I was back.

Scott Nelson: Boomerang. Yeah. Boomerang effect.

Erica Rogers: Yeah. Now there's a real lesson there Scott and that lesson is how do you exit companies exit them with grace such that when those kinds of acquisitions happen that you're invited to stay and in fact, that's what happened. Many people in the original Target organizations were let go in that merger because there was duplicity. I was preserved and in fact, elevated in my role in the organization in neuro and was able to stay in California and move up the ranks at Target Therapeutic inside Boston Scientific.

Scott Nelson: Got it. Okay. Take me back to that time frame because I have when you first founded Visiogen in the early 2000s. When you went to Target and then Target was acquired by Boston Scientific do you recall the dates?

Erica Rogers: Oh gosh!

Scott Nelson: I'm asking you to go back in time yeah. I was just trying to get a better feel for the timeframe to help people track along.

Erica Rogers: It was like four years doing neuro inside Boston Scientific. So, it was around '96. 

Scott Nelson: Got it. Okay, Okay, that makes sense. So, you were inside. You went to Target, which was obviously a very early stage company, Boston acquires Target and then you go to Three Arch Partners. So, walk me through that and how did you end up as an entrepreneur in residence at Three Arch leading up to the eventual formation of Visiogen. 

Erica Rogers: Well, that's one of my favorite parts of the story. When we take these right turns, and we decide to pursue the road less traveled. I was very happy at Target Therapeutics. We were just knocking the cover off the ball there and making enormous strides in intracranial aneurysm therapy and getting into an ischemic stroke. It was super-hot and super exciting, and I was working for great people and I had a great team under me. Then I got introduced to Three Arch Partners and they were looking for an entrepreneur in residence who had some background in the stroke arena, which is how I came across them. 

I was really torn as to what to do because I had never been inside the venture community. I'd never done a startup. I didn't know what an entrepreneur in residence even was and how would my success be measured and all of those things. I was coming out of this giant organization Boston Scientific and one of the partners at Three Arch sat me down and he said, look, if every single aneurysm in the world were coiled instead of clipped what would happen to the value of your Boston Scientific stock? I said, well, this is 2000 we're talking about, 1999-ish. I said, well, not a whole lot because at that time it was all about coronary and stocks rose and fell on the basis of coronary market share and coronary market entrance and stents and all of that stuff that was happening in the cardio Cath lab. 

So, what he was trying to tell me was that I had reached a point in my position there where I could no longer have an enormous impact on the state of Boston Scientific. He said, if you come here and you do this very early stage thing, you will have an enormous impact because you will go and found something if we do this right. I said you're right, I have to go do that. So, that was what was behind the decision, Scott. But then there was also this other small voice in my head that said, they're probably not going to ask me twice. Probably go do this with the leading venture capital firm in Silicon Valley at the time.

Scott Nelson: What do you think was it that attracted the partners of Three Arch to pursue you and want you to come on board as an EIR?

Erica Rogers: I have asked myself that question. I don't have the exact answer. But here is what I think. One is I had real core confidence in all things intracranial. Aneurysm and stroke that was a hot area of investment at the time. Three Arch obviously had some deal flow in that area. I would be helpful there as an Entrepreneur in Residence and a Principal in that capacity. It was one of the areas that they wanted me to incubate around. I knew all of the citizens globally, so that was helpful to them. 

But I also think that you can have an entrepreneurial spirit inside these large companies, and I think they picked up on my entrepreneurial spirit and wanted to tap into that. What separates some entrepreneurs are if you are an entrepreneur that has that spirit and that gut, and you also know what it's supposed to look like at the end. When it's a big company, you can connect the dots from early, early all the way up to what it needs to be at Boston Scientific. So, I think they became convinced that I could do that. I could start something very, very early, and nascent and I could take it all the way through and make it look and act like a big company

Scott Nelson: The notes that I am jotting down here is the ability to see the end in mind for a medtech startup. That's a powerful thing when in retrospect sort of looking at it under the guise of having 2020 vision. Let's fast forward your time now at Visiogen and then at Alex Medical. I think there's probably some interesting things to pull through at Alex Medical. But you're at Three Arch and then you decide to place a bet at Visiogen and slide back into the operator position. So, what led up to founding Visiogen back in the early 2000s?

Erica Rogers: Well, it really started with looking at a bunch of unmet needs in various diseases and therapeutic categories. One of the categories that my then thought partner at Three Arch, a phenomenal gentleman by the name of Reza Zadno, and I were kind of joined at the hip there at Three Arch to figure this out. One of the disease areas that were looking at or therapeutic areas was with presbyopia, the loss of near vision as we age, the change in vision as we age. So, we were two people from vascular backgrounds and invented this intraocular lens and we pitched it, I don't know, three or four times inside Three Arch to say this is the thing we want to go do because we're absolutely convinced that we're on to something and this is going to be big and going to be transformational in ophthalmology. 

We got the typical response. What the heck do you guys know? You're two people from vascular.  How can you actually know anything about inventing a lens in the eye? What do you know about ophthalmology and running a business in ophthalmology, etc.?. We were turned down multiple times. So, we had to really hone the arguments and hone our own skillset. Finally, we got it right and they allowed us to spin it out and then they dedicated the first financing, and we were off and running at Visiogen. So really, we were trying to solve presbyopia, and we were doing it with a cataract replacement lens which would give people at the time of cataract surgery back their full range of vision. It was an extraordinarily complex problem, and the learning curve was very steep. I did not know a whole lot about optics going into that. But I came out knowing a lot about optics and the eye and all of that. Did you also get into what led my departure or?

Scott Nelson: Yeah, Yeah. I was going to ask you one follow-up question before we go there. But I'm interested in getting the name of the other partner who helped you co-found Visiogen. What was his name again?

Erica Rogers: Reza Zadno.

Scott nelson: Reza. So, you both had a vascular experience. But yet to the point of some of the other Three Arch Partners who evaluated that deal and said what are guys doing with vascular experience trying to attack the ophthalmology space? Help me get inside your head because I think for most people they'd probably gravitate towards something.. If a company they were going to found and their domain expertise is in the interventional vascular medium they're probably going to gravitate more towards that space. But you both didn't considering your experience. So, was it the disease state, or was it just the new challenge? What was going on in your head and why did you decide to do a new therapeutic arena with Visiogen?

Erica Rogers: So, we were tasked with as I said looking at just becoming smarter around several different areas, and at that time, obesity was really hot, and ophthalmology was really hot and stroke. There were a couple of others. So, we would go to the major medical meetings in those huge categories. So, we went to the major ophthalmology conference is and they're relatively dull and boring overall, but we walked around the various breakout session and didactic sessions. We realized the ones where they were standing room only, and the rooms were packed, and you couldn't get in were the ones that we're talking about presbyopia. So, just through observation, we said well, this is interesting. People really care about this presbyopia. It's obviously a hot topic. So, we just dove in and one of the things that that one of my bosses said to me back in the Boston Scientific days. He said to me, "You know what I like about you, Erica, is that you're so brave and you'll just dive into anything because you actually have no idea that you can't do something." So, it never occurred to Reza or me that we couldn't invent an intraocular lens. We simply figured we have the skillset to study the problem and if we study the problem carefully enough and talk to enough people and do enough of the back of the envelope math and things like that we'll probably solve that problem, and we did.

Scott Nelson: Is that something that you believe is innate to your character or is there something that you learned over time?

Erica Rogers: I think it's innate.

Scott Nelson: Yeah,

Erica Rogers: I would love to be able to say you can learn it over time, but it's been kind of a tenet in my entire career, which is just taking these giant leaps into the unknown with absolutely not a thought that I wouldn't be successful. I was just like I'm going to go do that and I'm going to go do that and I'm going to be successful at doing that. Not in a cocky way and certainly I don't want to mislead you. I'm very aware of my shortcomings in doing so. So, the key to success in these leaps of courage is knowing what you don't know, being hyper-aware of knowing what you don't know and surrounding yourself with the people who know what you don't know.

Scott Nelson: Sure.

Erica Rogers: So, that is the only thing that allows me to take these giant leaps of faith.

Scott Nelson: That's a really good point because it's not like you're just jumping off a cliff per se. You're intentionally surrounding yourself with people that are going to have the expertise that you don't bring to the table or some value that you don't have and making sure that you're around those people that can bridge the gap in those situations. It's interesting you bring up this point. I remember listening to an interview of a serial entrepreneur in the tech space, and I think he made some comment a lot along lines of look... He was speaking to a pretty broad audience and he mentioned that you know, look, I get to the plate and swing more often than most people. So, of course, my batting average is going to be higher because I just swing more. Do you know what I mean? So, I think it's probably appropriate to somewhat of a similar analogy to your comment about willing to swing where most people maybe wouldn't. So, that's good stuff. 

For the sake of time, let's move forward because I do want to circle back to your decision to join Silk Road back in 2012. But I'd like to ask you a question in regards to Visiogen and then Allux. So, if we move forward in the timeline of your career, you said earlier that you were at a point with Visiogen that there was going to be pretty extensive regulatory hurdles, that you were going to be running into in the future, so you wanted to take another bet with Allux Medical. So, I think if my dates are correct, you joined Allux Medical in 2004. So, what did you see at Allux and why make the leap? Then talk to us a little bit about when that shut down, I think maybe around the 2008 timeframe what you learned from that experience.

Erica Rogers: That's a long tale. But let me start with Allux. Interestingly, when I made the kind of personal decision, it was time for me to exit Visiogen against both for geography reasons and also wanting to place another bet. I went back to the investors that were around the table at Visiogen and they said, well, let's just incubate you to go do something else and we'll do it up in the Bay Area where you need to be. So, it started with an incubator. I brought in another partner at that time, a physician and we were funded by Three Arch, Venrock, and Prospect to incubate a bunch of new ideas. Again, it was kind of back to where are the big unmet needs and looking at the clinical problems first, which I'm a huge fan of. 

Let's first look at the problem and then solutions to the problem and what we see a lot in our space is people who have solutions trying to find a problem. That is not what I do. I start the problem and then go try to find a solution. One of the things that we were incubating at the time was allergic rhinitis and the whole continuum of airway disorders, which is allergic rhinitis, nasal polyposis, acute sinusitis, chronic sinusitis, functional endoscopic sinus surgery. That whole continuum. Here we are again. I'm taking this massive leap into ENT. I didn't even know an ENT when I was incubating this idea.

So, we found some technology over in Europe that had not only received the CE Mark but had already published papers on the use of ultraviolet light in the interior airway and downregulating the immune system for the treatment of allergic rhinitis, polyposis, and sinusitis. That's what we did. So, I and this partner and these three investors we sat around and said this is enormous. I mean, rhinitis and allergic allergies are just an enormous market not to mention chronic sinus disease. So, we went after it knowing that there this published paper and data to rely on.  We licensed the intellectual property from this team in Europe and we started down the path to get into the United States. The good news was the technology had been mostly developed. 

We had to tweak it a little bit and we were very, very quickly into a clinical trial in the United States. We conducted a 350 patient trial during an acute allergy season, applying this ultraviolet light inside the nose, and we massively failed to hit the endpoint. So much so that way had to look ourselves in the eyes and say, how could this possibly have happened? There's a published paper already on the results of this technology. The thing that I learned, I completely underestimated, failed to appreciate how difficult it is to run a trial in patient-reported subjective outcomes. The outcome measure for allergic rhinitis and all those diseases was things like, how much you're sneezing, how much you blowing your nose, how much are you coughing, stuff like that. Patients have to report this in a diary every single day and they have to turn these diaries in at the end of everything. 

It turned out there is tremendous noise in that subjectiveness and in the patient-reported, although validated, patient-reported scales. This is why the drug companies that did you know Claritin and all the rest of those drugs literally have to enroll thousands of patients, two, three plus thousand patients to see the signals. That was completely lost on us. That was probably the closest example to a real in your face of you don't know what you don't know. Not having deep-seated experience in that whole disease state really took us by surprise. We surrounded ourselves with experts. 

We were working with a really well-known allergist. We hired some people who were experts in an allergy and immunology, but it was all lost on us. So, all of this was kind of crashing and burning right at the time of the economic crisis in 2008. We had a choice of raising a bunch more money and trying to figure out what we're going to do next or shutting the company down and cutting our losses, which at that time were very small. We hadn't raised that much money. Three investors, for them it was easier for them to write it off honestly in 2008 than it was for them to continue to figure it out. So, that is what happened.

Scott Nelson: Wow. So, the fact that you were able to surround yourself with experts in the space and you would think that something like that, someone would have noticed that along the way. Like, hey, this clinical trial, it's heavy on patient-reported outcomes that are very subjective. In hindsight, obviously, it seems like someone could have solved for that along the way. But do you ever look back and think? Wow, we could have done that differently or how did we miss that? 

Erica Rogers: Oh, absolutely, for sure. I think we relied too heavily on the previously published work, which has been a very small study, smaller than what we did. Yet they showed a signal. So, always be skeptical about other people's data, even though they're published in peer review journals. That's one note of caution. I think the other thing is we actually parse the data out and ended up discovering that the sickest of the patients actually did respond. So, I think the lesson there was if you're going to do a patient-reported outcome study, and that applies to a lot of things like headaches and pain. Those are two really tough spaces that are patient-reported. Although validated through scales in many cases, they're tough. So, I think had we chosen the sickest of the sick patients, to begin with, in other words, had the inclusion/exclusion criteria been such that we would have had very sick patients we would hit the endpoint.

Scott Nelson: I'd say, without a doubt, a good lesson for other medtech entrepreneurs that are listening for sure. Even your common about always be skeptical of others' data and where your clinical trial could potentially go wrong, I guess is such valuable feedback. So, I want to be sensitive to time. In the fact that I'd like to get to Silk Road Medical. But one other question about your background before we come up to the current time. But you spent some time at Nanosys and then joined Medicines360 as COO before joining Silk Road. So, your position at Medicines360 as COO, that strikes me as a little bit of a surprise considering. your strength in commercialization and building companies. Is there a rationale that others could learn from in regards to your move to Medicines360 before we jump to Silk Road?

Erica Rogers: Yeah, well, let me take them holistically, Nanosys and Medicine360. Both of those were driven by a desire to check a box for me. One was in nanotechnology. I really felt like nano was going to play an important role in medical devices, and I wanted to get smart about it and so I went and did that and that was super helpful. Medicines360, I had always wanted to be able to run a pharmaceutical company. Although I had a strong operational background and devices, I've never run a device company. I'm sorry, a pharma company that has all of its unique and different regulatory constraints and all of that. 

So, what was cool about Medicine360 is a drug-device combination. and the challenge that they were facing were on the device side. It is a very successful intrauterine device for contraception. They were having issues around the device piece of it. So, it gave me this brilliant opportunity to come in and be operational, solve all the device-related problems, and also get really, really smart about what it means to run a drug company. It was just a fantastic experience.

Scott Nelson: That's good stuff. I don't think I would have expected that response, but just the ability to like move outside your comfort zone and pick up on skillsets that maybe you wouldn't have other otherwise acquired along the year. That makes a ton of sense. Let's fast forward to 2012. You get the call to join Silk Road Medical but obviously, you have a lot of interventional and vascular experience, especially as relates to the crowded space. So, what were your initial thoughts when you got that call? Are you thinking why would I ever want to join a carotid company knowing how carotid stenting didn't pan out despite the hype?

Erica Rogers: I'm laughing. Yeah, it was no, and hell no. I think it was no and hell no like three times over the phone with the lead investors who were trying to get me to at least take a look at this deal. So, finally, they were persistent enough. I said, okay, okay, well, I'll at least sit down and listen to the story. I was very happy at Medicine360 as well so it's hard to extract someone to go do something crazy when they're really happy. So anyway, the investors sat down and told me about the approach which was very novel as I described earlier trans carotid approach. Not only was the approach novel, but their target customer made sense. 

They were targeting the vascular surgeon and a vascular surgeon has always and will always own the carotid domain. The problem with not only all the technical issues that transdermal Cath’s had in doubling the risk of stroke compared procedurally but all those technologies were also aimed at the interventional cardiologists predominantly. The referral pattern didn't go that direction. It was going to be incredibly disruptive to a lucrative and procedure that vascular surgeons really liked. So, they were going to hold on vehemently to that domain and they did. 

Did everything they could to squash carotid arteries stenting and very successfully. So, this Silk Road was going to go straight after the vascular surgeon and say, look, we want to keep carotid in your domain. We want you to evolve, you the vascular surgeon who has evolved everywhere else in the body So, they had, in the late 90s and early 2000s learned all the endovascular skills, obviously dominating the triple-A space doing atherectomies, [38:39inaudible], stents, everything else in the periphery. So, they were starting to convert their open surgeries to endovascular procedures. So, it made perfect sense to me. It was the right technology at the right customer. Still, there was the cloud of, well, what about coverage particularly CMS? But I thought, well, if we generate the right data and we do what's right for patients that will solve itself in the end, So, I took again a leap.

Scott Nelson: A leap. Yeah, no kidding. I've got to think that leap may have been even harder considering your domain expertise. It's just a hunch but sometimes those leaps could be given could be the most challenging when you feel like you really have an understanding and deep expertise in the therapeutic arena to make a jump like that. Before, I do want to touch quickly on the topic of coverage because as you mentioned earlier, you had a big win when it comes to CMS coverage last fall. But you have a unique relationship with Cordis right now where, from a procedural standpoint, you're leveraging their stent technology. So, walk us through that decision not to develop your stent technology, but instead partner with a large strategic in Cordis and Cardinal and utilize their platform instead.

Erica Rogers: Yeah, Well, first of all, I can't take credit for the genius idea. It happened before I got to Silk Road. The idea was to leverage the years and years and years of clinical data around an existing carotid stent because what we did carotid stents is that they were durable. Once you've got them safely, they were durable and provided the same protection against stroke in the long run as carotid endarterectomy. So, the only thing that had to be sold was how to get them there safely. So, we were able to leverage on existing PMA approved carotid stent and vastly shortened the PMA pathway is really what it bought us. We licensed that whole technology from Cordis and through the supply agreement they act as an OEM supplier for us.

Scott Nelson: Got it. I guess we don't have a lot of time to dig into that but that's a very interesting point. The fact that if you were to develop your technology, you're going to have to most likely, at the very least a 510(k), but most likely a PMA to your point. That is going to be so expensive. So, if it's going to take so long, why not partner with someone else instead? So, I'd love to learn more about how that came about. But we certainly don't have time. Nonetheless, it's a good learning lesson for other folks out there that are potentially at that point in time where they could develop their own technology but instead, maybe it makes sense to partner with someone else if it makes sense. 

So, before we get to the last three rapid-fire questions, let's touch on coverage. Obviously, Silk Road had a big win last fall when it comes to CMS coverage. I've got to think that there's probably a lot of complexities there, a lot of conversations, considering the fact that carotid stenting was really never widely covered I think unless patients were involved in the clinical trial. Help us understand how you went about that and maybe is there a good lesson for other medtech entrepreneurs to learn from in your approach to getting CMS coverage?

Erica Rogers: Yeah, by far this is the most significant thing that's happened to Silk Road, and it's something we're super excited about it. So, let me just start by saying in all my years in doing this in early-stage companies, this is the first time I've ever seen an early-stage company less than one year into its commercial life, achieve the trifecta, really of reimbursement, which is codes already in place, appropriate and good healthy payment levels in place and now a favorable coverage decision. Really, what is a brand new therapy apart from anybody else in the early stage arena? So, what did we do? Well, it starts with we solved several people's issues. 

So, we looked hard at what was the goal at CMS and the goal of CMS was to solve for the morbidity associated with carotid endarterectomy without trading off a stroke risk. In particular, in their high surgical risk patient population, elderly females, which happen to be the vast majority of the Medicare constituents. So, they did have a real desire to solve this. It's just that transfemoral Cath’s wasn't the answer in their minds. So, it starts with that and existing under the national coverage determination, which covers all of angioplasty and stenting all over the body and buried in that are the rules around carotid artery stenting. So, there was a real desire on their part to figure out how could we work within the existing infrastructure without starting all over and having to host medtech and all of those complicated things. 

So, the first thing we did was really understand where CMS goes, what was in it for them, what it meant to their constituents and what was important to the people at CMS, and how much work was going to create for them in a very constrained environment. That was number one. Number two was working with the Society of Vascular Surgery and understanding what was important to them. We knew that carotid artery disease was one of their top priorities, and research in carotids was one of their top priorities. We also knew that they were trying to advance a program called the Vascular Quality Initiative, which is they're putting these database modules in every hospital in America to collect data on all vascular surgery procedures to do hospital to hospital benchmarking and comparisons, to do regional comparisons, to leverage that to look at physician to physician comparisons.

It was all about improving the quality of vascular surgery care across America across all of the procedures. They wanted to create more and more reasons for hospitals to participate in this quality initiative. They also had a desire to do something with CMS. They were trying to figure out could the Vascular Quality Initiative be tied into CMS in some way. So, what we did it Silk Road was simply solving other people's problems and come to them with an idea, which was let's make coverage dependent on two kinds of stipulations. One, that coverage for TCAR should require FDA approved TCAR devices, trans carotid devices.

Turns out, Silk Road is the only company that has those currently. The second stipulation would be every one of the TCAR procedures will be logged into the Society of Vascular Surgeries registry, their VQI, their Vascular Quality Initiative and that would drive hospitals and physicians to participate in VQI and it would provide coverage for this really promising new procedure that CMS is very interested in and was, of course, leading research priorities for the society. It happened on the heels of our very, very promising early data from our original clinical trials.

Scott Nelson: Yeah. So, certainly, all the pieces were there for things to come to fruition quickly. But there's so much that I wish we had time to unpack there because, to your point that trifecta that you mentioned earlier I mean, it is very, very unique for medtech and I wish we had more time to unpack that answer. But you know what stood out for me, honestly, was your approach to CMS and the Society of Vascular Surgery and really putting yourself in their shoes, asking yourselves what they want. How hard is it going to be for them to get this done etc? There is such a good lesson there. But I know we're running short on time. I want to get to the last three rapid-fire questions. So, let's go and get to those and I'll try to squeeze these into the last minute here Erica if you don't mind. So, first, do you have a favorite business book that comes to mind?

Erica Rogers: I have a favorite book. I don't know if I'd call it a business book. Every single person needs to read "Daring Greatly" by Brene Brown. It is absolutely my favorite book. It is my Bible. It is how I want to run my company. It is how I want to run my life.

Scott Nelson: "Daring Greatly." I have actually not heard of that one, but definitely is getting jotted down in the notes. That's good. Second question. Is there a CEO or a business leader that you're either following right now or one that's really inspired you in the past?

Erica Rogers: Yeah, sure. So, the one that inspires me is my husband who is a CEO. He's like my behind the scenes board member, He is absolutely amazing. But the one that I am following is Omar Ishrak at Medtronic. He is big in a way; a big way and he is looking at the whole broad category of the episode of care. What does that mean for coverage, for device development, for providers, for hospitals, for payers? He is approaching it very holistically, not just what are the widgets that Medtronic sells, but can they solve this entire continuum of the episode of care, and I'm super impressed by what he's doing there. So, I'm following everything thing that he writes about.

Scott Nelson: I couldn't agree with you more. Last question and admittedly it's a little bit hard to answer in rapid-fire fashion. But if you had the chance to rewind the clock, what would you tell your 30-year-old self?

Erica Rogers: To settle down. 

For Part II of the interview transcript, check out the podcast link below.