Medsider: Learn from MedTech and HealthTech Experts

4 Rounds of Financing, CE Mark, FDA Clearance, and a Category 1 CPT Code – How NeoTract has Grinded its Way to Success Over the Past Decade

October 10, 2016 Scott Nelson
Medsider: Learn from MedTech and HealthTech Experts
4 Rounds of Financing, CE Mark, FDA Clearance, and a Category 1 CPT Code – How NeoTract has Grinded its Way to Success Over the Past Decade
Medsider: Learn from MedTech and HealthTech Experts
4 Rounds of Financing, CE Mark, FDA Clearance, and a Category 1 CPT Code – How NeoTract has Grinded its Way to Success Over the Past Decade
Oct 10, 2016
Scott Nelson

Biz Stone, the co-founder of Twitter, has famously stated, “Timing, perseverance, and 10 years of trying will eventually make you look like an overnight success.”   In the world of medtech startups, this is almost always the case.  And it’s certainly true with UroLift, a device that came to life in the fall of 2004...[read more]

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Show Notes Transcript

Biz Stone, the co-founder of Twitter, has famously stated, “Timing, perseverance, and 10 years of trying will eventually make you look like an overnight success.”   In the world of medtech startups, this is almost always the case.  And it’s certainly true with UroLift, a device that came to life in the fall of 2004...[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. If you're new to the program Met 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. If you've enjoyed these interviews of the last several years, please head on over to iTunes and rate our show. It's pretty simple to Dio. Once you're on iTunes, just click on the right a review button. You can then check the number of stars, preferably it's all five and write a few sentences if you feel like it. Trust me when I say the reviews really help. So if you feel up to it, please do us a favor and head over to iTunes when you get a chance. Second, I sent out a free email newsletter about once per month, highlighting my favorite med tech and or health care related stories. The ones that I personally get a lot of value from. I don't send the newsletter out very often, but when I do, I really try to make sure it's valuable. So if you're interested, head on over to med cider dot com. That's M E D s i d e r dot com and enter your email address as a bonus, I'll send you a free digital book that I think you'll find pretty interesting. And lastly, for those of you that subscribe to the email newsletter, you're probably already aware of this. But I recently joined the MedTech practice of W. C. G, a fully integrated marketing agency. So if you're looking for some marketing help, there's a few reasons you should consider our firm first were entirely focused on med tech. Second, our wheelhouse is analytics, which drives all of our recommendations and third or were fully integrated, which means you don't have to source capabilities from another shop. So if you have a project in mind that you like to discuss, hit me up at Scott at med cider dot com again that Scott S c o t t at med cider dot com. Okay, on to today's episode Biz Stone, the co founder of Twitter has famously stated timing, perseverance, and 10 years of trying will eventually make you look like an overnight success. In the world of med tech start ups, this is almost always the case, and it's certainly true with Euro Lift, a device that came to life back in the fall of 2004 in this interview with Ted Lambs in co founder of Neo Tracked in Primary. Inventor of your left. We learned how they achieved us in European approvals. Obtained a category one cpt code in near record time in their approach to convincing CMS and other commercial payers to cover their device. Here's Here's some of the topics we're gonna cover in detail Ted's experience that explore meant and how the idea for euro left came to fruition. The process Ted follows when pursuing ideas for disruptive medical devices. Why Ted and his team at New York track decided to pursue a C mark and what they learned through that process. Lessons learned after raising four rounds of financing. Four. New attract against the advice of consultants why Ted and his team decided to pursue positive guidance from Nice, how neo tract was able to obtain a category one cpt code four euro left. Less than six months after receiving FDA clearance in the approach 10 and his team are taking to convince CMS and commercial payers to cover your left course, there's a lot more that we're gonna cover this interview. But without further ado, here's Ted, Hate said, Welcome to the Med cider program.

Ted Lamson:   3:20
Thank you, great beer.

Scott Nelson:   3:22
All right, so you founded Neo Tracked back in at 2004. That's quite a while ago. We're recording this in the fall of 2000 sixteen's That's over over 12 years ago. A long time in the med tech space on you've been on quite a wild ride on experience, quite few challenges over the past decade, which I definitely want. Thio. I want to dig into as part of our conversation here this afternoon. But before we go back in time, can you provide us an overview of ah, of your product euro lift as well as the disease state that treats?

Ted Lamson:   3:55
Yeah, sure, happy to, um, so we'll start with the disease state. It's in large prostate, also called BPH, or benign prostatic hyperplasia on essentially affect half of the population that being you and me men. And by the time you're 50 about 50% of men have BPH symptoms. By the time you're 80 it's over 80%. So it is a really large problem. Quality of life issue leads to needing to have to go all the time, getting up several times at night. So you're tired and weak, and it's been proven a lead also to depression through isolation. So can really be, uh, pretty life debilitating. Um, the the options prior to your left, we're basically there's ah, there's a pretty good surgery that was developed in the 19 thirties called Terp. It's just, uh, where they go in through the urethra and carve out the inside the prostate. Um, it definitely remove the obstruction, which is the issue, but it's fraught with side effects. So the side effects are you're almost guaranteed to have sexual dysfunction one way or another, some kind of effect on that, um on. And then there are low chances of of other things, such as incontinent and strictures, transfusion and that sort of thing. So, um because of that, it's sort of a value proposition issue, and that is that it turns out that only about 3% of men that qualify for BP, a surgery actually elected and that a tiny minority so so really, the majority of patients are treated with medical therapy. There's a few different medicines, and the issue of the medicines is that they're palliative, so they make you feel a bit better. There are some side effects, dizziness, weakness and also sexual dysfunction. So with those things you have, ah, you know millions of men that are on one for medication or another, Um, but what turns out a lot of them are very well served, but there's a pretty large population of, um, that are not being very well served, but they really don't want the surgery. And so, um, you know, if you were to ask him, they give up taking a pill a day for the rest of their lives and give it to the side effects. If they had some wayto quote get fixed if they didn't have the risks or or the extended recovery, associating with surgery and and that's where your life, it's so that's that is the exact target we went after is how can we How can we create a procedure for BPH that a man will actually elect and men don't elect things very well. So that's actually attractive enough and safe enough that a man will elect it earlier in the disease process. And rather than sort of hanging on with drugs that aren't serving and well, actually get treated and remove the obstruction. And the way the thing works is, it's, uh, it's basically also goes into the urethra with the little scope that they used to diagnose the problem. And then with this system on the scope, ah, it deploys these little implants into the prostate and there they're really about the size and shape of the little things that hold price tags on clothes. But they're made with a lot of technology, and it's basically sized into the prostate at exactly where, um, where the device is put and what essentially that does is just ah, hold open the lobes of the prostate without removing the tissue are hurting it are cutting it or anything like that of these tiny little implants. Just hold the the obstruction open. And, um, the reason that's good is you haven't changed the prostate tissue or architecture so you don't affect sexual function. Um, and because it's just a quick little implant. Basically, the recovery is a lot more rapid. It's It's a matter of a few days being back to normal, Um, and a few weeks for significant improvement in symptoms versus weeks for recovery of surgery and months for symptoms and full recovery. So really has shifted the paradigm. And, uh, that's what we're seeing is the men that are electing this are indeed those that are unhappy with their options and coming in looking for something different.

Scott Nelson:   8:37
That's a great That's a great description. And just to re crap did I hear you right? Um, with respect to the incidents, you said 50% of men have this Our deal with this by the age of 50. In another, it goes up to 80% by around the age 80. Is that right?

Ted Lamson:   8:52
Yeah. Isn't that amazing? I

Scott Nelson:   8:54

Ted Lamson:   8:54
in 2020 15 there were 12 million men under care for BPH. Whether that's a drug or a procedure or something like that. So it's a really big target population, not just those guys suffering, but the ones that are actually getting some form of treatment.

Scott Nelson:   9:10
Okay, great. Yeah, that's that's Ah, that's an even higher incidence than I than I even suspected. And so right. You know, Prior Thio prior to your a lift, the procedure that was most common was this ter procedure. Pretty invasive procedure that was done, I would imagine in the O r setting.

Ted Lamson:   9:27
Yeah, that's right. Yeah, full anesthesia. And there are some other ways of doing terp You can. You can do it with a laser or bipolar terp or a button or there. There are just a tremendous variety of ways to remove tissue, and each has different advantages of maybe less bleeding in the end, quicker recovery. But they're all still full surgery. They're still removing tissue. And so they all actually still have a very similar sort of adversity and profile because they're based on removing tissue. Basically, I

Scott Nelson:   10:00
got it. God, it makes sense on and for those listening that want to learn a little bit more about euro left in terms of, you know, the device that the device itself, it's a little bit hard thio hard to understand or sort of get a visual representation just hearing it. I would probably encourage you to goto euro lift dot com. It's you are Oh, l i f t dot com to probably get a better idea of what? This. You know how this device actually works, But let's go. So you took so the patient, I just one more follow up question regards Thio sort of the market and the number of patients that deal with these types of this type of issue. It's an invasive procedure. And you said most, most men opt for pharmaceuticals is a way to treat their deal with the symptoms of this disease. Um, do the symptoms get worse? Over time, I would imagine, or the drugs get less less efficacious. Um, you know, if someone you know if someone has been on the drug for 10 or 15 years versus you know when they may 1st 1st start to take it, Yeah,

Ted Lamson:   10:56
that's ah, great point. In fact, what we're seeing is, uh, the men that are electing your life. They actually are stopping medical therapy at two points. One is very early on, and those are usually the guys that are just really upset with the side effects, if you will, um and then the others are quite a bit later in the disease process where it's really been wearing off over time. Because these drugs are based on, it's kind of a muscle relaxing. You could think of it that way. Um, these Alfa blockers and they have a very modest effect. Um, and you wears off a bit over time, and then you can add on another hormonal agent called a five day R. I bit now starts to shrink the process, but it it also does away essentially with the testosterone production process. And that's an important element for a lot of guys. So So there are side effects there, too?

Scott Nelson:   11:55
Yeah, okay. Makes sense. Well, now that we have a better idea of your left, you know the company that, as I mentioned before that you founded back in 2004 it's a long time ago. I I definitely want to dress. The level of clinical evidence that you have for this product is pretty robust, considering, you know, the, you know, it's it's it's, you know, a relatively new product. It's pretty disruptive in nature, but I'd like t to rewind the clock and really go back Thio the early two thousands when this sort of idea came to light, you were, um you were at Explorer Med. The incubator explore meant correct. And for those that aren't familiar with the explore man, maybe you could provide an overview of ah, of the incubator as well as kind of your experiences there and how how you are left. Came to fruition.

Ted Lamson:   12:40
Yeah, sure. Happy. D'oh! So I mean, I gotta say, I've been very fortunate to be a part of Explorer Med and its activities over the years, and it's primarily based on the fact that I was fortunate to work with my friend Josh Mack our when we were what both back in fighter in the very early nineties. And there he was kind of, Ah, initiating this think tank for how to come about how to innovate in howto how to address a clinical needs. And I was fascinated with that and running r and D for one of the divisions this back when Pfizer had medical devices such as AMs how Medica and Schneider and big companies and, um you know, we hit it off with, I guess, a mutual respect, Um, on what we brought to the table from innovation but also just complementary skill sets. And when he left either to start explore Mandhai, I came out of either. I forget what a what 67 months later and joined him in in the first venture. Coming out of that, which was called Trans Vascular but basically explore mint has a I'd say it's a single mission, and that's, uh, to create important positive shifts and healthcare. So ah, lot of medical device innovation really is focused on literate of improvement to devices and having another one like the other company and and that sort of thing and it's explore meant we really have no interest in that, and that's important work. But it's not ours. And really, what we're after is Is there a way we can absolutely improve healthcare in a in a dramatic way through a medical device? And so it's important that it also builds off of the core confidences, which for this incubator are really medical devices and mechanical work, and not drugs and health care, systematic changes, so to speak. So, um, probably the most special part of the process is what Josh started improviser and then further refined and explore med. And now it's become a two. Part of it is is the core of the Stanford bio design program. So it's actually taught, has a process. Now, um, and the key aspect, I'd say that that made it unique from a lot of others was the absolute belief. And I share this to this day that the most important thing you can do in innovation in medicine is to spend the money and the time of front to develop what need is and exactly what the need is and how to address all the stakeholders involved such that once you're done with that process, you create essentially a report card. Um, and with that report card, you will from then on gauge how your efforts are going and not deviate from it. And, you know, as engineers, we learn that engineering is done through compromise, and this is not a compromising thing. This is I have to hit these needs in order to do the paradigm shift. I'm trying to d'oh! And, um, that's that's the great strength is I think that process ends up with a very solid and validated need specifications. in taking that forward. You know, quite frankly, developing devices and bringing them forward is hard but doable. But unfortunately, there are great machines for bringing these things forward that when they get there, it turns out they aren't solving the right problem. So this really is a way to avoid that by making sure you spend time defining that problem and essentially solving the right thing once you get there,

Scott Nelson:   16:21
got it. So it really comes down to really defining that core need and being able to dress it and meet all of those, you know, checking all of those boxes on that report card. Now. Is that a process that's that's taught as part of the the Stanford Bio Design Program? Now,

Ted Lamson:   16:37
Yeah, that it absolutely is on.

Scott Nelson:   16:39
And I

Ted Lamson:   16:39
think you know, it's It's, uh, it's really a fundamental that I think we've been ableto prove through our successes, as you know,

Scott Nelson:   16:49
right, right. And I know I know you. You had mentioned kind of in our in our discussion before we we hit the record button here for this interview, that being able to identify that that true need on that and addressing it in a way that's achievable that, you know, having that sort of as your as your beachhead as you encountered various various challenges that hopefully we can address you over the next half hour. So that was extremely important in my Am I describing that correctly?

Ted Lamson:   17:19
Oh, absolutely. I think once you've done this process and you really have, um, you know, you believe in what you've come up with as as what needs to be done and you validate with everyone involved in the process of patients the docks, the administrators, the payers, everyone. Then it gives you this confidence and momentum that when you hit the hurdles, that and we all know there are hurdles at every step. When you hit them, you approach him with a level of yet, But I'm going in the right direction here, and I'm gonna figure this out because I need to get past this. And I think that, you know, that leads to enthusiasm. But it also leads to confidence and just sheer, um, you know, I kind of have called it before sort of irrational optimism, but But it is what gets you there A lot of times is knowing that you know this should be done, so it's going to be done. And here we go.

Scott Nelson:   18:15
Got it. Makes sense now specific to your left. You'll recall sort of how this how this came to fruition, were you Were you looking at other disease states or other needs to potentially solve or were you sort of really, really eyeing this thing? BPH, Disease State.

Ted Lamson:   18:32
Now, that's a great question. Um uh, So this actually started. It was just as explore meant was launching another company of Clarence, and I sort of took the task of Okay, I'm coming up with what's next. I'm gonna try and lead that effort. And, um, our technique and explore mint is usually to not have a single idea or a single disease day, but pick two or three and develop them in parallel. And what happens is as you develop them, they naturally shake out as though this is a much bigger need than that, or this one has a much, uh, more straightforward path to a solution and various things that you look for that differentiate them. And to be honest, I founded the what was called explore meant NC to first on an orthopedic idea. Um uh, and with it was a next to it with another specialty. And then during that time, actually, uh, we I had a personal incident where my father and uncle each had prostate issues and it really started peaking my interest there. And then it came up that maybe we should look at that. And, um you know, I think I think you talk about compelling yourself, Thio get into a project and get it going. There's nothing like a personal interaction with it to say. Wow, things could be better here.

Scott Nelson:   19:58
Yeah, that's interesting. So you are actually pursuing a couple other ideas at the same time when, you know, you sort of had this personal experience? Uh, that's that's an interesting story. Now, on that on that note, how far down the path do you typically get with? You know, as you move these different potential ideas down the down the pathway, Orin parallels you mentioned. Do you get fairly far along before you? You say we're not gonna pursue these other ideas. We're gonna We're gonna double down on this thing won this particular one.

Ted Lamson:   20:30
Yeah, you know it It seems like we go very park is a lot of work, but if you look on a basic time element, it's well under a year, you know, it's more like a, I think, for if I already used the attract as an example Um, you know, I started Ah, the NC two effort in 12 years ago, actually almost to the day and, um, started with that least two areas ran that for a couple months and then it was really around the beginning of 05 So about 1/4 into it that I started being very interested in BPH and probably in Q one of 05 was that it? We we threw everything else away and say, This is what we're doing. So yeah, I took 3 to 6 months. I'd say, Thio, get to that point where we narrowed it down

Scott Nelson:   21:21
before, Before your last game, that sort of came toe came to life anyway. Cool. I want I want to kind of fast forward to your experience is pursuing a C E mark. But before we go there just a few quick questions regards to your rate raising money, which is oftentimes pretty pretty difficult for for med tech but you raised I What I think is four different rounds in 69 6011. And then again in 2014. When you think about, you know, your experience is raising money throughout the course of, you know, You know, 10 to 12 years, you know, are there Are there certain best practices that come to mind? Are certain things that you remember that really stand out, you know, kind of looking at those different, you know, those those four different rounds of financing sort of holistically.

Ted Lamson:   22:08
Yeah, for sure. I mean, I think if there was one thing, the most important thing, it's the fact that raising money is entering into a partnership, and it's it's still and always is about people. And so if you have the ability and hopefully you dude t choose between a venture capital firms, choose the one that you have the most confidence is gonna be there with you through thick and thin. So over the years, I've, you know, explore med is focused with any A and I've done a lot of work with any, and I say they are. They're just that they're I've been, ah, up against the wall and they've been right there. And you know, none of these things. They're ever easy. There's always a snag. And, um, your investors have to have the same long view that you D'oh! And they were great. I would say my biggest challenge was in 2009 because, I mean, it was the perfect storm. Basically, we had the banking crisis where the economy was shot. The quite frankly, the VC firms were taking advantage of that because they could. I mean, G e stock looked like a startup. That and so essentially it was it was a really difficult time to raise money, not lose all all ownership in the company and wipe out your current investors. And, um, you know, we sort of pulled a rabbit out of the hat. And that was with the help of Johnson and Johnson Development core. And they are another great partner that, um, you know, they are just very mature and very much because they're in the business very much. Know that these things take time and they take doing it the right way, not the fast and quick way. So you know those two. Uh, we have other obviously ah, whole consortium of investors at this point, but those two have been sort of the rial backers during the early formative time.

Scott Nelson:   24:10
That's that's good advice. I I have Ah, I've always heard that J. J. D. C. Or Jobs John Johnson and Johnson Development Corp is a very good MedTech partner, but certainly it sounds like that was your experience as well. Now I'm kind of going back. Thio, um you know that the 2009 time frame that you reverence I guess that serves probably is a good transition to talk about, you know, your decision to pursue SETI mark. So at that, if you can remember back to that point in time, were you pretty far down sort of the regulatory pathway with with the FDA before you made the decision to pursue CEO Mark Or what were your you know what? What were the thoughts at that point in time with with me attract and your list?

Ted Lamson:   24:53
Yeah. So this is this is interesting. You know, there are a lot of things in a start up in a new venture that are all about you, and it's all about how you're doing and you're you're progressing. And then there's the great Big World and how that affects you. And in this case, it was It was a great big world. And basically, in addition to the perfect storm of the financing at that time, quite frankly, there were. There were some very serious issues that the FDA, they had a whistleblower issue. They were they had internal management issues and they were really working through how they wanted to work with industry. But the net effect Waas intended or unintended was that you simply couldn't open up a U. S I. D. Clinical study. At that period, they were, um, asking infinite questions and not allowing it to go forward. I will say my observation at this point is that that has been largely result, and we've been really happy with our relationship with the FDA. But there was a period in that sort of 22 09 2010 period where, I mean, I had a lot of friends trying to get into clinical studies that wouldn't start, and we actually ran into that and it came down to a decision, and as it did with a number of startups at that point where either we're gonna kind of duck and cover a meaning. Boy, we have to downsize to just enough to keep this thing going and waited out if you will, or we're going to go to Europe and we're gonna learn how to commercialize this, and it won't be profitable, and it won't be where we make it or break it. But we'll take advantage of this time to go learn how to introduce this into quote the real world and that that was the decision we made. It was a good one at the time because it really did give us a leg up on a number of things. So, um, I would say we went There may be some people thought we went there to make money, and maybe maybe I sold it as that. But it was. It was really not to make a lot of money in our real hope where that maybe it would break even the effort, which is even a struggle sometimes. But But in the end, what it did bring was maturity. We ended up with a mature products. By the

Scott Nelson:   27:11

Ted Lamson:   27:11
did go into a U. S study. We had a mature commercial product. This is not a G. I wonder if it'll work. Product. Yeah, And we also learned how to train physicians. We learned how you know what the marketplace did and did not tolerate. So there were a lot of good learning there. It was expensive and lengthy. But in the end, we saved a lot later on by that experience

Scott Nelson:   27:36
that those air good anecdotes just sort of that the maturation process, you know, pursuing that CD market in commercializing in Europe. It's probably probably taught you a lot about entering, you know, entering the U. S. Market. That's Ah, um, I mean, that's underappreciated. I guess sometimes you know, when when folks are considering pursuing See Mark versus, you know, versus FDA clearance. Initially on that note, I remember having a having a conversation with Duke Rowley in for those listening that want to go back and listen to that interview. Um, um, I highly recommend it, but he mentioned that I believe with CV ingenuity I can remember which started it was, but they made a you know, a very definitive decision not to pursue C e Mark on Instead, you know, pursue the U. S. Market alone, and that was a little bit that kind of more laddered up to their overarching strategy. But what are your thoughts on that in terms of, you know, a med tech startup and whether or not they decide to pursue the European approval versus versus a U S. A U S approval initially,

Ted Lamson:   28:34
you know, personally, I think it's it's really, uh, specific to the disease, the device, the reimbursement landscape, everything. I think it's a full business plan you want to go through to see if for that particular thing you're working on, it makes sense. And, um, I would say, you know, ironically, when I started um, neo track, I didn't want to go to your purse. I wanted it to be a U. S first thing, and that was primarily a sort of cultural connection.

Scott Nelson:   29:06

Ted Lamson:   29:06
that is that the U. S. Health care system is it rewards efficiency and less invasive and lower complication rates a bit better than a lot of other markets. And, you know, to this day, for instance, in Germany there are hundreds of men to get your lift, but everyone that does spend two nights in the hospital because that's how the system works. And here it's done in the office and you go home. So it's It's really kind of interesting how systems can dictate how care is given and valued, if you will.

Scott Nelson:   29:41
It's just,

Ted Lamson:   29:41
um so that the other is I mean, if there's an opportunity such as you really do have ah locked in reimbursement code in Belgium. You know, I'm first of all, I would never say Europe is Europe. Europe is all different. Countries

Scott Nelson:   29:55

Ted Lamson:   29:56
to kind of look within it. But if you have, it's like, Oh, I have this and there's a code there and it's been validated. They will be paying. Then you actually really do have a good early commercial opportunity. I know. Uh, I know Kevin sido had that with with his the same Francis technology, and that really worked out well in his venture. But it was also a lock in, and it kind of had the code. They're ready to roll. And that isn't always true. In fact, it's more often it's not true. It

Scott Nelson:   30:26
got it, got it. So for someone listening that wanted to gonna get you know yes or no answer for from you they're gonna get It depends which is which is probably the best answer. But I guess it's always interesting to hear, you know, here. You know these. You know, startup founders like yourself, you know, kind of weigh the pros and cons of going down a certain path way, whether it's, you know, FDA approval or okay, Clarence O R C e Mark. So, uh, that's gonna nail on that on that note. I know you guys ended up getting some pretty favorable guidelines when it comes Thio when it comes to nice, I think in 2014 if if my information here is correct on guy definitely wanted to use this is maybe, you know, a stepping stone to talk a little bit more about the reimbursement landscape and that you know that the challenges that you experienced in the U. S. But specific to nice it appeared that those were pretty favorable guidelines, you know? Are there any Are there any tips and tricks that you can share in regards to your relationship with nice And how you, uh you know how that sort of came about?

Ted Lamson:   31:30
Yeah, Absolutely. It's a long story, but I'll

Scott Nelson:   31:33
try and make it

Ted Lamson:   31:33
quick. But, um, you know, the UK was actually just shifting the national healthcare service when we were heading into Europe. They were they were very publicly trying to become more efficient, more patient centric. And they were saying overtly that they would value more efficient and less invasive approaches. And so we, quite frankly, against the recommendation of every consultant that I, um we we actually decided to embrace that and go in and and be try to become a flagship in that And, um, the way we did that and also one reason that kind of gave us the the, uh, the the boldness to do that was that we'd invested, you know, at that point, probably about $25 million in clinical studies. So we have the data, we had very high level. I mean, it was very high quality data, so we were able to sort of go in and say we're doing it the right way. Do you want to work together on this? And I think that, um I think that really carried the day. But I will say I I guess as a kind of maybe tipper trick to that is that good clinical data is central. It's worth investing in, and unfortunately, it's just table stakes. So the good data just gets you to the table. It doesn't win the hand. And you, my advice would be You never go to that table unless you've done all the other work, which is working with the society's making sure you have active clinical experience going on in that market, Um, and really building advocacy from within the market, such that someone's trying to pull it through as well as you pushing it through

Scott Nelson:   33:25
at that time, I don't want to spend too much time on this, but I do think it's interesting that you said that that basically all of the consultants that you had had conversations with, you know, as you kind of approached things decision with nice. They recommended not not not going down that path. But you did. Instead, you know what? What led you to sort of make that make that call, which, you know, hearing you describe it seems somewhat risky. But, um, I'm curious to get your thoughts around the,

Ted Lamson:   33:56
um you know, it was risky, and I will say that part of it was serendipitous as well. So in in building a sort of beef foundational business in the U. K. Under you know, not so good reimbursement because there was before nice and all that. Um, you know, we were we had built strong interests, were running a, uh, international clinical study that involved some of the rial ki opinion leaders in the UK And, you know, we were just ourselves, meaning that Ah, you know, one thing I'm really proud about what neo tract is, we really are very above board. And, you know, the feedback I get is they were good to work with because of that. It's a level of trust. And so we had gained that, and I just sort of felt like, Wow, all the all the people that are sort of tapped into this process are very much they trust us. And so I always feel like that is, in the end, what what wins the day and that no player ever decides to our health care system decides to adopt something if they don't. If they either don't trust the data or don't trust who is giving them the day. So So it really does come down to you know who we are, how we approach things, but also who we team up with and their relationships with us. And when I feel like you know what, we're all locked in this together and we actually there's a good credibility factor. Then it's not like looking at the stock market is a very specific stock. And you have the inside information.

Scott Nelson:   35:30
Yeah, yeah, that's ah, that's good. Good information goes back to your earlier point about, um, not sort of being above board. And you were confident in the fact that you you, you know, approached, you know, approached everything that you've done to that point in a in A in a solid sort of above the board type of fashion reminds me, actually, even of an article I read recently about Naval Robert Khan is the founder of Angel List, I believe, And anyway, he referenced 33 characteristics of founders that he he looks for in investing. And I think the three were, um, intelligence, perseverance, and last one was integrity, which he said it was often is the hardest to judge. But you hearing you describe your decision making process. They were kind of reminded me of that of that piece. Oh, kind of kind of piggybacking off off the nice, you know, the favorable nice guidelines and kind of, you know, shifting, shifting our conversation to the U. S. You, uh, the Euro left device got FDA clearance in the fall of 2013. I guess that's almost three years ago now, but it wasn't awarded reimbursement codes from CMS until the following spring March of 2014. If again, If my dad, that's correct, here on my end. You know, on that note, you know, I guess that wasn't too far off from when you when you were approved by the FDA. But, you know, I think most people would argue that reimbursement sometimes could even be the most challenging aspect of of going to market even more so than, you know, regulatory approval. So, um, you've had Ah, Well, I know a lot of big wins when it seems like from, you know, from the reimbursement reimbursement perspective, So can you maybe describes your approach to reimbursement here in the U. S. Ah, and then, you know, I know, you mentioned that your level of clinical evidence was you know, it is really, really good. And I'm, you know, anxious to hear your thoughts on how that played into the reimbursement for your left here in the U. S.

Ted Lamson:   37:29
Sure, I, um I don't know if I was precocious or lucky, but, um, you know, I was remembering this back in AA 2006 raising our series A after doing the first patients and, um, standing in front of investors. And basically, um, I remember my pitch was that our tallest hurdle was going to be reimbursement and so that no

Scott Nelson:   37:51
sex and

Ted Lamson:   37:53
sort of explained I remember saying we're raising $10 million but if you're not prepared to put in $30 million than then we were not. We shouldn't be talking. And it was about the fact that this was gonna take time and money, because here's why we first week, we need to develop the evidence for our customers. But importantly, we need to develop the evidence early, and we need it broad so that we can do a quicker and more thorough pathway through reimbursement. And, um, you know, I was just a ah young CEO at the time, but I I feel like looking back, that was probably one of my better

Scott Nelson:   38:39
10 years ago.

Ted Lamson:   38:42
But so basically, we actually raised him. Plan the company on this. We are going to develop inexpensive big, deep clinical package, and that is going to be our strength. So we did that early, and and I have to say I also tied in quite early to the specialty society, Um 2 a.m. A. Because they were evolving a process on cpt codes where they really didn't have criteria, but they were evolving them. And as that happened, I mean really ended up. We structured our clinical studies to deliver on the right publication set that qualified us to rapidly go forward. So you know the information is a little bit different. What it is is in September 2013 we got FDA clearance to market and almost exactly five months later, the M A approved Category one cpt codes which other than J and J's drug eluting stent, I'm not sure if anyone's done. That

Scott Nelson:   39:43
thing's extremely fast. And what I was doing research for our conversation. I saw you know, I came about sort of came about that or dug that up. And I was like, Wow, that does seem extremely fast, you know, 56 months, but yeah,

Ted Lamson:   39:57
yeah, I mean, it does unless you're in start ups, and then it seems like

Scott Nelson:   40:01

Ted Lamson:   40:06
but because the problem is that, yeah, they award the cpt code that February, and then they do rock analysis, and really nothing goes into effect until the following January, So that's an entire year away. So it all it all seems good, and then it just seems really far away. But but usually that that's a 2 to 3 year process. So, um, that really ended up. That strategy paid off very well, but it wasn't just the data. It was the fact that we made sure in our clinical studies we were very close to the specialty society in this case a U ey where key members were involved in the trial Ko Els, but also the site itself. We were informing him of the progress so that I mean, it's they that actually bring these codes forward, and, you know, they were comfortable early on and ready to do it before they might otherwise normally been,

Scott Nelson:   41:01
so that was probably the biggest. May be the biggest takeaway to your reimbursement successes is clearly the clinical data was really, really good. And you have done your you know, your done your diligence there. But but also just getting involved with the key clinical societies. Well, in advance of any of of the cpt codes cycles, I'm making sure that there's, ah, you know, the, uh that that when the time it was right, you know, the societies could sort of, you know, bring that, uh, you know, bring your device to the table.

Ted Lamson:   41:30
Yeah, it's a tricky balance with start ups because the general conventional wisdom is to be a secretive as possible, you know, because of competition, which you obviously have to be when you're really vulnerable in a patent basis. But, um, but beyond that, you kind of have to give that up a little bit and share the news. I believe you need to share the news with your customers or your ultimate customers because it takes a while for people to get comfortable with change and with a real new way of doing things. And I think that's something we've probably done right here kind of culture,

Scott Nelson:   42:07
that sze good stuff. Now I think most people would think, you know, with with a level one cpt code in hand, the rocks valued your code, You're off to the races. But there's a whole other phase of convincing the private payers to actually only cover this, but also pay for it. So maybe can you before we sort of concluded the three. The last three sort of rapid fire questions maybe talk to us a little bit about you know, how you approached convincing the private payers that you were left should be should be covered and that they, uh, they they should pay. They should they should reimburse it or pay for it.

Ted Lamson:   42:39
That's really because they all want to pay for anything, really. But no,

Scott Nelson:   42:45
no, it's

Ted Lamson:   42:47
we're still doing that. I'll tell you that. That is a work that is a job, secure environment, the reimbursement world. But, uh, you know, I think it all comes down to value, and it all comes down to pulling. So basically, my experience is that very few insurers will ever adopt and cover something if they don't perceive a need and that need means their beneficiaries and their providers are asking for it so they never want to hear the noise in the network. But they need to hear the noise in the network asking for it. Um, and so while that's going on being, you know, presenting your data and having a very steady cadence of publications, clinical publications, it's not just we did this study, but every quarter there should be another report coming out because that report creates the ability to have another discussion with the payer and so really lining up. Sometimes you just want to get everything published. But lining it up to just constantly, like an annuity of clinical evidence really help the process along and that that's been our strategy. So we're by no means done but the progress we have made I mean, it's just been, um, I think, another good example of pretty strong progress we you know, as of Halloween, I guess we will have all of Medicare in the U. S. Which for our BPH men that's the 65% of them. So that's great. Yeah. And then and then we have a lot of commercial insurers that do their own analyses have come on board. Some others don't do their own analyses. They just sort of looked to the side and wait for someone to step forward. So that to some extent, um, something we're working with now to make sure we're working with someone to take the first step forward, where all the competitors then jump in as well.

Scott Nelson:   44:49
Got it. I got it. Yeah. And so specific to, you know, convincing those you know, those those payers is that, I mean, what does that look like? You know, from a pragmatic standpoint, Is that Is that almost like a road show? You know where you're You're kind of you're making your, you know, your rounds through the, you know, into the end of the various, you know, payer offices throughout the country Or is that you know, is that amount of employing other field based, you know, people almost, you know, almost like payer sales rep. So to speak. That sort of do do that a lot of that legwork for you?

Ted Lamson:   45:24
Yeah, it definitely is. If you're lucky, it's a road show, meaning they never They don't need to talk to you. And so convincing them that that you should have a conversation is also, uh I mean, there's a whole industry, I think, based on making inroads into Wow, Could we actually have a conversation with a medical director team? Um, and and how do we go about doing that? And a lot of that have to do. I mean, to their credit, they're looking at all of healthcare. And in my world, it's all my one device in my one specialty. Um, and so they are very busy, and they do get a lot of early calls from people that really could never get coverage at that time. So they're they're a little bit gun shy on that. But, um, again, I feel like it comes down to finding inroads, finding people that are, um, uh in your specialty that have some sort of connection. And by that I don't mean financial or anything, but just that, but that they're comfortable with a medical director, and vice versa, so that when they actually say something there, they're somewhat believed in that usually get your foot in the door, and then the conversation is almost always You know, a lot of people think these things are all about? Well, it costs too much or whatever. It's almost always focused on clinical data and clinical value proposition. And that's why I love being in those conversations, because, um, you know, I just I know that. And I feel like I can tell that story because that what this is all about. And so that's that's kind of in my role lately. Is I actually do that? You

Scott Nelson:   47:06
got it? Yeah, that's good to know. That's good stuff. Um, before we get to the last last two questions here, any when you think about you know, the way you approach the reimbursement I know a zay mentioned It definitely seems like you've had a lot of lot of success and that's very cool news that, you know, bye bye. Probably by the time this this interview is, you know, goes live or soon, Soon thereafter. Anyway, you'll have you'll have all of the all of CMS sort of teed up, which is which is great for those patients that have BPH and want Thio, you know, want to want thio get the euro lift device, which is very cool. But, you know, look, it looking back would you do anything differently if you had to do it all over again?

Ted Lamson:   47:46
Um, you know, on the reimbursement side, I think. Okay, I think on the I'd say on the overall venture, it's kind of interesting. I am. That's an interesting question. I think that, you know, for me. So this this may be more of, ah, word to those founding CEOs out there. Um uh, I've come to liking ah, founding CEO to a starting pitcher. And, uh, you know, when these typically it's one person who can really take something and make it into are almost nothing and turning it into something and building a team around it. And a lot of times, it's a different person who then can take that into a real going concern. A riel successful commercial venture beyond that happened in my case, too. So, you know, I was the starting pitcher on the mound of the sixth inning, hand in the booth. They're always sadly walking off.

Scott Nelson:   48:46
It's an

Ted Lamson:   48:47
emotional event, but it is. It's a really important thing to do, and it's important to do it at the right time. Um, if I were to do it over honestly looking back. I feel like I gave up the ball in the fifth inning and I probably would have pitched to the seventh inning.

Scott Nelson:   49:04

Ted Lamson:   49:04
we're in the ninth inning now and we have the right guy pitching. And that's Dave Emerson, our CEO. And it was It was great to hire him to really build the stellar commercial organization, and I stepped aside and ran. Now I run all of clinical medical reimbursement, and I do some R and D and ah, a lot of stuff. But the non commercial stuff, if you will. Yeah,

Scott Nelson:   49:28
now that's that. That's that. That's good. So you wish you would've got a couple more innings, still had a little bit, a little bit of juice left in that e. I think that

Ted Lamson:   49:37
transition to Europe was one that I could have managed, and I think I called it a commercial organization before it was. And so I think I probably should have run that period and then brought David when we were teed up for the U. S. Because that really is where we're I

Scott Nelson:   49:54
got it cool, very good. Well, it's it's it's, uh, it's awesome to see kind of know that hear, hear more about the story of neo trackers. I think for those coming toe, you know, first getting the glimpse on kind of what, what what new tract is all about. I mean, it's yeah, of course. Of course you're you know, most people you'd be deemed a startup, But you've been working on it for 12 years. Certainly not an overnight success. By no means no, it's very It's very cool to see sort of what you and the rest of your team have built. So with that said, Let's get into the last three rapid fire questions. They don't have to be rapid fire answers per se, so feel free to expound if you want. But just this is tends to be more of a fun part of the interview. So 1st 1st rapid fire question would be What is your favorite nonfiction business book

Ted Lamson:   50:45
business and non fiction? No, no, Actually, I would say my that I was a Bible. I go back to a lot, is a pretty old one, but a

Scott Nelson:   50:56

Ted Lamson:   50:56
one, and that's crossing the chasm. And to me, that one, this sort of distribution of customers, the early adopters, the chasm that is there that you have to get across. I've seen it play out every time I've done this. And I also feel like it gives me a barometer not only with the market, but with the company and also with even an individual. I'm talking to to kind of like, figure out Where am I in this process? Because as a start up, you know, wow, you get, you know, $1,000,000 in sales. It feels like you are an overnight success, but that's not your goal. Your goal is, you know, hundreds of millions of dollars. And there is a huge chasm between those two, and

Scott Nelson:   51:39

Ted Lamson:   51:39
so I think that's been ah, really good book to help plan and and be honest with. Where are we in our process?

Scott Nelson:   51:47
Very good. Uh, now, having said that, is there a business leader that you're following the right now, Ted or one that has inspired you over the years?

Ted Lamson:   51:57
Yeah, there's several, um you know, I I would say just to go straight out of the industry or whatever. I'm just fascinated by Elon Musk in the stuff. I feel like he embodies thinking big and, um, in you know in the team he has developed, but you know, it's never, you know, just like the president were collecting this year.

Scott Nelson:   52:19
It is never

Ted Lamson:   52:21
the one person, but it is as a leader. It's what you set up. It's what you set up and we cultivate. And when you cultivate it an environment, it's amazing what can happen. And and I just see this guy out there with crazy big ideas. But because he's delivered and because he's built this environment around him, the idea's just get keep getting bigger.

Scott Nelson:   52:44
Yeah, that's Ah, that's always always, always a say Say that when you mentioned Elon. Elon Musk is that is a guy that you're, you know, business leader, that you're following on that No, I think I remember reading a recent piece where I think it was something like it was an incredibly low percentage of the of the goals that he sort of, you know, offers up in the public domain. It's like less than 10%. He actually hits, which I was extremely Look, you know, considering it seems like he hits every every every call that that he that he sets out there. But I think the fact that he's, he's, he's, he's done, you know, he's proved himself to a to a great degree. But you know, he I think he thean tent of making sort of those goals public is that he wants toe sort of. You sort of go big and set that expectation with the rest of the team. So it's cool that you mentioned that. So last question, Ted. It would be, you know, thinking back over the course of your med tech career, eyes there, one piece of advice that you tell your 30 year old self

Ted Lamson:   53:43
Hey, stay in shape mint.

Scott Nelson:   53:46
No, I I

Ted Lamson:   53:52
think that, um, you know what? What I would say. I've always kind of been in innovator, and I've always been really turned on by just changing things, and I think my 30 year old self, I would say, Hold on just a second. There's a lot to learn from the people around you and the people above you and I. I do think that you can be an innovator and you could be planning great steps in start ups and that sort of thing and being an environment, uh, let's see, where was I think I was in INF, either. At that point where there are a lot, there's a lot of great talent around you and you may not. I feel like the system as it is, as productive as it should be. But even if someone doesn't think actor or lead entirely like you do, there's always something really interesting to learn from him. So I think, uh, probably for me, it would've been a more open mind to those seasoned veterans that had a lot to offer but weren't so innovative.

Scott Nelson:   54:53
Always be learning is the phrase that comes to my mind as I listened to that advice, but certainly certainly good. Nonetheless, that sentence definitely something that I wish I would have listened to, maybe a little bit more, you know, you know, 10 10 years ago. But that's good stuff, so I just I like I said before, I think it's just the neo track story is very cool. Ah long one in the making and it's really, um I don't put the slightly when I say it's really cool to see you know what you and the rest of team have have built because you're now, you know in full on commercialization. Vote in new track. Correct. You've got sales reps in the field actively, you know, actively, you know, working with physicians and treating patients.

Ted Lamson:   55:32
Yeah, where? I mean, we're on the revenue commercial trajectory that, quite frankly, I have been dreaming about. We're hitting our goals and that's what everyone likes.

Scott Nelson:   55:45
That's great. That's great. Well, cool. Well, I'll have you hold on the line, Ted. But again, thanks so much for for your for your willingness to have this conversation and telling telling your story telling the story of neo Tractor, we really appreciate it. And for those listening to this interview, thanks for your your ear and until the next up next episode of Meds.