How to Move Forward After a Thumbs Down from FDA: Interview with Kevin Sidow, Former CEO and President of Moximed


  • Share on LinkedIn

In late 2016, I was able to sit down with Kevin Sidow. At the time, he was President & Chief Executive Officer for Moximed, and had been since 2008.

Prior to his time at Moximed, Kevin was President & CEO for St. Francis Medical Technologies, a privately held, venture-funded company focused on developing innovative treatments for patients suffering from degenerative spinal disorders. In January 2007, St. Francis Medical Technologies was sold for $725 million to Kyphon, which was acquired by Medtronic later that same year.

Previously, Kevin was the Worldwide President of DePuy, where he supervised the global orthopedic, spine, trauma, and sports medicine businesses, with annual revenue responsibility of over $3 billion dollars. Kevin holds a B.S. in Accounting from West Virginia University.

Interview Highlights with Kevin Sidow

  • How Kevin felt when Moximed’s first patient was treated with the Atlas System after 8+ years of research and development.
  • What makes the Atlas System different than other orthopedic knee implants.
  • How medtech professionals looking to take the next step in their career can utilize Kevin’s advice and learn from his meteoric rise to Worldwide President of DePuy.
  • How Kevin and his team responded when their device received an unfavorable response from an FDA panel.
  • Kevin’s approach to financing a medtech startup after raising nearly $100M to fund Moximed.
  • Kevin’s favorite business book, the CEO he most admires, and the advice he’d give to his 25-year-old self.

Read the Interview with Kevin Sidow

Scott Nelson

On today's program, we have Kevin Side out, who in February 2008 began his role as president and chief executive officer for Moxie Med. Prior to his current role, he was president CEO for Saint Francis Medical Technologies, a privately held venture funded company focused on developing innovative treatments for patients suffering from degenerative spinal disorders. In January 2007 ST Francis Medical Technologies was sold for $725 million to Kai Phone, which was later acquired by Medtronic. Previously, Kevin was the worldwide president of Depew, where he oversaw the global orthopedic spine trauma and sports medicine businesses with annual revenue responsibility of over $3 billion. Kevin Hold, CBS and accounting from West Virginia University here. A few the things we're gonna learn in this interview with Kevin. How he felt when Moxie Mintz first patient was treated with the Atlas system. After eight years of research and development, What makes the Alice is some different than other orthopedic knee implants. Kevin's New York rise to a worldwide president of Depew and his vice to other medical device professionals looking to take the next step in their career. How Kevin and his team responded when the device received an unfavorable response by an FDA panel. Kevin's approach to financing in med Tech startup after raising nearly $100 million to fund Moxie Med in Kevin's favorite business book, the CEO he most admires and advice he'd give to his 25 year old self. So without further ado, let's get to the conversation with Kevin. All right, Kevin. And welcome to the program. Appreciate you coming on, Miss Ida Radio.

Kevin Sidow

Yeah, great. Thanks. Thanks for having me.

Scott Nelson

All right. Well, let's start with, uh, Moxie Men. You founded it back in in February of 2008 or at least started there back in February 2000 eight's and we're now recording this conversation, you know, almost nine years later towards the end of 2016. And that's Ah, that's a long time, I think, from anyone's perspective, it is especially in sort of that the startup MedTech ecosystem. So tell us, Tell us how you felt when that first patient was treated with the atlas system for your i d. That was announced earlier this month.

Kevin Sidow

Yeah, not great. I mean, you're right. Got it. Really is a long time. Wakefield. We've always felt that the size of the opportunity make we'll make it work. Wait. So when the first Atlas went in Boston recently, it's really the culmination of eight years of clinical history. Would the predecessor device, which first went in in June of 2008 in Australia and all of the studies between the atlas and that first implantation of the tennis spring device, is what we call it really show consistent success across a patient that we feel is has been underserved by current surgical therapy. So, yeah, we're absolutely, tremendously excited about prospects and happy to see the first case take place in the U. S.

Scott Nelson

That is probably almost hard to describe that type of feeling, like looking back over the past, you know, 88 plus years or so and all the efforts that went into, Ah, you know the product. You know, the regulatory approval process, clinical trials, etcetera. So obviously wish you congratulations for sure. And so let's go ahead and level set things for the audience. Can you go ahead and provide a, you know, a high level overview of moxie Med and the Atlas system. And then I you know, I think in the past and doing some research for our conversation here. You called it a shock absorber for the knee. And so, just curious to get your take on how it differs from other knee plants that are on the market today.

Kevin Sidow

Yeah, that's a great question. So I guess I'll back up a little bit and just say, That must mean that came out of the incubator Explorer Med that also spawned a Clarence and me attract, which you're both companies, that great success in treating patients and filling in on that need so and explore med and moxie Med were originally and continue to be funded by any A. So we've been very fortunate in that they share our vision that this is the area, but that need is one that's well worth investing into. So what makes it different is I think it's first of all. It's a procedure that if for some reason it doesn't work for a particular patient, you haven't compromised any downstream therapeutic options. So what we're offering, really is this proposition for patients. You can maintain your own natural anatomy. In other words, we're not cutting out any bone or soft tissue you could maintain in the extremely high activity level without compromise. And as I said, you can also maintain those downstream therapeutic options such as Beauty Compartment all New York trip Last E until New Yorker plastic. So what's different about it versus those things are need. Knee replacement surgery works great, And you know, my background was worked for Johnson Johnson's orthopedic unit, and a lot of the time was spent on the hip and knee division. It's a great therapy, total knees, but it's really targeted and most successful for those patients who have moderate activity levels or low activity levels. What we targeted with the Atlas device are those patients who are high activity levels who eat it because of their job or because of their hobbies. You require or desire i activity levels and we think in in 2016 that's a fair proposition two to allow patients Thio maintain on, not compromise their their quality of what?

Scott Nelson

Sure that makes a thanks for that overview. By the way, that makes a lot of sense. And I couldn't agree with you more on record, Steve her common about in our current era, the patients becoming that much more proactive about their health. And I gotta I gotta think that bodes well for from Oxy met and, you know, into the future when it comes to that type of patient population aging and needing maybe something like the the atlas system. So, um, let's let's before we kind of go back in time and learn a little bit more about your career in med tech, help us understand your current commercialization efforts. So you've got a you got you started your idea. Ah, I d trials, as I mentioned before here in the U. S. Are you Are you currently commercializing in Europe right now?

Kevin Sidow

No way. Do have some. We have a few cases being done and being paid for in Europe visited. See, Mark. But our primary focus of the company is really addressing the U. S. Market availability through the regulatory processes. And the activity in Europe really is to do registry or single patient. Excuse me. Shouldn't single center studies, you know, support the clinical portfolio that we will submit to a FDA for approval?

Scott Nelson

Okay. Very good. And on that note, is there a date in mind that you sort of anticipate FDA clearance? Or is it too early to tell?

Kevin Sidow

Yeah, well, it's not too early. What I would say is that we we expect that, um, first of all, the patients have been enrolled in the primary and point will be hit early in 2017. So

Scott Nelson

you're okay? Very good. Well, yeah. Let's see what we're gonna circle back around Thio Moxie met here here later in the conversation. But let's let's use it some time as a transition to go to rewind the clock. As I mentioned before, you know, you started out as as, ah, dip you in the orthopedic division as the VP of sales for the Midwest. So what were you doing before? Thinks I'm curious. Sort of like your entrance into the medical device arena.

Kevin Sidow

Well, I started out with how Medica actually as a sales representative and I had how medica I was promoted up to the level of a director of sales position. But America, I always had this entrepreneurial instincts and interests. So at a certain point I went to work for a small spine distributor which was selling at that time. Medtronic products. I want to learn about this fine, just fine business because my main involvement had been hips and knees. But I also what we were considering a financial partner and I We're considering buying a small, independent hit, the need manufacturer that did not come together. But in the meantime, I got to know the spine business very well, which certainly later, because one of the one of the worldwide business is reporting into me at the pew was the spine business. So I had a sort of baseline understanding of surgeries. The needs of the patients, etcetera,

Scott Nelson

got it, make makes sense. And so you ended up not buying that manufacturer, but instead ended up kind of landing at Depew is that correct?

Kevin Sidow

Yes. So So it just came off. A friend of mine had recently started with the pew and you said, Look what we have a need for a I think originally they were proposing VP of sales, but I didn't want to move, so we I became sort of the VP of sales for the central part of the country. I didn't want to move to Indiana at that point, So that's where it started with a few.

Scott Nelson

OK, ok. And it seems like, you know, I guess before we get into kind of, you know, your what seems like a meteoric rise within within depew, it's pretty clear Justin are in early conversation here that you did in fact have that sort of entrepreneurial bias or bent early on, if you were considering a, you know, purchasing a on actual device manufacturer. Have you always had that instinct or was there, you know, was it was that your career sort of post undergrad? That really kind of fostered the type of behavior?

Kevin Sidow

Yeah, that's a great question. I think I think I always felt like I wanted to be to be able to build something fairly directly. And, um, you know, I think you cannot substitute for the things you learn by working for a big company in terms of process and in terms of, you know, even strategy and needs. But I also think there are lessons that you learnt as an entrepreneur that you can't learn anywhere else. And part of that is a really hard lesson about your capability. And I know it sounds funny, but you find that you could really do a lot more than you think you could do. You can work harder than you suppose that you could. So the those sort of lessons I learned fairly roll on in just sort of regular jobs. And I always wanted to put those lessons work for myself, or at least a small company that I could play heavy part in building.

Scott Nelson

Yeah, you know, I can completely appreciate appreciate that. I appreciate that And your your statement about the lessons learned at a big company. I've certainly experienced that in my career, and you just don't fully grasp the nuances at a large device. Come unless you've done that, you know, and add that sort of experience, so cool it sounds like you're similar thoughts anyway, So let's talk a little bit more about your time at the pew because, you know, like I mentioned the VP of sales in the Midwest. But then within 2.5 years, you were president of orthopedics. And I think less than a year later if my my timeline is right here, you were the worldwide president of DEPEW. So can you talk to us or help us understand what led to those rapid promotions during your time there?

Kevin Sidow

Yeah. So it was interesting because, you know, shortly after I joined and really I think it was a matter of a couple of months. The pew was acquired by Johnson and Johnson, so I think that accelerated my ability would come to be offered promotions because, you know, the work was intense in integrating the companies. I think people had greater visibility. Thio you resenting a lot of time together, and I think people have greater visibility to who works how and produces what results may be a little more quickly than they would otherwise. So for me, it really waas a unique situation in that at that time there was no worldwide. President of Tip You. Excuse me For the combined company, there was an international president in the U S. President of the hip knee division. Now this is what I'm talking about. The hip, any division only. So what happened? Waas. I actually was offered the international president position on the hip and knee division was in the process of taking that position because I thought it was the right time for my family. And it would have been a great opportunity speaking company because defuse international headquarters are in England, which makes it a little bit easier for the kids. And in the middle of that, actually, often when we were just about to move, the U. S. President resigned and moved out of the company. So left us with a dilemma. But in the meantime and what that Dylan was resolved by then asking if I would take the U. S. President's job, which I did. But in the meantime, I learned quite a bit about the international business. So a year later, when they looked to flatten the organization a little bit and combined something's on the TV business, I became a worldwide president of the first hip and knee business. And at that time, the worldwide trauma business started reporting into me as well. It wasn't until maybe another year. So I think it was probably a year or two. Maybe that worldwide sports medicine business, my tech and the spine business, uh, started reporting into May as well.

Scott Nelson

Okay, so it sounds like definitely some moving parts along the way. That sort of opened up, you know, opened up a path for you. For sure on that note, though, for so I mean, I know, Um, I think for most listening is there hearing you describe that? You know, looking back, it sounds like it's okay that makes sense at the time. I mean, those were rapid advancement, especially at a time when Jay and Jay was acquiring to Pew. There's big business involved. So I guess I'd like to ask the question for those listening in the audience that are at a at a similar point in their career, whether it's at a mid cap or a large strategic really want to go to a startup. But they sort of like they want to continue to advance their own career, where their ads you have any tips or tricks or advice that you can offer up? Yeah,

Kevin Sidow

I think it's just the stuff that you hear constantly, Scott, and that is you have to go where the work is. You have to go where the challenge is, and you have to be willing to step outside of your comfort zone. You're never going to grow. That's one thing I did. I put myself in a position where it would be slightly or more than or significantly uncomfortable because I knew that's the way to accelerate learnings and to become a better ultimate general manager. So So I didn't do that. But fundamentally, you also have to believe in and trust in the people you work with. Neither engender that trust or develop that trust, depending on which side of the equation you're on and also with the company and the products. Working with Johnson Johnson's tremendous company, they really are, and there are a lot of really good people there, so that made it easy for me, you know, every step of the way. But that's the advice I would offer, including when you look at those opportunities, you really do have to be flexible in terms of, you know, roll location and everything that goes along with this.

Scott Nelson

Thanks for those notes. I mean, they sound relatively straightforward, but, you know, maybe easier to speak to less harder to actually, you know, put into action. But you know, your last point about being flexible. You know, I remember a point my career where, you know, I had a similar conversation with regional sales manager and he made the same exact point that, you know, throughout his personal career has always been flexible. And you have been willing to make the necessary moves from a geographical standpoint. And if you don't have that flexibility, you're kind of making it hard on yourself. So that makes a ton of sense that you sort of reiterated the same thoughts. So let's kind of move on from your time at Depew. I think you spend about three years, is worldwide president of Depew and then made the move to ST Fickle Technologies. And to be honest, I have never heard of ST Francis Medical Technology his head, where you agreed to do this interview, try to do my own research. But, you know, can you tell us a little bit more about what drew you from Depew to ST Francis and then where the company was at at the time you joined.

Kevin Sidow

So it's an interesting question, and it caused me to think back the question. I was asked about a lot when I made the move. People thought, This really looks like a bad career move. You moving from large responsibility to start up that as you take that. Not that many people knew about the time. But what attracted me was mentioned earlier. I always had a very strong interest in, uh, doing entrepreneurial work. I love the space. I love the fact that there was a large unmet need, and in this case, it was that it that the need was just pure numbers. There were a lot of people with spinal stenosis, which is what the company ST Francis's product address. So I really was attracted to that, and it was a less invasive device that was reversible. So again, for some reason, if the product didn't work, you could take it out and you haven't compromised in any other therapy that the patient could go to. So those are the things that attracted me to it. And, you know, quite frankly, was also based in San Francisco in the Bay Area. So that was also a positive. But the main thing Wasit was a big space. And it was, you know, start up had many of the elements that I had always had on my my list of interest

Scott Nelson

in that particular device that become the X stop at HQ iPhone. Okay, okay. Got it. All right. And then And then when you join ST Francis, was there a product in commercialization, or was it still pretty early stage?

Kevin Sidow

So give this early stage, but it wasn commercialization. So it's an interesting tale, really, Because the company was doing a little bit of business in Europe with device. They had completed enrollment, and it's admitted for FDA approval. And the panel meeting was scheduled for US approval. So they were doing, you know, in in Europe. I don't know, maybe a 1,000,000 or two at that time. So what happened? Waas Shortly after I joined within two months, certainly we went to the panel meeting and the company had hit their clinical endpoints. But the panel did not approve the device So they turned down the device. They sent us back to the drawing board. Now, this is really where I learned a tremendous amount about the regulatory process. So what happened was we started to have conversations with the next level at F B A. At that time it was gonna be filming and she was great to work with because, well, there wasn't much interaction. She really had sort of a more of a big picture perspective. And so ultimately, we were granted a meeting with Dr Tillman and her team and the other members of Reviewers of Art of the Ex stop and sort of took them through where we were. The fact that we had had a number of these implanted with no safety issues in Europe and FDA ultimately granted approval to the device, I would say maybe a year, 15 months after we were initially turned down. In the meantime, I also learned a lot about cash burn because when you're dealing with a multi $1,000,000,000 company, you don't get it

Scott Nelson

concerned.

Kevin Sidow

But what we did Unfortunately, we had thio terminate, you know, between I think it was 35 40% of the people and the small groups. It was only maybe 9 10 11 people. Something like that. I don't remember the numbers now, but once we get through the regulatory process were approved. We hired everybody back, which which was great and real mo mentum builder. And then we launched in the U. S. And we're rock to the races. It was also interesting because our ability to ramp and take a different inflection on the ramp in Europe really helped save the company because we were in a very difficult position to fundraise, given the FDA decision. So we really became cash flow positive for the entire enterprise, not just Europe. After streamlining and again, unfortunately, terminating some people and driving that ramp too much steeper level. Oh, us way. Also, only I think the second year went to 10.8 million and became profitable on that in some ways, save the company because we didn't have to raise any more money.

Scott Nelson

Hearing you describe that situation reminds me of a conversation I had with Ted Lambs and who I'm sure you probably know the co founders of Attract, and I know he made a similar comment A little bit different story, but, you know, at neo track, due to some, just the at the time, it was just kind of a slow pace at the FDA in terms of, you know, their new products. And so they made the decision to go to Europe, and it didn't really miss their lead them to profitability per se. But it really helped them mature in terms of their commercial readiness for eventual FDA clearance in the U. S. So it sounds like maybe the you know, I guess it turned out it definitely turned out well for you guys, that sort of squeeze you into a position that maybe wasn't was an ideal initially but ended up turning out pretty well.

Kevin Sidow

Yeah, that's right. And again, it's like anything. It's like going back to your question about you know, what advice would you offer? The advice that one of things always got me is always try to continue to learn. And that experience was tremendous for that kind of thing. And yeah, it was hard, but it also I've applied it to everything I've done since. So ultimately it was great and very, very positive for me and for the company of associated with. Hopefully,

Scott Nelson

you know, I can only imagine and I want to get to mock cement in a second. But on that note, do you remember that time when No, you got that thumbs down from the FDA panel? I presume it was probably unexpected. And I know you double down on that regulatory window and eventually one, you know, one clearance, But can you speak to maybe a little bit more about your approach You personally dug in tow you in all things regulatory. But can you walk us through extreme your mindset and how you approach that at the time?

Kevin Sidow

You're exactly right, Scott. It waas unexpected because we had won the trial. The numbers said we want. So it was a shock, and part of it was there are a lot of members of the team there, including a couple of the guys who had been hired to prepare for commercial launch in the US Ultimately, those guys and I say guys generically were on the list of unfortunate people who determine ated for a period of time, and I remember we went out behind the the hotel where the meeting was held and at an impromptu session, saying, Look, here's the plan also got together in the room with everybody in the company, including the surgeons who were supporting us and just make some brief comments about no, we won this trial on, and that's a fact. And that's unshakeable. And we will use that as a basis to build back to the point where FDA understands that, and we'll actualize the vision that we had for the company. And I think that perspective was one that we all kept and kept us positive, kept our chins up and kept us grinding away at that vision because that was the building blocks for everything.

Scott Nelson

I mean, I can't, uh, probably easy to talk about right now, but But I can't imagine how much of a blowback that was at that time.

Kevin Sidow

I thought I was going to have to get some sort of Molly your crane or something to get

Scott Nelson

their jaws

Kevin Sidow

off the ground. But we all felt that way, Quite frankly, that plane ride back twist were located on the Bay Area, and we were at FDA in Maryland. That was a long plane ride home. I can tell you that

Scott Nelson

Yeah, that's along, let alone with that type of news delivered. So you mentioned that it was within about a year that the FDA ended up clearing. But now is, I guess, the ex top device.

Kevin Sidow

It's 15 months later, actually. So the time on this I remember very clearly because what was it, a steak for us? I think it was August or September when the panel turned us down. We had a meeting in May with Dr Tillman and her team and our reviewers, and there was a signal there that things were going to be more positive. And from there we ended up talking about labeling and sort of negotiating that and we were approved in November of, you know, the following year. So again, I think it's about 15 months. Elin from original panel guns down Thio. We got the fax from FDA saying products clear for sale in the U. S.

Scott Nelson

God, And did that require additional clinical data or was it just sort of, as time went on and through continual conversations, I guess with FDA is that sort of led to the ultimate clearance.

Kevin Sidow

Yeah, it was really while we probably submitted some day. Actually, I think we submitted data on mechanism of action from a study that we had done in Scotland. But it was mainly about making sure they fully understood. Look, And it was just a different approach that we hadn't taken to that point that said, Look, outside of the U. S. Data, we've also got this rich and fairly substance of numbers of cases and clinical history. Oh, us. And there is no concern with safety. And I think once they saw that, I think it's time we probably had 1500 implantation device is implanted, so I think what they sell, that they breathe a sigh of relief and started to look at the bigger picture and the day itself. In the fact that we had won the trial, they were really good about it. But I think perhaps between the panel, you spend a day with the panel. And sometimes some of the family members educate themselves very, very well before the meeting. And sometimes it feels like some of the panel members don't really educate themselves, even though they provided by FDA with a lot of information until they get to the panel meeting. We felt like we were given a fair assessment after that meeting. And that's what led to the reversals of decision. I

Scott Nelson

got it. And then I guess, shortly thereafter, ST Francis ended up being acquired by Kaif on and then Kaif on, I think I think, what did six months If if you know of my I did my research right, I think was was acquired by Medtronic. So interesting little lot one of their

Kevin Sidow

That's exactly right. Yeah, that's right. So So Medtronic had been involved in the auction. So the way this worked way had some offers when we were FDA approved for the company when we're cleared for sale in the U. S. But we felt like we wanted to execute improved way really believed in our team and our ability to sell. And we had a great great agents who have been with the pew spine and striker is fine and independence really, really good people. We did a great job, and so we execute well that first year of launch. And then we found the S one and we had had taipan had come in when we're FDA approved. And when we started selling Medtronic had come in with offers with offers that were significantly lower than what they ultimately offered. And then what happened was we found the S one to go public, and we hadn't really overplayed our hand in terms of our results. In the fact that we were cash flow positive, we hadn't made that generally known. And once they saw the followings and the information contained in the S one, then of course, they sell. We're doing better than they had thought. And the offers stepped up sufficiently. So way started an auction process while we were following within the S one and getting ready to take the company public, do the roadshow, et cetera, And the numbers from the metronome HQ, iPhone and at the time, Abbott Spine were such that we felt it was the responsible thing to do was take very, very seriously. And then and then Ultimately, Kaif on had the best offer. And then, as you said, Medtronic immediately set about acquiring Taifa.

Scott Nelson

I got it. Yeah, it's funny how those events all come full circle for sure. So and it looked like you didn't stay with Keifer Norma tronic very long. In fact, that point your career, you moved on democracy bad. And I remember reading a statement. I think from you during your time at ST Francis that you were working on projects. That quote wouldn't burn bridges. And is that sort of the concept that that sort of drew you to? Ah, moxie, Mint? Yes,

Kevin Sidow

it's one of the concept. The concept of reverse ability and not compromising anything downstream is one that I think is attractive patients and surgeons alike. And that moxie medic That was one element of it. It was the massive need, you know, when you think about and you look into osteoarthritis, the fastest growing segment symptomatic patients in the way is 35 to 65 right? So these days, 35 to 65 year olds are very, very active. I mean, the old joke, about 60 being the new 40 is true. And so you have this concept of not burning bridges, and you have unmet need for these highly active patients because again, total needs and you compartmentalize needs air great for moderately active patients. But we think someone who's going to be very, very active and that big growing target market fits that bill needed something else. So those were really the elements that attracted me to him. I

Scott Nelson

got it. And as you mentioned earlier, it's sort of the product started off. Is Kenneth Spring? I think if I'm pronouncing that right and then after initial implants in Australia, you sort of took a step back, brought the product back in house. Didn't make some generations to what is now the Atlas system, is that correct?

Kevin Sidow

Yeah, that's exactly right. So the adult system really is the culmination of 6.5 or seven years of clinical experience and feedback from the surgeons and patients who were part of that implant experience. So we feel great about it. We feel as though we've kept the best of the King of Spring, and that is the restoration of function and pain relief. But we made improvements in terms of making a smallish footprint of very straightforward surgery and the compressed very, very consistently compressed recovery time for the patient. So we're excited.

Scott Nelson

Yeah, absolutely. And it looks like you've raised, I think, close to $100 million or so at Moxie Med, and I know you mentioned in any is is one of the, uh, well known venture capital firm in in the med tech space that's been involved with with moxie men. So can you talk to us a little bit more about like your fundraising process? How you're maybe you're a round was different than your B round. And, you know, for those med tech entrepreneurs that are listening and sort of are at that stage, you know, with their company where they need to move beyond sort of the friends and family rounds. Jimmy, you know, advice for them, those types of folks.

Kevin Sidow

Yeah, I think that it's interesting because over the years there have been fewer companies that are focused on metssecond. Vestments were lucky in that. And again, not thio continually seem the virtues of any A because it's not just any eh. It's also killed over text GPS, Morgan Taylor, etcetera. We've been very, very lucky because those investors and this is the lesson that I've learned. Those investors shared our vision. They see there's a massive market. They see that the product is absolutely directed at the right spot in the patient continuum and the patient, the patient mature and their value added investors and board members. We've been, I would say, Look for those things Talk to the people who have worked with these companies. I know there's It's a tricky environment now and sometimes CEOs and management teams feel like they don't have a choice, and I think a lot of times that's true. But if you aren't in a position where you have a choice, I think learning about the interaction of the investors and the management team is very, very important and clearly understanding what the expectation in terms of timeline and company build is from those investors. Those are important things to get your arms around before you commit to those investors. That's what I would say. That's what I've learned.

Scott Nelson

That's good. That's good advice. And let's turn the page a little bit and talk a little bit more about the current reimbursement environment. So presuming Atlas system is cleared here in the in the U. S. By the FDA, will it fall under an existing cpt code? Or is this something that will require a new code all together with the corresponding challenges of getting coverage and reimbursement with both Medicare as well as private pears?

Kevin Sidow

Yeah, that's a great question. You know, you don't know until you actually are cleared for approval in and start to make this happen. What we do know is we presented to several key with peak societies and met with the coding representatives, and we've gotten positive feedback from them. So we feel good about that. Beyond that, you would just be forecasting on my part. And I don't think there's much to learn from that. But we do feel like in the meantime, we're collecting the right information that will support our reimbursement efforts. Not only that, they show that this is on the right side of the financial equation for everybody involved patients, the surgeons, you know, whether it's an A S. C in our case or ah, hospital wound outpatient center that that it will be a win win for that. One thing that we have done in terms of reimbursement is we have gotten feedback from the private payers. We do know that they are all over the data. They are very well versed, as you would expect on the real cost of, for example, total New Yorker plastic. And what we find encouraging is they realized that there are direct patient expenses for those patients who are waiting to become a Jor in activity appropriate for total New York plastic. So, in other words, those expenses are doctorsvisits treatment costs, increased medication and then indirectly, there are lost work days that these private payer medical directors have insight into. So we were pleased in our conversations with them that they fully recognize that, you know, waiting and watching is not inexpensive. There some data out there that says each of those patients costs about $4000 a year because of medicine treatment. And these Aaron do Act cost meds, treatment and doctor visits. So the other thing that on the other side of the equation, what we find that the private payers are very, very educated on his the fact that increasingly there patient population is higher activity levels and so called younger patients were are plastic are having arctic plastic because they feel like they need some sort of therapy to eliminate the pain and attempt to restore their function. Medical directors We talked to our full where the results with those younger, more active patients are not nearly as good as they are with as I've described before, moderately active Warlow, A patient with low activity levels. Well, economically, for the type of product that the atlas represent.

Scott Nelson

Yeah, absolutely. I guess the lesson learned, I guess, for me hearing you ah, riff a little bit about this whole concept of reimbursement and coverage encoding is is the fact that you're having those types of conversations this early in the process, right? Those conversations with at the societal level as well as with with private pair. So maybe that's the The lessons learned is you probably can't do that early enough, you know, in the life cycle of the product.

Kevin Sidow

Yeah, I agree. Scott really can make a break at some point. And you need to take into your plans. That feedback you're getting on both sides of that equation. But

Scott Nelson

private

Kevin Sidow

medical directors and the society coating representatives speed back.

Scott Nelson

Yeah, and I recall an experience I had when I was at Covidien, working with health care economics, folks, healthcare, economics and reimbursement, folks. I remember, you know, a couple people mentioning the fact that we couldn't go have these types of conversations with the payers until we had, you know, an actual code, And I always thought it was kind of I was thought it was kind of man. Certainly no, no expert when it comes to your healthcare economics and coverage, especially at that stage of the product. But it just seemed always kind of odd to me that why couldn't you have that type of conversation you know, earlier in the process? I'm sure if you get time, time on the books with a medical director, I'm sure they would entertain that type of conversation. It was gonna help them. You reduce the costs.

Kevin Sidow

Yeah, that's right. And I think you're right. You have to go back to what we said about being flexible in this case, being flexible and how you pose the question to them. So it's

Scott Nelson

sort of

Kevin Sidow

like if we had this sort of data over this kind of experience, what do you think about coverage plan?

Scott Nelson

Now, that's that's good advice. So as we kind of wrap up this interview with last three rapid fire questions, you know, looking back over your moxie, Manu is going back to 2008 you know? Is there anything that stands out? You know, in terms of things that you're really proud of you and or, you know, situations that you maybe would have done differently or ah or changed if you had had the opportunity to go back in time.

Kevin Sidow

I think what I found and I think the team has found, is when you're doing something very, very innovative. It's not a straight line. Think what were we as an organization of proud of? Number one is. We've always stayed true to the vision of really changed the paradigm of care because the patients is, Aziz said earlier. When you think about a 50 year old patient in 1985 when the PC knees were really accelerating, the uptake of total New Yorker plastic very, very different person very, very different lifestyle that people weren't nearly as active in the habits included a lot more smoking, let's say and those kinds of things we feel like we've maintained our eye on the vision of improving the lives of those patients who's always symptoms air growing with that group of patients where the only prevalence is growing more than any other area and meeting their needs. So through the feedback and the fact that it can be looked back. Nine years. Sounds like a long time. We've always maintain that belief that we've gotten it right and we'll get there. I think that's what I'm proudest of.

Scott Nelson

Yeah, let's get a good stuff. So, you know, with the last few minutes here we have, let's wrap it up with the three rapid fire questions. The rapid fire nature feel Frieda to provide brief answers or expand a little bit if you want. 1st 1 is, Is there a favorite business book that you can recommend?

Kevin Sidow

I think the one back there it is good to great.

Scott Nelson

I think the lessons

Kevin Sidow

are has been proven time and time again.

Scott Nelson

It's interesting that that comes up. You know, I think regardless of the age of the person that I have asked that you know someone who's who's younger or older are more mature in their career. It seems like that one continues to come up. So, second question, Is there a CEO that you're following right now or one that's really inspired you in the past?

Kevin Sidow

I think I've learned from everybody, really. I take little bits from here in there, so I wouldn't say there's a particular person that I'm following, I would say I tried to read about the decision making process of each of them as much as I can, either in the business news or as you said biographical material and learn from

Scott Nelson

a

Kevin Sidow

little bit from everybody.

Scott Nelson

I got it. And the last question is, Take us back to your you know, your 25 or you're 30 year old self. What advice would you would you give him a TTE? That point time?

Kevin Sidow

I think it's what we touched on a roll God. First you have to believe in the product that you're involved with, and you have to respect and trust the people around you and the company you're dealing with. Beyond that, the things we talked about, you have to work hard and it's open the shades stuff. But it's true, work

Scott Nelson

very

Kevin Sidow

hard and help create a culture of success and a culture that people find positive and healthy for them. Despite the fact they may be working very, very hard.

Scott Nelson

Good stuff and I can't thank you enough for coming on the show, and we'll certainly link up to moxie mad. And for those interested in learning a little bit more about the atlas system. They'll be links in the show notes to this particular episode. So, Kevin, I'll have you hold on the line. But again, thanks for coming on the program. Really appreciate it. All right, that wraps it up for this particular episode. Thanks for your listening attention. And until the next one, everyone take care.

Learn From the Best

The best stories from the world's brightest medtech and healthcare thought leaders. Subscribe for free and never miss an issue.

100% privacy guaranteed. Your information will not be shared.