Inside Orthopedics: Anatomy of a Startup - Q&A w/ Dr. Brett Sanders of Tensor Surgical (Podcast 24)

Brought to you by Tiger Buford.

Hello, orthopedic friends. Welcome to Inside Orthopedics. My name is Tiger. I'm an orthopedic industry insider and retained recruiter for early-stage orthopedic companies. Thank you for listening. This is episode number 24 titled Anatomy of a Startup, Q&A with Dr. Brett Sanders, founder of Tensor Surgical. Brett and I met about a week ago. This is our second conversation. Brett Sanders is an orthopedic surgeon who has reinvented transosseous arthroscopic tunneling fixation with some very clever, cost-effective tools. His company is called Tensor Surgical. This is a chance for you to look inside a surgeon founder startup that is disrupting the orthopedic industry, in this case, arthroscopy. I asked Brett a few questions and let Brett do the talking. Enjoy.

Okay. All right, Brett, we are live. Thanks for your time. Thanks for your time. You're in Chattanooga right now?

Yeah, we're in Chattanooga, Tennessee. It's a great place to be.

Yeah, excellent. So let's just jump right into Tensor Surgical. So fascinated by your story. So tell me, take us way back to the beginning of the idea. What was the origin? What was the aha moment?

Well, it probably goes back to residency. And just thinking about surgery and innovation and I've had a couple of ideas and seen them kind of come and go. And then, when I got into my shoulder fellowship, which was up at Mass General, we were having a little bit of transosseous technique was coming out at that time or was about to come out basically., and we were hearing a lot more about value, and, and those two things were kind of coming together. And I'm a fan of history, so I think, you know, we can learn a lot by going back and seeing, you know, there's nothing really new under the sun. And, uh, there's, there's been some, um, really, really smart people in the past that have done a lot of work on transosseous, and, and, uh, it kind of just fell together that that was a good kind of a no-brainer in the value-based era. And, you know, up at Mass General, this goes all the way back to, you know, E.A. Codman, the first guy who, you know, described cuff repair back in the early 1900s. And so, you know, the first cuff was done transosseously, and it could be argued that he was actually the father of evidence-based medicine and value-based medicine, looking at outcomes compared to cost. And that didn't work out so well for him. He basically got run out of town and, you know, died a pauper. That's kind of what happens to people who are disrupting the status quo.

First mover.

First, first, yeah, very first mover. And then, you know, throughout history, you know, guys were still working on that problem. Resh and Krishnan, and more recently we've had interest from Castaño, Burks, Tajedin. And so all these things kind of just congealed, and I felt that we had the skill set to put it together and make it work. So we decided to go ahead and go after it. So it's been It's been a fun ride. It's one of those things that, you know, on paper, if you look at the science and the biology and the biomechanics and the cost, on paper, it's really hard to argue against the concept of transosseous, but the real conundrum comes with business dogma, essentially.

Right, right. So tell me what— so you had an idea to bring transosseous fixation to the 21st century. So what did you do first?

What did you—

tell me how you started.

So, you know, like, like, I guess like many surgeons who are tinkerers, you know, had ideas, but, and had a, had a background in engineering, biomedical engineering, but, uh, had never really had any pragmatic experience doing that. So, you know, didn't really know what I was doing in the beginning. I hooked up with a biomedical engineer and sort of cut our teeth on a Class I positioning device called Quantum Ops, which is a mechanical arm positioner and a beach chair positioner for shoulder surgery. So kind of learned a bit about the innovation process and teamed up kind of in the old-school way of, you know, one surgeon, one engineer just being together in the OR constantly. Working nights and weekends. And that, that was something that appealed to me. I'd had a lot of frustration with sort of the modern paradigm of the big corporate system and, you know, 6-week turnaround or 6 months to get into the lab and just the slow process, frustrating process. I liked that one-on-one interaction. And then, and then we got together. This is Keith Harper and I, the engineer. And I pitched the idea of this transosseous device that would be reusable. So, you know, there were some first movers, for instance, like the Tornier ArthroTunneler, which was disposable, but it had some problems with targeting and the disposability and the cost, et cetera. And I felt like it was a relatively easy improvement technically, and I felt that that had to be done essentially by a surgeon. Just to take that through the normal corporate side, it would come out where you would lose the value play. And so, you know, it sounds like we could do that and we could get the techniques down. And, you know, when I was training, I think we, we talked in our last phone call about sort of the change in, in training and fellowship training, what the effect that that's had on, on surgeons. In the modern era, you know, when arthroscopy first came out, there were specialized unique instruments, curved shavers to get to the back of the meniscus and all these specialized devices. But, you know, now we can do most of the things with a spinal needle and a PDS and with technique over design. So, I felt like that was there and You know, and plus the fact that, you know, we're routinely talking about things like arthroscopic latterges and arthroscopic latissimus transfers and very advanced arthroscopic techniques. So to me, it was a really easy jump to just, or really just a sidestep, to just go transosseous suture management and design something that made it really easy to make a transosseous tunnel. And then there really wasn't a whole lot of extra skill set, just a slightly lateral move of your existing skill set to do that, and then preserve the value by making it reusable. And then we also eliminated some steps and made it a lot easier, to the point where you can, you know, put a tunnel in in 28 seconds, and it's really not much. The tunneling part is the easiest part.

So yeah, so, so I'm always fascinated by the design iteration process. So did you guys just prototype in— however, sawbones, uh, and then go through the Class I process and then use it in surgery and then keep changing the design? Or, I mean, tell me how you iterated.

Yeah, this, uh, that, that was a key, uh, thing for me. You know, in my, in my, uh, area, it was difficult to— there's a lot of scrutiny on surgeons, surgeon designers because of PODs and everything. And the, the fact that it was Class I and there was no implants allowed me to be able to do this, you know, sort of out of private practice. But yeah, the first design was totally different. It was, it was actually a two-piece assembly, and we, about on the seventh or eighth iteration, we got something that was just spot on, you know, targeted every time, never really missed, had a great built-in failure mode in that, you know, like some reusable things that have fatigue failure and just suddenly break or have a catastrophic failure. We had a design which is modular. It allowed various geometries of the tip to allow tunneling in other areas of the body. And the failure mode over time was just, sort of loosening on the grip of the suture and you could see that and change the barrel out if you needed to. So we arrived to that through trial and error and a lot of just creativity. I mean, I think, you know, some of these aha moments just kind of, you know, came in the shower one morning and this kind of thing, you know, when your subconscious mind is sorting out problems while you're sleeping, it just sort of hits you.

Yeah, common, common tale. But you have to fail along the way to, uh, find those. Exactly.

You got to put a lot of work in, and, and I think your subconscious brain sort of figures out the problems without your conscious knowledge, and then it just sort of hits you one day. But it takes a lot of hours to get there.

Absolutely. So how long did the 7 or 8 iterations take? Are we talking about months or about years?

Yeah, about 2 years to really get it where we needed to be. And then when we got there, it was obvious that this thing works and it's going to work.

Right.

And then it was just making it pretty and doing the clinical work and, you know, studying the outcomes. And we did a suture passer as well as a suite. So we wanted to have, you know, soft tissue repair a sort of modular limited disposable reusable, you know, repair set for the shoulder so that the surgeon could open up things à la carte and have a solution for this— for the cost containment era, or if you're competing on cost, you can actually do that, you know, where we're going to bundle the methodologies now with payment. And you hear stories of surgery centers around the country saying, you know, don't bring your cuff tear here unless it's just one anchor or like one or two anchors and basically you're paying the patient now. And that's just not feasible. I mean, you can't repair a cuff with one anchor or most of the cuff tears you can't repair with one anchor. In fact, you need, you know, many times the reason why you're getting dog ear deformities in the cuff and bird beak deformities and all these things is because you really need like 6 anchors and it's just, too cost— you know, too expensive. There's just no way you're going to do that. So you settle for 4, maybe 5 anchors, maybe 6 if you're talking BICEPS-2. So in my mind, we're trying to get to this clinical situation where the physician can decide what's clinically relevant and then add in and make a decision about the— what is the value for the technology that he's using and actually solve that conundrum. Now we're to the point where we're doing 8, 10, or 12 fixation point cuff repairs with, with an unlimited cost ceiling per case because the device, once you open it, you can use it and make unlimited repair or fixation points. So we're getting really excellent high fixation point density repairs and not sacrificing at all clinically, and we've solved that cost ceiling problem.

Wow, that's— yeah, there's no trade-off anymore with fixation and cost. So how does it compare cost-wise? So I know there's no such thing as an average repair, but like an average, uh, an average repair you see of 4 or 6 anchors?

Yeah, there is some data on that, and it was done with the Tornier disposable device, which is, you know, roughly double the cost of ours. So it should, you know— but the data by Lazarus out of Rothman showed about $1,000 a case savings with transosseous techniques in his paper. But basically the cost savings go up as the size of this tear increases. So our system is about the cost of 1 acre plus some suture cost. So if it's a 1-acre repair, you don't get, you don't see a whole lot of cost-benefit. Although one tunnel gives you two fixation points, so it's like two anchors. So you can actually make, in my opinion, you make a better single tunnel cuff repair is actually a very good repair. Might even be better. I rarely say that. It's at least non-inferior, is my claim, right, for most of these things. But as you go up, you know, you get into massive tears. 5 anchors, 6 anchors, 7 anchors, 3 tendon tears, Medicare population, you know, the older patients that have the bigger tears, trying to do them in your surgery center, this is where you really start to see the value.

Right, right.

And again, it's another thing that, that another, another paradigm that I'm kind of trying to drive is, you know, like I know that's true. Like I can say that I've done that on hundreds of patients. I've studied the outcomes. You know, ASCS scores in the 90s, start— starting in the 40s, going up into the low 90s. We're getting excellent outcomes, much less pain. But what I'm trying to drive is this paradigm in terms of teaching other doctors. Um, you know, we do a lot of hybrid repairs. So, we just do one anchor and we do multiple fixation points transosseously where we get excellent biology. You get no inert material in the repair site. You have cost savings, multiple small diameter, 1.9 to 2.9 millimeter fixation points. And then, you know, if you have a concern over being able to tension that or concern over bone quality, whether it's theoretical or otherwise, you can re-tension it with one anchor and put one anchor for cortical fixation, and you've got the best of both worlds. So, you know, surgeons aren't known for changing their minds easily, so You know, I think a whole new paradigm like this is going to be slow, but in the same vein as, you know, open, open arthroscopic cuff repair going to mini open going to arthroscopic, what I'm trying to do is facilitate that through, you know, full anchor to anchor transosseous hybrid, and then people will slowly realize that, you know, transosseous is effective and you can do it as a standalone procedure in many cases.

Yeah, so, yeah, so tell me what the typical learning curve training is. Is it done open first or—

It can be. It can be. I actually don't think that's necessary. Mostly it just depends on the surgeon's risk tolerance and confidence, essentially. Some guys will just go right at it and it's fine. Other guys want to do it, you know, open first, which is perfectly fine. Or, you know, certainly you know, use a sawbones first. But when, when, when you see the technique, it's basically working through an 8mm arthroscopic portal, and we use a 2.9mm awl medially. And so there's really no— there's very little downside to putting a tunnel in around an anchor to practice, you know, put them between anchors like a 4-anchor repair with a tunnel in between. I call that anchor-bounded construct. That's a good way to ease into it or do a small repair with just a single tunnel and simple sutures. There's really no downside. If you don't like it, you can just pull the sutures out. You know, you have a 2mm tunnel, you can put a 5.5 anchor in that, and the anchor actually works better because of the diameter mismatch. That was great. Interesting. The lateral tunnel is 1.9mm, so you're really not losing anything. You can always bail out, go back to an anchor. So, Right. We don't have a lot of device-related complications. It's mostly, I would say, for the beginners, it's mostly concern over just not being familiar with the suture management process and, you know, just concerns over maybe tangling sutures or unloading a suture or something like that. But again, that's the cool thing about tunnels once you get into them, and this is what I get excited about teaching people, you know, you can unload you know, a tunnel and pull 5 more sutures back in, you know, unlike an anchor where you burned your fixation point. You know, if you unload an anchor, now you've got an anchor right where you want to be. So if you completely mess up a tunnel, there's really zero consequence to that. You know, even if a suture cuts through the bone or something, there's very little consequence to that, you know, in the long run.

Yeah, let's, let's talk about bone quality. Where are there— what percentage of cases Is the bone just too soft or—

Yeah, great question. This is probably the most common sort of fear, I would say, that we encounter. And, you know, I always tell people it's, in my practice anyway, it just hasn't really been an issue. Maybe 1 or 2 cases a year that I see that, you know, it's a real problem. It's kind of an overblown issue from days past where we were, you know, days before the reverse arthroplasty where we were trying to fix 80-year-old, you know, females with irreparable cuff tears and they have butter bone and, you know, we, those people get arthroplasties now. So, you know, we're fixing cuffs younger, smaller, and we know that they progress. And so, we're just not seeing that horrible bone quality as much. In my practice, honestly, and in most guys who do this around the world, I think would probably agree with that. Of course, bone mineral density is like a Gaussian distribution, so you're gonna have, you know, in the middle of the pack or plus or minus 1 standard deviation from the mean, you know, going on the right side of the curve, basically everything works. You know, if your bone's hard, anchors, tunnels, it's anything works, it's dealer's choice. If you go to the far left end of that distribution and the bone is like just air, you know, there is no bone, it's like butter, everything fails. So sutures cut through and anchors pull out. The difference is that when anchors pull out, they float in the subacromial space or cause third body, third body wear and damage to the cartilage. So there's a downside to that, or they create huge voids, anchor voids. You know, 18-millimeter, 14-millimeter bone voids that you have to graft or stack anchors in later or whatever. And so, actually, one of my go-to treatments for large bone voids is to tunnel through them and fix laterally with some sort of augmentation, whether it's anchors, screws, or ACL buttons. I've done them all. You can fix cortical, you can augment cortex in various ways. But then, we let the cuff heal biologically to that., you know, to that clot. I think there's, there are still some situations where it's kind of an in-between zone where the bone's sort of soft where I don't hesitate to throw an anchor in if I think it's necessary, but I can always back it up and load share with sutures. Another interesting concept that is not talked about with regard to bone quality is that you'll have varying bone quality even within the same case. It's very common in cuff tears to have, for instance, a chronic supraspinatus tear that has bone loss or osteopenia in the old chronic tear, and then they'll have an acute on chronic infraspinatus tear. So, 1 centimeter away from that, you know, soft bone is very hard bone posteriorly, and then you go up in the biceps groove and the bone's really hard. So, you know, again, it's, it's, it's not a— it's not as simple of an issue as it's, you know, sort of been made out to be in the past. I think a lot of that is kind of, you know, anchors marketing, you know, saying that they're going to increase the pullout strength, you know, of the bone or whatever. But, you know, again, that's conflating the issue. I mean, the repair strength, the weak link in the repair strength is the tendon, tendon suture interface. And, and, you know, it's not, it's not having a strong anchor pull out a bone that you really want. You want, what you want is strong constructs. You want suture-tendon interface to be strong, and that has to do with fixation point density per surface area. So, the number of sutures crossing your repair site, which is what Scott Rodeo has shown and others, and every study in orthopedics basically has shown that. So, you know, this is a philosophical concept that I've come to that I'm trying to promulgate actually, which is in the literature if you follow this, what you'll see is sort of glee over transitioning the failure. We've transitioned the failure mode from the bone to the tendon. And so now we put anchor constructs in that are basically too stiff disc and they can't match the modulus or they overmatch the modulus and they transect the tendon and they truncate the tendon in half and then you have to revise that with a patch allograft or an SCR. And so, you know, it's like let's think about this for a second. You know, we've kind of gone down this path with blinders on. We've taken the failure mode in the, you know, in the mechanobiology of this complex soft tendon going to Sharpey's fibers going to the bone. You know, the one tissue in the body that heals with regenerative capability is bone. Bone can regenerate bone. You know, there's very few things in the body that can actually regenerate, and bone's one of them. And so if you have a hole in a bone, like, it could heal and you can come back later and you can fix into that hole. But the rotator cuff tendon is one of the worst healing things in the body. It's just like a scar, you know, and it degrades over time. It's got horrible biologics. I mean, that's the future is to figure out that problem, the biologics. So, why would we want to take the failure mode from the bone and put it on the worst tendon in the body? Makes sense.

Yeah, makes sense.

We've just followed the, you know, the anchor trail to its logical conclusion there. So, that's why we're kind of backing that up a bit.

And we talked about this earlier, the solutions in the future will be biologic solutions. And so you need to take costs out of the fixation system to make room for that.

Exactly. That's one of my dreams to do with this is, you know, it's so obvious that transosseous techniques and technologies synergize with other technologies so easily that you can— if you can take your cost off your commodity hardware, your anchors, you know, I mean, there's, we went from metal anchors to Peak anchors to resorbable anchors, resorbable vented anchors, double-loaded, triple-loaded, triple-loaded with different colors, tapes. There's not much else to do with that. I mean, everybody's got that. That's fine. They're great, but they're optimized. They're sort of maxed out. And they're commodities. So where we want to go in the future are patches and innovations that allow us to increase the biology, increase the speed, the cost-effectiveness, the value per unit of treatment that we can impart and allow us to continue to strive to apply new technologies. You know, I'd like to make, you know, biologic augmentation a standard of care. You know, in every case, you're augmenting the tendon. Right now, it's extra cost and, you know, when you're doing a superior capsule reconstruction, by the time you're done with that, that costs the same as a reverse arthroplasty.

Wow.

And so, we've got—

There's no room. Yeah, there's no room for this biologics on top of that.

Right. And we've got some users that have done some biologic SCRs with our tunneler and they're doing $600 or $800 SCRs, you know, with autograft the way it was originally described out of Japan. And that's a game changer, you know, to be able to actually do that. In the US, we have the resources where we don't always have to do that. In other countries, there are situations where that's all you're going to get. And so it's going to increase access there.

So how many— help me understand, how many cases has the Tensor technology been in to date?

Uh, thousands.

Wow.

Probably in the 3,000 range.

And US only?

Um, most of it's in the US. Um, you know, we've done labs and we've had a lot of interest, uh, internationally. Um, and, um, there has been some adoption there.

Um, but, uh, do you have the CE mark for Europe?

Uh, yeah, that's, um We actually held on that. That was a business decision of just trying to stay alive and grow organically. And, you know, we didn't— we weren't able to fund enough to kind of get everything we wanted with one go. So we kind of had to stay alive and get some revenue and then, you know, kind of bootstrap and get the interest, etc.

Uh, so that's starting later. Tell me, who's the— how big is the team? Um, you know, is there, uh, I'm sure you're outsourcing manufacturing, probably outsourcing regulatory filings. Uh, what and how is it funded?

Right, I mean, we started basically with seed and angel funding locally, mostly around here in Tennessee, and we had some VC involvement, um, and kept it kept it super lean, which means it's a slow grower, but we're able to sort of eke it out and stay alive, you know. But it's hard to compete with, with these big companies that have tons of resources. So we've just kind of eked it out with basically sort of a 3-man, you know, 3 or 4-man team. Most of the regulatory stuff was outsourced in the beginning and Fortunately, this is a Class 1 device, so there's not a huge regulatory burden, and so that was a blessing.

Yeah, the work still has to be done. So how are you getting— I've seen the website. It's pretty well explanatory. How are you getting the word out? Marketing, sales?

Yeah. Um, yeah, it's interesting. We ha— we've done a few, um, you know, most, most of our, uh, cash is used to just keep the lights on and, and keep, keep, keep the quality high and the safety good. Um, but whenever we've done some advertising, we've gotten a huge return. You know, the guys, the sales guys that are helping us, you know, tend to say like, I can't believe the return on this. Like we run an ad and we get all these calls back, you know, it's like that never works. But when we do it, it seems to work. But, you know, again, we're just— the bang for your buck there, it could be questionable. So we've kind of gone to some guerrilla-type marketing, email-type stuff, and website. And frankly, a lot of it's me on LinkedIn putting out techniques and word of mouth at meetings. And that sort of thing. So we're hoping we can hit a critical mass that way. Um, yeah, you know, so excellent.

So, uh, well, this is great. Um, so how would a surgeon learn more about the technology and maybe get some training? Where should they go?

Uh, tensorssurgical.com is the website, um, or they could, they could email me or find me on LinkedIn, Brett Sanders. Bsanders@sportmed.com is my email. And we're getting to the phase now where we're getting some interest from some academic organizations that are likely going to be doing some studies, you know, independent studies. And we're starting to run labs and kind of travel around the country. Anyone who contacts me who's interested is more than welcome to visit me in the OR and see it in action. I try to put videos out where it's self-explanatory. Like I said, there's a lot of trepidation, understandably so, of change in techniques. Like we discussed before, the advantage of this is a Most cases you can do a sawbones, look at the techniques, and, you know, we can help through the first case or two and then just proceed because it's pretty much just transosseous repairs have been around forever, you know. We're doing them all day long in the quad, triceps, and the hip, you know, all over the body. So, hopefully it's a pretty low activation energy once you get going. Probably it's not 3 to 5 cases and the learning curve, and then, you know, integrate it.

Off to the races. And like you said, there's no— you're not burning any bridges. There's no downside.

Yeah, it's not like you're all in and you put, you know, huge, you know, anchor voids or something, and then, you know, if you struggle, you're kind of stuck. You can always just bail or add anchors, you know. That's basically how I started when I was integrating everything and slowly adopting it. You know, I started with mostly hybrids and anchor-bound or tunnel-bound constructs where you would do one anchor and then tunnels around it or vice versa, you know, medial and lateral. And we went through all those iterations and kind of settled in on this lateral anchor hybrid that we just submitted to Arthroscopy Techniques. Hopefully that will be coming out soon.

Well, terrific. Thanks, Brett. Thanks for sharing your invention and new techniques to the world. I'm sure more people will hear about it and go there. And we will stay in touch. It's a— I love surgeon founder companies in orthopedics. You guys have a knack for obviously nailing the clinical advantage. The clinical problem really well.

This particular one, you know, one of these days maybe I'll— I'd like to do something sexier than this, but I think for the moment, you know, this is what's necessary. This is pragmatic, and the only way this is getting done is if a surgeon does it, you know. So that's kind of right or wrong, I picked up this burden and I'm trying to do it. But, you know, it's fun that the, you know, developing things is starting to be more accepted in the surgeon community and it's starting to be noted that there are plenty of things that we notice that are hard to get done for various reasons in the corporate world or whatever. And so it's been really fun. We're meeting a lot of interesting people and a lot more surgeons are doing this kind of thing. You know, it's really fun to get together and get that passion back, you know, kind of like at residency again where everybody's all excited and they're doing something that they're learning and they're having fun doing it. It's a nice way to kind of reinvigorate your career and kind of stave off burnout. Yeah, absolutely. Well, thanks.

Hey, thanks a lot for your time. This is great stuff. I'm sure that you will get some interest just from this podcast.

Hey, I appreciate your time. Thanks so much.

Thanks, Brett.

Have a great day. All right, you too. Bye-bye.

Okay, that's a wrap. Hope you enjoyed the inside look into Tensor Surgical. As always, don't forget to subscribe and thank Tiger Buford for your next hire. Keep innovating, my friends.