BoneChat #41 - Tesa Medical startup reinventing ACL surgery precision with Sean Cogan.

Welcome to Bone Chat discussion number 41. We've got Sean Cogan from Sydney and a brand new Bone Chat member. Sean's worked in sports medicine distributorships for, I think, 18 years, mostly repping Arthrex and Zimmer Biomet. His startup, Tessa Medical, is the first— I think it's the first ever to basically create a measurement for ACL tension that gives the surgeons real numbers, not just feel. So I'm handing the mic over to Sean, and he'll show us some— teach us about this.

Welcome aboard.

Thanks, Tiger, and I wouldn't say we're the first, but we think we're gonna do this really well. So, and I appreciate the photo you put up on, on, on LinkedIn with BoneChat. I had a lot more hair back then. So I apologize if there's a bit of glare and I'll try and not speak too quickly with my Aussie accent. So appreciate the opportunity just to share a little bit about Tessa and just from this group just to get a bit of get a bit of guidance around some of the things that are coming up that are quite meaningful for us. As Tiger said, I'm based in Sydney and I've spent about 18 years in the sports medicine space. So I've done a lot of ACL reconstructions and all that sort of thing. So really like this technology when I came across it. You're all, you're all well across the fact that currently in orthopedics, you know, there's a real digital revolution. There's a move to all smart technology and there's a major major focus around precision and this emerging growing population, particularly in sports. The younger generation live their life via Google, so they demand data and they demand a different level of connectivity. So when you look at the sports market as well, there's a real trend across the companies searching for solutions that can align with what the surgeons want to do, which is to, you know, improve the return to prior activity as well as lower their failure rates, which in the literature are fairly low but have good room for improvement. A lot of them are looking to technologies to protect or augment their soft tissue repairs or reconstructions. At the heart of what the surgeon does when they're doing their ACL reconstruction is that they're relying on their sense of feel to actually re-tension the new ligament or the repair. And what we know as people is that everyone, everyone, every individual's sense of feel is different. And ultimately, for surgeons and therefore patients, the actual tension that can be applied is variable patient to patient, surgeon to surgeon. This inconsistency and inability to actually be precise and measure also makes it very hard for surgeons to really dial in to the true importance of tensioning and the true ability to, um, um, you know, standardize and progress how they actually treat, uh, treat the, uh, these procedures.

Sean, what's the downside of too much tension and the downside of not enough tension?

Yeah, so downside of too much tension is really over-constraining the joint. It's also believed to play a role in the creation of, you know, in the onset of arthritis and issues with the condyle and meniscal side of things. Obviously not enough tension, the knee's not stable, so aside from potential damage that can be caused from the unstable knee such as other injuries, There's also just a confidence factor in the patient that if their knee just doesn't feel normal, doesn't feel reliable, that they're not going to get on with their life or get back to their sport. So there definitely is a sweet spot for getting it right. In terms of the literature, you know, probably the biggest thing that stands out is that only around 60% of people will actually get to their prior level, back to their prior level of activity. Depending on the cohort of patient, whether they're an elite athlete or a child or, you know, collegiate athlete, this can really vary. And this obviously has broader implications downstream if you're not getting back into sport or able to pursue the career that you were pursuing. As I mentioned as well, the re-rupture rates, while they're not as high as this, they're also fairly consistent and you know, when you look at the volume of patients receiving ACL reconstructions, it's still quite high. You know, it'd be estimated that around about 40,000 people in the US every year would have an ACL re-rupture and therefore secondary surgery. So it's quite a high number. As I mentioned at the start of this, you know, we're not covering new ground here, but What I think we've— what I think the team have done really well is put together something that's a lot more user-friendly, a lot more accurate than prior generations of devices. And we have seen over the years this continual re-emergence of tensioning being something that is wanted by surgeons. However, as industry, I don't think we've really found a way to enable the surgeons, to do this, to do this well and to do it reproducibly. What we've done at Tessa, um, that I think is, is really quite unique is we, we've managed to marry, um, our implant system with the tensioner, um, and ultimately enable the surgeons to seamlessly work it into their current workflow, um, provide a measured tension so that they actually know how much they're, they're tensioning the, the new tissue or the augmentation by But we've also got this neat functionality where it enables a surgeon to free their hands. It holds the reduction of, of the joint so that they can dynamically assess the stability. We also know that collagen in the, in the tissue relaxes. You get stretching and creeping, which is very hard to feel by, by hand, which ultimately impacts that time zero positioning. And the way that this works, you can actually see that relaxation happening, and, and you can make a live, informed decision about where the joint is at before you actually finish your final fixation. Um, what we know as well from the literature is that if you actually precisely measure your tension, you can lower your retear rate and improve outcomes, as well as potentially reduce the onset of arthritis down the track. From a, from a commercial standpoint, we're looking at providing a solution, a solution in a box for the procedure where the surgeon gets their fixation devices, the procedure-specific instrumentation, our, our novel tensioning solution, and then access to our proprietary software solution. Down the track, we'll have a digitally enabled tool that'll actually talk to the screen and provide much more data during the, the procedure. But at the outset, we're going to give the surgeons an ability to capture their data and engage with their patients in a different way. The tool has functionality throughout the body, but at a starting point, we're going to focus around the knee. And there are so many other procedures that can be more demanding for surgeons when it comes to tensioning, such as medial patellofemoral ligament reconstructions and the like, that if you get the tensioning wrong, you can have some really challenging post-operative outcomes. With small modifications to the tool itself, we can provide surgeons with a new approach to these procedures and create a much broader application for the tool. We know that there are applications outside of the knee as well, such as elbow, AC joint, shoulder, etc. So we're really working to build a platform but starting our approach around the knee. We've worked pretty hard to put together a scientific advisory board that comprises quite a number of, you know, high-volume active sports surgeons who've got a range of experience. We've also got some great clinical advisors who are researchers or industry experts that really give us— providing us great insights and really challenging the team on how to make sure that this is really user-friendly and valuable for surgeons. In terms of our launch plan, you know, we're going to take a regional focus and we're going to build it out from there. We'll try and leverage the 1099 network that's broad within the US environment. And, you know, this is one of the areas where I'd love to connect with some of you to get some advice and maybe some connections. And obviously, you know, this is a top 2 procedure and major focus in that ASC market. Around about 75% of these procedures are done in the ASC. So any help and advice in that space is also really welcome from my standpoint. I'm very familiar with the Australian, New Zealand, and even Southeast Asian landscape, but haven't actually worked directly in the US. So definitely need to call on friends and connections to to help navigate and avoid making too many mistakes at launch. You know, and in terms of milestones, like, we've made some really good progress. You know, we've done 3 design cycles now. We're currently completing our FDA submission work for some of the implants that we've got, and we're at design stable phase. For our, at least one of our tensioning platforms. So we're moving well and not in the not too distant future, should actually say Q4, we're gonna be moving into a price round, which will, which is designed to finish out the design components and get into commercialization. So team's been, team's been moving well. We're still currently finishing off convertible note at the moment as well, which has pretty favorable terms. We're still working under a $5 million value cap and there's about $300K remaining there. So if we've got any investors on the call or connections to people who like playing in that angel space, I'd really welcome a conversation and happy to share more about the business. But ultimately, this is it. This is our, this is our last round of design cycle. This is in the lab in in at UCSF, and you can see the tool in action, just, just going through the range. And you'll, next moment here, we'll, one of our design surgeons, Jeff Abraham, out of Stanford, will adjust the tension again and then just recycle, but recycle the joint. But as you can see, it's holding the reduction. It's, it's stable. It's held in place. And, you know, obviously frees up at least one set of hands, if not the assistant's hands, just to really understand what's going on. So that's it, Tiger. I've run out of slides and hopefully that's, hopefully that's informative and, and everything for the listeners. And yeah, I appreciate the opportunity.

Well, yeah, thanks for sharing a new technology before it reaches the US. This is great. I got one quick question to start off. What's the business model? Implants, instruments? Is the instrument reusable? Explain the dual nature.

Yeah, great question, Tiger. So we're working on a fully disposable system, trying to avoid the CapEx expenditure of instrumentation, et cetera. From that standpoint. We are— we do have some proprietary implants. We will OEM some implants. You know, the reality is we understand that there's price pressures, particularly once you go into the ASCs. So obviously, if we can have a solution that's more rounded, it gives us an ability to play the price game where we need to. We know that some of the implants that we're designing are going to be novel. And are going to be different and provide different functionality. So there's value there. We're trying to avoid spending money on things that we don't need to, such as adjustable loops and all of that sort of stuff that you can easily OEM and would probably get us in trouble if we tried to not be too clever. So that's really the model. And, you know, I think if you think about it from a strategic and an exit standpoint, The goal here is to show that the tensioner provides really good value and the packaging solution helps you then drive your implants much, much like robotics has in the arthroplasty world. We had experience with Mako down under before it had a joint attached to it and then Stryker bought it and Mako's really taken off since it's had a sales force and a, and a, and a revenue stream attached to it.

Yep.

Razors and razor blades. Ted's got the first question, then Joe.

Yeah.

Hi, Sean.

Great presentation. It really takes me back. My very first product manager role was almost 40 years ago for an arthroscopic isometric drill guide for ACL reconstruction that was developed by the orthopedic surgery team out of Aspen, Colorado. So it was, it was all the rage. It was new back then. Very similar kind of a, a manual measurement guide that, you know, would attach to back then. This was like late '80s. So it's where I cut my teeth, you know, in marketing. That was at J&J Orthopedics before it was even Depew. But I'm, I since moved into spine, you know, I spent 30 following years in spine, but sports medicine I'm kind of getting back to these days as a, advisor and board consultant. So, uh, understand the science and believe in it. So my question is really about IP, you know, what's the protection that you have, you know, around what you've developed here. And pleased to see that, you know, there's some objective measurement. And what I could see, it looks like you could get Bluetooth, so it'll be readable on, on a screen in the OR, which would be great. And then you've got data to work with.

Yeah, no, 100%. So we're actually in the process at the moment where final stages of submitting, it'll be, it'll work out to be around about 12 individual patents, a group that relate to the data and the IP piece, sorry, the IT piece, and then a group that will relate to the biomechanical components. So tensioner design, how it engages fixation devices, that sort of thing. So We, the company has a previous patent that's currently being reviewed that aligns with some of this. And we do have some exclusive license to some original IP out of LSU, which we're working through whether that still fits long term. But ultimately, we've got a suite that really in this last 12 months we've developed and believe we've got a pretty good chance at claiming some turf.

Yeah. And, and timing-wise, I think you had it on your slide, uh, when, when are you doing your alpha launch? What's your timeline for that?

Yeah, so we'll do, um, so we'll do some, um, we're aiming to be in doing first-in-human in this last quarter. Um, obviously where I live, Australia is an interesting place. The regulatory landscape's really hard, but across, across the pond in New Zealand, you actually don't need an FDA clearance or anything. So We'll do some first-in-human there. I, I had a trip there recently, met with a bunch of high-volume surgeons who are keen to give it a try, um, potentially join our SAB and, and be some of our early clinical guys. And the tensioner itself, the analog, is a, is a notification. So we're working with being able to get that in a box and get it in the hands of our SAB and just start developing some of that clinical insight and, um, and just working through some of that early iteration while we do the submissions for our implants.

Yeah, great. So by Q1, say AAOS, you know, March next year would be a good time to broaden it out a little bit.

Yep, 100%.

Good.

I'm planning to be there.

Fantastic. It would be great to meet. Maybe we can grab a beer.

Absolutely. I should have put my rugby post background up. I'm an old rugby player from England, so I like to I like to spar with my Aussie friends.

There we go. Well, rugby, rugby is my sport. So fortunately I kept my ears intact though.

So yeah, good for you.

How quickly we get down to beers and rugby. It's incredible. All right, Joe's up and then Eric.

Yeah, sure. Can you guys hear me all right?

Yes.

Yep.

All right.

I tend to have issues with my mic. But yeah, great presentation. I will say that I am, I'm definitely not very versed in the world of ACL repair, more on the joint replacement side of things. So this is more of just a generic question for my own understanding. I agree, I'm part of that younger generation that loves data-driven decision-making and all that. That's how I want to drive a lot of the decisions that are made around my company or our office. And I was curious, it's great to, to get the measurements. I know that it's super helpful for the surgeons to get measurements and get actual data on what the tension of the ACL they're replacing is. But I was curious, is there acceptance criteria that surgeons are looking for? Like, is it every ACL supposed to be around 90 Newtons or does it vary from like 140 Newtons? Like, what are they looking for? Does it vary patient to patient? 'Cause, you know, the data is not gonna be too useful, I guess, if they don't know where they're landing. So I'm just curious.

No, look, it's, it's a, it's a great question. It's a great question, Joe, and you, you're spot on that, you know, the, the clinical data is really quite all over the place. And I, and, you know, trying to look at it as objectively as I can, it's really hard to translate something from the lab, which gives you pretty good insight to the clinical setting. One, because there's lots of variable factors, but at a base level, there hasn't actually been something that can really allow you to hit the mark every time and be consistent and reproducible to therefore really dial into it. So I think that's something that we're going to learn. You know, it is a question I get asked often. But what we do know, and there's already some basic science and we're working on building this out as well, is that, you know, surgeon to surgeon, patient to patient, there's just an inconsistency when it comes to this component of the surgery. And, you know, we're going to be able to remove that because the number you get is the number you get. And at least then consistently you'll be able to make a decision. You know, these guys are making a decision today.

Yeah.

But they're making it without that data. So we're going to be able to create consistency. And I think out of the consistency, you know, that, that'll start to lead to standards and enable better studies to work out exactly what to do. I think at a base level, the functionality will all— of the tool will also drive utilization because it's, you know, the freeing of the hands. We, we've done a pretty good job of removing steps as well. So, you know, I, I think there's some utility in there outside of just the number as well.

Absolutely. And I mean, at the, at the bare, bare minimum, you're now building a data pool that, you know, after a year, 2 years, however many surgeries you collect, you'll start to be able to lean on that data of— and a surgeon will be able to lean on that data. As you know, I've seen most successes if I'm, if I'm tensioning a patient of this body type to this level of Newtons or whatever it might be, they'll start to get comfortable with that because now they have something to measure to as opposed to it feels like this today and then tomorrow might feel like that. So, yeah, definitely you're, you're building that, that foundation to start helping the surgeons make those decisions. And then, yeah, I know that if a surgeon can have 10 hands, they'd still need an 11th. So being able to loosen them up, free up some hands is a great thing.

Yeah. Yeah. No, I think it's it, it, there's a lot of utility in, in what this can do. Um, I think that, that, you know, the team that have put it together, you know, over the, as a collective, have just done a great job of really challenging that concept. So, which is great.

Great stuff. Hey, to build on, to build on Joe's question, um, about the proper tension, is there a difference between, uh, patella tendon hamstring allograft?

Yeah, 100%. So, you know, your hamstrings here, they're your most elastic. And when you look at the literature, you need a higher level of tension. Your patellas are very stiff and quads are similar to patellas, but they're still considered a soft tissue graft. So just in those 3 types of grafts, there's variability. And when you look at hamstrings as well, and hamstrings are still the dominant graft outside of the US. So, you know, it's the most, most used, but probably the most unreliable from that standpoint as well. So, and then obviously when you go into allograft, it's, it's, it's had the processing, it's, you know, dead tissue, etc. So it does have a different feel. The other factor is, you know, when you look at the patient population now, it's broadening, you know, with the, with the the pickleball population that's, that's growing, that's actually the fastest group of ACL or growing ACL patients because of the demands of the sport. So, um, you know, you're bringing age into it as well now, which is, um, which is also a factor.

Yeah, primarily it was girls soccer, or right, or football.

Yeah.

Yeah.

Yep. Interesting. Eric's got a hand raised.

Yeah, Shawn, very, very interesting. And just like Ted, you know, I started my career on ACLs and everything that I did in school was ACLs. So I was, I was the rogue spine guy. But, but, but anyways, Ted stole my first question, of course, about the IT, and then Joe stole my second question. So good, good questions, right? So, yeah, and Tiger took my third one too. But ones that remain is when you put the ACL graft in there and you apply the tension with the tensioner, does, does the ACL graft not lose most of its tension Yeah, as soon as, as soon as it starts, uh, starts healing. And, and, and if, if, if so, then, then the, um, you know, how much tension you put it on, on the beginning, how much does it matter after, after the healing starts?

Yeah, look, it's a good question, um, and one I can't really answer for you other than a bit of, a bit of the work that we've been doing around around the basic science with it is, you know, you need tension. Tension plays a role in healing. So if you don't, if you don't have the right amount of tension, that, that can, that can have a role in it. You know, time zero, you want it to be as stable as possible because if it is going to relax off, well, you know, you don't want to be a bit too loose and then, and then loosen off to the point where you've now got the unstable knee. So They're really good questions, Eric, and ones I can't really answer other than to say that, you know, we're probably going to give them an ability to sort of dial in on it a bit more and understand how important it can be and remove some variability in it. So, but yeah, it's a really good question.

So, you know, I mentioned, you know, 30 years ago when I worked on an ACL graft, we had built this tensioner. But the hardest thing that we were trying to do is build that knowledge and, you know, basic science behind it such that we could tell the surgeons, hey, here's what you need to do. And one of the hardest things that we came across was making sure that the tension that we measured was a tension that was on the graft on the inside. So not only postoperative but intraoperative, making sure that they coincided and we're able to validate that. So I would recommend that, you know, that's something that might be on your to-do list for sure.

Yeah.

Yeah. No, and that's some of the work that we've actually started. I'm fortunate where I live, there's someone that some of you guys might have come across, Bill Walsh. He's part of our scientific advisory board. He's originally out of Brown, US citizen, Moved to Australia, fell in love with Coogee Beach and surfing. So, but he's got an animal lab and we started doing a bunch of stuff and this is a big focus, just making sure that, you know, we are providing something that's accurate, that the tension that's being applied is the tension that's being applied. So it's a really good call out, Eric, because that's, that's, that is part of what we think we've got is something that allows real accuracy. And, and real precision just based on how the tool places, um, in, in, um, how we position the tool in place.

Right. Um, and then, then my, my last question is— I, I think you may have answered it— um, are you, are you planning an implant that would be able to be used exclusively with, with your tensioner?

Yeah, yeah. So we'll, we'll have some proprietary implants and they'll connect, they connect specifically with the tensioner. So it makes the using and the mating quite unique. And then we will have an ability to use something generic like an interference screw. So we are, from my world, fixation can't be a barrier. If you make fixation a barrier, you instantly lose a bunch of potential customers. So we've worked really hard to have something that's modular but that works with the various different fixation styles. Which, yeah, the team have done a good job of so far.

Great.

Well, good.

Glad to see you guys working on this, and I hope that it all works out.

Right.

Thanks, Eric.

Mark.

So, first of all, congratulations for getting up so early. So pretty early over there. I've actually, I've been horrified since the '80s at watching ACL repairs and the lack of precision. And one of the things that I enjoyed seeing about 15 years ago was the onset of the soft tissue repair with the kind of the ability to dial in some degree of tension intraoperatively and with the ability to completely reverse what you'd done so far if you didn't like what you had. I presume yours will be completely reversible. Uh, if they don't like what they have, they can do that. Will it be, uh, usable on both bone, tendon, bone, quad, and soft tissue, all the different types of abilities?

Yes.

Yeah, and we've— in the lab so far, we've really focused most of our attention around BTB and Quad from the standpoint of, you know, they're the highest volume graft types, but they're also the ones that, you know, we wanted to make— we basically want— I wanted to make sure we had a platform that if a surgeon used a different type of graft, they could still get precision regardless of what it was. So we've essentially modified it to enable that. And therefore that enables the option of what fixation type they use, etc. So, but yeah, it's depending on what our fixation variable is, we're working to make sure that they're all reversible as well so that you can, you can go in both directions., as best you can. So, and the tensioner allows you to tension or, or reduce tension depending on, on how you wanna use it as well.

So, interesting.

Yeah.

I don't know what the ratio is now exactly. I know that in Europe, the soft tissue hamstring, you know, quad is very, very popular. And here I think, the, quad with one, you know, one bone side has become very popular. And BTB never went away.

Yeah. Yeah. No, definitely, definitely. Like, outside of the US, you know, you've got greater than 50% use hamstrings or quads. Whereas obviously in the US, it's much more like 85% are using that BTB as the primary graft. But obviously the emergence of quad, I think, is taking a bit of a volume of that from what I'm picking up from the different surgeons I'm speaking to.

Also, um, you know, one suggestion might be to sort of increase your package price, or is a, uh, packaging and, uh, augmentation, which is very, very popular now. Yeah, might as well, might as well put it in your package.

Yeah, I like that.

Good, good suggestion. Go ahead, Dave. Dave's got a allograft.

Yeah. Hey everybody. Nice meeting you all and super presentation, Shawn. My niece just moved to the Gold Coast.

Oh, beautiful.

About 2 years ago and she loved it. So I hope— and she hasn't come back yet. So you're doing something right over there.

It's a beautiful part of the world, Mark. You should get down. It's where, where most of our pro surfers come from, actually. There's some pretty good surf breaks up there, but also beautiful people also.

So I'll pass that along. And they are beautiful people. I come from more of a spine background, most recently biotech, but in the past spine, and not great familiarity with, with knees apart from I had an ACL. Done several years ago. But so I don't really have that expertise, but I can appreciate sort of the elegance and the utility that's being described for the device. I was— I just took a quick look at your website and I— and at this point I'm guessing that, you know, the functionality website is probably— is down the list for sure, I'm assuming. But A few things that I noticed that just popped out at me, just a sort of cursory look, is that I know you guys received a patent in 2014, I think it was, right? And your last news update is 2021 on there. So, and again, this at this point in the game, this may be like no help, but if for me, if I'm going and I'm sort of evaluating a company out there, and you're early stage, I understand, but I'm sort of looking for those, you know, milestones and those, and what the company's been doing lately and if they're progressing. And so for me, that's something I kind of key in on a little bit. And again, to the extent that it is of use at this point in the game, you know, maybe if you have that, you know, other milestones or other content that you can put on there, that would provide a little more confidence in those who maybe show up and take a peek at you through the website, that's their initial interaction. That might be some benefit. Also, I was thinking the homepage is your third, I think it's your third page or that you have a video page, right? By the way, video is great. I love the video. The animated video is cool. Thank you. But if maybe you took some of those videos and you put maybe one of them on the main page or in any— I'm not sure what— if there are regulatory constraints that you have to deal with, with respect to what you load on there from content perspective. But to the extent that maybe you can front load that on your site because it's really compelling. And it tells the story really well for me. That might be something to consider down the line. So that was sort of my initial thought when I sort of took a very, very cursory look at the website.

No, and I really, I really appreciate that, David. And, you know, just to share, you know, as you say, like, you know, startup mode, sort of working out what goes where. I am actually very lucky. My brother-in-law is a graphic designer and a web designer. And I've actually got a website that's ready to go and I've, it's taken us a little bit longer to get our current lot of IP ready. Obviously we're a $5-10K path. So we're a little easier to jockey on the back of. So I've been trying to make sure that we can get that secured down. And the plan is to actually then bring that website up under the domain and we, you know, some of those things that you touched on. We've got an investor page that, you know, every quarter I do an investor update. So we're posting, you know, it'll have some of that sort of thing, you know, some of the animations will be on some of the pages, you know, depending on how we sort of talk through it. So I might share the link with you and, you know, I'd love to get your thoughts on it if you're open to having a bit of a look at it for me and Loved it. Yeah. So, but yeah, no, that's definitely the plan and probably maybe, maybe I've been a little bit too cautious around the IP piece. But that's probably been the main reason that I haven't actually uploaded it because he's the poor guy did it about 2 or 3 months ago and he's like, when are we, when are we, when are we putting it up? And I'm like, just hold on. Yeah.

Well, if you have to weigh those 2 things, protecting your IP and having a little more content on your website, I think you're making the right decision to err on the side of the IP for sure.

Thank you.

All right. Yeah. Nice meeting you.

You too.

You too.

Thanks. So Andy, you know this space really well and you're a clinical expert. What would you— Sean, are you going to do clinical studies in the US?

Postmarket?

We, we, we'll do, yeah, we'll do what we need to do, Tiger. Um, you know, it's in the budget to, to do some clinical work. Uh, we'll try and do some, we'll try and do some stuff in New Zealand, just given that we can go pre-FDA, we can do some stuff even if it's basic, basic sort of safety and efficacy sort of stuff, you know, works as well as. Um, but like the fact I had attention of that sort of a, a study We were talking the other day with our surgeon advisory group about maybe doing something that's a bit more robust, you know, something like around hamstrings, some, somewhere where you're probably going to see a bigger impact of what you do. So we're sort of exploring that. Australia does also have a pretty tax optimal landscape in that you can get, you can get about 41 cents back in every dollar spent on R&D. So, depending on how we do it, if we can run it through Australia, then we can, you know, we can recycle quite a bit of the money. So, so yeah, so we'll, we'll do a lot of our early biomechanical stuff down here for that reason as well.

Got it.

Yeah, certainly. I think that's, you know, like you said, Tiger, I mean, certainly clinical, go, go on the $510K path. You've got a little bit of an advantage in terms of you can get your $510K and, and kind of focus on your, your post-market and how clinical kind of feeds into your commercialization plan. And, you know, Tiger, you and I, that's something we kind of talked about. A lot of companies kind of, you know, that are able to go that 510 path, you know, how do you incorporate clinical into your commercial? Because I think the two can kind of go hand in hand very well. I've seen that in my career, and that's kind of what I've really focused on is, you know, and, you know, Aaron Smith, I spent actually my most recent company was Ardalon, one of the little logos you had on there. You were just acquired by Stryker. So, you know, certainly echo—

Congratulations.

Thank you. Yeah, certainly echo the idea of including an augmentation in your product. I do think they're very great products. But, you know, from the, you know, kind of early clinical perspective, you know, my suggestion would be kind of engage your surgeon. It sounds like you're doing it already. Early and often, you can certainly start with some case studies that can lend into white papers. Your KOLs helps get them on the podium at different conferences and get your name out there. And then, kind of go from case studies to case series to maybe just a retrospective kind of safety efficacy review. And, you know, something what would be interesting, this is definitely would probably be way longer term for your company is, you know, getting this, all these, this data. Somebody had mentioned earlier about kind of what's the right tension you need on the device? Like what's the, you know, appropriate amount of Newtons? Does it vary by patient, by patient, by allograft type, autograft type? Having some sort of registry database where you track that and you track specific outcomes of these patients. So long term, you know, surgeons have access to something like that. There's a lot of different ways you can do it.. And I think it's, it's pretty cool. And I think, yeah, the technology sounds, sounds really neat. And that, you know, like I'm pretty young myself. So yeah, getting that kind of digital new age kind of having, having that, you know, automatic feedback in the OR, not only for the surgeons, but maybe incorporating something for the patients afterwards. You know, certainly a lot of options, but yeah, it sounds like it's, you know, you guys are doing some pretty cool stuff and kind of doing the right thing. So yeah, looking forward to seeing it come over to the US and maybe seeing it at a AAOS or AOSSN next year?

Yeah, no, definitely. We've, we've had it, we've got a development partner called Core Medical Ventures. I'm not sure if any of you have come across them at all, but they've been sort of displaying the various iterations as we've been moving through the design cycles and all of that sort of thing. So we'll definitely be at AAOS and, you know, become, become a bit more visible ourselves as we go. So, yeah, I'd love to pick your brains, Andrew, because obviously seeing when Artelon got bought by Stryker, you know, it just shows that the big guys are active in sports and, you know, that augmentation's just fresh, right? It's what people are looking for.

Yeah, absolutely.

Well done.

Good, good comments. Dave, you're back.

Uh, yeah, I was almost going to lower my hand because Andrew, uh, talked about white papers and that's where I was going. But one other question I guess is, uh, what's the predicate device, um, for this product?

Yeah, so when it comes to, when it comes to the tensioner, it's a, it's a notification. So we, um, we don't actually have to have a predicate for that. For the implants we do, um, you know, we've identified a bunch of the implants that align with that, with that core. Our development partner have actually developed a bunch of sports products as well. So that's helpful around that side of things. But when it does come to the time for our digital attention, we sort of fall into a really broad category where we actually fit in with a lot of these robots and the likes. We will have to, we will do a pre-sub with the FDA. Just to make sure that we're, we're headed down the right path. But it's a really broad group. There's really not a lot of predicates with exactly what we do, but there are a couple of devices that we think probably align around that space that would probably make a better sense than lining up against the Mako robot or something like that.

Yeah.

Hey, before we run out of time, I want to, I want to answer Sean's, get Sean's questions out there. First question was, what's the best practices in developing a 1099 sales force in the US? And second question is, how do you best get into ASCs?

Anybody? Answer to number 1 is tread carefully. Don't get— don't give away whole states or massive territory. I think, you know, just there's a lot of, you know, I would rely on— there's a lot of experts and people like Mark, you know, that have been in the distribution world and others that You know, I would rely on some expert advisors, you know, with respect to who you engage with, but I would keep it very focused, would be my recommendation, as you should for any kind of new technology anyway. Walk before you run, you know, surround those early clinical advisors you have with the right distribution partners, and then as you're starting to have those conversations and you get exposure to experienced, you know, distribution people. I mean, there's some real talent available as these larger companies have been shedding, you know, commercial leadership from Mitac, from places like that that are very plugged in and very connected. So I know a few of them, so I can help you with some names, but I would recommend that you just pick carefully and just don't get ahead of yourself, uh, focus it in on what your goals are to kind of build momentum. Because as a one-product company, it, it's difficult, you know. Your goal, I would assume, is to get enough traction and momentum going where the strategics start to take interest, and you can have that conversation like, uh, like Andrew and the team at Ardalan did with the big boys and let them plug it into their commercial engine. But very carefully select your partners as you go, focusing on quality, not quantity. Yeah.

No, that's right. That reminds, yeah, that reminds me of what Blake Helm taught us a few weeks ago, sort of the top-down approach where you already have US KOLs and they're probably gonna be the first users. So you say, okay, what's your, who's your favorite rep? You know, and hopefully you can sign that rep up and not conflicted. And that's, that's a good starting point. But don't give away a whole state. That's a great idea. Give, give away a zip code.

Yeah. Yeah.

So you've got, speaking of someone who started a few of these 1099 sales forces, you almost never leave the dance with the one you brought. There's a lot of— there's going to be some turnover, and the idea of the top-down approach starting with your advisory board KOLs is not a bad idea. And if you can get a foothold these days, what's almost more important than sales is product approval. If you get a KOL in a big city and he can get you into a big system, do everything you have to do to get that done, because then the 1099 guys will beat your door down to get your product. Because the first question any dealer asks these days is, where are you approved? And you're not going to be approved anywhere. Yeah. So because we here, here at my house, I run a compliance company for medical practices and hospitals, but I also run a boutique orthopedic dealership. And I'm one of those guys that never wants to stay married to the same company more than a couple years.

Yeah.

So I like startups. So I'm not that guy who's had Zimmer for 15 years or Arthrex or anybody. I mean, after 3 years, I'm so bored, I want to get rid of them anyway. So, so I like the little guys that come in, you know, from different places. So it's not the most profitable way. But that's okay, you know, I don't care about that so much. I— we all die with the same amount of money anyway.

Yeah, some great quotes there, Mark.

And on, on the ASC question, you know, I would say again, talk to your KOL groups. Some of them, I would assume, are partners or maybe investors in ASCs. You know, look at those networks.. And you know, there's people that specialize in, in, in groups of ASCs and, and you can get introductions to them. Like I know a group down in Miami that just own this network up and down Florida, and it'd be good to talk to them and show them the benefits of your product and see how it fits. And it, it all comes down to the business model too. You know, how much is you gonna charge for this? You know, how much money do they make? How much are they able to get on it?, so you have to have your business, your, your numbers, you have to make sense. And, you know, again, walk before you run before you start getting into big, you know, ASC companies that have nationwide networks because, you know, as a startup, you're just getting way ahead of your skis on that.

Well, no kidding.

SCA with Optum, you know, stay away from those guys. Just go selectively around these more, you know, independently surgeon group-owned, you know, facilities and, and, and test the waters and, and go, go to Scott Becker's ASC, you know, meeting that he holds or connect them with Scott Becker and that group. They do a great job really connecting innovative companies with ASCs.

That's great advice.

Yeah.

Hey, I've got a question, Sean. Is, do you think these tensioners gonna be the lead, uh, pitch and it's gonna sell the implants or the implants are gonna be the lead pitch that, you know, the new implant that's not developed yet and then that's, oh, by the way, we've got this great tensioner.

I, I think that's a really good question, Tiger. I think it'll be horses for courses. Um, I, I think the tensioner will be the intriguing bit. You know, I think once you, once you play with it, um, and you, you actually see the functionality of it, I think there'll be guys who'll be intrigued to try it. Um, I think our, um, you know, our fixation device that can enable you to, um, to tension two, um, devices differentially will be very interesting because it'll align with, you know, what Artelon have done. What Arthrex are popularizing with internal brace and those sort of things. So, and look, I think, I think once we go digital, that'll be really interesting. But my, my, um, uh, the bit that drives my head around the digital side is that once you go digital, you've got to deal with IT departments, even if you're not dealing through their networks. But, you know, having sold camera stacks and, and all of that sort of stuff, that's always a bit of a a gnarly space to play in. So, you know, we've got to go through the change, but I think it'll be— it'll depend on the surgeon. But I think the tension is the bit that's going to have the most appeal. Um, and, you know, we all know orthopedic surgeons like toys. Um, and, you know, this is— this will be— this will be the new toy for them to try. And hopefully we've done a good enough job that they want to keep using it.

It was a French company, um, that had a manual tensioning technique that was acquired by, I think, Olympus. And, uh, there is going to be a string of those users, you know, in Europe and also the United States, that appreciated the ability to tension precisely, even if it was manually. That would be a good, maybe receptive, uh, physician audience to the tensioner idea. The name of that company was FH Orthopedics.

Oh, I know FH well.

Oh, you do?

Yeah. So I, when, when I started in orthopedics, we used to sell the, the company I worked for sold FH, FH's prosthesis. And I'm wondering whether you, you're talking a little bit to the TLS, which is their, their ACL system.

Yeah, the TLS, the one that Arthrex copied. Yeah.

Yeah.

They paid off a, they paid off a doctor in Chicago to take it down to Naples where they just copied it. He was doing it.

Oh, wow.

He was taking away a lot of business.

Yeah.

Right.

Okay.

I wonder if there's any, any data from that product you're talking about, Mark, that they, you know, were able to acquire that might inform you know, starting to calibrate your system, John?

You know, there might be. They did a lot with, was it the Instrum? That the tension, that the, is it the Instrum device that measures tension? I think they did a lot. They did a lot on pullout strength. They did a lot on, they did a lot on pretensioning so that there was no further laxity after fixation supposedly. So I don't know, I'm not, I was an English major. I'm not an engineer, but I just, I just, I just sell the stuff.

Well, it's a, it's a good, it's a good tip in, Mark. Anyway, so the guy who employed me actually still carries the FH Orthopedics range.

So really, there you go.

Yeah. So I might be able to connect with David and and see what, see what he knows. He's, he's managed to get a good little group of users in, in Queensland. Um, that's our Florida. Um, so, um, yeah, I'll connect with him, but that's, that's a really, really interesting, uh, thought as well.

How many cases have you done with the tensioner, Sean?

We haven't done any cases yet, Tiger. So we've done In my time, we've done 6 Cadaver Labs, um, and we've had— we have had progressive iteration each time. Um, the, the, the bulk of the tension is, is pretty much done. That we've— the one change we've made most recently is we've just made the cleating simpler. Um, that's, that's the bit in my head that's going to be the bit that'll blow us up. Um, if that bit's too fiddly, or takes too long, the surgeons won't adopt it. Whereas if that bit's quick, that's where I see that we'll get adoption.

Yeah.

Yeah. Man, I would really encourage you to get some first-in-man cases in New Zealand or wherever you can. I mean, it's, you're not gonna hurt any patients and you're gonna get great feedback.

Yeah. Great. Yeah.

Great.

Cool.

I gotta, I gotta close and say that if you ever go to Oktoberfest, And you go to the Low and Brow tent, the most fun table in the whole tent is the Australian guys. They are crazy and they drink some beer.

So Mark, we, I, I did Oktoberfest in 2007, the Rugby World Cup, going back to a conversation on rugby earlier. And we had our first day, which was a pretty big day. And for some reason, we thought that we had to be there by 7 AM to, to get a table, not knowing that the tent didn't open till 10. And I think I'd had about 2 hours sleep. So I'm probably telling too much here. We were looked after by some very good Germans that day and we actually found the waitress who looked after us. The, the beer lady was an Australian girl and we just had a rule. It's €10 a pint, a stein. And it was a pretty rugged day, but it was a lot of fun.

Yeah.

Yeah. I've been, I've been, I've been to Oktoberfest in Munich. It is, I've never seen so much beer drinking intense in my life. And there's people just passed out in the grass everywhere. It's crazy. Yeah. Why do we always, we always go back to beer and rugby here for some reason.

I'm feeling at home, Tiger.

Yeah, I know. I know. When, when will you be in the US?

So I'll probably be in the US end of October. That we've got another lab scheduled for then. We've got a little bit of testing we've got to do through this month of September. But that's, that's really the time that we'll be looking to get across. So probably the last, last week of October, I think I'll be, be in the US. So be great to connect if, um, if anyone's around. So I tend to, tend to spend a bit of time in New York and then back in San Francisco. That's where, that's where our two pods are based of, of, um, of surgeons at the moment.

Got it.

Any other questions that, uh, Sean, you could— anything at all?

Look, I, I really appreciate today. It's been really informative and, you know, really enjoyed the questions, but also, you know, just getting to put some faces to names and a bit of an idea. So I'll definitely use the Slack functionality, reach out to some of you guys just to say thanks, but also just ask some more questions. But yeah, really appreciate the opportunity, Tiger. It's been really enjoyable and really informative from my side of things. So thank you.

Good. Well, I'm glad you were here. Good. Keep innovating. Uh, keep up the good fight. All right, we'll do— we'll wrap right there. Thanks, guys. We'll go have a beer. Thanks, everybody.

Thanks, y'all.

Thanks.

Thanks.

Have a good night.

Yeah, cheers.

Bye.

Cheers.