BoneChat #121: The "Non-Destructive" Bunion Correction – No Bone Cuts, No Fusion

Alright. Okay, this is Bone Chat discussion number 121. Today we have the founder of HyperFlex Medical, Dr. Geldwert, from in Manhattan, and CEO Bob Peterhans, who's really a serial entrepreneur in the ortho space. This will be really interesting. Most bunion systems have turned the procedure into a total knee, like with cutting jigs. And HyperFlex has created a novel and simple solution with no bone cuts and no fusion. It's fascinating. So I'm handing the mic over to Bob and Dr. Geldworth and take it away.

Super, thanks Tiger.

And Joe, I'll just share my screen and then why don't you talk—

a little bit of history. Yeah, yeah. So I've been, I've been doing this for a long time. Probably 50 years of operating on bunions and thousands and thousands of bunions under my belt. And for the first 35 years in practice, all of the procedures that I was doing were either an osteotomy or a fusion, you know, a laparoscopic procedure. Because we were all doing it. And about 15 years ago, Arthrex had a device that they were using to correct instability of the ankle joint post-trauma called the Tightrope. And they repurposed that little device to correct bunions. And so I started using that device because it made sense that there was a different way to correct a bunion without being as traumatic or as destructive to the native anatomy of the foot. And it was a neat little device. It was a suture button device that connected the first metatarsal and second metatarsal and were able to gather those two bones together. And it was quite effective, frankly, in reducing the width, the big gap between the first and second metatarsal, and did so very consistently and reliably and very powerfully. In fact, to the point where we'd get the kind of correction that you could get with a fusion procedure or a Lapidus osteotomy.. And the patients, by and large, were extremely satisfied with the procedure and that they were able to get up and walk a lot sooner with a lot less post-operative burden and morbidity. And so I kept on doing that procedure and found that It worked quite nicely until it didn't. And when it didn't, it caused some fairly catastrophic problems. The major one was that it created fractures of the second metatarsal. The tightrope that connected the two buttons acted like a saw and cut through the second metatarsal. And when that happened, it created a tremendous amount of instability in the front part of the foot, a lot of pain for patients, and it required going back in. Besides taking out the device, we then had to— these are transverse plane fractures, very unstable, and so it required plating and screwing. And so all of the benefit that we gained from doing the soft tissue bunion correction sort of went out the window. And this occurred in too many cases, frankly. It occurred in about 15% of the cases, which is a big number. And so I stopped doing the procedure. However, it was at that point that I started developing HyperFlex because I was absolutely convinced based on the positive results that a soft tissue correction could work. It just was a bad device. And so we needed to come up with a device that didn't create the problem but was still powerful enough to enable the kind of correction we wanted to get. So that was over 10 years ago. And engineering a device that protected the second metatarsal took, took quite a lot of engineering and a lot of testing in order for us to finally get to the point where I was satisfied. All our mechanical testing proved it out, and then we stressed the device both in fatigue, in a fatigue manner, and biaxially, which is really a functional test where we move the two implants up and down and under stress. And the device, we took it out to 3 million cycles and just stopped the test because the device didn't fail. That is, the titanium plates didn't fail, the suture didn't fail, The screws didn't fail, nothing backed out, and we were quite pleased. And of course, for the FDA, you have to test it against a predicate. So we tested it against Tightrope. And so 3 mil— our 3 million cycles, um, they went out to 118,000 cycles and their, their device, uh, broke apart. So our, uh, engineering, you know, we sort of engineered away the complications. Got FDA approval. And so now we've got a device that, that, you know, allows us to correct bunions without doing those irreversible sort of destructive procedures. Right. If you cut a bone and move it over, whether you use a jig or you do it freehand, you are really destroying a normal first metatarsal. You're creating a deformity in order to fix a deformity. And when you do a Lapidus procedure, which is a fusion at the base of that first metatarsal, you are getting rid of a joint in order to fix a bunion. So HyperFlex does neither. And by doing neither, you avoid all of the complications that are associated with doing an osteotomy or fusion. Malunion, nonunion, avascular necrosis. So those are, that's, that's pretty powerful. We do it minimally invasive. It's done through a small incision in between the first metatarsal and the second metatarsal. And unlike Tightrope, we don't use the device to bring the two bones together. The two bones are brought together by using a bone reduction clamp. And then I just place the HyperFlex device on the first and second metatarsal and it holds it in place. And so our thought is for mild, moderate bunions, this is a great procedure because it doesn't do all the things, you know, that I spoke about earlier. The other thing is that it allowed me to have my patients walk immediately, and they walked immediately in either a protective shoe for as little as 3 days or as much as 2 weeks. But every single patient that I've operated on with HyperFlex has been in a sneaker by 2 weeks. Postsurgical, which is also a big advantage. And then because we're not cutting bone or fusing bone, we've just stayed away from opioids. And in fact, I don't give my patients a prescription at all for pain medication. I give them a recommendation that they should take dual-action Advil, you know, take 2 dual-action Advil every 8 hours for the first 2 days. And the overwhelming majority of those patients, that's the only medication they've taken. They stop by 48 hours post-surgical. So a lot of really positive outcomes with a procedure that, yeah, with HyperFlex. The way things are though, when we first started presenting this to my patients, Patients who, even though we're looking for mild to moderate bunions to fix in the beginning, you know, patients come to you with what they have, right? And so if you take a look at what this pre and post HyperFlex image Bob brought up, I mean, that's a very severe bunion. That's a bunion that normally would require some reconstruction, at least a fusion at the base., and some major, you know, some major cuts in order to move that over. But this is a patient who's an architect who has put— had put off having any kind of surgery done because she didn't want to go through the lengthy postoperative convalescence. And so I agreed, and she really wanted me to do HyperFlex, and so I agreed to do it. And we got a fairly significant reduction of her bunion deformity. And she's out walking and active, and by 9 weeks post-op, she was at 80% back to doing all the activities that she had been doing prior to surgery. So in fact, 80% of the cases 80% of the earlier cases that I performed on were patients with severe bunions. So now we're looking at also not just operating on mild, moderate bunions, but also severe bunions. In those cases, we're gonna add a little screw at the backside of that first metatarsal just to take some of the stress off of the HyperFlex device. And it sort of will work synergistically with HyperFlex. That is, HyperFlex will take stress off of that proximal screw and the screw will take some stress off of HyperFlex. So that's where we're at.

Yeah, we've done 10 cases total. The last case we did was really interesting. It was a, a revision of a previous osteotomy that the doctor and the patient wanted to try, and it came out successful. And it, you know, as Joe said, our initial view of this was mild to moderate, which is one, you know, size of market. Adding increases the market, adding in the ability to do revisions on previous osteotomies increases the market even more. So we see this as you know, kind of an expanding opportunity to expand the market from what the current products offer as well.

Yeah, so philosophically, it's, we are preserving the patient's natural anatomy. We're preserving their joint. We're preserving the first metatarsal. We're allowing patients, if you saw some of the videos of our patients post-surgically, early on, 4 weeks post-surgical, They've got very dynamic gaits, very propulsive gaits because their functionality has been improved around that big toe joint. And so that's, that's been very exciting to see.

So I have one technical question. Is the little tether distance the same for every device or can it be changed?

So that would— there was an evolution there. It's only one, it's only one distance, Tiger. And we got to that point because after doing 60 cadaver sessions, this was the length that predictably and reliably brought the intermetatarsal angle down to a normal value. And so for us, it was, you know, one choice for the surgeon. And if they use HyperFlex and implant it, it's going to bring the intermetatarsal angle down to about 5 degrees every single time. So, um, there was no need to really do multiple, multiple lengths.

Yeah, I see there's a question, Kyle.

Yeah, so it looks like you guys got original clearance in late '24, maybe did some updates and got other clearance in '25. So, When I heard you say 9 patients, my initial thought was that you had had this in market for a couple of years, but really you guys are just getting it out there and just—

yeah, yeah, we launched in September. And, uh, as Tiger said, uh, to the beginning, to Joe and I, you know, ask this group questions and maybe they can, they can help you with all the collective wisdom. The challenge we've seen with this is while we, we get a lot of people agreeing that this is a very interesting and and, you know, has a great potential. Surgeons themselves are reluctant to try it until they see more surgeons try it and longer, you know, longer time from the surgeries to see how the follow-up is, which is kind of a, you know, it's kind of a catch-22, you know, how do you start that? So we are seeing a few additional surgeons start to catch on and start to do these procedures and not just Dr. Geltwerk, but that is one of the challenges we see is How do we get others to be willing to be early adopters? And then I see Alap Shah has a question.

Yeah, thank you.

I have a quick question. I'm sorry. Go ahead. Oh, no, no, go ahead. I mean, if you're still asking, I'll wait.

Go ahead.

Go ahead, Kyle.

Thank you.

So a couple of things you have working in your favor is not everybody likes doing the two oblique, extremely oblique screws, including one right up by the joint for a distal transverse osteotomy, plus it's still a pucker factor to have 100% displacement. So I think you guys are onto a market opportunity there. Not everybody is in love with that, and it's not technically easy. We're past the golden age of everyone gets a Lapidus all the time. That's still a valid procedure, but there was a period of time where that was the only treatment that was marketable. So there's a space here, I think, for you guys to operate. The one thing I imagine you're working against to some degree, and maybe you have an answer for us, this is probably a bit more invasive than most, you know, MIS procedures, but it's trying to do something different. And what you're trying to do is become less bone invasive, which I think there's a story there. Um, how has that— how has that series of conversations gone for you? And are you finding like your corner of the market here?

Yeah, I think—

go ahead, Bob, I'm sorry.

Um, so we, we are having that exact conversation. It's like, oh, I like MIS because it's a small incision, a keyhole, you know, I can, I can do that with small soft tissue disruption, and then we bring out the point you just made, which is, but this is minimal, actually no bone trauma, right? So the overall trauma to the foot is much more extensive when you're trying to, you know, burr and move a capital fragment so much and then try to get the back and all the recovery that this takes. This really is minimal trauma to the person. Forget about minimally invasive as far as how much exposure you get to see what you're doing. This allows, we think, the minimal trauma to the patient, and the patients love it. I mean, they're back on their feet immediately. They feel no pain. And, you know, the patient that we just did with the recurrent osteotomy, her sister's looking to do it now because she, you know, she was convinced by what she saw in her sister, and she's going to be the next, you know, probably the next patient. So thanks, Kyle. That is the conversation we are having. That's the way we're trying to message it. And Joe, whatever you want to add.

So there's some generational issues, Kyle. The docs who were around in the heyday of mini tightrope only focus in on the 15% failure rate. Um, and that looms very big, uh, in their sights. And so that, that is a very strong barrier that, uh, we've had to try to overcome. And even though 85% of the cases have worked and have worked long-term and have been very effective procedures, were having a difficult time, uh, wiping that 15%, uh, sort of hammer off of, uh, uh, off of them, um, off of their face. So, and they see it as a hammer. They see it, really see it as, uh, as something that is unacceptable. And so in spite of, uh, showing him the, uh, showing him our mechanical testing, um, and it's a completely different device at all. I mean, it's a load-sharing device. It really does not function like the tightrope whatsoever. We've had a— that's been one barrier to overcome. Then there is a— there's actually a difference in how the two professions look at it, meaning the podiatric profession and the orthopedic profession. The orthopedic profession, if you have to make an inch or inch and a quarter incision, that's no big deal. I mean, it's no big deal. What do you tell— if I describe the dissection, the incision to them, it's a non sequitur. It's an easy dissection. It's very, very basic. And those individuals who just can't see doing minimally invasive bunion surgery and cannot see the logic behind, you know, cutting the bone and transposing it 100% and throwing 2 bolts in, see this as a really viable procedure. Podiatrists, on the other hand, especially those that are not doing a lot of surgery or have embraced minimally invasive procedures look at the incision as being a little more ominous than it really is. So we've had to sort of coax that group along a little bit, a little bit more.

And I want to get back to Alep. I think you had a question, Alep Shah.

Yeah, great. Thank you. Appreciate it. So I have two questions. First is, I think the biggest problem with the tightrope issue as far as recurrence was— and I think you did state that at the beginning— that the key point is making sure you've got the right patient. And that's going to be the mild to moderates. But it's also going to be patient morphology, activity level. Big failure in recurrence in tightrope was patient weight, patient activity. And then the other thing I wanted to mention was addressing the, the actual bunion deformity with the rotational aspect of the metatarsal. And that is something I'm not sure how much corrective correction you're going to get unless it's a hypermobile Ray. But for the most part, you may not address a lot of that, which is also a big reason why there's going to be failure or recurrence of the, of the deformity, because it— now you're just really addressing soft tissue, not any osseous pathology.

Um, all right, so that's it. There's a I mean, there's a philosophic difference. I think most, most of the deformity really is, is a soft tissue failure and a ligamentous failure in and around the first MP joint. And I think the first metatarsal is just sort of falling away. And I know there's those who are in the Lapidus camp, very fixed on hypermobility as being the underlying cause. But if you take a look at the guys who are doing minimally invasive and really just pushing the head all the way over laterally, they're not getting much of a recurrence. The recurrences in minimally invasive surgery, frankly, is when you don't push it as far, right? Because you're a little bit concerned. But if you're moving at 100%, most of those cases are not are not recurring. So if individuals were hypermobile, I think you'd get a recurrence there. So what HyperFlex is doing is sort of rebalancing, handling the tie bar system around the— between the first and second, sort of acting like an intermetatarsal ligament. And it does help create stability between the first and second. Also, HyperFlex, which tightrope didn't do allows for normal sagittal plane motion, up and down sagittal plane motion. So every single patient that I operated on has greater than 75 degrees of first MP joint range of motion. In order to do that with the Lapidus, you had to really drop the first metatarsal. And if you do that with a minimally invasive procedure, you have to shorten the first metatarsal. In order to get adequate first MP joint range of motion. The valid, the real valid concern is in terms of are we getting frontal plane correction with HyperFlex? Well, it's a device really designed to get transverse plane correction primarily, but we do have the ability to get some frontal plane correction. And we've, we have a cap that we place over the first head of the first metatarsal and we run a K-wire through that cap and then we joystick the first metatarsal in order to get some frontal plane correction. Now you can only go so far without really freeing up the first metacuneiform joint. But we can get reduction, especially in cases of the mild to moderate hallux valgus deformity. In the severe ones, you know, frontal plane reduction is not going to be wonderful. We'll do a more extensive lateral release, you know, we'll do a fibular apparatus release in order to really mobilize the sesamoid complex, and we will get mobilization of the sesamoids in doing that. And we can reduce our sesamoids down to maybe position 2 or 3, but in those really severe bunions, we're not gonna be able to get it down to a 1 without really freeing up first metatarsal joint.

Tiger, did you have anything else you wanna add? I know there's another question from Todd.

Todd's been waiting patiently, so. Hand him the mic.

Okay, Todd.

Hey, great concept. I like— I encourage you guys. I was early on in navigation where we were for computer navigation, where we were out front of everyone, and we just hit so many roadblocks that we ended up pivoting away for joint navigation. And now you see it's like the precursor to everything that's out there. So, uh, yeah, I like what you're— I like what you guys are doing, and, uh, I think it's, it's super interesting. And not only am I trying to hold off my wife from getting a bunion procedure, this is, this is finally one I can see her getting because I, I know too much about it. A couple questions. I, I could, I have a lot of questions, but I'll limit it because of other people. You mentioned IMA angle. You're trying to get it back down to a 5, correct? Okay, so some studies show it's normal, it's like just less than 9, right? So if you are you— you're just trying to get it below 10 because you're not really correcting any HVA.

So we're not. So, you know, it corrects, you know, hyperflex corrects, you know, metatarsus primus varus and not really hallux valgus. So most of the cases we're doing achinosteotomies also because, you know, we can reduce the first and second, get it down to a really nice IM angle. And then sometimes the hallux, especially if it's track bound, is still leaning toward the big toe, so that we'll do an Aiken osteotomy. The Aiken doesn't cause us any difficulty in terms of weight-bearing, and it's a low-impact procedure and is really helpful correcting the HV Aiken problem.

Okay, yeah, yeah, I was gonna ask about that, 'cause obviously this patient you have on the screen I didn't get that correct because you're gonna just, you're gonna use one screw on the Akin.

Right.

Okay.

Yeah. So a lot of the Akins, I've got one of my younger associates, does minimally invasive surgery and she's been scrubbing all these cases with me. And so she floats a lot of her Akins and doesn't fixate them.

So, gotcha.

So this person actually did have an Akin, but it was a non-fixated Akin.

Okay, question. 2 incisions, 2 windows, one over each met, first and second, or are you doing it through an incision in between and moving implants over?

Single incision.

Okay. Okay, yeah, I have trouble seeing that on that image. And then reimbursement, have you guys had any troubles with this? Kind of going after similar to codes used for the typical 2-screw distal MIS approach? Is that where you're pricing it?

And yeah, pricing is 2 different questions, 2 different answers, I guess.

One, we're pricing it underneath kind of the lapoplasty. We're pricing it similar to the MIS advanced systems. So that's kind of the range that we're pricing it. And Joe can talk about the, you know, what he looks at for reimbursement and CPT codes.

So if we're doing it with an Akin, we go 28298, and my recommendation is to append a modifier 22, which means it's just a more extensive procedure. And I've written rationale that physicians can use to send to to send to the insurance companies for the modifier -22. If we're doing HyperFlex as a standalone procedure, it's 28292 with a modifier -22. Same thing with the rationale for the modifier -22. So as a standalone procedure, it gets priced a little bit below an osteotomy procedure. With an Akin, it's, you know, it's about the same. It's a wash.

Great. Love the concept.

Appreciate your feedback.

Thank you.

Thank you, Tiger. I can try to share like an animation of the surgery if that would help everybody. I'm not sure how well it will come across on Zoom. Let me just try it. If it doesn't, I'll just stop sharing.

It usually works. We'll give it a shot.

The other point I did want to make, and maybe I didn't, I and, you know, I don't recall whether I did or not, is that it really, the procedure keeps every future option open. So if, for example, if the HyperFlex just blows up, you can go ahead and do a minimally invasive bunion procedure or you can do a Lapidus procedure. So it doesn't destroy any of the first metatarsal. It doesn't destroy the first metacuneiform joint. And so it will allow a surgeon to go in and, you know, do a downstream procedure. I think that, you know, the way I see HyperFlex in terms of the treatment algorithm is orthotics, PT, you know, modified shoe wear. And if that doesn't make you comfortable, then HyperFlex is really the procedure that, you know, you should be performing on your patients. A, because it's effective in terms of reducing the bunion and correcting the bunion. And B, it will still allow you to do something down the line if in fact it doesn't work. And so it's preserve first and cut bone second. Got it.

Okay, we see the animation. Uh, let's see.

Yeah, it's just maybe the bandwidth, um, isn't, isn't enough here to do both the Zoom and the Animate, because I'm doing it over our website. So it may just, um, may just be too much for it right now. But, um, I mean, um, corporate commercial, if you do want to see more, you can go to our website, uh, which is www.hyperflexmedical.com. And, you know, on there it has our animation. It has some of our patient pre- and post-surgeries, has patients walking, you know, a lot, lot of information. Okay, it looks like we have a couple other questions. Chance, do you wanna go first and then Mark second?

You bet. So gentlemen, congratulations.

Thank you.

It obviously takes a tremendous amount of work to get where you are today. And I think if I heard correctly and saw correctly, you have FDA clearance, a lot of discussion on the clinical side, which is great. Didn't see the rest of the deck, but I'd be, be curious if it kind of answers kind of the 5 specific things to actually get into market these days, right? First and foremost, what is the clinical problem that you're solving? Secondly, how does it create a better patient outcome and how do you document that from the podium and from the reputable journals? Thirdly, how does it create a better surgeon user experience? And does it fit into their current workflow of what they're doing? And then you address— I don't know how, in a sense, it's packaged. I'm assuming some of it is sterile packed and maybe some of the instruments or the instrument sets, because I haven't seen the rest of the deck. It seemed to be concentrated on one slide. But then you addressed reimbursement, right? So then it becomes down to what is your commercial plan to drive adoption? How do you create intimacy with, you know, the rest of the, you know, foot and ankle surgeons and address this in a way that allows them to understand what's in it for me, right? Why do I convert? And so is that kind of— is that in the rest of your deck?

Some of it's in the rest of that. I wouldn't say it's all— it's comprehensive that way. I would say that what we're trying to do right now is affect adoption by showing outcomes. So we— I don't know if the rest of you have used this kind of app, but there's something called Circles and Insights where you can do kind of your own clinical studies as a company. And it's not through any other academic center, but it's— It's a website that allows you to capture, you know, pre-surgery, surgery, and then your follow-up, all the data, all your X-rays, all your patient pictures. And we're doing that very methodically with all these. So all 10 of these patients that we've had so far are going through that, and there's including a patient-reported outcome using the Manchester Oxford Foot Questionnaire. So that we understand what their pain, their mobility, what their social aspects are to how they're feeling before the surgery and then after. So we're doing this as a clinical study early on so that we can use that body of data to then convince others of, you know, how this procedure should look. So I know that's only answering one. You asked a number of things that—

Well, they're all kind of intertwined, of course.

Yeah.

Joe, do you wanna add anything else? You always have. Something good to say?

No, I mean, I think we need outcomes, but we need surgeons who sort of see the value of doing a soft tissue approach. And even though it seems obvious, if you take a look at what an osteotomy does to the first metatarsal, and you take a look at, you know, a minimally invasive distal metatarsal osteotomy and you look at it objectively, I think any surgeon would tell you that you're really destroying that first metatarsal. So why not use a surgical approach that doesn't do that to the native anatomy? Well, I see it, but not everyone sees it. They're, you know, an individual. I mean, we're coming— I'm coming across docs who I know who do minimally invasive surgery, and they're looking at me and they're going, well, how do we know this is going to work? What, you know, what are the bad things that can happen? I could say, well, let's say the whole thing just falls apart. It's never as bad as a complication with the first metatarsal osteotomy. Never, you know. So when, you know, when you are cutting that bone, it is irreversible. And when that goes bad, it is a big-time problem. And I don't mean bad, just recurrence. I mean, you know, nonunion, malunion, malposition, you know, avascular necrosis. Those are big problems. So, and So those are big problems. Number 2, there are very few doctors in the country who are adept at doing good minimally invasive bunion surgery. I don't know, a dozen, two dozen maybe, but it's a very few number. And it took them, you know, maybe 50 cases before they got good. That's a big ramp up. In terms of, sorry, in terms of learning curve, in terms of learning curve. So with a lot of problems associated with it, with a lot of problems associated with it. And so if you've got a doc who's doing 20 bunions a year, every single time he's doing a minimally invasive bunion surgery, it's as if it's the first time, He's doing it, and there are problems associated with it. And it's the guys who are doing it well can do the procedure in half an hour or 40 minutes. But the guys who are in there doing, you know, one a month or one every other month, it's taken them an hour and a half to do the case. And there is a litany of problems associated with it. So, um, I think we fit into a very sweet spot. And I think over time as we get some adoption, we need some brave, you know, some brave KOLs to come along with me. And I think once we do that, I think we'll be on a roll.

Thanks, Joe. Hey, Mark, did you have a question still?

Yeah.

So I've been watching you guys do bunions since Dr. McLamore was on the old Atlanta Eye Hospital in Atlanta. Sure. For a lot of years. And, um, it's been a really interesting experience watching the evolution. Um, I remember going to France to the Minimally Invasive Society there, which pioneered a lot of the techniques you're talking about, which they basically stole from the American podiatrists, by the way, historically speaking.

Yeah.

Uh, that goes way back. I've also through the years attended countless first-year residency lectures that always start with the same thing: stability, stability, stability, stupid. And the next one is bone is your friend. And when I look at a minimally invasive x-ray of a completely destroyed first met, I always thought, man, that's a real huge violation of rule number 2. So I think what you've got there would be an incredibly fun project. And I made a career out of basically making new markets, and it's the most fun thing you can do in the industry. And I always called it the Braveheart approach. Gotta go find brave young doctors or brave doctors that'll be your early adopters and KOLs. And they're not, they're not easy to find, but they're out there. But I think you've got something else too, which time has given you, and basically the information age has given us. And that's the ability to educate the population. If I were a patient, just a regular patient, reasonably educated, and I saw an X-ray of a first— of a minimally invasive for first MIT where the bones are hardly touching, and then I saw this and the message was, you know, don't burn your bridges or your bones. I would definitely give this a shot because like you said, The very worst thing that could happen is you gotta go back and do some more traditional procedure. That's a great, great position for a patient to be in. And the reason I say I've watched you guys do these for decades is that I saw what Treece did. And the reason Treece was successful is because of the high recurrence rate in the more traditional methods. There was so many failures. And they brought a procedure that was maybe not perfect, but certainly a little more— seemed a little more predictable. Anyway, it's really, really been fun to listen to you guys do this, and I've, I've already heard about your product from a couple of my people. So I'm looking forward to see what the market says.

Yeah, thank you.

Yeah, thanks for your input.

Stephen, uh, here, let's do one more question, then let's talk about surgeon adoption as a group.

Go ahead, Steve.

Congratulations. Um, just question, where are you commercially? Where have you tried to get in with distributors and kind of where in, where in the country?

So we've, we've, uh, tried to focus for to start, um, in the, uh, Northeast and, uh, right around, you know, kind of the New England, New York, New Jersey, kind of that corridor. Um, we, we've started with a distributor there who has presence all over. I'm not going to go into that too much detail. We're not completely thrilled, so we're looking at trying to improve that, helping or looking at augmenting. We really wanted to concentrate regionally first before we went too far. We're not trying to build a company where we're, you know, we're trying to be a big commercial organization across the whole US. We do think that if we can show success in a region and then multiply that in another region and a couple of few regions, our exit is likely to be to a strategic. We just think we need to show momentum, show surgeons who are doing multiple cases and having good outcomes and build that up enough that it takes the risk away. A bigger orthopedic company who has the distribution can then take that and use what they're strong at not innovation necessarily, but distribution. So we, we're trying to bring the innovation, take the risks away, and then be able to translate it to somebody who can then distribute it stronger.

Awesome.

Congratulations. So, you know, we're in a large academic institution. That was actually our first approval. We're at Mount Sinai in New York City Health, you know, throughout their whole health system. So that was a big, you know, that was a big get for us. And then we're starting to, you know, branch out. It looks like there's some— this— our orthopedic distributor has some decent contacts in New Jersey. So did a case in a surgery center with another physician there. And I think it's starting to, you know, starting to pick up in surgery centers. But our KOLs who are two foot and ankle orthopedic surgeons from HSS and a podiatrist from Upstate Binghamton who are well known. I mean, Squido LaPorta, who's on the podiatry side, and Holly Johnson and Marty O'Malley on the orthopedic side. We're still trying to get into their institutions. And, you know, we've gotten, you know, HSS has actually given us approval to do 10 cases there. And so we're working on getting that. I think if we get into HSS and we get, you know, Holly and Marty to start doing some cases, I think that'll be another springboard for us., and, you know, sort of move, you know, sort of move from, from there. But we do need, we need some, some KOLs who, who'll do— they don't have to do a lot of cases. We can give them to do 5 to 10 cases, uh, and get, you know, 4 or 5 guys doing 5 to 10 cases. It'll build up our, our patient, uh, our patient load, and we'll be able to get some data, and we'll be able to start writing some, some white papers at least and getting some short-term, you know, outcomes out there.

Got it. So let's, let me throw it out as a group. We got a lot of smart people here. So if you, you, you know, understand the product, I think you understand the patient selection. How would you go out and find early adopters in New England based on everything you, you've seen? There's a lot of different ways to do it.

Um, Stephen, I don't want to plug my own thing here, but I've essentially built— look, I was a foot and ankle distributor in South Florida, so it's why I asked, is because HSS South, I can help you guys with the distributor network down there. I've essentially built the last year of trying to figure out a platform to identify early adopter physicians, all based off of Rogers Diffusion Theory. And so this is a platform that essentially allows you guys to identify in natural language, find me early adopter physicians that are presenting on podium the most, or conference presentations, and you can find them right here and there. So I'm happy to kind of show it to you guys, but I've already got about 50 here identified for you.

Oh wow.

Yeah. Um, and Bob, I'll send you that report. But essentially, I think—

yeah, I'll look at that.

You know, the studies of essentially being able to identify who early adopters are becomes very, very interesting, and I'm happy to share that with you as well. A lot of it does not really— it's not volume-based at all. I think it's kind of the wrong way that we look at identifying early adopters. So I think, again, happy to send it over to you, but I've got a list ready to roll for y'all.

Yeah, terrific.

Yeah, Bob and Steven can talk offline. That's a great start. Bob, last time we talked, you were raising, I think, $4 million. And have you— do you have funds?

Yeah, so the raise right now, we are just closing a round for this year. So We raised $1.2 million, and that's just to get through the year. And then I think what I was telling you, Tiger, is that we're looking for our first equity raise probably at the beginning of next year, and we're looking for that to be around $4 million. We're trying to get through what we've named it for ourselves, the clinical evaluation, which is approximately 20, maybe 30 cases. Well documented with at least 2 to 3 months follow-up. And we think we need that in order to kind of go to the next level of investors. We've done most of this with some small institution, but mostly friends and family type relationships. And so to go to the VC level, we feel we need to have a little more of a clinical risk, you know, understood and be able to just say this is more just blocking and tackling, we're trying to do more of the same, and not prove that this thing works and that people accept it and it's being adopted.

What do you think the milestone is to get the $4 million equity? So many patients or so many months follow-up, or what is it?

That's what I said. I think we think, you know, a 20 to 30 patient with 3-month follow-ups, 3 to 6-month follow-up is, is kind of what, what we're— is necessary, which is kind of our, our goal for up till third quarter this year.

Got it.

Are you sharing cases on social media, uh, just to get reach?

Uh, yeah, we're, we're using social, using, um, LinkedIn, we're using MailChimp, starting to get, uh, information built up so we can do TikTok and, um, you know, Facebook and others. So we're, we're We're dabbing our toes into that area, but we're definitely building it up. We don't wanna like launch TikTok without having something we could for a month have continuous content. So working on that. But it'll probably another month or so before we launch.

Yeah.

I mean, social media, what people don't realize, it's if you, if you do it right, it's free. I mean, it's literally organic, free. Just upload cases, upload x-rays before and after. It's free. Now, if you want to target New England only or certain zip code, then you're going to have to start buying ads. But, um, yeah, I would, yeah, I would definitely do that. Any, any other suggestions from the group on finding early adopters?

I like LinkedIn.

Yeah.

And LinkedIn, however, requires someone to be extremely sophisticated, knowledgeable about the Boolean search. Not just knowing Boolean, but knowing how LinkedIn does it, and also realizing that LinkedIn changes the rules about every week. They're always trying to keep the bots at bay, the AI at bay. I mean, and they're pretty They're huge. They're really, they're, they're good at fighting the good fight and protecting what they have. Yeah.

Videos, videos, short videos do really well on LinkedIn. They, the algorithm pushes it up. So, you know, like, yeah, go ahead, Stephen.

I was gonna say YouTube Shorts perform typically better than, than TikTok. And Opus Clip is a great tool that you could use to take these types of presentations that you do. And put it in there, and it'll build you a ton of YouTube Short videos, and you could target better, uh, on that as well to your audience. Those, those perform very well.

And what was the tool you said?

Opus Clip. I'll put it in the tech, the chat.

Okay, thanks.

Great, appreciate that.

Do you have a landing page on your website that shows like a, a surgeon that's interested, wants to learn more, get a sample or see an animation or scrubbing?

Yeah, we have, um, we have a contact page so that, you know, anyone can contact us and it comes through to a number of people. Um, we have a testimonial page that does show— we have right now 3 videos. We did a short segment for LinkedIn called Back on Your Feet, and, um, it just has 3 30-second kind of videos with the patient quotes on what they felt doing this procedure and how they— how it kind of differentiates from others. And then we have, you know, a page for getting all the information about our product and, you know, the VACS and, you know, the animation, how you do CPT code, you know, quoting different things. So we have a lot on the website. I'm sure we can improve it, but But it's a, it's a good landing page for people who are interested.

Yeah.

Good.

Have you ever thought about doing a community around it, a Slack channel or something of that nature so your physicians can share between each other? Because then it's easier for them to essentially spread the word amongst their community as well and getting them involved in something.

Yeah.

Thank you. Another idea I've heard is when you have, when you're a startup, you don't have a lot of money. But you have samples and you can, you, if a surgeon has an interest, you can mail them a prototype in a FedEx envelope and they can look at it, play with it, and mail it back to you.

You know, we have done that. You know, the, the one that Joe showed you at the beginning, which just is a, a sawbones with, with the plates on it, that people love that. I mean, 'cause it just explains exactly what's happening. As soon as they see it, they get it.

Yeah, I mean, burn no bridges, cut no bones, walk earlier. I mean, just like lower learning curve. I mean, you guys are just checking every box. Go ahead, Todd.

Oh, I was gonna, I was gonna say exactly like I, I've, I'm one of those, I should be a spine back patient, but I opted for no fusion because that's just, it's just bad, right? And so I'm, and, and, and I think there is a, there is a camp out there of patients that you could probably market to. But what about, and we've, I've had a lot of success in surgery centers instead of hospitals just because of the time it takes to get into a hospital. It, it's could be a year, could be 2, even for really innovative products, right? So, and this is, and it's kind of a question to the group, but, we always find a lot of success in surgery centers that are owned, physician owned. That is, is such an easy route. Now we know of those, but then it's, I'm, still struggling with trying to find those in the future, right? A proactive instead of a reactive approach. And, and I'll definitely agree with Stephen's comment about channels where you have your surgeons' KOLs showing the best product, their best, their best case. You know, the fabulous one would be your last one where you're doing a revision, your patient number 10, which was a revision of a failed bunion. That stuff, that, that's only, it's really easy to scale. It's like a digital digital group of like-minded people. That, that to me is, is where we're trying to go in this industry. So I like that thought. I'm gonna second it.

Good, good comments.

Maloney.

So, Bunyan, basically, if only, if you, if you were only marketing to women by women, you would kill it. And there's a— there are groups of women that no one's ever exploited. I live in the South, and in the South— and I've been— I'm gifted with 6 younger sisters, 3 of them done in repairs. So the South has a— has an army of sweet-talking, strong women that sell probiotics and makeup and all this other crap, and No one's ever exploited those groups. And I, you know, that would be, that would be an interesting approach, a re— a kind of a referral program where you exploited all those women selling all those products and just marketed to women.

And good, good, good-looking feet in cute shoes. 'Cause my wife, you know, her fear right now, 'cause she need one knee, she needs abundant surgery and she's like, I can't wear cute shoes like your beach shoes, your open-toed shoes. If you showed before and after with cute shoes. That's just gonna— it's gonna cause a lot of us married men headaches because now we have to go buy more cute shoes for them. But I think that's an amazing— I like your idea.

All these Southern women that love to, you know, wear sandals in the summer and wear cute dresses, and they're all— you think they're all blonde, but they're not. They all act like they are. It's really, that, that would be an interesting idea. I may talk to one or two of my sisters, see what they—

I like it.

We appreciate it.

Yeah, I love it. Before and afters, uh, images are really powerful with bunions because everybody can see it. Yeah, absolutely. Yeah, I asked, I, I asked Therese a long time ago, why does direct-to-consumer work well with, with the lapoplasty? It's because they said the patient can diagnose their own problem. So when you have back pain, you don't know where the back pain is coming from, but when you have a bunion, you can see it and it hurts, and you know that's not right. So yeah, direct-to-consumer outreach would probably work. Well, this has been great. Any last question, comment? John's been really quiet.

Yeah, yeah.

No, I was just going to say that the early adoption question is certainly the, you know, the Rubik's Cube that we all deal with, and it is a very difficult challenge. I think I relied a lot on really knowledgeable and solid distributors because they know who the early adopters are. And if you can pour fuel on them and help them find those individuals, they know in their neighborhoods who the surgeons who would be apt to try these things, and they're excited usually to do that. So that can be a good resource. And I think, you know, having— working really hard on a special focus distribution channel, although hard, you know, there's contracting involved, there's— everybody wants a piece of it when you exit too early. You know, there's all that, all those battles that you've got to face. But some of my strongest success stories have come from those partnerships with really talented distributors. So there, I bet you there are people in the big metropolitan areas that you could find that will— they'll each have 5 surgeons that would jump on this pretty quickly and be advocates in your value analysis process, which is a whole other thing. I was going to just mention too that that's very— as you guys, it sounds like you know, it's very critical to have that buttoned up on kind of economic, clinical, patient and surgeon satisfaction side.

Anyway, so sorry.

All right, Stephen, last comment.

Quick question, Bob. Are you a Claude user at all?

The what?

Claude, you know, the AI tool.

Oh, ChatGPT.

Okay. I built the Claude tool kind of exactly what John just said. It's free. It's a value analysis tool that'll help you build out and analyze kind of on that. So kind of doing it myself now, and it's just a nightmare. So I kind of wanted to make it reproducible. So I'll send that over to you as well.

John, that was a great point, the value analysis side of it.

You can't do it without good doctors and good distributors.

All right, well, I'll follow up with you. A lot of things we can connect on, Stephen.

Thank you.

Yeah, this has been great. Well, thanks. Keep it— keep innovating. I love it.

Thanks for the time, Tiger. Appreciate being on here.

See everybody. Okay, thanks for all your inputs.

Bye-bye.

Bye.