BoneChat #78 - MY01's sensor tracks limb perfusion & pressure, detecting acute injuries post-trauma.

Foreign.

So this is bone chat discussion 78 with Charlie Allen, who's the CEO at My01. I guess My01 MyO1.

Yeah.

So Charlie has carved out a diagnostics niche and trauma that solves a big clinical problem in a unique way. And can't wait to dig into his tech and the business model. And I'm going to hand the mic over to Charlie. Welcome.

Great. Thank you. I'll. I'll just show a few slides about what we're up to so people get a sense of what's going on, and then I'll open it up to any questions. But really nice to take the time to meet everyone and. And connect. My name is Charlie Allen. I've got an engineering background, so I helped got mechanical engineering and then bioelectrical engineering. This is a project that I got introduced to through an orthopedic surgeon and took it from an idea all the way through to commercial. We're in about 50 trauma centers in the US now, growing 100% year over year and really driving a new standard in limb perfusion monitoring and positioning this as a new vital sign for acute limb health, really soft tissue management. So I'm excited to show you this, really the essence of what we're trying to do and in general, shift clinical diagnosis to use objective data, and then with that, improve care. And this has happened a lot in. In history. There's a lot of different examples. One more recently is pulse oximetry. Before that, patients, they waited until patients turned blue. Now today, with. With this technology, they can get in front of that and drastically improve the safety of anesthesiology and unlocked a really big market opportunity. So we're doing a very similar thing, but for limb health. And what we've been able to do is develop a biomarker, initially pressure and perfusion, and then soon another biomarker that can address the two major issues related to any acute limb injury, and that's acute limb ischemia and compartment syndrome. And we've got breakthrough market authorization and reimbursement coming later. This is highlighted by a story. Christy, She's. She was surfing off the coast of California and hyperextended her leg and broke her tibia at the time. So pretty, you know, important and dangerous and painful injury. The issue is that when she went to the hospital, they diagnosed her fracture, they were able to fix that, but they missed a vascular injury that happened at the same time. And by the time they were able to catch that problem, the only option they had was amputation. And really this is just highlighting the problem. Christy, through her journey, met us and she's actually representing us in the California market and has been doing a very good job spreading the word and making sure that this doesn't happen to anyone. Again, really the key in all this is time to diagnosis. I know everyone's familiar in the orthopedic space, but I'll just briefly come over this today. Compartment syndrome and acute limb ischemia are basically managed through clinical signs. Pain is the primary sign that they're using. Very subjective time to diagnosis is everything. Five hours can be the difference between walking and never walking again. This is what you do to correct the procedure. It's called the fasciotomy. It's a very invasive procedure, very morbid. You don't want to do this on a patient that doesn't require it. But when there's no other tool to be able to know what's happening, this is more often done in order to avoid the risk of losing the limb. So where we come in is we can give an objective monitor to this disease and be able to really measure how it's progressing over time. So I'll just highlight a quick case as a 21 year old male, mid shaft tibia fracture comes to the hospital, has no clinical signs in the morning and at night, and then all the way through the night, doesn't develop anything until early the next day. They have mild pain. So you're a physician, you're trying to understand what's happening in this case, very difficult to make that decision to do the incision and therefore really usually you'd wait a little longer on that case. So now we'll look at the same patient this time, leveraging our technology. So same patient this time you've got the sensor placed and this is a real case that happened not too long ago. There's an actually accepted clinical practice guideline. At 30 millimeters of mercury, as you can see at the beginning, it's about borderline. As the night progresses, the perfusion drops and the white line, the pressure starts to climb significantly. That trend continues over the same period of time. Now, by the time that the patient starts showing clinical signs, the physician's already had six, seven hour head start on where this is going and then can make an intervention in a timely fashion and in this case improve the outcome of the patient. And so that's really high level. The technology starts with a sensor. We've got prospective clinical studies that have shown it's 100% accurate when combined with clinical science. And you're actually able to address the problem five hours faster. Here's how it's deployed. Very simple procedure. You can place it into typically the anterior muscle of the lower limb and the bowler compartment in the upper limb. And once it's placed, rotate the introducer 180 degrees and stick the device to the patient. There's a little adhesive that sticks to the back and then you're good to monitor continuously for up to 18 hours. That's usually the at risk period. And that's pretty much it really. The key is the IP around our sensor technology. That's my background and it's really where we spend a lot of our time is putting everything into the sensor and that's actually in the body. So it's a very reliable signal. And that's what we're using to drive all these insights then goes to a connected system. So if anyone wants to know about how do you connect data and all that, we can go into that in a long time. But basically from the device now you can coordinate care through this data and be able to know which patients are improving and which patients are deteriorating and need to proper diagnosis. And so we've got a whole suite to basically help manage this disease. So with that I'll pause and if there's any questions, happy to answer them.

Yeah, I'm wondering how many patients you did the trial on. You said 100% accuracy and zero false positives and false negatives. That's incredibly accurate.

Yeah, it's in combined with clinical science that we 150 patients were in the, in the studies and that they happy to send you over the publications.

So what do you mean combined with clinical science, what does that actually mean?

So, so when you're so in as you're diagnosing the patient, being able to see the trend of the patient and how it's evolving and then combining that with what the patient's feeling, you, you can correlate that very well. So the data has shown that if the pressures are very low and not within range and even if the patient's having clinical signs, they typically don't get compartment syndrome. And we saw that in our study. But as the pressures go up, that's really the key point is the trend is the most valuable piece and that's what we provide to the physicians. So we're not trying to replace the physician, the physician is still part of the whole experience. We're just able to get them to the answer quicker.

How, how long before a patient's out of the woods After a high injury trauma surgery.

Yeah, so, so we're used preoperatively, so right after the injury. And they were also used post operatively as well for the recovery. So you can induce compartment syndrome post operatively through the, the procedure itself, whatever, doing the nail or whatnot. So usually that's 18 hour window and you're at, you know, it's typically within the 6 to 12 hours. You know what's happening our device within 3 hours, you can see the trend and you get a good sense of what if that patient's going to be okay and you can start thinking about discharging them or you want us to keep them for observation a little longer.

Got it. Eric.

Yeah.

Hey, the, the 100% claim, you know, peaked made my ears perk up as well. How, how much is your accuracy, that 100 accuracy dependent on getting the, the device placed in the right place. And, and, and does, does the placement know. Hurt your accuracy if it's not in the right spot?

Yeah.

Yeah. So, so we, we.

It's.

It needs to go into the muscle and you need to, so there is an educational portion of, of putting the needle in. But most physicians and residents were in the study that once you give them basic training of, of how to deploy the device, it's a lot easier to hit a muscle than it is to hit an artery or vein. And so they're, they're, they typically get it right and you can verify with ultrasound if it's in the right place. But yeah, I know it's important that the device gets placed in the muscle or else you won't get a good reading.

And was that part of your study where you determine that accuracy? Did you purposely place it in the wrong spot to see how much that effect it had?

Oh, we trained them effectively to make sure that they deployed the vise in the right place. Yeah. No, part of the study was to see if they were able to deploy properly and that was done. There's a lot of other work that we'd done prior to the study around basic science, anatomy, a lot of cadaver work to make sure that the way we trained and the way the device is deployed is done in a timely fashion in the right way.

Thanks, Keith. And then Elizabeth.

Hey, Charlie, I just have a question around the actual program itself. So I guess the respective resident or attending surgeon downloads the platform on itunes or wherever the app store. And then would each resident have access to that specific patient or is it just individualized to whoever is downloading for that person?

I know that the institution.

And if you're.

If you have access to the institution, then you have access to the data on that patient. You don't know. The device itself has a unique identifier, but we don't know what the patient is. And no one that's looking at the data would know what the patient is unless you have an understanding of when it was deployed and which device is in which patient. And that information is not solidified. So it's part of the way that we get around some of these compliance standards.

Good. Elizabeth?

Yeah.

I was just wondering two things. One is, you said you're in 50 trauma centers, I believe. What kind of, you know, why not devil's advocate? Why not 75 or 100, you know, I. E. What sort of obstacles or pushback are you.

It's just time. We're in process with several other ones we've been targeting deliberately. Level one trauma centers, they're usually large academic centers. They take a while to get approved, so that's accelerating over time. So we're just a big part. When you're creating a new standard and a new practice, there's an educational component. And so what we want to make sure is when people decide to buy into our technology, it's not just you put on the shelf and then you use it when you want. There's like a clear protocol and a process and an education that we bring all of our customers through. And so it's a. And because that. That's the way you get the. The true value of the technology. So. So that's part of what we do with our customers.

Is there one question, or maybe two questions that have come out of the hospitals, you know, more than others, are they asking about any one particular aspect of the technology?

I mean, with any new data stream, like understanding the. How to interpret the information, there is an educational component there because this is new new data, especially trends that have not been something that they. That the orthopods have. Are familiar with. There are certain analogies that are similar in other parts of the hospital that you can, you know, draw correlations to. But it is new information. So being able to interpret that data while you're in the middle of a case is part of that educational program that we. We bring our customers through. And then. Yeah, and there's always a hesitancy of, like, of deploying it early in cases that are at risk. That concept is. Sometimes it takes some time to. To get that buy in, because mostly most times you'll deploy a technology like this after the patient's you know, pretty far down the disease process. And the whole point of what we're trying to show is, is that we can figure out which patients they need to spend more time in front of earlier so they can maybe more efficient in how they take care of their patients and all that. And that's. There's. There's a leap of faith and a journey that you take with the customer.

Sounds very interesting. Thank you.

So, Charlie, I mean, you haven't. How long have you been in the U.S. take us through the regulatory clearance and the.

So it was a 510 initially, and we got our first approvals in 2021. And it was, you know, we were doing an early market release with certain hospitals. We're also waiting for the clinical studies to get done. And then we went pretty like, full on commercial a little over a year ago. And so a lot of what you see in terms of the growth is us spending the time, but we still don't have a huge sales presence. We're still in that. That stage of building out our organization.

Yeah. So 50 level one trauma centers in a year is amazing. So who makes the buying decision? Since it's, I mean, trauma. Trauma surgeons aren't used to diagnostics? I don't think. So who makes the buying decision?

Yeah, so the way. Yeah, and that's also evolved over time.

But we're.

We're basically, we start with a champion. I think that's the same thing with any technology. Start with the clinical champion. So that in our case, orthopedic surgeon or vascular surgeon are usually two groups that we start with while we're doing that, because of the nature of the technology and the way it follows the patient, it's important that you start looping in as much of the organization as you can within the hospital. And so what we found work, well, is getting introduced to the trauma program manager that usually has a better sense of how systematically patients move through the hospital and has more of a global view and can get the right people in the room at the right time. And so we get them involved, we show them what we're up to. We've built a program to basically help measure the outcomes of using this technology as a. As a full program. And, and that's part of the process. We go with our customers to get them to deploy it in larger scale.

Got it. I've got a bunch more questions, but I'm sure other people do too. What's the cost? Is it. It's a disposable, I assume, and it's.

It costs a lot more money not to use our technology. And we have a lot of data that shows that right now, what we've been able to do with our devices demonstrate that we can reduce the rate of skin grafts by 35%. When you do a fasciotomy like this, it's not a benign procedure. Patient, depending on what the core morbidities are, staying in the hospital much longer have a higher risk of infection and all of that. And so our device, we were able to save on the average around 2 to 3,000 per patient when it's deployed.

So Christina left a comment that she and an orthopedic surgeon, Dr. David Johnston, were very impressed with your presentation at MNVC in Memphis. As an orthopedic surgeon, he absolutely understood the need and was impressed with the presented results. So, yeah, surgeons get this.

Yeah. And that's what we find. It's a pretty. And the more we're getting known, the easier it's getting and the more data we have. So there was. There's always. In any group, there's always some physicians that'll say, you know, they can do it without data and they've been comfortable. And there's. Some people are afraid of the data. But in. In general, that trend's moving in different direction. You're realizing that this data is. We're not trying to replace the physician. We're just trying to help them get to where they need to go and get to that decision faster and optimize the care.

And that's been a theme on Bone Shot, where hospitals are understaffed, they have staffing problems, and any. Anytime you can bring technology that makes the staff more efficient with, you know, less checking on the patient is a home run.

And that's something also we learned when we first launched the product. We were. It was a device in the mobile app. And then what we found is that to involve the nursing team and to be more of an integrated system, we now have a cart that has a screen that connects directly to the device and that helps so that everyone can view the data and it's all connected more efficiently. And yeah, in the business model, I just saw that one of the questions was it's a single use device, so we have per patient fee. Got it.

Jesse, Ben, Mark. We had a lot of trauma experience here.

Yeah.

I have a question. I know this was a hot topic for Wildfish when Stryker divested their. Their pressure sensor. Everybody's kind of scrambling trying to find replacements for it. So it's kind of came in at the right time. I guess my question is more on like the progression future. Like is this sensor only pressure? Is there other applications that you could use this, the sensor technology for. For real time?

Yeah. Yeah. So now that we're in the. In the market, we're getting pulled into vascular applications and cardio applications. And what we found is that we actually have a biomarker that that was in our device that in studying is actually a very good indicator of an early sign of limb ischemia. And so we're going to be launching that at the end of this year. Access to that information, it'll be just the data, but eventually we'll have a clearance focused on acute limb ischemia over time. So that's one area that we're looking at. And then we've also got a lot of pipeline of other sensors that we're working on.

And we didn't ask the question, but I'm sure you've got patents around this. What are the.

Yeah, we've got 50 patents. Yeah.

What are the key claims? Is it just.

There's all kinds of stuff. There's how we introduce the device into the body, making it as efficient as possible, as simple. There's the sensor technology that we've developed, how we're able to get an accurate reading in such a complex part of the body. Yeah, a wide range of different pieces.

Yeah, you've got well protected. Christina, go ahead.

Yes, apologies. It's gorgeous here in Nova Scotia today. So I'm outside. I was just wondering, Charlie, has to do with like the FDA and also Health Canada process. Is it because like by the. The fact that it is really. It's not necessarily diagnostic in and of itself. It's supposed to be used with, you know, the support of doctors. It did that help in terms of regulatory acceptance that way rather than to do a PMA or something of that sort?

Yeah, exactly. So. So there was already the pressure in managing problem syndrome is not a new concept. It had been around. There were technologies available. So we, we used that same wording that they were using to get. Go through a 510 process. So it's cleared under an aid to diagnose. And so we're not saying that we can replace the physician. In fact, we don't want to replace a physician. We just want to help them in their. In their. In their process. So that helped a lot using that, that information. What we've seen over the time perfusion is actually a new data set that, that isn't something that that was in the other Technologies. And so that. That actual indication, we got breakthrough designation beforehand and then we got approved. And that that approval came in April of this year. So there's another also part of the journey and, you know, the limb ischemia is the next evolution of where we're at.

Fantastic. Congratulations on that.

Go ahead, Mark.

Yeah, thanks. Sorry I was a little bit late.

The.

I may have already missed this, but I'm interested in the. The recommended protocol. Most of the compartment syndromes I've seen diagnosed are usually accompanied by an expletive like, oh, we missed it, you know, or something like that. So how do you get ahead of it?

Yeah, so we have a. There's a list of injury types that are, that are more at risk. So we used the tqip, the Trauma Quality Improvement Program data set, to look at which injuries were more susceptible to compartment syndrome and then build a list of recommended procedures to deploy the device proactively. And so these are patients that you should be placing, if they qualify, within that, at risk. So it's usually young males. Tibia fractures are the highest risk, but there are other injury types that are susceptible, and that's what our study was also looking at to be able to help manage those patients. So the earlier the device is deployed, even before clinical signs, the better, because what we've been able to show is that we can actually pick up on the disease prior to clinical signs showing up, and that helps just manage the patient more efficiently through the hospital.

And do you worry about reimbursement? You know, so many trauma patients are basically not, you know, not necessarily really profitable for the hospital. Although that's not always true. And you must have thought about that because you.

Yeah, yeah, yeah. No 100%. And it is cost, especially in the orthopedic world, is, Is always an issue. And trauma specifically, there are patients that. Yeah, yeah, they're in. In the US I guess it's. It's more and more of an issue. Doing a fasciotomy on a patient like that is, Is going to cost more than. Than monitoring. And what we've been able to show is that we can reduce that. That rate by having more objective data to go off of.

So.

It becomes actually more economical to use this technology rather than go off clinical science and then do a fasciotomy just as a prophylactic procedure. And that's really a key point. Our value analysis process has been pretty efficient for the last year. We onboarded 20 hospitals in the last six months. I think it was six or seven months. And with 100 vac approval rating. So we've got a clear, robust story to tell when it comes to economics.

Pretty good.

Yeah.

Yeah. Charles, speak to. I know you guys run a lean company and you haven't raised a lot of money. So give us your funding background and, and how you manage 50 hospitals with a small team.

Yeah. There's only four strategic account managers in the US that, that are out representing us on a daily basis. And, and we're, we're, we've, we're starting to build out a whole medical education team and that's really where we're going to put more and more of our efforts. We haven't, we, we're just starting to bring on more of a sales agent approach. But we've, we, that's been, you know, getting the right sales agents getting to go. I'm sure we can have a whole conversation around independent sales people. A different topic. But yeah, and the way we've funded the company is through both equity financing and then, and then some. There's a lot of incentives. We're a Canadian based company based in Quebec and there are local programs that have helped support us financially. But we've raised around $20 million so far to get us to the stage we're at.

Yeah, well done. So we, Charlie and I were talking last week or two and I think where this is going is if you have to do a fasciotomy because you didn't diagnose compartment syndrome, it's going to be in the US that's going to be malpractice in the future. If you have, if the, if my 01 is available in every hospital and they're not using it on a high energy trauma patient and there's a problem, I think the lawyers are going to get involved and it's going to be standard of care, but it's going to take a while for that to become standard of care.

Yeah, we got our head down. Just keep working on what we're doing. Yeah, there is a big medical liability, medical malpractice liability with, with missing and delayed diagnosis and over treatment and a lot of that is getting pushed on to the residents today, which is unfortunate. And so yeah, anyways, if we can help in any way, that'll be a win from that perspective.

Yeah, that's a good point. The residents are the ones that see the patient when they come in and you know, diagnose what broken bones and what damage and stabilize the patient and then, and then there's some grand rounds that happens and they decide what to do. With the patient. But the residents do all the work and they're rotating in and out all the time. So how do you, is it. Can this is something easy for a fellow or a resident to understand and use?

Yeah, yeah, but education is a key component. So we, that's why we're spending more time, we're building a more and more of an educational team and we're really a medical education company because we're building the awareness around how to manage this problem with technology instead of just with clinical science alone. And so yeah, so we, we have to match up our educational program with the rotations to make sure that is properly trained. And then with time, what we've seen is the, the residents, the upper year residents get familiar with the technology they're training the, the younger ones or the new groups that are coming in. And so the, the, the organization will find a way to, to make sure that they're, everyone's benefiting from the, the device for the solution.

And, and is your medical education like, hands on, like you got a rep that's showing the, the resident everything?

Yeah, we have the theory, we have the interpretation of the data, we have the, the basic science, the, the clinical technique guide. It's a pretty simple procedure, but we still have them run through it several times to make sure that they're comfortable. And then, and then we'll, we'll be ready to support a few cases at the beginning to make sure that they're, they feel comfortable putting it in.

And then after three, four, five cases, they're on their own.

Yeah, it's, it's a very simple procedure. It's like, it's like an IV in terms of its complexity.

Yeah. And if you can't hit the quadriceps muscle, you got other problems, I guess. Mark.

So who do you have work in the military?

Yeah, so we, we had a, a DOD funded study initially. That's actually where some of this data came from. We're, we do have some connections in. We have had the device deployed with some of the special forces, but it's still, it's, it's a work in progress. We're building up a whole. Yeah, it's, you know, we're just continuing to, to do what we do and.

Okay.

I got, I got a guy for you.

Okay. Yeah, sure.

Yeah. Mark's retired military. He knows a lot of people. Vinay.

Hi.

Hi.

Charlie, this is a kind of a curiosity question. Could you share your perspective on why you went on a path where you chose an invasive device versus a variable non Invasive one to measure these intercompartmental pressure. Are there any specific limitations or accuracy concerns that prevent a variable versus you know, invasive device?

Yeah, yeah. People have tried to do it with ultrasound and with pulse oximetry and with any. And then trying to measure pressure outside of the body. The complexity comes in trauma. There's. Sometimes there's bleeding, sometimes there's. There's different causes to compartment syndrome and there's. There's a complexity in traumas, inherently messy. And those things will, will make it difficult to use something that's non invasive. Not saying that it's not feasible in the future, maybe with, with AI and more technology development in that space, but for now, this. And it was also the most efficient way to get through the regulatory process. So combining all that, it was the, the best solution at the time.

And the needle's tiny, right? It's.

Yeah, it's. It's very minimally invasive. Like it's. Yeah, you're. We're not talking about something that's, that's complex. And if you look at the different. The decision to do that versus do a fasciotomy, it's not very hard to see why.

And through your, through your needle, you are actually inserting the. I may have missed this initially, but you insert the sensor through that needle.

Yeah. We have an introducer that helps the device get to where it needs to go and then the needle gets removed and the sensor stays there. Thank you.

Everybody's really quiet. What are your challenges, Charlie? I mean, we collectively have a lot of experience here. If you had an ask for the bone chat members, what, what do you need help? Say how to go grow sales faster?

Yeah, yeah. I think we're just, we're just trying to continue to build it out more at scale. So, you know, we've got a model that's working, but it's now it's just about continuing to build it out and do it as efficiently as possible. And we're trying to get the right partners around the table to do that. We're looking at strategic collaborations as part of that growth plan. So it's all part of the next steps. Yeah. So there's always challenges every day. It's a complex product in general, but we're tackle each one as they come.

To the ota. And I guess you're going to Somos. Oh, sorry there, Jesse. No, go ahead. Are you going. I guess you've been going to the OTA meeting, Charlie. And also.

Yeah, yeah.

You go to that one too.

Yeah, yeah. And if you're there.

I'll.

I'll connect you with Eddie V. Or our chief operating officer who's been leading a lot of the military efforts.

Yeah, so my question was on. I know you kind of broached on it and then, I mean everybody has the same headache with respect to bringing on independent sales and outside salesforces. And I'm going through the, the call patterns that most of these people have. I mean, have you had success so far with getting the right independent agents? Because it seems like in the US that would be a very difficult hurdle.

Yeah, we're. It's. I, I'd say like generally not yet, but I like. It's. The profile is important and the amount of investment you put into them in terms of education. So we're just starting to spin up our, our. That's really geared towards getting our, our independent sales teams to be more effective. So I'd say we haven't had that much success in the past, but I don't. It's achievable. I just, I think you need a lot of support from, from ourselves, especially something like us, which is much more of. And we're not. Yeah, there's. There's a lot of upfront work with the customers to get them to really understand how to interpret the data, how to, how to use it and how to deploy it in an efficient way. I don't think that'll ever be the sales agent's role. I'll be our role, but they'll help with facilitating those, those conversations and then just making sure that routine maintenance gets done. So it's figuring out how to work with them. I still haven't figured it out and if anyone has, you know. Yeah, great.

It's. That's. Go ahead, Mark.

So that's a really good question. And I've been on a couple of trauma startups and you know, as Target knows, one of them was actually called E Trauma. And so there are things you can do to really short circuit that huge amount of time wasted. I'm picking the wrong agents and wrong people and so forth. And, and not all of it needs to be done like there.

You can.

A lot of it can be done remotely. So I mean one easy tip and trick was to call the emergency room on Friday and ask who's on call tonight. Instead of talking to 20 docs, you just talk to one or who's on call, you know, this holiday and just focus on the, the guys that are stuck taking call. And it's often it's the younger docs. They're not getting a lot of traffic anyway and they would love something like this. And I mean, you're probably also working hard. The ortho residency programs talking.

Yeah, yeah, that's been. Our focus has been level one trauma centers, the academic centers that have residency programs.

Yeah.

But the need is throughout the whole system and they become more. As you get into the hospitals that don't have as much residents that they can. Bodies that they can throw at it. And that's. We're not at the scale now in terms of our sales reach to be able to do that work, but it's, it's kind of where we want to go and how fast we can get there is going to be, you know, if we get sales agents that to be productive, that'll be an important growth driver for us.

Yeah.

I mean, the problem with the level ones, even though they get a lot of trauma, is there's a lot of talk and not so much walk. And the level twos, where the docs that are actually working for food or money, they're the ones can get stuff through a lot faster. I think that was my turn anyway.

Yeah, we've had good success, but it does take longer to get approved in a, in a large academic center. But we're. Yeah, it is for sure there. Yeah.

So are you guys in Montreal?

Yeah, we're based in Montreal. Yeah.

Do you know the emoji and. Yeah, you know them? You know the oligometic. Sam Salmani.

No, I don't know.

I don't know them. They're also there. Okay.

Yeah.

So I was. So you said the, when you went through the fda, basically the diagnostic is a suggestion, but it doesn't say for sure you have compartment syndrome. It just shows a trend and it's.

An aid to diagnose.

Okay.

Yeah.

So we don't, we don't have specific thresholds that are, that we place. We don't have warnings or anything like that. And that's how we get around some of the. We just provide the data to the physician and have the physician make a judgment call.

I think that's brilliant. I think that's really smart. You're not trying to be doctor. You're just trying to give them better information. So can you, can you iterate the algorithm without having to go back to the fda? If you change the user interface or, you know, make.

Yeah. Software. I mean, the rules are changing daily in that, in that space. Like we're, we tend to be on the, the more conservative side when it comes to any Any changes? So we will. We'd rather just put another so we will. We'd rather just put another application through the fda. We've had a really good track record so far with them and having breakthrough and having application through the fda. We've had a really good track record so far with them. And having breakthrough and having breakthrough clearance, it gives you a faster path. So in our roadmap, any bigger changes will. We will usually pass it through. Got it before we roll it out.

What was the total. I'm curious, with your breakthrough, what was the total time frame between submitting and getting clearance?

I could tell you. I think it was. We were. We probably submitted. I think we submitted in November and we got it approved in April. Breakthrough clearance, it gives you a faster path. So in our roadmap, any bigger changes that will.

That is fast. I mean that's just barely fast. That's a little longer than a 510k.

Yeah, that is.

You had clinical, you had some clinical work with that.

We, we didn't have to show too much clinical. We, we added some of our clinical data and.

Yeah, your first patients were in Canada not. Is that right?

Initially, Initially it was in Canada, but then we. Yeah, we have. Yeah, we have data from the US and did the.

I'm, I'm just so curious. Did the FDA use the Canadian data? Did they accept it is or did they.

Yeah, we. Because there was already predicates around the data.

They, the.

That we weren't. They, they weren't concerned about pressure. They were like, they were more, you know, concerned about is it biocompatible? Like the, the general testing you have to do, but the, the actual like the usefulness of the data, especially because it's an aid to diagnose. There's. We'll usually pass it through.

Got it.

Less concern around, you know, clinical evidence.

I think that's brilliant. Definitive diagnosis and it would have stalled them with the regulatory bodies. I think that's brilliant.

Before we roll it out. Yeah.

What was the toe? I'm curious, with your breakthrough, what was the total time frame? Interesting. Are you planning to go to other. Other markets like Europe or you know, Asia?

We have CE Mark so when we first, first got approval, we went through the mdsat process and had CE health.

Between submitting and getting clearance.

Canada and fda, which was a lot of work up front, but you know, that gave us flexibility, it turns out. I mean we, we have some activity going on in Europe, but. And our, with the size of our. Team, we don't have enough bandwidth to support multiple markets. So we were just spending all of our time in the U.S. got it.

That's, that's the big market, obviously.

Andrea, can the device be used in other anatomical areas or for other, other.

Today it's cleared for extremities, so upper extremity, lower extremity. There are, there's abdominal compartment syndrome. We do, we have done animal work there and it is an area that's on our roadmap, but not something that we're focused on today.

Have you, have you crafted the IP in a way that would potentially cover that as well?

Yeah, yeah, that's fine.

It sounds like IP is really strong.

It can always be stronger.

Yeah. And then your goal ultimately is an exit is like acquisition.

Yeah. I mean we want to make this a standard of care. And to your point, I think we're on the right path to making that. It's just, it's just a matter of time and could tell you, I think it was, we were, we probably submitted, I think we submitted in November and we got it approved in April and just continue doing what we're doing. I think ultimately to get there. It's not like having a strategic on board to make that happen will, will just accelerate the, the process. And so yeah, I, I do think that this will be, that's where this ends up at some point.

Yeah, I mean I, I, I've written about this, but I love startups that create they car category. Wow, that is fast. And I mean diagnostic trauma. I mean who's, that's a brand new category. You have no competition. There's less pushback on pricing. Less you're not compared to anybody. It's just, it's a wonderful world. It's hard work because nobody, you got to teach everybody like.

Yes, that's the tough part.

Right.

We first presented the data and I mean everyone had the same gut reaction. And when we said 100% accuracy and we did that in front of the entire ota. Yeah. It was like it wasn't received with glowing remarks initially, but now that people have had it and used it, they're, they're less combative. Yeah, Mark.

So, you know, I'm thinking on the, the sales lead generation side, having spent time as a, you know, director of sales for a bone growth stimulator and.

X just barely fast, that's a little longer than a 510k next company.

Those guys basically live and die on the open grade three tibia fractures. They all need a bone growth simulator. They all need an X fix. And although I Think most of them are probably direct. There's a lot of salesforce guys that make money on the side.

Yeah.

The advantage to you is that there's no real.

Yeah.

That is fact. You had clinical.

You had some clinical work with strong attachment, permanent. So, you know, come liquidity time or acquisition time, there's no big buyout.

Just.

They don't really.

They're just kind of a shadow anyway.

Yeah.

Yeah. Know it's part of.

Yeah.

Our. I mean, you gotta get the right person that has the right relationships and is doing that. We. We didn't have to show too much clinical. We. We added some of our clinical direct cases, but they. And they're typically direct. But you know, we've.

Yeah, yeah.

You just need an introduction and it goes from there. And then they know where all the body parts are buried.

Right.

So.

Data.

And we've talked a lot about how startups can build a salesforce. I mean it's like that every week we talk about this. And hey, Mark famously said that, you know, doctors sell doctors and you need to. You need to sign up as many KOLs as you can get. Find the young guys that are ambitious and hungry. Don't give them equity, don't pay them, but get and let them do your selling for you on the other side. You've got to have feet on the ground. So you need 1099s that want to pick up a little extra. They're already covering trauma and they want to pick up a little extra. But it's so hard to stay at their top of mind because they've got hundreds of products in their bag.

Yeah.

And they sell. They want to sell the. The high, the high margin stuff first.

Yeah. I think that that's where education comes in and that's where, you know, we, we don't want to put too much effort on the. The sales agent running our sales. If we do the right job and we've created the right need and the right awareness around what. When to use the product and how to interpret it. It shouldn't be a difficult sale maintenance draw. Yeah.

Your first patients were in Canada, not. Is that right?

Initially.

Initially it was in Canada, but then we. Yeah, we have. Yeah, we have data from the US And.

And did the. I'm. I'm just so curious. Did the FDA use the Canadian data?

Did they accept for the sales agent to do the job? But it's a lot of upfront work for us. And so that's been, you know, building up that whole program, building up all the. The documentation and Showing the, the evidence that it's working. It's. That's a lot of the heavy lifting that we've been doing.

Yeah, you're gonna, you're slowly turning to medical education company because the product, the product works. I mean it works. It saves the hospital money, saves patients, you know, trauma. But it's just you, you're creating brand new. A brand new category. That's the hard part. Yeah.

So we're just spreading the awareness, trying to get as many people that. To know what we're up to and hopefully with that makes it a little easier day by day.

Mark.

Yeah, I got one before I gotta run. So. I mean obviously I love trauma. They're the coolest guys in the room to me. Are you using AI? You mentioned your kind of a lot of your medical education is or did that.

Yeah, we, because there was already predicates around the data that we weren't.

The AI is really good for that. Where are you there?

Yeah, we're the. We haven't integrated into our product yet.

We're.

We're collecting data right now and building and it's something that's part of our roadmap in terms of education. It is something we're.

Were.

They weren't concerned about pressure. They were like they were more playing around with. But we're. Yeah, we just want to make sure that what we say is exactly. Is the right thing to say. So we're, we're leveraging a lot of our clinical expertise in our literature reviews to, to do most of the work or you know, concerned about is it biocompatible.

So do you have a list of all the Level 1 trauma physicians in the country or.

We, we leverage Acuity Maryland.

So you've got, you've got the names.

Yeah. And it's. And it's been very helpful from that perspective of, of knowing who's related to who, how much, you know, volume. They see all that. It. Just having the right data is. Is important. It's not going to get you the. It's not going to do everything for you, but it helps you at least know point you in the right direction. Yeah.

I think what Mark's alluding to is there's AI tools now that can do outbound sales calls and, and in like.

The, the general testing you have to do. But the, the actual like the usefulness of bound.

He's playing with that.

Yeah, yeah.

I mean I got a website called preventus.com that introduces AI.

Okay.

And basically you could like stick a phone number on a text or your website or anything, or the data, especially.

Because it's an aid to diagnose.

There's, you know, hey, Dr. Smith, so and so said you're doing a lot of trauma, you're on call this weekend. Call this number and you know, we might be able to help you. Something like that.

Just.

Yeah, you never know.

So.

Yeah, I appreciate it.

I gotta run, tiger. Thanks a million, everybody. It's pretty exciting stuff. I'm. I'm jealous.

Who, yeah, who.

Who were the less concern around, you know, clinical evidence.

When we got idea come from Charlie. You, you mentioned a surgeon that was trying.

Yeah, yeah.

So I think that's brilliant.

Yeah. As an orthopedic trauma surgeon that's been dealing with this type of issue his whole career and he's like, there's got to be a better way to do this. And I happen to be working on sensor technology. And so when he explained to me the problem and he's like, I think there's maybe a sensor that we can do to do this. And I was like, okay, yeah, probably. And we started to work on it. Yeah, cool.

So you were in the right place at the right time, you. And you got the clinical need. That's.

Yeah, I wasn't a technology looking for a need. It was really. We started from the need and worked our way to attack, to work that works. And that was part of the exploration.

Definitive diagnosis and it would have stalled them.

We tried a lot of different things, a lot of different biomarkers, but we ended up where. Where we ended up.

Are you familiar with Canary? Canary, yeah.

Yeah.

Another Canadian company. All roads lead to Canada. Yeah, I mean they're doing. We've had Bill Hunter on bone chat. He's fascinating, smart guy. And orthopedics is just one tiny element of what he's doing at Canary. But the, the data they're getting from total knees is unbelievable. And it predicts, it predicts with the regulatory bodies. I think that's brilliant. It predicts loosening and, you know, infections and everything way before the patient or the healthcare can see those.

Yeah, yeah, that's. It's the, the value of data is that you can then start looking at. When you measure something, you can start to optimize. And that's the key, I think, trend in a lot of healthcare to try.

To remove a lot of the interesting. Are you planning to go to other markets like Europe or Asia?

We have CE mark efficiencies and the cost is going to be in measuring. And so, yeah, they're looking at One area of the spectrum we're more in the acute setting and there's plenty of opportunity in other sensor technologies other areas of the hospital that we're excited about where things are going and it's fun to see that the market and the strategics are getting more and more interest in that.

One word of caution about strategics because I'm an old guy I've been around a long time is I talk to startups every week and they, they. They tend to tease startups along forever and don't ever invest. They want. They want early looks into startup technologies and they want to know how you're doing it and you know how fast you're growing and and but they're. They'll. They'll waste your time. They'll. So it'd just be really. It's best to be.

So within the when we first first got approval we.

Went through the MDC play hard to get and you know don't that process.

And had CE don't jump when they.

You know want a meeting or I mean they rarely nowadays they rarely invest in early stage stuff. They want to see tens of millions.

Canada and FDA which was a lot of work up front but in sales.

Before they get serious. So a word that's just caution about strategics.

Yeah there's, there's gave us flexibility it turns out I mean we tons of rabbit holes you can go down with any one of these areas. I mean it's such a complex market and environment to go down so like yeah try you dabble but you never go all in and think that's going to be the the key to this all your success for sure. No I appreciate the the words of advice.

Yeah yeah I've just seen too many startups that are said they say oh we're about to get funding from a strategic. We got another meeting next month and it just goes on for. For years. They lose focus, they lose. It's expensive. Yeah.

And that that happens every day. It's like I'm trying to figure out where the priorities are. Yeah yeah.

And what happened. What I finally realized is that your startup solves the problem for the strategic because they need the business development people need something to do.

We have some activity going on in Europe but are with the size of.

Our but you the strategic doesn't solve your problem where you need funding and and maybe some mentoring team.

We don't have enough bandwidth to support multiple markets so we were just spending all.

Yeah well that's good. That's great to hear. Any other Questions or we'll just cut it right here. Everybody good?

Well, thank you, everyone, for your time.

All right, this is fascinating. We're pulling for you, Charlie. Yeah, this is. I hope I'm never in a level one trauma center, but if I am, I'm gonna know what to ask for. All right, thanks, thanks.

Thank you. Thank you, Charlie.

Thank you very much.

Thank you.

All our time in the U.S. got it.

That's, that's the big market, obviously.

Andrea, can the device be used in other anatomical areas or for other. Other.

Today it's cleared for extremities, so upper extremity, lower extremity. There are, there's abdominal compartment syndrome. We do, we have done animal work there, and it is an area that's on our roadmap, but not something that we're focused on today.

Have you, have you crafted the IP in a way that would potentially cover that as well?

Yeah, yeah.

It sounds like IP is really strong.

It can always be stronger.

And your goal ultimately is exit, like acquisition.

Yeah, I mean, we want to make this a standard of care. And to your point, I think we're on the right path to making that. It's just a matter of time and just continue doing what we're doing. I think ultimately to get there. It's not like having a strategic on board to make that happen will just accelerate the process. And so, yeah, I do think that this will be, that's where this ends up at some point.

Yeah, I mean, I, I, I've written about this, but I love startups that create. They carve out a brand new category and I mean, diagnostic trauma, I mean, who's, that's a brand new category. You have no competition. There's less pushback on pricing. Less. You're not compared to anybody. It's just, it's a wonderful world. It's hard work because nobody. You got to teach everybody, like.

Yes, that's the tough part.

Right.

We first presented the, the data and I mean, everyone had the same gut reaction. You know, we said 100 accuracy and we did that in front of the entire OTA. Yeah, it was like it wasn't received with glowing remarks initially, but now that people have had it and used it, they're, they're less combative. Yeah, Mark.

So, you know, I'm thinking on the, the sales lead generation side, having spent time as a, you know, director of sales for a bone growth simulator and X fix company, those guys basically live and die on the open.