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

All right, so this is Bone Chat Discussion 78 with Charlie Allen, who's the CEO at MYO1, or I guess myo one.

Myo one.

Yeah.

Myo one. So Charlie has carved out a diagnostics niche in 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. Uh, I'll, uh, 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, uh, 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 biological 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, uh, and positioning this as a new vital sign for acute limb health, uh, 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, uh, clinical diagnosis to, uh, use objective data. And then with that improve care. And this has happened a lot 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 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 authorizations and reimbursement coming later. This is highlighted by a story. Kristi, 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. Kristi, 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 with the orthopedic space, but I'll just briefly come over this. Today, compartment syndrome and acute limb ischemia are, are basically managed through clinical signs. Pain is the primary sign that they're using. Very subjective. Time to diagnosis is everything. 5 hours can be the difference between walking and never walking again. And so, and this is what, what you do to correct the procedure is called a 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 object— 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. It's a 21-year-old male, had midshaft 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 that this time you've got the sensor placed in. This is a real case that happened not too long ago. There's actually accepted clinical practice guideline at 30 millimeters of mercury. As you can see at the beginning, it's 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, you know, 6, 7 hours head start on where this is going and then can make an intervention in a timely fashion. And in this case, you know, 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 5 hours faster. Here's how it's deployed. Very simple procedure. You can place it into Typically the anterior muscle, so of the lower limb and the volar 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. The 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 of 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 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. We, 150 patients were in the studies and then they happy to send you over the publications.

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

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 can correlate that very well. So what the data has shown that if the pressures are very low and no pain, are not, um, not within range. And even if the patient's having clinical signs, they typically don't, uh, get compartment syndrome. And they— and then we saw that in our study. Uh, but as the pressures go up, that's the really the key point is the trend is the, is the most valuable piece. And, uh, and that's what we provide to the physicians. So the—

it's—

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.

Yeah.

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

Yeah, so, so we'll, we're used preoperatively, so right after the injury, and then we're also used postoperatively as well for the recovery. So you can induce compartment syndrome postoperatively through the procedure itself, whatever you're doing, the nail or whatnot. So usually that's an 18-hour window and you're, 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 gonna 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 100% claim, you know, piqued, made my ears perk up as well. How much is your accuracy, that 100% accuracy, dependent on getting the device placed in the right place? And does the placement, you 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 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 determined that accuracy? Did you, you know, purposely place it in the wrong spot to see how much that affected that?

Oh, we trained them effectively to make sure that they deployed the device in the right place. And so the, so, The, yeah, no, it, the part of the, 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, that the way we trained and the way the device is deployed was, was, 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.

And I know that the institution, and if you're ready via access to the institution, then, then you have access to the, 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— it's all de-identified. 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.

In process with several other ones. We're, we've been targeting deliberately level 1 trauma centers. They're usually large academic centers. They take a while to, to get approved. So, uh, that's accelerating, uh, over time. And so we're just, uh, and, and a big part when you're creating a new standard, uh, 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, uh, you know, 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 true value of the technology. So, so that's part of what we do with our customers.

Yeah.

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 'cause this is new data, especially trends that have not been something that the orthopods 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. And so being able to interpret that data while you're in the middle of a case is part of that educational program that we bring our customers through. And then yeah, and then 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 get that buy-in 'cause 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 that we can actually help them figure out which patients they need to spend more time in front of earlier so they can maybe be 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 need to take with the customer.

That's very interesting.

Thank you.

So Charlie, I mean, you haven't— how long have you been in the US? Take us through the regulatory clearance and the—

So it was a 510 initially and we got our first approvals in 2021. And, and it was, you know, we were doing an early market release with certain hospitals. We were 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, uh, sales presence. It's— we're still in that, that stage of, of building out our, our organization.

Yeah. So 50 Level 1 trauma centers in a year is amazing. Uh, 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?

Uh, yeah, so the way— yeah, and that's also evolved over time, but we're, um, We're basically, we start with you need 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 worked 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 full program. 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 disposable, I assume, and it's What's the cost?

It, it costs a lot more money not to use our technology. And we have, we have a lot of data that shows that. There's right now what we've been able to do with, with our, our devices that demonstrate that we can reduce the rate of skin grafts by 35%. Uh, when you do a fasciotomy like this, it's not a benign procedure. Patient, depending on what the comorbidities are, 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 $2,000 to $3,000 per patient when it's deployed.

So, 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.

No, and that's what we, we find. It's a pretty, and the more we're getting known, the, the, the easier it's getting and the more data we have. So there, there was, there's always in any, any group, there's always some, some physicians that'll say, you know, they're, 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, in the, in different direction. You, 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, they need to go and get to that decision faster and optimize the care.

Yeah, that, that's been a theme on BoneChat 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, 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, and the business model, I just saw that one of the questions was, it's a single-use device. We have for patient feet.

Got it.

Jesse, Ben, Mark, we got a lot of trauma experience here.

Yeah, I, I got, I have a question. I know it's, this was a, a hot topic for a while, especially 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. It was 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, that we've been studying is actually a very good indicator of an early sign of limb ischemia. And so we're, we're starting, we're gonna be launching that at the end of this year, the access to that information. It'll be just the data and then, but eventually we'll have clearance focused on acute limb ischemia over time. So, so that's one area that we're looking at. And then we've also got a lot of pipeline of, of other sensors that we're working on.

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

What, what are the, Yeah, we got 50 patents.

Yeah. What are the key claims?

Is it just, uh, there's, there's all kinds of stuff. There's, there's how we introduce the device into the body, making it as efficient as possible, as simple. Uh, there's, uh, the sensor technology that we've developed, uh, how we're able to get an accurate reading, uh, in the, in such a complex, uh, part of the body. Um, yeah, a wide range of, of different Yeah, you've got well protected.

Christina, go ahead.

Yes, uh, apologies, it's gorgeous here in Nova Scotia today, so I'm outside. Um, uh, I was just wondering, Charlie, um, has to do with like the FDA and also Health Canada process. Um, 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 the support of doctors. Did that help in terms of regulatory acceptance that way rather than to do a PMA or something of that sort?

Yeah, exactly. So there was already the pressure in managing Parvo Syndrome is not a new concept. It had been around. There were technologies available. So 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 a physician. In fact, we don't want to replace a physician. We just want to help them in their process. So that helped a lot using that information. What we've seen over the time, perfusion is actually a new data set that isn't something that was in the other technologies. And so that actual indication we got breakthrough designation beforehand, and then we got approved. And that approval came in April of this year. So there's another also part of the journey. And the limb ischemia is the next evolution of where we're going.

Fantastic. Congratulations with that.

Mm-hmm.

All right, 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 recommended protocol. Most of the compartment syndromes I've seen diagnosed are usually accompanied by an expletive like, oh, shit, 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 more at risk. So we used the TQIP, the Trauma Quality Improvement Program dataset to, 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, that you should be placing if they're, if they qualify within that, that at-risk. So it's usually young males, tibia fractures are the highest risk. But there are other injury types that are, that are susceptible. And that's where, 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've—

Yeah, yeah, yeah.

We've—

No, 100%. And it is, cost, especially in the orthopedic world, is always an issue. And trauma specifically, there are patients that, yeah, yeah, in the US, I guess, it's more and more of an issue. Doing a fasciotomy on a patient like that is, is gonna cost more than monitoring. And what we've been able to show is that we can reduce that rate by having more objective data to go off of. So it's, it becomes actually more economical to use this technology rather than go off clinical signs and then do a fasciotomy just as a, prophylactic procedure. And that's, that's really a key point. Our value analysis process has been pretty efficient. We're, for the last year, we onboarded 20 hospitals in the last 6 months, I think it's 6 or 7 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, we're, we're— there's only, uh, 4, uh, strategic account managers in the US that, that, uh, are out, uh, representing us, uh, on a daily basis. And, and, um, And we're, we're aim— 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 were 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 them 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 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, 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 U.S., that's going to be malpractice. If in the future, if you, if you have, if the M, if myo1 is available in every hospital and they're not using it on a high-energy trauma patient and there's a problem, I think 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're just— we got our head down, just keep working on what we're doing. Um, yeah, there is a big medical liability, medical malpractice liability with, uh, with missing and delayed diagnosis and overtreatment. Um, and a lot of that is getting pushed onto the residents today, which is unfortunate. Um, and so, yeah, anyways, if we can help in any way, that'll be a win from that perspective.

Yeah.

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. Um, so how do you— is it— can— this is something easy for a fellow or a resident to under— understand and use?

Yeah, yeah, but education is a key component. So we, uh, that's why we're spending more time. We're building up more and more of an educational team. And we're really a medical education company is because we're building the awareness around, uh, how to manage this problem with technology instead of just, uh, uh, with clinical science alone. And so, yeah, so we, we have to match up our educational program with the rotations to, to make sure that everyone, uh, is properly trained. And then with time, uh, 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, 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, from the device or the solution.

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

Yeah.

Yeah.

We have like a leg model. 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 3, 4, 5 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, and 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. Um, uh, but, uh, it's still, it's, it's a work in progress. We're building up a whole, um, uh, yeah, it's, you know, we're just continuing to, to do what we do.

And okay, I got a, I got a guy for you if you—

Yeah, sure.

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

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

Yeah, yeah, yeah, yeah. The, the people have tried to do it with, uh, ultrasound, uh, and, uh, with, uh, pulse oximetry, um, and, uh, and with any, and, and trying to measure pressure outside of the body. Um, it, the, the complexity comes in trauma. There's, there's sometimes there's bleeding, sometimes there's, there's different causes to, uh, compartment syndrome. And there's, there's a complexity in trauma is inherently messy. And those things will, will make it difficult to use something that's non-invasive. I'm 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 best solution at the time. Yeah.

And the needle's tiny, right?

It's—

Yeah.

It's very minimally invasive. Like, it's, yeah, you're, we're not talking about something 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 needle, you are actually inserting the, I may have missed this initially, but you insert the Sense sensor through that needle?

Yeah, the, the— we have an introducer that, and, and that, uh, that helps the, the device get to where it needs to go, and then the needle gets removed.

Ah, got it.

And the sensor stays there.

Yeah. Good. Thank you.

Everybody's really quiet. Um, what are your challenges, Charlie? We, I mean, we collectively have a lot of experience here. Is it— if you had an ask for the BoneChat members. What, what do you need help say? How to go grow sales faster?

Yeah. Yeah. I think we're, we're just, we're just trying to continue to build it out and 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, 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 it's— there's always challenges every day. There's— it's a complex product in general, but we're, you know, tackle each one as they come.

Yeah.

I also—

you're going 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.

Did you go to Somos? Yes. You go to that one too?

Yeah.

Yeah.

And, and if you're there, I'll, I'll connect you with Eddie V, 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 sales forces. 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'd say like generally not yet, but I guess 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 educational program that's really geared towards getting 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 our side, especially something like us, which is much more of a—

and we're not—

yeah, 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. It'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, uh, I've been on a couple of trauma startups, and, you know, as Tiger knows, one of them was actually called eTrauma. And so there are things you can do to really short-circuit that huge amount of time wasted on picking the wrong agents and wrong people and so forth. 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. Hmm. Instead of talking to 20 docs, you just talk to one.

Mm-hmm.

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.

Mm-hmm.

And I mean, you're probably also working hard, the ortho residency programs talking to— Yeah.

Yeah.

That's been our, our focus has been on level 1 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, and how fast we can get there is gonna 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 2s 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 anyway.

Yeah.

No, we, 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 I, yeah.

So are you guys in Montreal?

Yeah, we're based in Montreal.

Yeah.

So do you know the Imovi and—

Yeah.

You know them? Do you know the Oligomedic, Sam Samani? Oligomedic?

No, I don't know.

You 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, it's an aid to diagnose. 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, we just provide the data to the physician and have the physician make a judgment call. Okay.

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. I, I, 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 application through the FDA. We've had a really good track record so far with them, and, and having breakthrough and having breakthrough clearance, it gives you a faster path. Um, so in our roadmap, any bigger changes, we'll, uh, we, we'll usually pass it through. Got it. Before we roll it out.

Yeah.

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. I think that's the—

Wow, that is fast.

Yeah.

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

Yeah.

That is fast. You had clinical, you had some clinical work with that?

We didn't have to show too much clinical. We added some of our clinical data. And yeah.

Your first patients were in Canada, is that right?

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

And did the— I'm just so curious, did the FDA use the Canadian data? Did they accept it? Or did they?

Yeah, we, because there was already predicates around the data, they, the, the, we weren't, they, they weren't concerned about pressure. They were like, they were more, you know, concerned about like, is it biocompatible? Like the, the general testing you'd have to do, but the, the actual, like the usefulness of the data, especially because it's an aid to diagnose, there was less concern around clinical evidence.

And when we got approved, yeah, I, I think that's brilliant. Definitive diagnosis and it would've stalled them with the regulatory bodies.

I think that's brilliant.

Interesting. Are you planning to go to other, other markets like Europe or, you know, Asia?

We, we have CE mark. So within the, when we first, first got approval, we went through the MD-SAP process and had CE, Health Canada, and FDA, which was a lot of work upfront, but you know, gave us flexibility. It turns out, I mean, we have some activity going on in Europe, but 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 US.

Got it. That's the big market, obviously.

Andrea?

Can the device be used in other anatomical areas or for other—

Today it's cleared for extremities, so upper extremity, lower extremity.

There are—

there is 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 crafted the IP in a way that would potentially cover that as well?

Yeah.

Yeah.

That's right.

It sounds like IP is really strong.

It can always be stronger. Yeah.

And then your goal ultimately is exit, is like acquisition.

Yeah. I mean, we, we wanna make this a standard of care. And to your point, I think it, we're on the right path to making that. It's just, it's just a matter of time and, 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, uh, 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, like, yes, that's the tough part, right? We first presented the data and I mean, everyone had the same gut reaction when we said 100% accuracy and we did that in front of the entire OTA. Yeah. There 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.

Good.

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 ex-fix company, those guys basically live and, live and die on the, open grade 3 tibia fractures.

Mm-hmm.

They all need a bone growth simulator. They all need an X-FIX. And although I think most of them are probably direct, mm-hmm. There's a lot of Salesforce guys that make money on the side.

Yeah.

The advantage to you is that there's no real 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. No, it's part of, yeah, our, I mean, you gotta get the right person that has the right relationships and is doing the right 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 they know, they know where all the body parts are buried, right?

So, so we've talked a lot about how startups can build a sales force. 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. It's 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 job for the sales agent to, 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. That's, that's a lot of the heavy lifting that we've been doing.

Yeah, you're gonna, you're slowly turning into a medical education company because the product, the product works. I mean, there's it, it works. It saves the hospital money, saves patients, you know, trauma. But it's just, 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 got to run. So, I mean, obviously I love trauma. They're the coolest guys in the room to me. The, are you using AI? You, you mentioned you're kind of a lot of your medical education. AI is really good for that. Where, where are you there?

Yeah, we're the, we haven't integrated into our product yet. We're collecting data right now and, and building and It's something that's part of our roadmap in terms of education. It is something we're, we're 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 leveraging a lot of our clinical expertise in our literature reviews to, to do most of the work.

Yeah.

So Do you have a list of all the Level 1 trauma physicians in the country, or—

we, we leverage AcuityMD.

So, yeah, 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, uh, all that. It just— having the right data is, is important. It's not going to get you the, it's not gonna 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, and inbound. He's playing with that.

Yeah.

Yeah. I mean, I got a website called Provencis.com that introduces AI.

Okay.

And basically you could like stick a phone number on a text or your website or anything, or 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. Oh, I appreciate it.

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

Who, yeah, who, who, where did the idea come from, Charles? You, you mentioned a surgeon that was trying to, yeah.

Yeah.

So, um, Yeah, as an orthopedic trauma surgeon that's been dealing with this type of issue his whole career, and he's like, I, there's gotta 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 might be 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. He saw, so you were in the right place at the right time. You've, and you got the clinical need.

That's, yeah, it wasn't a technology looking for a need. It was really, we started from the need and worked our way to, to a tech to work that works. And then that was part of the, the exploration. We tried a lot of different things, a lot of different biomarkers, but we ended up where, where we ended up.

Yeah.

Are you familiar with Canary? Canary Medical? 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 a fascinating, smart guy. And orthopedics is just one tiny element of what he's doing at Canary. But the data they're getting from total knees is unbelievable. And it predicts, it predicts, it predicts loosening and, you know, infections and everything way before the patient or the healthcare can see those.

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, that's the key, I think, trend in a lot of healthcare to try to remove a lot of the inefficiencies and the cost is going to be in measuring. And so, yeah, they're looking at one area of the spectrum where more in the acute setting, and there's plenty of opportunity in other sensor technologies, other areas of the hospital that Now 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 interested in that.

Yeah. 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 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, play hard to get and, you know, don't, 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 in sales before they get serious. So a word, that's just caution about strategics.

Yeah, there's, there's tons of rabbit holes you can go down with any, 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 key to all your success for sure. I appreciate the words of advice.

Yeah.

Yeah.

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

Yeah. And that, that happens every day. It's like trying to figure out what 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. But you, they, the strategic doesn't solve your problem where you need funding and, and maybe some mentoring. Yeah. Well, that's good. That's great to hear. Any other questions, or we'll just cut it right here. Everybody good?

Yeah.

Well, thank you everyone for your time.

All right.

This is fascinating. We're pulling for you, Charlie. Um, yeah, this is, uh, I hope I'm never in a Level 1 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 everyone.

Thank you.

Good luck.