All right, good morning everyone and thank you for coming to the industry forum. My name is Daryl Barnes and I'm the CEO and co-founder at Sonix Health. Today we're going to introduce you to who we are at Sonix and then Dr. Demetrio Ogula is going to discuss his experience with using UltraGuide CTR and then Dr. Jay Smith is going to demonstrate the UltraGuide CTR and also our new device for trigger finger release, the UltraGuide TFR. And then we'll have questions and answers at the end and talk about next steps. So at Sonix Health, we strive to be the world leader in ultrasound guided surgery by delivering physicians innovative therapies that reduce invasiveness, improve safety, and lower the cost of care. We're really driven by our core values. We believe in refining and simplifying just about everything that we do from diagnostics to therapeutics, from the way we educate and train our physicians on our new solutions. We believe in disrupting the status quo because if we can't change the way we treat our patients, we can't very well expect we're going to do anything better for them in the future. We believe in thinking differently and what I mean by that is that we look at patient problems from different perspectives, from the patient's perspective, from the payer's perspective, and of course, from the surgeon's perspective, and that's how we create great solutions for today's and tomorrow's problems like the UltraGuide CTR, which is a device to treat carpal tunnel release in a simple, elegant, safe, and effective way in a less intimidating environment in a lower cost setting while the patient's wide awake. And best yet, the patient gets better faster in three to six days versus four to six weeks. So our experience so far is that we've done over 10,000 CTRs with the UltraGuide CTR, and patients have had excellent symptom relief. We've had no device-related events. We've had multiple peer-reviewed publications, specifically seven peer-reviewed publications and 17 presentations of which two of those are being done here at this ASSH meeting. Of the seven published manuscripts, 93 risks were at three-month data and 131 risks at one-year data, and we had no neurovascular complications, two reoperations, but a large percent of those were done with simultaneous bilateral releases as well. And at Sonex, we're really a data-driven company. We have our own database called the APEX database. We have 25 practices that are participating in that, nearly 1,000 patients enrolled, and our primary endpoints that we're looking at are return to activity, return to work, we're looking at Boston Carpal Tunnel questionnaire, the QDASH, and then also a global satisfaction and net promoter score. So this is what our data looks like so far. You can see that there's significant clinically important differences that we see within the first week, two weeks, and then significant improvement thereafter sustained out through one year. When we look at the Boston Carpal Tunnel questionnaire, we see similar results with significant changes within the first two weeks and then sustained out through one year. We also measure intraoperative pain scores, and our median is one out of ten. Nearly 70% of patients are getting back to any work within seven days. The global satisfaction scores are at five out of five, and the net promoter score is ten out of ten, with patients being extremely likely to recommend the procedure. So what's next for Sonics Health? You know, we just talked about Carpal Tunnel. We're also doing work for a device for Dupuytren's, cubital tunnel, and also de Quervain's. What we're really excited about is our next device called the UltraGuide TFR, which is designed to treat trigger finger. And we've built integrated safety features in this which allow it to be adoptable and give the surgeon confidence. We're going to demonstrate that here today, Dr. Smith will. We're really excited about this. And so what I'd like to do now is introduce Dr. Demetrio Aguila, who is a plastic surgeon specializing in peripheral nerve surgery. He's a CEO and president at Healing Hands of Nebraska. His training is at Johns Hopkins University. He's a fellow at the Dallin Institute for Peripheral Nerve Surgery. So thank you, and welcome, Dr. Aguila. Good morning, and thank you for joining us today, and thank you, Daryl, for that kind introduction. As far as disclosures go, I am a paid consultant for Sonics, I also am a paid consultant for Smith & Nephew. Nothing that we talk about today will have to do with Smith & Nephew. So what has been my experience? And I'm going to try to keep this quick, because I know as good looking as I am, you're here to see what Jay can do. So I want to make sure that we focus on what's important. So most of my experience prior to adopting the ultrasound-guided approach to carpal tunnel surgery revolved around mini-open, as well as endoscopic carpal tunnel release. And I had good results. I was pretty happy with it. So I was rather skeptical of what this might offer. And it was actually at the AAHHS meeting a few years ago that I heard somebody talk about this particular approach. It was at one of the presentations, and I said, come on, you can't really see that stuff on an ultrasound. And shortly after that, I went down to the Samsung booth, and the rep there put the ultrasound probe on my wrist, and I could see the fascicles, and I could see the palmar cutaneous branch of the median nerve, and I was blown away. I said, wow, so you really can see this stuff. And so I started looking into it. Again, I was rather skeptical about it. And really, there are two main reasons that I've adopted it. For one, from my perspective as a surgeon, the fact that I can see every single critical structure that I'm concerned about, whether it's the thenar motor branch, or the palmar cutaneous nerve, or the third common palmar digital nerve, or the ulnar artery, the superficial palmar arch. I mean, you name it, we could see it. And obviously, as a surgeon, I want to do this in the safest way possible. And then the main reason that my patients are primarily interested in it is because they get back to work and all their regular activities, in many cases, almost immediately. I don't send them home with any activity restrictions whatsoever. We routinely will have patients coming in and undergoing the procedure over their lunch break, and then they're back out in the combine that afternoon. I see a lot of farmers. I see a lot of ranchers, people that use their hands a lot. And this has been life-changing for them, and it's been transformative for my practice. This is the procedure room in which I do my procedures. You can see it's not a very complicated setup. We have an ultrasound. We have the table or chair that we use for this, and a Mayo stand, and that's about it. We did our first case a little over two years ago, and of course, shortly after that, COVID hit and slowed things down. But in the last three to four months, we've had a significant ramp up in the number of patients that we've treated. I've done over 100 of these now. All local anesthesia, no complications, no conversions, and my patients have generally been very happy. One thing that I routinely did not do before I started using ultrasound guidance was bilateral procedures on the same day, and now I do unilateral by exception, typically because those patients only need one hand done. The patients tolerate it really well. They don't have any problems using the bathroom afterwards. As a matter of fact, the very first patient I did this on was one of the nurses in my office. I happen to like her, by the way, and she likes me, so it's not like I was trying to torture her. I did both of her hands. I had three more of these to do that same afternoon, and she assisted me in all three of them right afterwards, just to give you some idea how quickly patients can get back to work. You can see the data here that Daryl already touched on. You can see the data from my practice. The results are sustained longitudinally, and here are the numbers. Return to full work, median two days. Heavy duties, 100% within seven days, 75% within three days. Return to normal activities, typically the same day, if not the next day. Patients are generally satisfied, and they're telling everybody and their mother. Over 50% of the patients that come to see me for this now are referred by other patients. So at that point, I'm going to turn things over to Jay, Dr. Smith, and he's going to go over what you really came here to see. Thanks, Demetrio, and thanks, Daryl, and thanks all of you for joining us today. We're going to do a brief demonstration of the UltraGuide CTR procedure, and for those of you that were at the demo earlier today in the Solution Center, you know, you get to see it twice, although we're going to do the opposite wrist right now, so we have a left hand instead of a right hand. The first thing we're going to do for the procedure, and during this, Daryl and Demetrio will add some commentary. They may stop me and redirect me and keep me on track, but we'll have ample time for questions and answers. So first of all, I'll do this carpal tunnel release, and then we'll move on to trigger finger, and then we'll have questions and answers and discussion. So the first thing we're going to do is mark the incision line, and to do that, we're going to find the pisiform, which is one of the bony landmarks that we like to use with ultrasound, and the pisiform, as you know, is at the level of the distal wrist crease. So if we place the transducer across the distal wrist crease and we just look, we'll be able to identify some of the important anatomy that you already know, even if you're new to ultrasound. So again, the top of the screen is always superficial in ultrasound, and then we go deeper. I have this transducer, as you can see from the picture-in-picture cameras. The transducer is oriented in an anatomic axial plane. The left side of the screen is going to be ulnar, and the right side of the screen is going to be radial. So this structure here, this is what bone looks like under ultrasound. This is the pisiform. All bones look like snow-covered mountains. They're just different shapes depending on the bone. So this is what the pisiform looks like. This is what the scaphoid tuberosity looks like, and this is the proximal osseous tunnel. In the center of the osseous tunnel, we have the median nerve. This is the median nerve. It's a relatively dark ovoid structure that looks like a honeycomb, and you might not appreciate that as much at this point, but I'm going to scan proximally a little bit, and just as Demetrio said, you can see the fascicles in this nerve as I scan proximal and distal, the fascicles of the median nerve. So the median nerve is sitting deep to the forming transverse carpal ligament at the level of the pisiform. You can actually incidentally notice this other honeycomb structure, which is the ulnar nerve, which is exactly where you expect it to be, next to the pisiform. So from here, we're going to keep our eye on the median nerve and the pisiform and move distally, and we're going to see the pisiform disappear, and we're keeping our eye on the median nerve, and we see another bone emerge from the deep side of the carpal tunnel. It's a little bit more angulated. It's still on the ulnar side and distal to the pisiform. It has to be the hook of the hammock. There's nothing else this is. So this is what the hook of the hammock looks like under ultrasound, and on the right side, or radial side, the scapoid tuberosity has been replaced by the tubercle of the trapezium. So inside the tunnel, we still have the median nerve tucked in, and then all these are flexor tendons. Notice the flexor tendons in cross-section look like the end of a broom. They're bristly. The white dots are just the collagen bundles, and the dark stuff in between the white dots is the interfibular ground substance. Now we look in the distal tunnel here because we're trying to locate and define the safe zone, and the safe zone for the procedure is the distance between the edge of the median nerve, which is here, and either the hammate or the ulnar artery, whichever is closer, because that's going to be our working space. So we're going to center this in the screen here and put it in the center of the screen, and I'm going to make a mark on the skin here because I know that this mark on the skin defines the safe space in the distal carpal tunnel. From here, I'm going to scan proximally. So I'm going to go back proximally. We're going to pass by the pisiform on the way again. So here's our pisiform emerging. I'm passing on a straight line from the safe zone proximally until we see this other bone emerge on the bottom of the wrist, and this is the lunate. This is the apex of the lunate, and at this level, this is going to be our incision site, which approximates the proximal wrist crease. Here's how we have the honeycomb architecture of the median nerve over to the right. Here's the ulnar nerve over here to the left. The ulnar artery, not seen well in a cadaver because the lumens collapse, but this is calcification in the lumen of the ulnar artery. So we know that this incision site right here in the center of the screen is going to be safe, because you can see as I'm hitting this with the pen, it's marking it. So what we have here is a safe line that tells us that's the way we're going to put the device in. That's how we're going to do our local anesthesia. So the next thing we're going to do is local anesthesia. As Demetrio said, most of these procedures are done under only local anesthesia with or without epinephrine. It just depends on the operator, and you can start this anesthesia. I'm using just a 22-gauge, one-and-a-half needle for the purpose of this demonstration, but you can do this a variety of different ways. You can make a little skin wheel here, and you know that as long as you stay subcutaneous and direct the needle towards the distal dot, that you're going to be safe initially, because you're out of the median nerve and the ulnar artery are out of play. Eventually, though, I'm going to go to this view here, and you'll see the needle on the right side of the screen, and I'm going to actually inject. As I inject this and I penetrate the antebrachial fascia, you're going to see this needle enter the carpal tunnel and dissect the tissues away from the carpal tunnel. I'm going to move the transducer distally. This is a longitudinal view now. I am distal to the left on the screen, and notice how well you can see this needle as I'm injecting this fluid. Now, the fluid separates all the tissue away from the underlying transverse carpal ligament. This allows us to do subcutaneous anesthesia at the incision site to really mitigate any incisional pain. It gives us anesthesia in the canal, in the carpal canal, and then also provides some space through hydrodissection, creating some space. You can do that hydrodissection as much or as little as you want. It just starts separating the tissues. Once we get that done, we're ready to do our incision. The incision can be a linear longitudinal incision or a transverse incision. This is a number 15 blade, which is the most common blade that our users use. Some people use number 11s, dealer's choice on that. Again, we want to be entirely safe. Notice here when I lay the transducer back at the incision site, this is the fluid that I had already injected with the needle. Here's the median nerve over here to the right, which is radial. Here's the ulnar nerve and the ulnar artery over here to the left, which is ulnar. I'm going to simply touch the skin with the blade at this point in time. I'm not going to go through, so you'll see in the top of the screen, in the center of the screen, you know exactly where the blade's going to come through, so you know the median nerve and the ulnar artery are safe. I'm just going to pop through and then make my small incision here. The incision is generally going to be three to five millimeters in length. The next part of the procedure, which is an optional part of the procedure, but most of our surgeons like to use this, is an elevator. This is a blunt-tipped elevator. This happens to be a Penfield elevator. It's a spatula with a blunt tip. Many surgeons like to use this because they're used to putting elevators in the tunnel to create space. It also allows them to kind of test their trajectory and approach before they put the device in, but we're going to demonstrate this today. We'll use this for demonstration purposes. I'm going to put this into the incision and I'm going to find this in the tunnel. Once again, let me get my arrow out of the way here. You can easily see in the center of the screen, as I twist the device, you can see the echo of the elevator. On the right side, which again is radial, we have the median nerve. I think Daryl's going to come down and point, and on the left side would be the ulnar artery, but we're going to follow this elevator all the way into the level of the hook of the hammock because we're going to basically get this to the safe zone. All right, so as I go distally here, you can see the hook of the hammock, and here's the elevator next to the hook of the hammock in the distal tunnel. I'll twist it right here. Once you know that you're deep to the TCL, deep to the transverse carpal ligament, so you're not in Guillain's Canal, you're not stressing anything in the Guillain's Canal, look at the median nerve off to the right, which is radial. Now I'm going to use this and do some additional tissue dissection. So we're going to move this elevator back and forth in the tunnel underneath the transverse carpal ligament. So as opposed to the hydro dissection that we did with the anesthesia, with the fluid of the anesthesia, this is a way that you can do a little bit more mechanical synovial dissection. It's not a rasper or anything that dramatic. It's just a blunt tip spatula. And once you're done this, you'll simply pull this out. Now if we've done all our work well, then we're going to be able to put this device in with very, very minimal effort. But before we do that, I'm going to try to zoom in here, see if I can demonstrate some of the features of the UltraGuide CTR. So the working tip you can see on my palm here, and I'm going to, there are two inflatable balloons on either side of the working tip, and they're not inflated right now. And they're filled with normal saline or sterile water, whatever the operator wishes to fill them with. And what happens is when you push down on the balloon activation lever, these will fill up with the normal saline, and they will effectively increase the diameter of the device from four to eight millimeters, increase its cross-sectional area, and create space in the carpal tunnel. And the center between the two balloons is a blade track. And so you know exactly where the blade's going to be, because there's a retrograde blade that's hidden in the distal tip here that is not active until the blades go up. And once the blades go up, this button right here, the slide button, can be used to activate the blade. You can see the blade come out, and I'll put it back in and out of the tip, and it will cut the TCO in a retrograde manner and then recess proximally. And you could either leave it proximally or put it back distally. And that's the essential function of the UltraGuide CTR, is to create space and then cut the transverse carpal ligament in a retrograde manner. So again, if I did everything correctly, this should go in very easily. And I'm going to do it without ultrasound first just to demonstrate, and then we'll do it with ultrasound. So you can see I basically am only holding this device with my fingertips, and you can just slide it into the carpal tunnel without any resistance at all. So we're going to do this under ultrasound so you can see, because that's how we recommend doing it. So here's the echo signature of the device in the center of the screen. Notice how you can see the gap in the center of the working tip. So the balloons are not up, so you're not seeing any balloons, but that's where the blade track is in the center of the device. It's got a flat top, and on the right you see the median nerve. And so we're going to move this into the carpal tunnel just like we did before, and I'm going to move this distally to the level of the hamate. So in the distal tunnel here in the level of the hamate, here's my device in the safe zone. The median nerve is off to the right, and the ulnar artery, of course, is superficial off to the left. And now what I'm going to do now that I know that I'm safe in the safe zone is I'm going to go to this longitudinal view again. So what we have here is a longitudinal view of our device, distal is to the left, okay? And so I'm going to try to accentuate here for you the transverse carpal ligament. In the center of the screen, where Daryl's pointing, is a very football-shaped structure that is the tri-layer complex of the TCL complex. And I say the TCL complex, you can actually freeze that, Daryl, and I'll just use the markers. I say the TCL complex because this is actually three layers of tissue, right? The TCL is not this entire construct. The deepest part of this is the TCL, there's a middle layer that's the interthenar fascia, and the superficial layer, as you know, is the palmar aponeurosis that continues off to the left, which is distal, as the palmar aponeurosis only. So right here where this taper is, that's where the TCL and the interthenar fascia layer end. This is important because this is where we want to start cutting, we want to position the device here and cut in a retrograde manner. So we're going to go to a different view here, and I'll show you where we are with the device. So we position the device at the end of the TCL, and then we're going to go to this transverse view, now that we know that we're long enough, and we're going to blow up the balloons. So as I blow up the balloons here, you can see the balloons blowing up. The right side is going to be the radial balloon, notice how it displaces the median nerve, and then the left side, which is slightly shadowed by the curvature of the TCL, is going to be the ulnar balloon. And as I scan proximally, you'll see the balloons in their full form there, moving the median nerve out of the way. So this creates that space in the tunnel and lets you know exactly where the blade's going to be. So at this point in time, I'm going to be getting ready to cut, and I'm going to put my thumb on the blade slider button here, but we're not going to go into it in great detail today, but now I'm going to check things. I know I'm distal enough, but I want to scan distal at this point, and I'm going to keep my eye on the median nerve, which is off to the right, and the ulnar artery to the left, and we teach everyone how to check for the third common palmar digital nerve and the superficial palmar arterial arch, because they're going to be crossing into the third space. Now notice how at the top of the screen, that's the echo of the device. That's the tip of the device, way up at the top of the screen. So we teach every one of our users to recognize ultrasonographically the third common palmar digital and the arch to make sure they're safe. Once they get to that point and they're ready to cut, we're simply going to engage the TCL. So I'm back to this longitudinal view, distal to the left, and I'm going to activate this blade, and you're going to see this blade come up, and it's at the center top of the screen. I'll move it so you can see. There's the blade up there. It looks like a shark fin, and I'm going to cut this TCL from distal to proximal. I'm going to engage the TCL in this view, and then after I get a little bit of a bite out of it, I'm going to go back to this transverse view for us. Now with this transverse view at the level of the hamate, so the hamate is on the left, we like to cut in this view because it gives you total control. Notice how the dot at the top of the screen is the tip. That's the tip of the blade that's superficial to the TCL. We have both balloons in view. We've got the median nerve in view to the right off radio, and then the ulnar artery is off to the left, which again, you can't see very well here, but will be very easy to see in a live individual. And at this point, you can simply do what we call an inchworm technique or an inching technique where I can move the transducer approximately and then cut into that area, and move the transducer approximately and then cut into that area, and move the transducer approximately and cut into that area. So you're in total control, seeing all the surrounding anatomy. Notice how we're passing the pisiform now on the left side so that we know we're getting out of the proximal osseous tunnel and into the distal form fascia, and you can extend that incision into the distal form fascia all the way up to the incision site. And then once you're done, if you choose, you can take a second pass, and I'm going to demonstrate a second pass just so you can see how this looks tracking this longitudinally. So here's the blade going back from proximal, which is right, to distal, which is left, and I put it back. I'm going to put it back in its tip, and I'm going to show you what this looks like to track in a longitudinal view. Now if you're going to take a second pass, you know the anatomy has been distorted by the first pass. You're going to check everything again, make sure everything is where you think it is so that you're not avoiding, so that you're not getting into any of the neurovascular structures. And I'm just going to show, but I'm not going to do that today for the sake of time. I'm just going to show you what it's like to track this blade in this view. So here we are up top, because some of our users do like to use this view, and this is how you track this blade in this longitudinal view. Now notice that Daryl's pointing out that kind of dark rope that's on top of the blade is not the TCL. That's the palmar aponeurosis. So the blade is actually coursing deep to the palmar aponeurosis and through the two deeper layers of the TCL complex. And then we'll finish that cut approximately. After you're done the cut, you're going to go back to the level of the hamate, and we're going to reduce, we're going to deflate the balloon. So at this point in time, I'm simply going to, there's a button on the balloon activation lever, and the balloons are deflated, and you should be able to pull out the device very easy because there's nothing sharp or protruding. At this point in time, we will probe the TCL. How do we document that there's a complete release? We're going to functionally probe it with this elevator that we used for the second stage of the procedure during the demo. We're going to put this next to the hamate in the distal tunnel. Notice how we always come back to the hamate, right? The hamate is kind of the lighthouse of the procedure. So we're in the distal tunnel. We've got a view of the hamate. Here's the elevator, and you simply lift up, and you go through the TCL. This is called a lift-up test. So I'm putting it next to the hamate, and I'm going through the hole in the TCL, which I'm actually showing you the hole in the TCL. I went vertical with the elevator to show you the incision in the TCL. And so we probe this and pop through. This is called a sonographic lift-up test, and that's how we prove that we've got the whole TCL. You can then do one step further, go to this view, which is a longitudinal view, and I'll get back on this. And you can drag the elevator out in this view to make sure that the elevator stays superficial and is not pushed back dorsally by any fibers of the transverse carpal ligament. And then that's the end of the procedure. Go right to TFR? Yeah. Do you have any questions about that portion of the procedure so far before we move on to the trigger finger release? All right. Excuse me. All right. So I'm going to show you this. This is UltraGuide TFR. This is the new device that Daryl had mentioned. It's not commercially available yet, but coming soon. You can certainly see it at the booth. It's a single-use device, just like UltraGuide CTR. The basic concept is that it has an introducer tip, which is threaded into the flexor tendon sheath and under the A1 pulley. And then there's a blade that is sitting in the handle of the device here that is laying horizontal that's attached to this blade handle. And after you thread this into the flexor tendon sheath and under the A1 pulley, you will advance the blade onto the introducer and into the flexor tendon sheath and under the A1 pulley. I know you can't see the blade very well without magnification, but the blade is going to be at this point. And then you'll rotate, you know, all single-handed use, you'll rotate the blade into a vertical position by rotating this blade handle 90 degrees, and then you will pull in a retrograde manner, and that will cut the A1 pulley and the flexor tendon sheath in a very similar way of UltraGuide CTR. And then you'll lay this blade handle back down horizontally, and as we'll demonstrate, you'll be able to use this as a probe to make sure that you've incised the A1 pulley and the flexor tendon sheath, and then you're done. So let's talk about the relevant anatomy first for the pulley system. So we'll focus on the middle finger today, and we'll see if that pulley, we're not expecting the pulley to be abnormal, but the middle pulley is usually a thicker pulley for demonstration purposes. We're going to place the transducer in mid-palm level at the level of the middle finger. And what we see there in the screen is the ovoid structure that you should recognize as tendon. It doesn't look like a honeycomb. It looks like the end of a broom, so that's tendon, and that's going to be the FDS and FTP tendons of the third digit. Deep to that, we should recognize the hyper-echoic or bright border of the bone. That's the bolar surface of the metacarpal shaft at this point. And as we scan distally towards the metacarpal head, you can see that the metacarpal is becoming rounded at this point in time, has a dark layer on top of it, which is hyaline cartilage. Just superficial to that is the palmar plate, which is trapezoidal. We still see the flexor tendons, but at this point, we can see a dark ring that encircles the flexor tendon. So I'll go back approximately where the ring disappears. So there's no ring right now, and then as I come distally, you can see this ring encircle and envelop the flexor tendons, and this is the A1 pulley. So we call this a Mona Lisa sign so that the flexor tendons are Mona Lisa's head and face, and the A1 pulley is the hair. So her hair is the black ring around, and this is how we localize the A1 pulley. So what I'm going to do now is simply make a mark on the skin here just for demonstration purposes where we were with ultrasound, which shouldn't be surprising. The A1 pulley is going to be right here. This is the way we mark the midline, and then I'm going to move proximal to the incision site, and the incision site is essentially at the head-neck junction. It's certainly going to be a little bit more of a proximal incision than you're used to for some of your traditional approaches to the A1 pulley where you cut right down on it. So it's going to be more in the region of the proximal palmar crease. So at this point, we're ready for our local anesthesia, and similar to the carpal tunnel procedure, you could do this local anesthesia without ultrasound guidance, at least initially, because you have your safe path. You have this path. I'll move this here. You have this path between the incision site and the center of the flexor tendon at the A1 pulley, so you could make yourself a skin wheel here if you want, and I'm not going to belabor the local anesthesia for our purposes today, and you can direct that needle distally towards your distal spot, which will keep you in line with the flexor tendon safe. Again, you want to provide the anesthesia at the incision site, and then make sure you get the anesthesia over the A1 pulley. Next we're going to do an incision, and similar to the carpal tunnel procedure, we'll use a 15-gauge blade. This can be a transverse or longitudinal incision. We'll use a transverse incision today. The methods are very similar to what we used for the carpal tunnel. I'm denting the skin, so you can see the dent in the top of the screen right over the flexor tendon, and then I'm going to move the scalpel through the skin over the flexor tendon, and as soon as I get deep enough, I'm going to move to this view here, which is our longitudinal view, distal is to the left, and you can see the scalpel on the right upper corner of the screen, and I'm just going to come down and just touch the tendon sheath. We're not getting into the tendon. We don't want to get into the tendon. We're just touching the tendon sheath. Now notice the big round bone in the center bottom of the screen is the met head, and then to the left of that is the proximal phalanx, and you're looking at the MCP joint and the flexor tendons stacked on top of each other. So after this, we will insert the device. This incision, by the way, similar to the carpal tunnel incision, if I could even find it here, is going to be a three millimeter incision in general. So here's what we see. As soon as we put this through the incision, we can see the echogenic features of the introducer of the UltraGuide TFR, and we want to make sure that we're centered over the tendon, and that's kind of what I'm doing here. I'm making sure that I'm centered over the tendon. Once I know I'm centered over the tendon, I can move to this view and move this into the tunnel, and I'm going to make a little bit of a bolster here under the finger and then redo this. As opposed to the carpal tunnel where the bolster is a little bit more proximal, this bolster is a little bit more distal under the knuckles. So we're sliding this under the A1 pulley right now. This is only the introducer. Now, the introducer has a point on it, but is not cutting. It's not a cutting surface per se. And it's snug. It's going to be snug with any trigger finger, and we'll often use these two dimensions. You can see here as I scan towards Mona Lisa, you can see this crown on Mona Lisa's head. We're going to be under her hair as we extend this distally. So we're going to advance this into the appropriate point of the pulley system. Now, what we want to do is at least get to the peak of the proximal phalanx. So what we're going to do here is I just simply flex the finger, because if you get resistance because of too much extension at the MCP, all you've got to do is flex the finger and that will open up the pulley system and you'll be able to get by any sticking points. So at this point in time, you're seeing on the bottom of the screen, the met head on the right, the proximal phalanx on the left, the introducer is well beyond the met head. We won't get into it today, but you can easily identify A2 and avoid A2 with these procedures. And we want to make sure that we're under the pulley. So we go back to Mona Lisa in this cross section view, and you can see at the level of the met head that her hair is on top of the device. The device looks like a crown. The crown is on her head, but under her hair. And see, as I rotate this, you can see it deflecting the pulley. As I move side to side, I'm totally locked in the sheath underneath the A1 pulley. So I'm ready to go. The neurovascular bundles are on either side and are safe. On the right side, you can see a little bit of one of the digital nerves on the right that Daryl's pointing to right now, the typical honeycomb appearance of a common palmar digital nerve. At this point, we can activate the blade. We're simply going to slide it into the incision and then we're going to follow it down the blade track. So you can see the blade coming down the introducer. It's going to be guided directly along the introducer. It's a slotted introducer underneath the A1 pulley in the flexor tendon sheath, nearly to the tip of the introducer. And you can see the extra white line now that is the blade shaft and the blade sitting on the introducer. At this point, you can simply rotate this blade handle 90 degrees, and that makes the blade vertical. So at the top of the screen there, you see the top of the retrograde cutting blade. And now I'm ready to just pull this. So you can actually pull this in this view, similar to what we did with carpal tunnel. So here's the blade. I can lower the blade. I can make it more vertical or less vertical, depending on the pulley thickness. And I'm simply going to do that same inching technique that I did before. And I can hear and feel the pulley being cut as I do this. And then when I'm getting to the incision site, I'll lay this down and pull it out. Now at this point, you can probe and make sure that you've cut it, or if you didn't, you can take another pass. We're going to go back to where Mona Lisa is, and we're going to see where the crown is. And the crown now, we don't really see any hair above the crown. And if I move the introducer, you can see I can actually get the crown off of her head now. And that's because I'm now outside of the sheath and outside of the pulley, and I'm not trapped anymore. And that's how we document the complete release here. And once you're done with that, this device comes out and you're done. So a pretty straightforward procedure, you know, local anesthesia like you're used to doing, a small incision, introducer under the A1 pulley, get the blade in, retrograde cut, probe, and out. And that completes the demonstration. So I'm going to start off our question and answer session with a question for you, Jay. You know, as surgeons, we're all very familiar with this anatomy, we're very familiar with different techniques for addressing and getting to the anatomy. The one thing that for some of us can be rather intimidating is the use of the ultrasound. Obviously, I can tell you my experience with that, but I was hoping maybe you could share with everybody Sonex's approach to overcoming that potential hurdle. Yeah, I mean, I think ultrasound is the biggest barrier. When I started doing ultrasound, it certainly was a barrier for me, but I saw its great potential. So for me, it was definitely worth it. And I'm very convinced it's worth it for every hand surgeon. And I love teaching hand surgeons ultrasound because you're so anatomy focused. You know the anatomy already, as soon as we give you a frame of reference and learn and teach you how to identify certain things, you get it. The nerve looks the same no matter where it is. Every nerve is a honeycomb. Every tendon looks like a broom, you know, bristly. So we teach you those fundamentals. And once we teach you the fundamentals, the learning curve is accelerated dramatically because those bones look the same. You already know those anatomic relationships. You know if this is the median nerve that the palmar cutaneous branch should be coming off the median nerve in the distal forum on the radial side. And you'll be able to find it because you'll know what a nerve looks like. You'll know where to look for it, and you'll say that must be it. And you'll confirm that. So our approach is really to teach you the fundamentals, you know, start with wax on, wax off. But then we accelerate very quickly. And because of your bimanual skills with arthroscopy, doing needlework under ultrasound comes very easy as well. It's not something that you don't need to practice, but it comes very, very fast. Just one quick question. What is a reimbursement by Medicare or other insurance by using ultrasound in office? Thank you for that question. So related to your question or embedded in your question is another question I think I should address first. When it comes to carpal tunnel release, we all know that there's one code for open carpal tunnel release, and there's a different code for endoscopic. The code that we use here for this procedure is 64721. All of you are familiar with that as the code for the open carpal tunnel release. We add on to that the 76998, which is the CPT code for interoperative ultrasound guidance with real-time documentation. And so the reimbursement for the 64721 is the same as you have experienced previously. And then, you know, obviously the reimbursement for the 76998 varies from region to region, from carrier to carrier. But these are all well-established codes, and it's something that I think would be easy to find out from your billers and coders in the area where you're located. I don't remember the actual number. I think for Medicare in my region of the country, I'm in the Omaha, Nebraska area, the reimbursement rate for the ultrasound guidance interoperatively is around somewhere in the neighborhood of like $150 or something like that. But it may be different where you are. The question may have also, you may have also been interested in just general ultrasound. Was that part of the nature of your question, or was it just the procedure? Yeah, so, yeah, you know, there are only three codes for ultrasound, and I think most of you, you know, may be members of AAHS, but I did a webinar with John Fowler and Kevin Cruz in February, and I did a little coding and billing part of that for one of the AHS webinars. So if you're a member and you want to check that out. But in brief, there's a limited diagnostic code, a complete diagnostic code, and an interventional code. And the limited diagnostic code would be, I scanned the median nerve, I measured its cross-sectional area, I said what it was. That's all you would need to do. And that could be 50 to 80, you know, it varies, but that range. And then a complete diagnostic exam would be a diagnostic exam of a region, which would mean if you were doing the volar wrist region, there would be, you'd have to be taking pictures of a bunch of different things. Most of the time, it doesn't really fit very well into, you know, busy surgeon schedules. The interventional code is an add-on code with the exception of joints at this point. So joint codes are bundled. So if you did like a radiocarpal injection as a medium joint injection, there is a medium joint injection with ultrasound code, and that pays a certain amount, and I don't usually commit those to memory. But if you do a tendon sheath injection or a carpal tunnel injection, those are not bundled, so you would bill that injection plus the 76942 as an add-on. And that's pretty much the nuts and bolts of it. It doesn't get more complex than that for the basic ultrasound codes in the office. Half hour, five minutes, an hour apart, how far apart are you booking them? So in my practice, we do these procedures two different ways. Some patients will come in. You know, we use a screening questionnaire over the phone to determine, here, I'm going to take my mask off so you can hear me a little better. We use a screening questionnaire over the phone to determine whether or not those patients have a strong enough indication for carpal tunnel release that we can book everything all in one visit. If they don't meet those criteria, then we'll set them up for an initial consultation, which includes the ultrasound, the diagnostic ultrasound, and have them come back on a separate day for the procedure itself. If we're going to do everything all at once and it's unilateral, we'll set up an hour for the consultation, the ultrasound, and the procedure itself. If it's bilateral, typically we can get that done in about an hour and 20 minutes, hour and 30 minutes. If we're setting them up just for the diagnostic ultrasound, typically that visit, or the ultrasound plus the evaluation, that's maybe half an hour. And then for the procedure itself, if they come on a separate day, that's also half an hour. And that's all inclusive from the moment they walk in the door until the moment they walk out the door. So it ends up being less of my time. That's the total time for the patient. One of the nice things about using the ultrasound is that there are well-established criteria for the size of the nerve and other parameters that correspond well to carpal tunnel syndrome. And so in a lot of these patients, one of the reasons they elect to undergo the procedure this way is that they don't need to do any electrodiagnostic testing. And that is a way to abbreviate the episode of care as well. I mean, many of you probably saw the recent in-press release, John Fowler from Pittsburgh who does a lot of carpal tunnel ultrasound research. His article just came out in press, just focusing on if you did in-office ultrasound and the evaluation of carpal tunnel patients, it actually reduced the number of appointments and had faster time to surgery for those patients that needed surgery. So there are many, many surgeons are using, for carpal tunnel, using it in the office to really abbreviate the episode of care for straightforward cases, obviously. You know, carpal tunnel, maybe you're using a CTS-6 score, just your clinical judgment. Nerve is big, don't really need anything else, you know, we make a decision as to what to do. And that can really save you and your staff time, you're not scheduling EMGs, you're not scheduling a return appointment or a phone call to talk about the EMG, you can kind of get it all done and decide what you need to do. So, for those of you in the back that may not have heard the question, first question, tell me if I got this right, is have there been instances with an endoscopic procedure, as opposed to the ultrasound-guided approach? Okay, so an endoscopic procedure where there's been an incomplete release, and then number two, have I had to go back and then redo that, convert to open, in patients who had that? So, I've done open and mini-open and endoscopic carpal tunnel releases in the past. There have been incidents where there have been incomplete release with the endoscopic approach, which I've had to convert. One of the things I really appreciate about the ultrasound-guided approach, as opposed to the endoscopic approach, is that at the end of the procedure, as Jay demonstrated earlier, I like to take a freer elevator, put it into the carpal tunnel, and then look with the ultrasound to see, is there anything there that's still compressing the nerve? So, I know probably a number of you do that with some type of elevator at the end of your endoscopic approaches, and you do it by feel. In my case, I do it by feel and by visualization, and I have a greater confidence than that we haven't missed anything. So far, I haven't had to convert any to open when using the ultrasound-guided approach. Well, since there's a little gap in questions right now, I just wanted just a little bit of a moment to expand on the comment about the education, what Demetrio had said. As far as the procedures that we teach, other than teaching people the fundamentals of ultrasound so that they can really integrate ultrasound into their practice broadly, when people are training on ultra-guide CTR and when they would train on ultra-guide TFR, we have a very regimented training program that includes cadaveric training. It's a three-step program, so we're very serious about that training, and that's why I think we've all been very successful. Part of that program includes the possibility of traveling to our headquarters to do some face-to-face learning with us, but we also train, obviously, at your place. And then part of this system that you see in front of you, this has got two cameras, but we also have a virtual training platform that we developed to help us with distance training. So we have a package that we can send people in a case that's no bigger than this, that has a laptop and a webcam, and it's plug-and-play. It hooks right into your ultrasound machine, and then we can do bi-directional audio-visual picture-in-picture training. So you could see a picture just like the picture I had up on the screen, just with one camera, one webcam, and that allows me or someone else to just work with you and teach you. We can get a cursor on the computer, and it's been very successful to teach people who just need a little bit of extra time or they wanna learn something a little bit different. So we take training very seriously, and we explore all opportunities for that. Another question, another question. Thank you. Just a quick question. Do you offer this as an option for people who are having recurrent carpal tunnel, or are these people who have never had any sort of open endoscopic or mini-open procedure? So before Demetrio answers that, because I'll let him answer it, but yeah, at this point in time, in the IFU, the safety and effectiveness of this device has not been formally studied in patients. It's not a contraindication, but it's not been formally studied in patients who have recurrent carpal tunnel. That being said, I'll give it to you, Demetrio. Sure, thanks, Jay. So in answer to your question, have I used this device and the ultrasound-guided approach in patients who have recurrent carpal tunnel syndrome, the answer is yes. About 2 1⁄3 of the patients who have come to me who had recurrent carpal tunnel syndrome, whether it was two years later or two decades later, I end up doing a mini-open approach, and about 1 1⁄3 I've done using the SX-1 Micronet, the ultraguide. Now, the question then becomes, well, how do I decide which category those patients fall into? And I don't know, Jay, if you could demonstrate this with the ultrasound, but one of the things that I found is that as I'm using the ultrasound transducer on the patient's wrist, in a patient, let's say, who has never had any surgery done in the past, depending on where you are in the patient's wrist and also the angle at which you hold the transducer, applying pressure in certain places causes the median nerve to shift one way or the other. And what I discovered is that I can tell, in patients very often, whether or not that median nerve is stuck in the synovium and in scar tissue by pressing with the ultrasound in order to see if I can get it to shift. If the nerve is mobile, then I'm pretty confident that all I need to do is make more room for it. If I'm not confident that the nerve is mobile, then I'll do a mini-open approach so that I can get in there and really free it up from whatever it's stuck in. Yeah, that would be accurate. I would just add that another thing that people will often do is when they're doing a carpal tunnel injection on that person, which many times they're doing to help them make decisions about what's going on, if you do that under ultrasound, you can use a little bit of extra fluid and you can do that hydro dissection and you can get a sense of how mobile the nerve is. Because if you're injecting the fluid around the nerve and the nerve is not moving, it's just stuck and it's not separating from anything, then you have a good idea that it is scarred and you might need to do something more than just another release in terms of a neural lysis. Great question. Another question here? You say that you're going to some training sessions at your headquarters, and maybe we can get some information on that. Yeah, feel free to come by the booth. The training sessions at our headquarters are for people that are in the training pipeline. And so people that have engaged our commercial team and are, okay, I'm planning, I want to integrate this procedure into my practice, that is an option for them to come, as part of that training, to come to our institute and just outside of Minneapolis where our headquarters is. So yeah, I mean, our commercial team would be happy to talk with you about those types of things and what that is all about at the booth. Absolutely. Question up here in the front. How much do the disposable elements cost? The disposables for, so we can certainly speak to the CTR device. And that is, if you want to come by and talk to our PDCs, we can certainly talk to you specifically about the cost of each device. But each device, it's around $1,000. Do you have an age limit or any age to the procedure? Oh, there you are, sorry. Do you have an age limit, any age you can do for the carpal turleys ultrasonically? So the IFU, less than 18, which of course would be incredibly rare. I mean, that's not, that would be, that's a contraindication. But the upper limit is, there's no upper limit in terms of contraindications. Demetrio can speak to how, what his age range is. I know from our database and our recently launched registry study, I mean, I've seen 95-year-olds who have enrolled, so they get up there. I think the youngest patient I've used this device on is 21, and the oldest one was two weeks ago, she's 88. And I did, in both of those cases, I did both hands at the same time. Well, like one right after the other, not like two hands simultaneously. I'm not that talented. Does Medicare pay for the device? It's been my experience so far that Medicare does not pay for the cost of the device. And so, and this is one thing I was gonna touch on. You know, we often think as surgeons that the surgery we do is all about our training. In our office, we've discovered that training the entire team is really important. And so, one of the discussions that everybody on my team has with the patient before they actually get to me is a very upfront discussion about the cost of the device and what that means to them. And obviously, some patients are gonna walk away from that as a result. But a lot of patients, I have found, respond well depending on how you frame the question. Patients will come in and they'll ask, well, how much does this cost? And we've trained our team to turn the question back around and say, well, how much is your time worth? Because patients don't often think that. They don't ask themselves that question because nobody's ever asked them that question. And so, in our Medicare patients, as an example, one of the things that we find in Medicare patients is that because of a number of different restrictions in terms of what you can do, how many different visits a patient can have in a day and what things you can do in a day, we end up having to split those up into two visits. In our Medicare patients, fully half of the patients that have come to us have decided to sign an ABN, pay cash for the whole thing so they can get it all done all in one visit. And that's been a tremendous surprise to all of us. Finding out that there are a lot of patients out there who, when asked what their time is worth, will really think about it and say, well, that's a really good question. I guess my time is worth the money and that's the way I wanna go. And we do, just to expand on that, we do have several users. Because it's such a minimally invasive procedure, several users have integrated same-day surgery. So there's many that will do same-day surgery. There's some pre-screening on a phone call and things, but for straightforward patients who come by the phone, they do questionnaires over the phone and it looks pretty straightforward and they'll offer them and say, well, we're gonna evaluate you the day you come in, but if you want it done, we're gonna do it. Just like if you go to a dentist and say, we're gonna fill your cavity today, we're just gonna do it. And that saves everyone a boatload of time. Of course, there's always the person comes in, it's not what it was billed as and you're not a candidate, but that is because it's so relatively easy to set up for them and integrate into the office flow that they capitalize on that. And we found that to be the case in our practice. More than four-fifths of the patients will come in and get everything done all in one day. When you do bilateral procedures, do you use the same device or do you, since they're single-use, do you have to use a separate one for each? I give the patient the option. And many patients will choose to do bilateral because I'll use the device, the same device on both hands. Obviously, there's the potential for some concern about the device being designed for one hand and the blade dulling and so I make sure that the patient is aware of that. I haven't run into a problem with it so far. Great, we wanna thank everyone. We've come up on the half hour here at 12.30, but we'll be happy to answer any questions at our booth. Please come and see us and we do have other events going on tomorrow in the surgical suite. Please pick up, there's some information outside of the door if you didn't get that on your way in. Thank you very much.

Sonix Health

ultrasound-guided surgery

innovative therapies

UltraGuide CTR

carpal tunnel release

trigger finger release

excellent results

faster recovery times

improve patient care