Trace Orthopedics Partial Tendon Tear Repair: From Home Depot to the OR

[Dr. Jacob Fleming]
Shifting more toward the primary topic today, as well as renowned diagnostic radiologists, you perform a lot of musculoskeletal interventions.

At this point, you've invented several devices in this arena. Can you tell us a little bit about this interplay between diagnostic and interventional radiology and innovation? How do things flow between those ostensibly different disciplines?

[Dr. William Morrison]
In radiology, like I said, there's a lot of repetition and a lot of things that are "something we've always done." We've always done it that way. You learn dogma that may or may not be right. You go back and look at why you're doing it that way. It's not always clear. It derives from a frustration about things that don't seem efficient. You may have a PAC system that requires 20 clicks for you to open a case and you're like, "Why can't this be simpler?" We've all asked that question. Everybody has tons of ideas about making things better, making things more efficient. I think that stems from a low frustration level, which I definitely have, and some element of laziness, which I have, because if something takes a lot of clicks or takes a lot of steps, I want to try to reduce those steps because I'm relatively lazy. That low level of frustration and laziness has led me to try to figure out ways to make things faster or easier. When you're talking about products, bringing them to market, you have to-- like I said, we all have ideas. It might be for a birdhouse. It might be for something else. It has to be something you can do, and it has to be something in your wheelhouse.

You can come up with an idea like, "Oh, well, we have voice-to-text programs that we use, dictation systems. We have translation, so why not make a universal translator? We can stick a little earbud in, we can speak and listen to what we said in another language, and go to other countries. It sounds like a great idea. I think people are working on that, but I can't do it. It's not in my wheelhouse. I have no experience with that." It has to be something that you can actually do. In terms of medical devices, I've been doing intervention for a long time. When I was in the Air Force, I was doing a lot of spine intervention, a lot of nerve blocks, and discography, which was popular then.

L5-S1 was always the hard one to get into. We always said you make your money at L5-S1 because it's relatively low, and iliac crests overlie the disc, and so you have to curve the needle in. We used to take an 18-gauge needle and park it outside the disc, and then take a 21-gauge 6-inch needle and make a permanent curve over a hypodermic needle syringe, and then put that through, and it would curve into the disc when it came out of the 18-gauge needle. I thought, "This is a lot of steps. If it doesn't come out exactly right, patient has pain. Why not just make a steerable needle?"

I thought, "Well, let's take that solid stylet inside the needle that we've been using for 100 years and make it into two components. One component goes over a barrel with a lever, and you can deflect the tip." It worked pretty well, and we brought that to market after 15 years of development, but it didn't do that well. I figured out why because it costs about 10 times more than a straight needle, number one. Number two, people are used to using straight needles, so it involves a change of how people do things.

It didn't really catch on, but it's being used now for mostly celiac plexus blocks in patients with pancreatic cancer. That's a really nice thing. I'm really happy about that. In fact, just yesterday, I saw an interventional radiologist that was very proud that they were doing an anterior approach for celiac block through the liver. A typical way of doing a celiac plexus block is to go through the bowel, and patients can get peritonitis, which can be a big problem in patients with pancreatic cancer. The idea was with a steerable needle, you can go posteriorly and go around the spine and get to the celiac plexus.

This person was going through the liver, and it was like, "Well, that can cause complications too." It has to catch on. It has to be a need for it. That's the third thing. It has to be people asking for it. That brings me to Trace Orthopedics. After my experience with the steerable needle and how it didn't do that great, I took a hiatus in thinking, "Well, my ideas obviously aren't very good." I spent five years just things on the back burner. I was doing a biopsy of a humeral head one day near the rotator cuff and I was thinking-- at the time, I had partial-thickness rotator cuff tears, and the surgeons didn't really want to treat them because they said, "Well, to treat a partial thickness tear, what we do is we make it to a complete tear, and then we reattach it."

He said, "Why don't you just go through rehab?" I spent a year or two going through rehab. In the meantime, I couldn't do weightlifting. I couldn't golf. I couldn't do things with my shoulders. I was thinking, "This is really terrible. Why can't we just repair these partial-thickness tears?" I was reading that biopsy and thinking, "We can tack these tendons down percutaneously." I developed a device in my garage to do it and tried it out, and it worked really well. I made it out of Home Depot material and the spring in a pen and it worked really well.

Then I figured, "Well, this probably isn't going to work," so I sat on it for five years, and then just more and more cases came through. My mother had gluteus medius tears, and she got muscle atrophy, and now she has difficulty getting around, and I'm thinking, "I got to do something about this because there's a real need for it." There are also reimbursement codes, so it's not like it's going to be a problem in terms of the financial part of it and here's a real clinical need for it. It's in my wheelhouse. It's not much different than what we do now with dry needling, tenotomy, PRP, things like that.

At that point, I took it to our innovation office at Jefferson, and they liked it. We got a provisional patent for it. At that point, as the provisional patent was about to expire, we were going on to a full patent, and they were only going to cover it in the U.S., and we wanted international coverage. They said, "Okay, we'll release the IPTU." We formed a company, Trace Orthopedics, and went on from there.

[Dr. Jacob Fleming]
That's really interesting, and I think any of the radiologists or other musculoskeletal specialists can relate to this problem, the very common gray zone of tendon injuries in the shoulder and the hip. We see it all the time, and it's like, "Well, it's not really a surgical issue," but as you said, you follow these patients along, or if you are one of these patients or your family member is one of these patients, you realize doing nothing is not really a benign action as well. That's really interesting about what you talked about earlier with seeing the need for it and it being within your wheelhouse. All those things have to align, and that's really interesting.

[Dr. Jacob Fleming]
One of the things I wanted to bring up before we end is I saw you had a somewhat recent tweet maybe a few months ago. You said one of the challenges in pitching a minimally invasive procedure device like this is just to explain to the potential investors or whoever you're presenting to the concept as radiologists who perform procedures or who are involved clinically. Why is this such a problem for us and how do we solve it to promote more minimally invasive innovation?

[Dr. William Morrison]
One thing that was very apparent to me is that most of the public doesn't know that radiologists do procedures, that we do intervention. Investors certainly don't know that. Most of these angel groups, they'll have a doctor on their advisory board, but oftentimes they don't have any experience in what you're doing. If they do and they have an orthopedic surgeon, a lot of times they're either super sub-specialized or they're very general. They have difficulty envisioning the market perhaps for our device particular. I think a lot of this has to go back to our societies who collect our money for annual fees, but they don't do a whole lot of public relations in telling the public what we do.

I think that would go a long way toward bridging that gap, which really needs to happen, I think, fairly soon because we're getting to another inflection point in radiology, where we have challenges on all sides. I think showing our value is extremely important, not only to the public, but also to payers, legislators. They need to know that what we do can lead to a cost savings. That, for instance, an MRI can lead to a cost savings. It's not all expense. That if we apply radiology early on in the medical cascade, we can actually save a lot of money in the long run by directing people to the correct imaging and the correct diagnosis early on. I'd like to tell our societies all the way from RS&A to our subspecialty societies that we really need to do a lot more funding of public relations.

[Dr. Jacob Fleming]
I'd agree with that completely, [Dr. William Morrison]. My focus is more on the interventional side and the clinical side. This is a problem I think about all the time when a patient asks, what is my specialty or what do I do? Even after a few years now, I'm still struggling to have that 15-second pitch down. It's much easier to say, "Oh, I'm a hip surgeon." Everyone gets that, than saying, "Well, I'm a radiologist who performs procedures from head to toe using image guidance and imaging diagnosis." A lot of people eye's start to glaze over in that part. I think it is a challenge to do this. I agree with you.

I think that having the more public relations there. I don't see this in any way that we have to exert our dominance or pound our chests in any way compared with the other specialties. I think that we bring something unique to the table in terms of what we've been talking about this entire discussion about seeing things from the imaging aspect and then seeing problems from a certain perspective over and over again, you start to think about different ways of solving them. Whereas historically, there's the old t-shirt or the adage that says, "Interventional radiology, inventing procedures for other specialties since whenever." Which is a little bit of a shame. I think it's great that eventually, these devices and ideas can get to a point where they're benefiting a lot of patients.

I think the more that radiologists are clinical and involved, it really provides an additional benefit as well. I'll tell you in my fellowship, we're very clinically heavy. We have clinic pretty much every single day and seeing patients all the time. The frequency with which the patients are coming in with an adequate and correct understanding of their diagnosis is actually close to 0%. Part of that has to be with, most patients are not seen by a surgeon or a subspecialty surgeon, the definitive treatment person. They go through different specialties of different degrees of expertise. Most of them are not really looking at the imaging. They may be looking at the imaging reports.

Of course, as a diagnostic radiologist, we're a little bit hamstrung. We don't have the patient in front of us to know what may or may not matter. When a patient comes in and they've got lateral hip pain and you see on the MRI that they have IT band friction syndrome findings or things like this, you can pinpoint exactly what that is. Using that skill set of diagnosis, which is acquired from sitting in the dark reading room for a long time and extrapolating that to a clinical setting, is something pretty special, I think we bring that to the table. At this point, just preaching to the choir, but I agree with you completely.