Rethinking orthopedic implants with Arthrosurface CEO Steve Ek | DeviceTalks Podcast

Sarah: Steve’s office is not your typical corporate office. It’s filled with models of the human skeletal system and demos of the company’s implants. It’s a good representation of Steve’s career in medtech, since he’s spent nearly 30 years building and selling orthopedic devices and implants.

Sarah: Steve is president & CEO of Arthrosurface and he’s also one of the company’s founders. He told me that the inspiration for the company’s technology came from talking to surgeons and learning that there was a group of patients that these surgeons just weren’t sure how to treat.

Steve: I saw, and a lot of surgeons saw this too, that when a patient is a certain age, they go from tearing their meniscus or tearing their ACL and needing a slight rotator cuff repair or whatever, then as you age on, some of that damage you did starts to turn into joint disease. And a lot of those injuries in fact trigger the start of those pathologies and time goes by, twenty years later and those patients now need more intervention.

Steve: So they sort of age out of the sports medicine world, and start entering into the total joint world. But now, with the activity levels of people and what-not, that’s a big bracket. So that people who are aging out, so that they can no longer really get a benefit from arthroscopic procedure but they’re arguably too young for total joint, they can get stuck in the middle and when we started this company, a lot of surgeons would say ‘Well, you’re too young for total joint so change your lifestyle, stop doing those activities, and come to me when you’re 55, 60.’ And we saw that so much, that we said, you know there’s a real opportunity here for the orthopedic tweeners if you will, and that’s when we started this company.

Steve: There was a moment where a founding surgeon, Tony Miniaci – who is now at the Cleveland Clinic but at the time practiced in Canada – I went to a closed meeting with him, where there were a number of surgeons presenting their patients that they couldn’t do anything else with and about six guys got up and showed individual cases of patients they had no idea how to treat and they were all joint defects where there was a loss of cartilage and they were symptomatic. So they were feeling the same pain you feel that drives you in to get a total knee or a total hip. They were feeling but the amount of damage was much earlier on. So, say you’re missing something besides a quarter on a joint surface, every time you take a step, you still feel that pain. But the joint, for the most part was still intact in these people, but they had a localized area that was gone. And all of them were basically disabled, if you will, or had to give up all of their activities because they were all symptomatic.

Steve: So we said, well why don’t we take the concept of doing a joint replacement but do a very small version of it and just replace this damaged area.

Sarah: It took four years for the company to complete its preclinical work and bring its first implants into human beings. Since then, Steve and his team have learned a lot about what it means to build a functioning implant.

Steve: What we learned was you have to develop an implant that will try to pass the loads through to the joint, in as close to a normal way as possible.

Steve: So then we looked at what have total joints done and a lot of them didn’t do that. A lot of joints, there’s a boney portion and most long bones in our body are hollow and so a lot of traditional joints would just stick a stem into these hollow spots, cut everything else off and rely on that sort of press-fit fixation into the stem or cement and expect that to try and last some amount of time.

Sarah: As it turns out, that’s not really the way our body works. That process doesn’t authentically replicate the load that the joints take on. So Arthrosurface tried something different, according to Steve.

Steve: So what we try to do is A: keep the implant as small as we could, keep the implants as thin as we could, and try to design the implant so it passes most of that load through in a normal, anatomic way. And so when you look at all of our implants, they all have a sort of similar attributes.

Steve: We have very thin implants, as thin as you can get them. And when you compare that to traditional joint replacements, they’re very different. So very thin implants so that some of the loads pass through. And then all of our implants also have this sort of, concept where we put a fixation element into the bone, it’s a tapered screw. It’s tapered so that each ring of the threading won’t shield the more proximal or more distal thread from the loads, and that thread and screw pass the loads into this, what’s called a subchondral bone. So all we’re trying to do is, if I put a load here, in engineering terms, you’ll see sort of a triangle of loads that form into the bone.

Steve: We just wanted to replicate that. Try to get the loads to go into the bone. There’s Wolf’s Law, in orthopedics. If you un-stress a bone, or change its stress, it will react. So people that have, that are involved in a lot of activities and exercise, their bone density increases. Because the body says, I need to thicken up this bone to make it stronger. People that don’t have thinner, less dense bones. If you shield a bone from a load, the body will resorb it. So that’s what we took, to have an implant that goes into a young patient and has to survive a long time, we have to maintain the bone around it, not just design the implant to last five million cycles, we have to design the system so it still passes the loads into the bone and preserves the bone.

Steve: We have to really recreate the existing geometry or else it will be a disaster, right? So, we learned how to do that fairly early on.

Sarah: The company has a number of implants in its portfolio, including ones for the shoulder, wrist, knee, foot and ankle. To figure out where the company should create new products, Steve told me they talk to doctors to find out where the most need lies.

Steve: There are a lot of operations and orthopedics where the procedure is designed to eliminate pain, but at great compromise to the function. And so when we see procedures like that, we’re like, okay, we got this, this is our sweet spot.

Sarah: Arthrosurface also determines new potential clinical areas for their products by learning that doctors are using existing products off-label. For the company’s wrist implant, for example, they learned that surgeons were using Arthrosurface’s toe product off-label in the wrist.

Sarah: And then, of course, there’s the question of how long the implants can last. Steve told me that when the company first launched, they conservatively told surgeons that the implants would last five years.

Steve: So when we first launched we were very conservative and said, this is an interim treatment it will buy you five years to continue your activities and then the other part of this is, we design all of our systems so that if the patient goes on to need a traditional joint replacement, you take our hardware out and it’s like they’re going in for a procedure like we were never there.

Sarah: But now, the company feels comfortable telling patients that they could get nearly a decade of use from their implants. And even more interestingly, Arthrosurface is exploring whether or not their implants could stop the progression of arthritis altogether.

Steve: We had two cohorts of patients with treatment group A and our treatment group, and we saw that at two years, with our implant in, we actually quiet the joint down. So you are halting some of those degenerative changes. So to me that’s one of our boldest claims we’ve made as a company. Imagine that if you, the historic thinking is, you just have to ride it out and then get a total joint. That paper to me, makes you challenge that and say, no you want to treat it and halt it, and you might be able to stop the progression. It’s a singular paper right now. But it’s, I think it’s something that can be, it will paradigm shift the thinking clinically over time if that continues to be born out.

Steve: I realize now, I had a rotator cuff repair a few years ago, and so you spend, you know, six-months regaining function of your shoulder. And I got a real appreciation for how frustrating it is, I mean you adapt because we’re humans and that’s what we do, and we’re realists, so we say, okay I don’t have my shoulder, so I’ll just figure out some other way to do it. But you learn that, wow my legs and hips get me there, but my shoulder allows me to do most everything else. And you start looking at things you are incapable of doing and you realize, you understand what the different parts of our body, it gives you kind of an evolutionary appreciation.

Steve: Okay first I have to ambulate to get there, then I have shoulders and hands and elbows to do the fine motor skills. Like you start realizing, okay I can do some things, but I can’t do other things, and it’s, I don’t know. We should all have to do six-weeks in a sling just to get a better appreciation.

Sarah: Steve also pointed out that the need for the company’s technology is really rooted in an aging population.

Steve: People born today, their life expectancy is somewhere around 120 years. The diseases that we are targeting start showing up in your forties. In the evolution of traditional orthopedics, you are getting an implant at 65 and presumably you are checking out 75, 80. So you have to really rethink the whole thing. You can’t just assume there’s gonna be a single intervention. There probably has to be multiple interventions along the way. So, I think we’re in a great spot where we are. And we’ll have to continue to watch.

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