FITM Extended Interview: Simon Mifsud (Garland Surgical, Ltd.)

Garland Surgical's flagship product, the TriActiv Hip (formerly known as the MaltaHip), replaces the ball-and-socket geometry that has defined hip arthroplasty for 120 years with a cylindrical bearing system inspired by the biomechanics of the ankle joint. Simon Mifsud, CEO of Garland Surgical, explains how this design virtually eliminates dislocation risk and reduced wear by 75 percent in accelerated testing.

Mifsud walks through how the cylindrical design achieves its stability advantage — larger contact area, linear reciprocating motion that avoids cross-shear of the polymer — and why surgeons at AAOS and ACUS told him stability matters far more to them right now than durability. He describes the four patient populations this technology targets, from chronic dislocators and post-spinal-fusion patients to the roughly half of the global population whose daily activities involve squatting and cross-legged sitting. The TriActiv Hip stays in place through all of it while offering range of motion that constrained liners cannot match.

https://www.garlandsurgical.health/

The business story is just as instructive. Garland Surgical is a University of Malta spinout navigating a pre-revenue funding landscape where deep-tech hardware competes against AI and digital health for investor attention. Mifsud shares how a hybrid of equity and non-dilutive grant funding — including a 1.4 million euro Malta Enterprise award — has kept the company moving, and how a successful FDA Q-sub cleared the biggest objection investors had. For innovators building physical devices in a software-obsessed market, this is a roadmap worth studying.

⏱️ Chapters:
00:00 Introducing Simon Mifsud and the TriActiv Hip
00:49 Why ankle biomechanics inspired a new hip design
02:54 Four underserved patient populations
06:19 How cylindrical bearings reduce wear debris
08:18 What "a hip for life" really means
09:41 Proof of concept: cadaver surgery and the garland pose
11:03 Cross-compatibility with existing femoral stems
13:11 Licensing model versus becoming an OEM
15:04 FDA 510(k) pathway and regulatory strategy
16:01 UK launch, ODEP, and training early adopters
17:26 Funding a hardware startup in a software-first market
20:23 How investor feedback shaped the regulatory approach
23:15 What surgeons at AAOS and ACUS actually wanted
26:46 Managing relationships with academic co-inventors
29:26 Where the TriActiv Hip fits in five years
33:27 What "from idea to market" means to Garland Surgical

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This podcast is intended for educational and informational purposes only.

The content discussed does not constitute medical advice and should not be used as a substitute for professional judgment. Clinicians should rely on their own training, experience, and clinical decision-making when applying information from this discussion.

#AnteriorHipFoundation #AHFPodcast #TriActivHip #GarlandSurgical #HipReplacement #TotalHipArthroplasty #THA #HipDislocation #CylindricalBearing #MedicalDeviceStartup #SimonMifsud #HipForLife #510k #OrthopedicInnovation

Transcript

Simon Mifsud 0:26

Hello, my name is Simon Mifsud and I'm a co-founder and the CEO of Garland Surgical Limited based in the UK. And we're developing a novel hip replacement system called the Malta Hip.

Joseph M. Schwab 0:37

Simon, take us to the beginning. What curiosity inspired this research into the difference between the ankle joint and the hip joint?

Simon Mifsud 0:49

Sure. Well, um, as you know, for 120 years, hip implants have been designed in the same basic way, a natural ball and socket, um, as, uh, we were given by nature and they've used different materials to try and improve, uh, performance and durability over time. Uh, typically some form of metal and some sort of polymer, but, you know, ceramics have been introduced and, uh. Clever coatings, et cetera. But there's always been this limitation on the longevity, uh, of and, and how long they'll last. And it's increased from about 15 years to, uh, 25 years now. But there've been incremental increases and, and nothing's really, um, taken a massive leap forward. So the geometry of the ball and socket when you are using these materials, uh, leads to, um, high wear when you have, especially when you have metal on polymer. And once the, once the hip, um, wears out or if there's a, a significant enough buildup of these wear particles, the body itself gets, uh, its own sort of autoimmune response and then you get a rejection of the implant and. Um, you know, aseptic loosening, um, osteolysis, et cetera. So, um, we have, uh, taken a, a different, a very different route, uh, to developing the, uh, the Malta hip. The ankle joint is a joint that doesn't suffer with arthritis in the same way that the hip does. And the reason is the biomechanical nature of its design and it's a cylindrical, uh, design essentially. So we've, uh, been able to incorporate everything that makes the ankle efficient in resisting. Um, by utilizing, um, three cylinders, each dealing with a, a plane of, or a degree of freedom. So, um, this has led to a, a massively reduced, uh, wear cycle, um, during the use of the, of the implant.

Joseph M. Schwab 2:55

addition to the uniqueness of this implant, Garland Surgical wants to address health inequality. In your opinion, what patient population is currently most underserved by today's standard hip replacement technology?

Simon Mifsud 3:11

That's a great question. Um, we've actually addressed four distinct patient groups that we think that we can, uh, that we can help. Um. The first probably is those patients who are chronic dislocators, so patients who've already had a, a, a procedure and, and require a revision, maybe, um, with a poorly pro, uh, positioned primary implant or they've had some sort of trauma, um, hip dysplasia patients. Who naturally will dislocate and, and the soft tissue around, um, their, their natural joint will be stretched out, let's say, um, or maybe even patients who've had some f form of, um, spinal fusion, particularly around the lumbar region, and they've got a reduced spinal pel. Um. Movement, which will lead to dislocation risks. So they probably would be our first patient groups that we would, um, would look to address. But then there are the younger active patients, sort of patients in their forties, fifties, um, who currently have to make a decision about having a hip replacement, don't they? They either have one when they actually need it, when they're, when they're immobile, when their quality of life is, is compromised. Or they wait and by waiting, their quality of life's gonna decrease. Their re uh, reliance on pain meds and anti-inflammatories is gonna increase and what they can actually get up, get up to, and, and do. Um, the third group of patients, um, is probably those patients who are active at any age. Okay. So, uh, we're all living a lot longer. And many, many areas around the globe. Uh, there are patients living well into their a hundred years of age and they're demanding more modern patients, demanding more from their implants. And they wish to do things like yoga, play tennis, play golf, what have you. And these are all, um, as we get older, as you know, um, the, um, musculoskeletal system, um. It becomes compromised not only from a bone perspective, but from the, the surrounding soft tissue and connective tissue. So they're at risk of deification, um, most likely because, um, they'll put their, their new joint into positions where the soft tissue can't help them to, to maintain the, the integrity of the joint. And then finally, um, which is, uh, which is a, a huge group of patients actually. Um, these are the patients where, um. A high degree of mobility is required because of the way that they, um, perform their activities of daily living. So populations where cross-legged sitting, uh, squatting and general floor based living is, is the norm. And that's probably up to half of the, of the global population and, uh, current hip replacements if put into those positions. Um, are quite likely to dislocate, um, and, uh, especially within the first 12 to 24 months. So the multi hips, unique stability, um, combined with a wide range of, of, of mobility that it offers, um, allows those populations to move freely without compromise, really.

Joseph M. Schwab 6:20

So you talked a little bit about the cylindrical bearing portion of the Malta hip. How does moving from that traditional spherical design to a cylindrical one solve the wear debris problem?

Simon Mifsud 6:33

Okay, well, um, it's, um, it boils down to first principle engineering actually. So, uh, in the first instance, a cylindrical bearing geometry, um, with the articulation in a. A linear reciprocating motion for each of those degrees of freedom, uh, provides an implant with a larger contact area, um, than compared to the sort of legacy spherical ball and socket design. And that increases the point of contact and reduces the stresses that linear articulation also doesn't, um, cross the molecular chains of the polymer polymers. So we don't. Find that we are getting cross share, and it's that cross share effect that creates the wear debris and dependent on the volume and the particle size, whether it's bioactive, uh, size or not, will depend on the, on the speed that the body, um, eventually, uh, rejects, uh, rejects the implant. So it's a combination of two things really. The, the cylindrical design allows us to, to, to have that cylin, uh, that, uh, cylindrical reduction in, in, in, uh, contact stress and the, um, the articulation doesn't generate wear. And in fact, in the accelerated wear testing that we did, um, on a, on a fairly uh, um. Basic, uh, prototype, uh, for the proof of concept that we did. Uh, we reduced the wear, uh, reduction by 75%. In fact, they couldn't actually measure the wear particles, uh, by comparison to a, uh, comparative, uh, ball and socket design hip using, um, highly cross-link, uh, polyethylene.

Joseph M. Schwab 8:19

So one of the aims that your company reports is creating a Hip for Life, and that phrase, hip for life, is it specifically in reference to the wear debris or does it mean something else?

Simon Mifsud 8:34

I think we are using the, the, the phrase in the broadest sense. So a hip for life, uh, means that patient can receive their implant at a point when they need it. Not when they are old enough to outlive it, let's say, and they can live their life, whatever that happens to be. If they are younger, active patients or older active patients and they pursue activities such as golf, tennis, horse riding, surfing, whatever, whatever it might be, or even if they just want to get down on the floor, um, play with their grandkids, you know, they can actually live their lives. We also take it as meaning that it's one hip replacement during the lifetime of that patient. So whilst right now, as mentioned, um, younger patients are having to wait really, or making that decision either wait and put up, um, or have the surgery and have multiple surgeries. So we took that, um, uh, saying, uh, and, and, and use it in the broadest sense of, of what it means.

Joseph M. Schwab 9:41

So this concept was clearly a a thought experiment at one point, but at some point it became viable beyond just a theory. What was the earliest moment of feedback that you received or data that you were able to gather that proved this concept was gonna be viable?

Simon Mifsud 10:03

There were probably two moments, uh, to be fair, that made us realize that the concept was. Viable behind the, uh, behind theory. Um, in June of 2019, we did our first cava um, surgery at the University of Malta, and two multis surgeons tested, uh, and implanted the device using a standard, um, approach, and they were able to demonstrate the resistance to dislocation of the implant. Demonstrating that the, the hip remains stable, even at leg positions that are usually prone to dislocation. For example, sitting cross-legged or putting a leg into a figure of four or a deep squat. And in fact, that's when the, um. When the idea came about that this device would allow a patient to get into, uh, the deep squat in yoga, which is known as the malana pose, but is also known as the garland pose, and that's where we drew our name from.

Joseph M. Schwab 11:04

You also designed this, uh, the Malta hip to be compatible with existing stems, and so how do you ensure sort of cross compatibility with across other companies' products?

Simon Mifsud 11:18

Yeah, I mean, it's a great question. So, uh, one route we could go down is to try and validate this, uh, this acetabular system, let's call it, uh, with every stem that's available out there. But that would be very, very costly. Um, so. Actually, uh, last month, uh, we went out to Dallas to the acus meeting and we met with a number of, um, vendors and manufacturers and have identified. At least half a dozen companies that are willing to work with us and provide us with a stem. Uh, and our intention is to pick the best one. Um, that is, uh, gonna suit the primary and hopefully we're developing a revision system version as well. So we may need some slightly different stems, but we. Developed it with a, uh, to be compatible with a standard taper. So for us, it's just a case of adjusting the, the finish and the taper engagement to be able to be compatible with that stem. Um, and then we'll do all of the validation work, um, that we need to do to get it, um, through the, uh, the bench testing, uh, for regulatory clearance for FDA and um, for MDR. So, um, throughout the general, the, the general, uh, development of the malhi, we've tried to remain as company agnostic as possible because our ultimate aim, and I think the quickest way to get this device out to market is to de-risk it to a certain level, get the regulatory clearance, um, done. We controlling the IP as well. And then license it out to a larger orthopedic organization with existing sales channels, existing customer base, um, so that we can start to generate clinical data, um, in the quick fashion, but the safest fashion. So.

Joseph M. Schwab 13:11

Were there reasons other than speed or safety that you chose a licensing model over becoming sort of a full scale OEM yourself, or was it, were those the primary reasons?

Simon Mifsud 13:23

So I think those were the primary reasons. Um, obviously nothing is, nothing is set in stone. Um, and as a small, um. Pre-revenue startup, we can't predict the future, right? So we have to, um, we have to have our game face and we, um, this is what we would like to be able to do and this is what we're working to be able to do, and we have to back ourselves in that, right? But, um, we also have, uh, the ability to, um, to manufacture ourselves. I mean, all of the. All of the prototypes that we've manufactured, we took the decision early on because of that very reason that we'd work with, uh, large orthopedic OEM manufacturing groups. So all of our critical suppliers, all of our manufacturers are, um, capable of making this device on our behalf. And because they've been involved in the, in the development, let's say, and producing the prototypes. Um, they are fully aware of what's required. They have already, um, started to work with us, uh, to work out how we can scale this device and produce it in, in large numbers. Um. So we've got, uh, we've got a couple of options open to us. Obviously, we're gonna take the best option, um, for the shareholders and the stakeholders within the organization. Um, but you know, with my background, I've been involved in 30, uh, in orthopedics for 35 years. So I have a lot of orthopedic distributor friends out there, um, who would like to have a sniff at the, at the malls hip if it became available. So, um, if we have to go down that route, we will, but it'll be a just, it'll just be a longer journey. So.

Joseph M. Schwab 15:03

And how does this partnership model change your approach to, for instance, FDA clearance, which you mentioned versus submitting the device on your own?

Simon Mifsud 15:13

It doesn't really, because, um, it doesn't really affect it at all. Actually, to be fair, because we're gonna white label the, um, the femoral stamp component. So we will, um, we'll subject the, uh, the device to the FDA's, um, rigor, uh, alongside the stamp. So, um, the stems that we are looking at at the moment all have a five 10 K clearance, so there won't be any issue, um, with that as long as the device passes all the bench testing that we're required to do. And believe me, there's a list, uh, as long, there's two of my arms, uh, uh, bench testing that we'd have to do to get that clearance. But it's all part and parcel and it's what you'd expect to bring a, a hip replacement to market these days. So we're fairly comfortable and confident that we're gonna be able to manage that.

Joseph M. Schwab 16:01

Are there hurdles in the UK with getting it listed on Odep, for instance?

Simon Mifsud 16:08

No, not, not really. I mean, it has to start to be implanted. Um, f that's the first hurdle. So with, um, with the FDA, uh, recently announcing that there, uh, is an alignment with, uh, UK CA, um, for the five 10 Ks, then that might be, uh, advantageous to us. We'll have to just wait and see how that pans out. Um. But, uh, we will have to, um, find some product champions here in the UK who are willing to, uh, to utilize and use the hip. Um, and then. It'll start to develop and build its own up rating over a period of time. Um, that's not something that you can buy or purchase. It's, it's, it's, it's time served and it's based on the clinical results. So it's only time will tell on that, but we are going to carefully launch this product, um, train the people that are gonna use it well, uh, because there are a couple of nuances in terms of orientation, um, et cetera, that need to be taken into, uh, consideration when implanting it to get the best out of it. Um, and those initial sort of early users, we would hope would help us to kind of roll out, uh, the use of the device in a, in a very structured, organized way, uh, to make sure that, um, it's been used correctly. So,

Joseph M. Schwab 17:26

You had mentioned about delivering for your shareholders and your stakeholders. Currently, you're navigating that sort of crucial funding phase for, uh, a company like this. What's been your biggest challenge for securing capital? Um, for what one could describe as a really innovative, slightly different product than normal, that's preclinical.

Simon Mifsud 17:50

Yeah. Um, so you're right. The biggest challenge, uh, for us has been, um, has been finding investors who. Understand this space. Okay. So there are a lot of medical device or deep tech, uh, investors out there, but they got used to, and certainly definitely post COVID, um, investing in companies that can give them a quicker return like digital, like ai. Um, and obviously we're good old fashioned, uh, metal and polymers, so we are not as sexy, uh, as some of those new digital technologies. So, um. The number of investors that are willing to listen, uh, is, is, is, is, is a lot smaller. So you, you know, and I think, um, the way we've got around that is just by being dogged and determined and speaking to anybody that would listen. You know, I'm very often carrying a mal hip around in my pocket. Uh, so you never know who you're gonna have a conversation with. I attend a lot of networking events. I try and teach to talk to as many, um, industry experts, um, investors as possible, and just doing my due diligence myself really, and just finding out who actually has operated in that space and invested in that space. But it is, um, it is a case of, of being really, uh, determined. Um, the other thing that I recognized quite early on is that if we. If we sought grant uh, funding as well in parallel with the, the diluted funding that equity, uh, investment brings. It gave, if you like, a bit of a supercharge to any investment that was made. So we've been really successful at that and we've developed a lot of in-house capability at um. Applying for grants and we've been quite successful. We won an Innovate UK smart award of, of half a million pounds initially, and then some subsequent smaller awards that were, um, made available to us locally and more recently as part of our, uh, existing seed round that we're just closing this month. Actually we won 1.4 million euros in grant funding, uh, for r and d. From multi enterprise. So that's been really helpful because it brings an additional, um, amount of cash into the pot that is non-diluted. So anybody that's coming in or for, even for existing investors and shareholders, they're not diluting whilst we're still making progress. So that combination of that hybrid approach has worked really, really well for us.

Joseph M. Schwab 20:23

Has there been any interesting feedback that you've received from these potential investors? Anything memorable for you that has maybe altered the way you've considered going about either developing or thinking about marketing the product?

Simon Mifsud 20:38

Not necessarily from the investors. One of the biggest concerns from the investors that we've spoken to, and, and believe me, I've spoken to hundreds, um, was the ability to get, uh, a regulatory clearance for this device because it was so novel. I mean, everybody got that. It was unique. Everybody gets that. It's a elegant, uh, solution. But there was concern around the ability to get some, some, um. Some regulatory clearance. Now, we did in the summer our, um, our Q sub with the FDA and, um, we used a, a really, um, experienced company, uh, from the US called Bruta Consulting to help us get across that line. Uh,'cause we had, none of us internally had experience of dealing with the FDA and that was extremely helpful to have that level of support and expertise. And we had, um, I, I guess a, a really enlightening conversation with the FDA when it came to the, the opportunity to talk to them in our teleconference call. And they were really happy to see the device. Uh, they felt that it was really, uh, unique and had some, um, some opportunities for the patients that I described to you earlier on in the, in, in the conversation. But. Um, they also felt that provided, we met, uh, the bench testing requirements that they were going to sort of lay out for us. Um, then there was a, there was a route to, to regulatory. So that gave, I think, um, those investors that were sort of sitting on the fence, if you like, um, um, more confidence that this, this had a route, um, without having to go down like a PMA route, say, for example, which would take a lot more money and a lot more time. And as mentioned, you know. There's a, I mean, a few investors that are willing to kind of wait that length of time, um, probably to, to, to, to, to bring something like this, to market. So I think we've been, um. We've been clever, uh, in the way that we've approached it, uh, just to make sure that, you know, we we're de-risking at every level. And I think that's really important. Um, certainly for something that's quite novel. You know, you have to build confidence incrementally. Um, you, you're not just gonna get instant credibility no matter who you are. So you have to, you know, build your team well, uh, to give that confidence and those, those members of the team have to deliver so that for the money that you're getting off investors, you know, for every dollar that you spend, there's, there's a, there's an, a advance forward and, and we've been able to demonstrate that, which I'm, I'm really pleased about. So,

Joseph M. Schwab 23:16

You're also actively seeking critiques from surgeons. Um, what's the most useful piece of advice you've received from any of your surging critics so far?

Simon Mifsud 23:28

So that's been, um, massively helpful to us and we've been over, uh, we plan to launch in the US first, right? So we did three things. Um, before we spent a dollar on, um, on r and d. Uh, we spent about$20,000 on some independent market research in the us. And that was really important to us.'cause like everybody thinks their baby's beautiful, right? So we wanted other people to, you know, to say, yeah, this has got legs, if you'll excuse the pun. And there's, there's an opportunity here for, um, for us to use it. So we did that and we had a very positive response. Okay. But that was like, you know, uh, independent market research. Earlier this year we attended Academy, um, in San Diego, and that was the first chance that we got to speak to us. Surgeons face-to-face actually put the device in their hands. Uh, we took, um, a dislocation model called Eddie, who we, who we take around with us. Uh, and he's got a, a dual mobility modular dual mobility implanted in one side. And a, uh, malt hip implanted in the other, so we can show the range of motion, the comparative, et cetera. The biggest takeaway that we got is that, um, the durability element is not necessary. Their biggest concern, it's the stability side. Um, because those are the things that are affecting, affecting them in the here and now. Obviously, you know, we're using, um, we are using. Advanced materials that are, are, are routinely used at the moment. So our poly is a highly cross-linked, uh, vitamin E rich poly. Um, so the, the stability element though is something that everyone is suffering with. Um, you know, okay. The anterior um, approach has reduced that quite dramatically, but it, it's still possible for, for a highly active patient or, you know, a set of circumstances to. To, to occur and, um, where, where the, where the hip can dislocate. And I was talking to a surgeon who, who had his patient's hip dislocate postoperatively as they were taking an x-ray as they turn the patient over. These things happen very unfortunate, but these things happen, right? That's not possible with our device. And we were able to demonstrate that very nicely with our dislocation models. So all the advice that we, uh, that we got, um, from a a OS. Really focused our, um, attention on the stability. And that's what we did, um, have done, um, for the last six months. And we took all of that learning and all of that progress to acus, uh, in Dallas. Um, we didn't actually have a stand, um, in acus. We, um, we pulled Eddie around on the back of a trolley and, uh, gave him a set of cowboy boots. Just fitting for the Texan, um, the Texan location. And we had a lot of conversations with surgeons who were just curious about what we were doing, uh, with this skeletal model to hip replacements and cowboy boots. But they, you know, they, they really helped us to like laser focus in how we're going to approach, uh, the launch of this, of, of this device.

Joseph M. Schwab 26:47

For our innovators who are listening, do you have advice about how to manage specifically relationships with academic inventors? Bringing them through a commercialization journey's unique, set up a, a unique set of circumstances.

Simon Mifsud 27:04

Yeah, I think managing the relationship with the original inventors, especially if they're co-founders, um, is really important and it's certainly been important to us. In our development and our commercial journey. I mean, these guys aren't business people, so they don't understand. So having clear communication, um, being able to kind of explain in simple terms what a particular step means or what a particular contract means, um, is really useful. And they appreciate that massively because they're not involved in the type of conversations that I'm involved in, say, on a day-to-day basis. So that's been really, really helpful. And as a result, you know, they continue to generate, uh, energy and ideas and they've been, uh, creatively inputting still into our, into our development. And as I mentioned. Um, you know, one of the co-inventors, Donald Dally, he's actually one of our employees now, so he's our principal development and en engineer. Um, and he is just so excited and, and energized to be part of the development, uh, continued development of the device from what was a proof of concept when we got our hands on it to something that you could look at and, and you would. You wouldn't be able to tell that it wasn't a hip replacement that could be implanted. So, you know, using, you know, state-of-the-art, uh, additive manufacturing, umm uh, manufacturing capabilities, direct compression molding of highly cross-linked poly, you know, it, it, it, it looks, the, it looks part, we just got to now prove that it can do what we say, uh, it can do, or we believe it can do. So having them involved has been massively, massively, um, helpful to us. And actually setting up our subsidiary of Malta, um, allowed us to continue to work with the University of Malta who are also shareholders.'cause we're a spin out essentially from the University of Malta, so the four inventors and the University of shareholders within our company. So every time I go to Malta, uh, which is about once a quarter, I, I'm sure to arrange a meeting as where we explain what we've been doing. And just having that chew and fro of information is, is, is very important. I think if you ignore them, then you are missing a massive opportunity as well as just, you know, ticking them off. So.

Joseph M. Schwab 29:27

Looking ahead, um, where do you see the Malta hip fitting into standard arthroplasty practice, say in the next five years?

Simon Mifsud 29:38

So let's just imagine that it's probably gonna take us three years, uh, to get, to get to market, or maybe our first inhuman. And I think we are gonna take a very staged approach. Um. We're focusing on those, those difficult patients that every surgeon probably has. Um, those, um, repetitive dislocators those people with instability. Um, and like this thing works like a constrained liner, right? So it, it, it, it, it keeps the hip in, in place. But where it differs from the constrained liner is that it has a massive range of motion. Whereas a constrain line has a very limited range of motion. So this is gonna immediately appeal to those surgeons because they will, you know, some of those patients are really young, um, and they're gonna want a device that gives them the comfort and the confidence. And also that gives the patient the comfort and the confidence that they're not gonna dislocate when they perhaps, uh, forget themselves or do something silly or, you know, when, when, when they get, get out and, uh, and do. What they do in, in life. And I believe, um, then I mentioned four different patient groups. So we are gonna continue with a regulatory journey into Europe. Uh, into Asia, um, and, and the Middle East, um, UK will come with the European, um, or possibly with the, uh, with the, with the five 10 k, uh, alignment as, as we already discussed. So. These things evolve. But, um, once surgeons start to build their own confidence with the device, then this device is eminently suitable or will be eminently suitable for, for the majority of patients out there. So, whether it's a, you know, an 80-year-old lady who, who just needs com comfort that the hip's not gonna dislocate when she swings her affected leg, leg out of bed to get out of bed or pull her. Socks on to keep warm, um, to a, you know, 50-year-old, you know, guy that wants to keep going to the gym or wants to go for a jog or what have you. So I think there's a wide range of patients that it would be suited for. Um, but we need to build that, you know, that confidence not only, uh, in for individual surgeons, but just for, I guess, the community because it is so different, 120 years of a ball and socket. Implant is gonna take a little bit of changing, but those surgeons that we've shown it to, that perhaps have a more engineering focused mind, get it straight away. They have concerns absolutely right, that they should, and we are gonna address those concerns, but they get what it could possibly offer and, and, and that it'll, it's gonna be those guys, I guess that will probably put the hand up and use it first, uh, in the, in the early, early stages. And that's great because they'll understand some of the nuances that are required for this type of device. So yeah, I mean, we are not looking to, uh, flick a switch and, and, and, and have global domination. Um, you know, for me, I think the ability to offer something that has truly transformative, um, properties not only to patients, but to surgeons and healthcare providers alike. Um. By reducing perhaps the rev number of revision surgeries, the number of dislocations, um, and giving people the ability to get back to their lives, get back to being active, get back to being productive. You know, that has a massive thing. And that's, I feel, really honored to be leading the charge in that, uh, in that regard. And I back myself to achieve that and I back my team most importantly.'cause without now, I wouldn't be able to get, uh, to get to that spot. So.

Joseph M. Schwab 33:28

So our series is called From Idea to Market, and in in one or two sentences, what would that phrase mean to you personally at this stage of Garland Surgicals journey?

Simon Mifsud 33:42

Well, I think, um, for me, um, just having the team around me to be able to, uh, to develop out. The proof of concept Malta hip to where it is today has been, uh, uh, inspiring, but within a short period of time and with relatively limited funds, you know, we've developed a primary cup, um, through, with the latest, um, manufacturing techniques. I ality manufacturing and, and direct compression molding. We've developed a, a, a hip revision system, variant of it. So I think, um. The team around me inspires me, and I've always, I've always sought to employ people who are far more intelligent and far more capable than me because, uh, they make me look good at the end of the day because I'm leading the charge. And, but I'm gonna give them credit because without them we wouldn't be where we are today. And that's all stakeholders involved, not, not just staff. Uh, employees, but the advisory board that we have that are guiding us along the way and the existing shareholders and co-founders, so, um, that team is, is, is absolutely crucial. Without it, you're never gonna get, achieve what you need to do and, and just handing me ability to back yourself and back them.

Joseph M. Schwab 35:05

Simon, thank you for talking with us today.

Simon Mifsud 35:08

It's been my pleasure. I hope, uh, it's been useful for you and interesting for your listeners to hear about the, the journey of the Malta Hip.