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

• 0:26
  Simon Mifsud: Hello, my name is Simon Mifsud and I'm a co-founder and the CEO of Garland Surgical Limited based in the UK.
• 0:33
  Simon Mifsud: And we're developing a novel hip replacement system called the Malta Hip.
• 0:37
  Joseph M. Schwab: Simon, take us to the beginning.
• 0:40
  Joseph M. Schwab: What curiosity inspired this research into the difference between the ankle joint and the hip joint?
• 0:49
  Simon Mifsud: Sure.
• 0:49
  Simon Mifsud: 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.
• 1:09
  Simon Mifsud: Uh, typically some form of metal and some sort of polymer, but, you know, ceramics have been introduced and, uh.
• 1:15
  Simon Mifsud: Clever coatings, et cetera.
• 1:17
  Simon Mifsud: But there's always been this limitation on the longevity, uh, of and, and how long they'll last.
• 1:22
  Simon Mifsud: And it's increased from about 15 years to, uh, 25 years now.
• 1:27
  Simon Mifsud: But there've been incremental increases and, and nothing's really, um, taken a massive leap forward.
• 1:34
  Simon Mifsud: 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.
• 1:45
  Simon Mifsud: 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.
• 2:00
  Simon Mifsud: Um, you know, aseptic loosening, um, osteolysis, et cetera.
• 2:04
  Simon Mifsud: So, um, we have, uh, taken a, a different, a very different route, uh, to developing the, uh, the Malta hip.
• 2:15
  Simon Mifsud: The ankle joint is a joint that doesn't suffer with arthritis in the same way that the hip does.
• 2:23
  Simon Mifsud: And the reason is the biomechanical nature of its design and it's a cylindrical, uh, design essentially.
• 2:30
  Simon Mifsud: So we've, uh, been able to incorporate everything that makes the ankle efficient in resisting.
• 2:38
  Simon Mifsud: Um, by utilizing, um, three cylinders, each dealing with a, a plane of, or a degree of freedom.
• 2:46
  Simon Mifsud: So, um, this has led to a, a massively reduced, uh, wear cycle, um, during the use of the, of the implant.
• 2:55
  Joseph M. Schwab: addition to the uniqueness of this implant, Garland Surgical wants to address health inequality.
• 3:03
  Joseph M. Schwab: In your opinion, what patient population is currently most underserved by today's standard hip replacement technology?
• 3:11
  Simon Mifsud: That's a great question.
• 3:12
  Simon Mifsud: Um, we've actually addressed four distinct patient groups that we think that we can, uh, that we can help.
• 3:18
  Simon Mifsud: Um.
• 3:19
  Simon Mifsud: 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.
• 3:36
  Simon Mifsud: 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.
• 3:53
  Simon Mifsud: Um.
• 3:54
  Simon Mifsud: Movement, which will lead to dislocation risks.
• 3:56
  Simon Mifsud: So they probably would be our first patient groups that we would, um, would look to address.
• 4:03
  Simon Mifsud: 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?
• 4:13
  Simon Mifsud: They either have one when they actually need it, when they're, when they're immobile, when their quality of life is, is compromised.
• 4:20
  Simon Mifsud: Or they wait and by waiting, their quality of life's gonna decrease.
• 4:25
  Simon Mifsud: 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.
• 4:34
  Simon Mifsud: Um, the third group of patients, um, is probably those patients who are active at any age.
• 4:43
  Simon Mifsud: Okay.
• 4:44
  Simon Mifsud: So, uh, we're all living a lot longer.
• 4:47
  Simon Mifsud: And many, many areas around the globe.
• 4:49
  Simon Mifsud: 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.
• 4:57
  Simon Mifsud: And they wish to do things like yoga, play tennis, play golf, what have you.
• 5:01
  Simon Mifsud: And these are all, um, as we get older, as you know, um, the, um, musculoskeletal system, um.
• 5:07
  Simon Mifsud: It becomes compromised not only from a bone perspective, but from the, the surrounding soft tissue and connective tissue.
• 5:15
  Simon Mifsud: 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.
• 5:28
  Simon Mifsud: And then finally, um, which is, uh, which is a, a huge group of patients actually.
• 5:33
  Simon Mifsud: Um, these are the patients where, um.
• 5:37
  Simon Mifsud: A high degree of mobility is required because of the way that they, um, perform their activities of daily living.
• 5:45
  Simon Mifsud: So populations where cross-legged sitting, uh, squatting and general floor based living is, is the norm.
• 5:51
  Simon Mifsud: And that's probably up to half of the, of the global population and, uh, current hip replacements if put into those positions.
• 6:00
  Simon Mifsud: Um, are quite likely to dislocate, um, and, uh, especially within the first 12 to 24 months.
• 6:07
  Simon Mifsud: 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.
• 6:20
  Joseph M. Schwab: So you talked a little bit about the cylindrical bearing portion of the Malta hip.
• 6:25
  Joseph M. Schwab: How does moving from that traditional spherical design to a cylindrical one solve the wear debris problem?
• 6:33
  Simon Mifsud: Okay, well, um, it's, um, it boils down to first principle engineering actually.
• 6:38
  Simon Mifsud: So, uh, in the first instance, a cylindrical bearing geometry, um, with the articulation in a.
• 6:45
  Simon Mifsud: 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.
• 6:58
  Simon Mifsud: 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.
• 7:10
  Simon Mifsud: So we don't.
• 7:11
  Simon Mifsud: 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.
• 7:30
  Simon Mifsud: So it's a combination of two things really.
• 7:33
  Simon Mifsud: 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.
• 7:46
  Simon Mifsud: And in fact, in the accelerated wear testing that we did, um, on a, on a fairly uh, um.
• 7:54
  Simon Mifsud: Basic, uh, prototype, uh, for the proof of concept that we did.
• 8:00
  Simon Mifsud: Uh, we reduced the wear, uh, reduction by 75%.
• 8:03
  Simon Mifsud: 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.
• 8:19
  Joseph M. Schwab: 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?
• 8:34
  Simon Mifsud: I think we are using the, the, the phrase in the broadest sense.
• 8:38
  Simon Mifsud: So a hip for life, uh, means that patient can receive their implant at a point when they need it.
• 8:47
  Simon Mifsud: Not when they are old enough to outlive it, let's say, and they can live their life, whatever that happens to be.
• 8:54
  Simon Mifsud: 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.
• 9:13
  Simon Mifsud: We also take it as meaning that it's one hip replacement during the lifetime of that patient.
• 9:19
  Simon Mifsud: 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.
• 9:32
  Simon Mifsud: So we took that, um, uh, saying, uh, and, and, and use it in the broadest sense of, of what it means.
• 9:41
  Joseph M. Schwab: So this concept was clearly a a thought experiment at one point, but at some point it became viable beyond just a theory.
• 9:52
  Joseph M. Schwab: 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?
• 10:03
  Simon Mifsud: There were probably two moments, uh, to be fair, that made us realize that the concept was.
• 10:10
  Simon Mifsud: Viable behind the, uh, behind theory.
• 10:13
  Simon Mifsud: 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.
• 10:32
  Simon Mifsud: Demonstrating that the, the hip remains stable, even at leg positions that are usually prone to dislocation.
• 10:40
  Simon Mifsud: For example, sitting cross-legged or putting a leg into a figure of four or a deep squat.
• 10:45
  Simon Mifsud: And in fact, that's when the, um.
• 10:48
  Simon Mifsud: 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.
• 11:04
  Joseph M. Schwab: 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?
• 11:18
  Simon Mifsud: Yeah, I mean, it's a great question.
• 11:20
  Simon Mifsud: 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.
• 11:30
  Simon Mifsud: But that would be very, very costly.
• 11:33
  Simon Mifsud: Um, so.
• 11:36
  Simon Mifsud: 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.
• 11:47
  Simon Mifsud: At least half a dozen companies that are willing to work with us and provide us with a stem.
• 11:53
  Simon Mifsud: Uh, and our intention is to pick the best one.
• 11:56
  Simon Mifsud: Um, that is, uh, gonna suit the primary and hopefully we're developing a revision system version as well.
• 12:04
  Simon Mifsud: So we may need some slightly different stems, but we.
• 12:07
  Simon Mifsud: Developed it with a, uh, to be compatible with a standard taper.
• 12:11
  Simon Mifsud: 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.
• 12:20
  Simon Mifsud: 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.
• 12:34
  Simon Mifsud: 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.
• 12:54
  Simon Mifsud: We controlling the IP as well.
• 12:57
  Simon Mifsud: 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.
• 13:10
  Simon Mifsud: So.
• 13:11
  Joseph M. Schwab: 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?
• 13:23
  Simon Mifsud: So I think those were the primary reasons.
• 13:26
  Simon Mifsud: Um, obviously nothing is, nothing is set in stone.
• 13:30
  Simon Mifsud: Um, and as a small, um.
• 13:34
  Simon Mifsud: Pre-revenue startup, we can't predict the future, right?
• 13:38
  Simon Mifsud: 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?
• 13:49
  Simon Mifsud: But, um, we also have, uh, the ability to, um, to manufacture ourselves.
• 13:56
  Simon Mifsud: I mean, all of the.
• 13:58
  Simon Mifsud: 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.
• 14:09
  Simon Mifsud: So all of our critical suppliers, all of our manufacturers are, um, capable of making this device on our behalf.
• 14:15
  Simon Mifsud: And because they've been involved in the, in the development, let's say, and producing the prototypes.
• 14:21
  Simon Mifsud: Um, they are fully aware of what's required.
• 14:24
  Simon Mifsud: 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.
• 14:32
  Simon Mifsud: Um.
• 14:33
  Simon Mifsud: So we've got, uh, we've got a couple of options open to us.
• 14:36
  Simon Mifsud: Obviously, we're gonna take the best option, um, for the shareholders and the stakeholders within the organization.
• 14:42
  Simon Mifsud: Um, but you know, with my background, I've been involved in 30, uh, in orthopedics for 35 years.
• 14:48
  Simon Mifsud: 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.
• 14:56
  Simon Mifsud: 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.
• 15:02
  Simon Mifsud: So.
• 15:03
  Joseph M. Schwab: And how does this partnership model change your approach to, for instance, FDA clearance, which you mentioned versus submitting the device on your own?
• 15:13
  Simon Mifsud: It doesn't really, because, um, it doesn't really affect it at all.
• 15:16
  Simon Mifsud: Actually, to be fair, because we're gonna white label the, um, the femoral stamp component.
• 15:22
  Simon Mifsud: So we will, um, we'll subject the, uh, the device to the FDA's, um, rigor, uh, alongside the stamp.
• 15:32
  Simon Mifsud: 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.
• 15:44
  Simon Mifsud: 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.
• 15:51
  Simon Mifsud: But it's all part and parcel and it's what you'd expect to bring a, a hip replacement to market these days.
• 15:56
  Simon Mifsud: So we're fairly comfortable and confident that we're gonna be able to manage that.
• 16:01
  Joseph M. Schwab: Are there hurdles in the UK with getting it listed on Odep, for instance?
• 16:08
  Simon Mifsud: No, not, not really.
• 16:09
  Simon Mifsud: I mean, it has to start to be implanted.
• 16:11
  Simon Mifsud: Um, f that's the first hurdle.
• 16:13
  Simon Mifsud: 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.
• 16:26
  Simon Mifsud: We'll have to just wait and see how that pans out.
• 16:29
  Simon Mifsud: Um.
• 16:30
  Simon Mifsud: 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.
• 16:38
  Simon Mifsud: Um, and then.
• 16:40
  Simon Mifsud: It'll start to develop and build its own up rating over a period of time.
• 16:44
  Simon Mifsud: Um, that's not something that you can buy or purchase.
• 16:47
  Simon Mifsud: It's, it's, it's, it's time served and it's based on the clinical results.
• 16:51
  Simon Mifsud: 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.
• 17:10
  Simon Mifsud: 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.
• 17:24
  Simon Mifsud: So,
• 17:26
  Joseph M. Schwab: You had mentioned about delivering for your shareholders and your stakeholders.
• 17:31
  Joseph M. Schwab: Currently, you're navigating that sort of crucial funding phase for, uh, a company like this.
• 17:37
  Joseph M. Schwab: What's been your biggest challenge for securing capital?
• 17:41
  Joseph M. Schwab: Um, for what one could describe as a really innovative, slightly different product than normal, that's preclinical.
• 17:50
  Simon Mifsud: Yeah.
• 17:51
  Simon Mifsud: Um, so you're right.
• 17:53
  Simon Mifsud: The biggest challenge, uh, for us has been, um, has been finding investors who.
• 18:00
  Simon Mifsud: Understand this space.
• 18:02
  Simon Mifsud: Okay.
• 18:02
  Simon Mifsud: 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.
• 18:19
  Simon Mifsud: 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.
• 18:27
  Simon Mifsud: So, um.
• 18:29
  Simon Mifsud: The number of investors that are willing to listen, uh, is, is, is, is, is a lot smaller.
• 18:35
  Simon Mifsud: 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.
• 18:45
  Simon Mifsud: You know, I'm very often carrying a mal hip around in my pocket.
• 18:49
  Simon Mifsud: Uh, so you never know who you're gonna have a conversation with.
• 18:52
  Simon Mifsud: I attend a lot of networking events.
• 18:55
  Simon Mifsud: 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.
• 19:09
  Simon Mifsud: But it is, um, it is a case of, of being really, uh, determined.
• 19:14
  Simon Mifsud: Um, the other thing that I recognized quite early on is that if we.
• 19:19
  Simon Mifsud: If we sought grant uh, funding as well in parallel with the, the diluted funding that equity, uh, investment brings.
• 19:27
  Simon Mifsud: It gave, if you like, a bit of a supercharge to any investment that was made.
• 19:32
  Simon Mifsud: So we've been really successful at that and we've developed a lot of in-house capability at um.
• 19:38
  Simon Mifsud: Applying for grants and we've been quite successful.
• 19:40
  Simon Mifsud: 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.
• 19:55
  Simon Mifsud: Actually we won 1.4 million euros in grant funding, uh, for r and d.
• 20:01
  Simon Mifsud: From multi enterprise.
• 20:02
  Simon Mifsud: So that's been really helpful because it brings an additional, um, amount of cash into the pot that is non-diluted.
• 20:10
  Simon Mifsud: So anybody that's coming in or for, even for existing investors and shareholders, they're not diluting whilst we're still making progress.
• 20:18
  Simon Mifsud: So that combination of that hybrid approach has worked really, really well for us.
• 20:23
  Joseph M. Schwab: Has there been any interesting feedback that you've received from these potential investors?
• 20:28
  Joseph M. Schwab: Anything memorable for you that has maybe altered the way you've considered going about either developing or thinking about marketing the product?
• 20:38
  Simon Mifsud: Not necessarily from the investors.
• 20:40
  Simon Mifsud: 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.
• 20:54
  Simon Mifsud: I mean, everybody got that.
• 20:55
  Simon Mifsud: It was unique.
• 20:56
  Simon Mifsud: Everybody gets that.
• 20:57
  Simon Mifsud: It's a elegant, uh, solution.
• 21:00
  Simon Mifsud: But there was concern around the ability to get some, some, um.
• 21:05
  Simon Mifsud: Some regulatory clearance.
• 21:07
  Simon Mifsud: 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.
• 21:22
  Simon Mifsud: 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.
• 21:31
  Simon Mifsud: 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.
• 21:41
  Simon Mifsud: And they were really happy to see the device.
• 21:43
  Simon Mifsud: 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.
• 21:54
  Simon Mifsud: But.
• 21:55
  Simon Mifsud: Um, they also felt that provided, we met, uh, the bench testing requirements that they were going to sort of lay out for us.
• 22:03
  Simon Mifsud: Um, then there was a, there was a route to, to regulatory.
• 22:06
  Simon Mifsud: 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.
• 22:22
  Simon Mifsud: And as mentioned, you know.
• 22:24
  Simon Mifsud: 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.
• 22:34
  Simon Mifsud: So I think we've been, um.
• 22:37
  Simon Mifsud: 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.
• 22:44
  Simon Mifsud: And I think that's really important.
• 22:46
  Simon Mifsud: Um, certainly for something that's quite novel.
• 22:48
  Simon Mifsud: You know, you have to build confidence incrementally.
• 22:51
  Simon Mifsud: Um, you, you're not just gonna get instant credibility no matter who you are.
• 22:56
  Simon Mifsud: 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.
• 23:14
  Simon Mifsud: So,
• 23:16
  Joseph M. Schwab: You're also actively seeking critiques from surgeons.
• 23:20
  Joseph M. Schwab: Um, what's the most useful piece of advice you've received from any of your surging critics so far?
• 23:28
  Simon Mifsud: So that's been, um, massively helpful to us and we've been over, uh, we plan to launch in the US first, right?
• 23:35
  Simon Mifsud: So we did three things.
• 23:37
  Simon Mifsud: Um, before we spent a dollar on, um, on r and d.
• 23:41
  Simon Mifsud: Uh, we spent about$20,000 on some independent market research in the us.
• 23:47
  Simon Mifsud: And that was really important to us.
• 23:49
  Simon Mifsud: 'cause like everybody thinks their baby's beautiful, right?
• 23:52
  Simon Mifsud: So we wanted other people to, you know, to say, yeah, this has got legs, if you'll excuse the pun.
• 23:59
  Simon Mifsud: And there's, there's an opportunity here for, um, for us to use it.
• 24:03
  Simon Mifsud: So we did that and we had a very positive response.
• 24:07
  Simon Mifsud: Okay.
• 24:07
  Simon Mifsud: But that was like, you know, uh, independent market research.
• 24:12
  Simon Mifsud: Earlier this year we attended Academy, um, in San Diego, and that was the first chance that we got to speak to us.
• 24:19
  Simon Mifsud: Surgeons face-to-face actually put the device in their hands.
• 24:24
  Simon Mifsud: Uh, we took, um, a dislocation model called Eddie, who we, who we take around with us.
• 24:29
  Simon Mifsud: Uh, and he's got a, a dual mobility modular dual mobility implanted in one side.
• 24:35
  Simon Mifsud: And a, uh, malt hip implanted in the other, so we can show the range of motion, the comparative, et cetera.
• 24:41
  Simon Mifsud: The biggest takeaway that we got is that, um, the durability element is not necessary.
• 24:47
  Simon Mifsud: Their biggest concern, it's the stability side.
• 24:52
  Simon Mifsud: Um, because those are the things that are affecting, affecting them in the here and now.
• 24:58
  Simon Mifsud: Obviously, you know, we're using, um, we are using.
• 25:02
  Simon Mifsud: Advanced materials that are, are, are routinely used at the moment.
• 25:06
  Simon Mifsud: So our poly is a highly cross-linked, uh, vitamin E rich poly.
• 25:11
  Simon Mifsud: Um, so the, the stability element though is something that everyone is suffering with.
• 25:17
  Simon Mifsud: Um, you know, okay.
• 25:18
  Simon Mifsud: 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.
• 25:31
  Simon Mifsud: To, to occur and, um, where, where the, where the hip can dislocate.
• 25:35
  Simon Mifsud: 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.
• 25:43
  Simon Mifsud: These things happen very unfortunate, but these things happen, right?
• 25:47
  Simon Mifsud: That's not possible with our device.
• 25:49
  Simon Mifsud: And we were able to demonstrate that very nicely with our dislocation models.
• 25:52
  Simon Mifsud: So all the advice that we, uh, that we got, um, from a a OS.
• 25:59
  Simon Mifsud: Really focused our, um, attention on the stability.
• 26:03
  Simon Mifsud: And that's what we did, um, have done, um, for the last six months.
• 26:06
  Simon Mifsud: And we took all of that learning and all of that progress to acus, uh, in Dallas.
• 26:11
  Simon Mifsud: Um, we didn't actually have a stand, um, in acus.
• 26:14
  Simon Mifsud: We, um, we pulled Eddie around on the back of a trolley and, uh, gave him a set of cowboy boots.
• 26:21
  Simon Mifsud: Just fitting for the Texan, um, the Texan location.
• 26:25
  Simon Mifsud: 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.
• 26:35
  Simon Mifsud: 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.
• 26:47
  Joseph M. Schwab: For our innovators who are listening, do you have advice about how to manage specifically relationships with academic inventors?
• 26:56
  Joseph M. Schwab: Bringing them through a commercialization journey's unique, set up a, a unique set of circumstances.
• 27:04
  Simon Mifsud: 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.
• 27:14
  Simon Mifsud: In our development and our commercial journey.
• 27:17
  Simon Mifsud: I mean, these guys aren't business people, so they don't understand.
• 27:20
  Simon Mifsud: 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.
• 27:32
  Simon Mifsud: 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.
• 27:41
  Simon Mifsud: So that's been really, really helpful.
• 27:43
  Simon Mifsud: 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.
• 27:54
  Simon Mifsud: And as I mentioned.
• 27:56
  Simon Mifsud: 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.
• 28:04
  Simon Mifsud: 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.
• 28:19
  Simon Mifsud: You wouldn't be able to tell that it wasn't a hip replacement that could be implanted.
• 28:23
  Simon Mifsud: 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.
• 28:45
  Simon Mifsud: So having them involved has been massively, massively, um, helpful to us.
• 28:50
  Simon Mifsud: And actually setting up our subsidiary of Malta, um, allowed us to continue to work with the University of Malta who are also shareholders.
• 28:58
  Simon Mifsud: 'cause we're a spin out essentially from the University of Malta, so the four inventors and the University of shareholders within our company.
• 29:06
  Simon Mifsud: 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.
• 29:14
  Simon Mifsud: And just having that chew and fro of information is, is, is very important.
• 29:19
  Simon Mifsud: I think if you ignore them, then you are missing a massive opportunity as well as just, you know, ticking them off.
• 29:25
  Simon Mifsud: So.
• 29:27
  Joseph M. Schwab: Looking ahead, um, where do you see the Malta hip fitting into standard arthroplasty practice, say in the next five years?
• 29:38
  Simon Mifsud: 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.
• 29:48
  Simon Mifsud: And I think we are gonna take a very staged approach.
• 29:51
  Simon Mifsud: Um.
• 29:52
  Simon Mifsud: We're focusing on those, those difficult patients that every surgeon probably has.
• 29:57
  Simon Mifsud: Um, those, um, repetitive dislocators those people with instability.
• 30:04
  Simon Mifsud: Um, and like this thing works like a constrained liner, right?
• 30:08
  Simon Mifsud: So it, it, it, it, it keeps the hip in, in place.
• 30:12
  Simon Mifsud: But where it differs from the constrained liner is that it has a massive range of motion.
• 30:17
  Simon Mifsud: Whereas a constrain line has a very limited range of motion.
• 30:20
  Simon Mifsud: 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.
• 30:31
  Simon Mifsud: 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.
• 30:43
  Simon Mifsud: What they do in, in life.
• 30:45
  Simon Mifsud: And I believe, um, then I mentioned four different patient groups.
• 30:49
  Simon Mifsud: So we are gonna continue with a regulatory journey into Europe.
• 30:52
  Simon Mifsud: 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.
• 31:07
  Simon Mifsud: So.
• 31:08
  Simon Mifsud: These things evolve.
• 31:09
  Simon Mifsud: 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.
• 31:24
  Simon Mifsud: 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.
• 31:37
  Simon Mifsud: 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.
• 31:47
  Simon Mifsud: So I think there's a wide range of patients that it would be suited for.
• 31:50
  Simon Mifsud: 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.
• 32:04
  Simon Mifsud: 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.
• 32:16
  Simon Mifsud: 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.
• 32:33
  Simon Mifsud: And that's great because they'll understand some of the nuances that are required for this type of device.
• 32:37
  Simon Mifsud: So yeah, I mean, we are not looking to, uh, flick a switch and, and, and, and have global domination.
• 32:44
  Simon Mifsud: 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.
• 32:59
  Simon Mifsud: Um.
• 33:00
  Simon Mifsud: 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.
• 33:11
  Simon Mifsud: You know, that has a massive thing.
• 33:12
  Simon Mifsud: And that's, I feel, really honored to be leading the charge in that, uh, in that regard.
• 33:18
  Simon Mifsud: And I back myself to achieve that and I back my team most importantly.
• 33:22
  Simon Mifsud: 'cause without now, I wouldn't be able to get, uh, to get to that spot.
• 33:26
  Simon Mifsud: So.
• 33:28
  Joseph M. Schwab: 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?
• 33:42
  Simon Mifsud: Well, I think, um, for me, um, just having the team around me to be able to, uh, to develop out.
• 33:54
  Simon Mifsud: 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.
• 34:11
  Simon Mifsud: I ality manufacturing and, and direct compression molding.
• 34:15
  Simon Mifsud: We've developed a, a, a hip revision system, variant of it.
• 34:19
  Simon Mifsud: So I think, um.
• 34:22
  Simon Mifsud: 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.
• 34:36
  Simon Mifsud: And, but I'm gonna give them credit because without them we wouldn't be where we are today.
• 34:41
  Simon Mifsud: And that's all stakeholders involved, not, not just staff.
• 34:44
  Simon Mifsud: 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.
• 34:57
  Simon Mifsud: 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.
• 35:05
  Joseph M. Schwab: Simon, thank you for talking with us today.
• 35:08
  Simon Mifsud: It's been my pleasure.
• 35:08
  Simon Mifsud: I hope, uh, it's been useful for you and interesting for your listeners to hear about the, the journey of the Malta Hip.