June 5, 2025 • 52 mins
OvertureTi is designed in a way that allows you step by step to avoid a total knee [replacement] because it’s so bone-sparing,” Overture Orthopaedics cofounder Riley Williams tells Bloomberg Intelligence. In this Vanguards of Health Care podcast episode, Williams and CEO James Kim sit down with BI analyst Matt Henriksson to talk about Overture, the development of focalplasty and its benefits over total knee replacement as a minimally invasive treatment option. They also discuss the importance of treating osteoarthritis early in the disease progression. Additionally, tune in to learn how it was once cheaper for Kim to hand-deliver the implants and tools instead of using overnight delivery, and about Dr. Williams’ time as a consultant for Bill Hader’s character in the movie Trainwreck.
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Episode Transcript
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Speaker 1 (00:18):
So welcome to another exciting episode of the Vanguards of
Healthcare series. My name is Matt Hendrickson, the medical technology
analyst at Bloomberg Intelligence, which is the in house equity
research platform of Bloomberg LP. We are pleased to have
Overture Orthopedics with us today, including CEO James Kim and
doctor Riley Williams, Chief of Sports Medicine at HSS. Overture
(00:39):
is a privately held medical device company that is developing
focal plasty, or a type of knee resurfacing system for
osteothritis in the knee. James and doctor Williams, thank you
both for joining us today.
Speaker 2 (00:52):
Thank you happy to be here.
Speaker 1 (00:54):
And doctor Williams, I might start with you because as
I was reading your bio ahead of this episode, I
didn't help but think of Bill Hayter from the movie
train Wreck. Now, is that a right or wrong observation?
Speaker 2 (01:08):
Yeah, that is technically a correct observation. I will add
in the fact that I was consulted by the producers
of that movie with regards to the roles and responsibilities
of a team physician. So yes, there is some activities.
Speaker 3 (01:23):
Okay, so I'm gonna say yes to that.
Speaker 1 (01:26):
All right, Well, then why don't you know people who
have never seen train wreck before? I don't want them
to think that you're the one drinking all the time.
So why don't you tell me about your current role
at HSS.
Speaker 2 (01:37):
Yes, so I've been at I've been at Hospital for
Special Surgery HSS for thirty two years. I started there
in nineteen ninety three as a resident and a fellow
in nineteen ninety seven, and I started my practice in
nineteen ninety eight. My primary objective when I started there
was to start a program in cardlyge repair. So for
(02:01):
those who are unaware, cartilage is the spongy and to
the bone which he roades away. So technically, when you're
carlige starts the road, you have arthritis. And in the
nineties there really weren't a whole lot of options for
affected patients, so it could have really bad consequences for say,
folks that maybe you know tour their acl or tor
meniscus when they were twenty. Now they're forty and they
(02:23):
were too young for knee replacement surgery. But we're certainly
in need of some help. So that that's been basically
the professional sort of engine of my career if you
will as a n surgeon.
Speaker 1 (02:37):
Okay, that's very cool. And then James, your background is
more in the private company side, So walk us through
your path to kind of where you got to with
overture today.
Speaker 4 (02:49):
Sure.
Speaker 5 (02:50):
So I went to a good business school, got my
MBA at USC two thousand and four, and decided, do
WAN want to go to entertainment, which a lot of
USC students do, or do I want to go into
this area called healthcare where you know, when we're talking
about baby boomers and you know it's going to be
a market that continues to grow. So you know, it
(03:12):
was an opportunity for me to go and join a
smaller company that was looking into medical innovations, looking into
healthcare and how we can make it even better for
this huge population growth, right the baby boomers. So went
in and I've been a part of not only big
companies such as Johnson and Johnson, Algam Medical, Cardinal Healthcare
(03:35):
most recently Acumed, but I've also been a part of
four other small companies that we took to the next level.
Speaker 1 (03:42):
Yeah, and so that's kind of one of the things
that you have, that background of being able to you know,
take and expand private companies. What was your first of
you with overture? How did you get involved with them?
Speaker 4 (03:58):
Sure?
Speaker 5 (03:59):
Well, so for those of you who don't know, Hospital
for Special Surgery is a very special and unique place,
right It really is a hub for a lot of
medical innovations, specifically for orthopedics and sports and medicine. So
you end up working with a lot of the surgeons
who are at HSS, and so you know, I've built
(04:24):
a lot of friendships. And funny enough, we were at
a mutual friend's birthday party in New York City, a
very well known surgeon named Edwin Sue and doctor Williams
and I and another surgeon, doctor Hayn Bae, the other
surgeon co founder. The three of us sat there instead
of talking about hey, doctor Williams has this idea. At
(04:48):
this point, doctor Bay was getting ready to, I guess
take a company called Engaged to the Next Level, and
I was doing that with a company called Xcement, which
was enhanced. So timing just kind of aligned, and you know,
did a little bit of research and I saw okay, well,
so you know, the early Austria arthritis market, especially for
(05:12):
cardiage repair and the knee is about you know, one
point five billion dollars. You know, in twenty thirty one,
it's probably going to grow to about six six point
five billion. So there is a ton of opportunity. The
space has been very driven by like biological options, but
(05:33):
you know, there probably is a place for something where
when biology fails, but you don't want to go to
a full, partial new replacement of total new replacement. I'll
that doctor Williams talk a little bit more about that,
but you know, the market dynamics, the opportunity to work
with doctor Williams and doctor Bay and just really build
this thing was was super attractive for me, right and
(05:56):
you know I basically work with them to put some
of the bolts in place. But I did tell them, look,
I've got to finish things out because Acumen is going
to acquire us, and you know, let's get the we'll
call it like the liquor license, which is the FDA approval.
Speaker 4 (06:12):
Yeah, you know, before you know, I come on full time.
Speaker 5 (06:16):
It will raise money and we'll do these things, but
it just it doesn't feel right to come in and
take a salary as a CEO until we are able
to generate sales.
Speaker 1 (06:24):
Yeah, and that's you know, that's a good way to
approach it. But then, so doctor Williams, and you sound
like the brainchild for focal plasty and this technology. Why
don't we just start with, you know, the landscape of
how to treat osteoarthritis, because you know, when I'm thinking
about you and you were talking, James, you were talking about,
(06:45):
you know, the one point five billion dollar market currently
I'm thinking of you know, ten fifteen million patients who
have osteoarthritis, but really only seven hundred thousand or so
have a total knee replacement each year, so leaves a
good thirteen fourteen million patients who are not ready for
that treatment yet. So while could you provide just a
(07:08):
kind of a brief overview of how you treat those
patients through the progression of the disease?
Speaker 2 (07:14):
Right, Yeah, that's interesting. Well, listen, I think I'm old
enough to have witnessed the development application and quite frankly
durable outcome of total knee replacements, So we'll start there.
Total knee is basically resurfacing all the surfaces of the knee.
It's a big procedure, but one that is effective at
(07:38):
reducing pain. However, if you dig beyond the surface level
and start asking patients about function and functionality. It's not great.
And we live in a time now where where exercise
and mobility are sort of key life drivers for quality
of life as well as longevity. So people really don't
(08:01):
like knee replacements. So that's seven hundred thousand number. If
you really look at it, it's going to be six
fifty six hundred. People really don't want a knee replacement.
So that's where really we come in because you know,
in the time since I started practice in ninety eight,
there have been all sorts of biologic options, you know,
(08:24):
growing cells and putting them on a patch, or coming
up with a plug made from the skeletons of starfish,
you know, ostecono allographs, which are donor pieces of corlage,
which I've done thousands of, And largely there is this
sweet spot that exists between people who are too far
(08:46):
gone for a biologic option, and that's mainly because what
happens in our knees as we get older, there's an imbalance,
and the imbalance tilts towards breakdown. We call it catabolism.
So it's really hard to put a patch with some
cells in it in someone's knee who's like that and
expected it's going to grow into something. So all we
(09:08):
did with the the focal plasty sort of approach was
to say, just like you intimated earlier, you know, feeling,
you're feeling a cavity, you're feeling a tooth. There there
is a role for that type of technology right when
you really just can't grow anything in a knee, but
(09:29):
that the objective findings of disrepair are limited and it's
typically load associated, and and and uh, there's just such
a enthusiasm for these limited approach you know. The overture
system is technically a unique compartmental orthoplasty. It is a
(09:53):
minimalist unique compartmental orthoplasty. But the the incidents and application
of unit compartmental technology is exponentially rising since twenty ten,
while TKR is going down, So we fall that's the
reason for the name overture. We're at the beginning, right,
And Overture is designed in a way that it allows
(10:15):
you step by step to maybe avoid a total need
because it's so bone sparing that technically you could do
a more formal bone resecting type unicompartmental earthplace if this
one should fail or your disease progress to a point
where you need it that next level.
Speaker 1 (10:33):
Yeah, and maybe let's just step a take a step
further into why total knee replacement is such a or
considered such a last resort. And my thought is that
because once you start doing a total need replacement, you're
cutting everything around the bone, including ligaments and cartilage and everything.
(10:54):
So walk us through, like why just having to do
a hacks off removing everything is not the best treatment
for these patients.
Speaker 2 (11:02):
There are two real focal points to make about that,
not to make a complicated. Number One, arthritis is the
erosion of cartilage, bone on bone, right, that's what that means,
and that hurts because you don't have the cushion. But
what people don't realize is that that bone on bone
rubbing creates particles in the knee, and most of these
knees are inflamed angry knees. So when you go in
(11:25):
and you do this, like you said, this hack saw
and it really is quite a quite an aggressive surgery.
Effective surgery, but aggressive. There's always this exacerbation or winding
up of that inflammatory response, which which quite frankly, can
result in some stiffness or feelings of tightness and just
sort of chronic swelling that that just takes people a
long time to get better from. So that's that's that's
(11:48):
problem one. Problem two is you mentioned it now, I
want to call it out. You are replacing the inner ligaments,
the antire crucied ligament, and the poster crucied ligament of
the knee with knee replacement, and you're replacing it with
a post. So you can imagine golf, skiing, tennis, pickleball,
(12:08):
all the things that people as a kind of age
out of other types of exercises tend to get into.
That makes that rotatory component just feel unnatural. And that's
the big downside of it. So the reason the unis
are much more prevalent now is because those aren't sacrificed.
You retain all of your normal ligamenture, tendons and everything.
(12:30):
All you're doing with these resurfacing type strategies is to
replace the missing surfaces with new surfaces. So it's it's
it really is a targeted you know, hence the name
focal plastic type of type of approach.
Speaker 1 (12:46):
Okay, let's let's dive into that focal plastic because how
does the implant. I mean, this is one of those
things where we're on a podcast, so it's it's you know,
you have to be you have to describe the visual components,
but walk us through the design of the product itself.
Speaker 3 (13:02):
What does it look like?
Speaker 1 (13:03):
And you know what, how does the procedure look Maybe
not getting total need because we talked about kind of
you know, totally is the hacking. We're trying to talk
about focal being more of a mainly invasive procedure, but
compared to a UNI or to the partial knee replacement,
how does that differ, and including things like how is
the image, what type of imaging do you need to use?
(13:25):
Is it just simply X ray or do you need
to have a CT scan? And you know, just the
process of you know, patient from going from day one
saying I have knee pain to gain the focal plasty
and then post procedure, how soon can they get back
out and doing their running or golfing or skiing.
Speaker 2 (13:42):
Yeah, all valid. So first thing I'd say is most
patients who are ideally suited for this procedure have normal
X rays and it's largely an MRI diagnosis because MRI
is more sensitive. So you can see more. Uh. The
reason I bring up the normal X rays is because
with this particular procedure, we're not replacing meniscus, we're preserving it.
(14:04):
We're not you know, substantively rebuilding and they we're just
resurfacing worn surfaces of cartilage. So, uh, you want to
have good alignment, you want to have a you know,
a reasonable weight profile, things like that. Those are all
kind of played to it being successful. But once you
find a patient who has say some eroded carlage, and
(14:25):
that can be anything from as small as ten millimeters
up to about forty top to bottom on the on
the con dile or the end of the femur, the
thing that you walk on, so that's round, almost like
a cone, and then the tivious flat like a like
like you know, like the floor in the room. So uh,
the the overture implant, basically on the femur comes in
(14:46):
two varieties. They're there their gold it's like a gold
filling that was picked purposely. Their titanium, so they have
a tin nitrate cover. Then they have a tiny titanium
body and then what we call a a boning growth
bottom which looks porous and the reason we did that
that way is because ideally you like the implant to
(15:07):
bond to bone so that you can do all those
sports that you talked about, all the running impact stuff.
And then on the tibial side, it's actually a polyethylene
or high density plastic surface that's around and if you
took your thumb and just wiped it over the top
of the tibia surface after a procedure like this, you
(15:28):
shouldn't be able to tell a difference between you know,
where the implant starts and where the surface begins.
Speaker 1 (15:33):
Very nice, and then once the procedure is done. I
guess the way I can ask this is this the
same day procedure. Are they able to leave the hospital
for sure?
Speaker 3 (15:43):
Yeah?
Speaker 1 (15:43):
For sure?
Speaker 2 (15:44):
Yeah yeah. I mean to do a resurfacing of the
tibian femous probably about a forty to forty five minute
outpatient procedure, small incision, you know, crutches for maybe four
or five days. As soon as you start feeling reasonable,
you can start to walk on it. Cadence would be
(16:04):
something like you know, PT twice a week for six weeks.
I think at the end of two weeks most people
are like like pleasantly surprised, it's not very uncomfortable. By
six weeks, they're super happy because there's an achy pain
that comes with this type of a diagnosis that immediately
upon putting the implant in is relieved. So once the
(16:26):
haze of the surgery sort of passes through, which again
not a bad surgery, but you know, two weeks in,
I think most people are like, wow, okay, they're very optimistic,
and as they're working their way through the therapy, I
usually I usually see very happy, sort of like uber
optimistic patients at that six week mark.
Speaker 1 (16:44):
Yeah, and walk me through your design versus kind of
some of the predicate designs out there, because you did
get five to ten K, so you had to use
a predicate and Arthur's Surface, which I think was acquired
by Anika four or five years ago. I don't think
that product is still on the market. So what was
kind of the the the con or the you know,
(17:09):
the you know, what was missing with that device that
you were able to be able to alleviate in your design.
Speaker 2 (17:16):
You know, I'm glad you asked that because I was
a big fan of the Arthur Surface conceptually, was not
a big fan of it practically, and not to get
too much in the weeds, but the the way by
which you you fixed the implant on the femur, you know,
there was some principles involved there in development of it.
(17:38):
There was a screw and there was like a c
taper interface with the implant. It was just weird, like
I just didn't understand, and I should say my colleagues
didn't either like why it was that way. And then
on the tibia you had to do this kind of
weird like retrograde saw and you ha to pull it down.
It was very imprecise and will my my clinical results
(18:02):
with the Arthur Service were very good. I just never
got a comfort level with the way it was put
in and I suspect that that probably had something to
new with its with its overall utilization, however, really good idea, right.
So so when COVID started UH and we were not
operating basically to get back to what James was talking about,
(18:27):
I was involved with the engagement plant just as a
as a late investor and utilizer, and I thought, you know,
it's time to make hay On this is this is
the time to do it, if we're going to do it.
So I used that that eight weekhiatus. We had to
really kind of set down the basis of forming a company.
Speaker 1 (18:43):
Yeah, so basically one of the I thought what I
took away from that is that there was like a
retrograde drilling or cutting that took place.
Speaker 3 (18:50):
What was the biggest what was the biggest.
Speaker 1 (18:51):
Design feature in overture that kind of you know, eliminated
that cutting difficulty.
Speaker 2 (19:00):
So the the the main design improvement we made with
our implant was going back to principles of arthoplasty firm
early fixation. It's a partial cementation process with pegs which
the Arthur serface did not have, so we added that.
Then the bone end growth would allow some stability. So
(19:23):
it's just basically as you walk on the implant, it
helps with bony healing, like that's what you want. And
then on the tibia as a as a as a
carlist transplant surgeon, I knew for years that you could
detach an insertion of the meniscus and put it back,
and when you do that, you've got a beautiful view
of essentially the anterior four fifths of the of the
(19:46):
tibia interest so typically where the disease is. So that
was the change. It was what we call an antigrade
approach as opposed to a retrograde, which which again is
a very simple arthoplastic principle.
Speaker 3 (19:57):
Yeah, that just comes.
Speaker 1 (19:58):
I feel like that just comes from twenty five thirty
years of experience doing that type of work as your
cartilage repair to begin your career. And so that gets
us to the five ten K. And here now, James,
welcome back. When you had this conversation with Riley and
the other you know, doctors as they were beginning this design,
(20:21):
were you expecting this five ten K to come as
quickly as it did or was it? Were you ready?
Were you antsy and ready to go?
Speaker 5 (20:30):
You know, I think it was an unknown. The Arthur's surface,
which you mentioned earlier, that was the predicate device. So
you know, you just kind of look at history and
when you do submissions, you know, if you have a
predicated device that's already out in the marketplace and has
clinical data, which it had a lot of published clinical data,
you know, it almost seemed like a slam dunk.
Speaker 4 (20:51):
It was just a matter of when. Yeah, so I
think we had.
Speaker 5 (20:53):
Submitted it, doctor Williams. I think it was late maybe
it was November.
Speaker 2 (20:59):
Of twenty twenty two.
Speaker 5 (21:02):
And we were abas in Las Vegas. I still remember
March twenty twenty three and we get a phone call
at four am. You know, hey, it's five teen k cleared, right,
And so that's when the excitement really started happening. You know,
this is it's really interesting because I actually also launched
(21:25):
the product that was the longest ever reviewed by the
FDO was thirteen years.
Speaker 3 (21:30):
Wait, what device was that?
Speaker 5 (21:31):
That's an anatomically shaped breast implant for patients to have
breast reconstructions.
Speaker 3 (21:35):
Okay, that took thirteen years.
Speaker 5 (21:36):
Thirteen years. And again I had nothing to do with
the submission. I had nothing to do with except that
I just kept board. And then they said I got
a paper and said, hey, we're launching this thing. So
it was really exciting to get the notice. And we
just knew that since we already had we'll call it
our stable of surgeons who were ready to starting this device.
(22:01):
They were already trained, they already knew all the mechanics
behind it. Obviously, there's still a learning curve. We're still
trying to refine the surgical technique and you know, figure
out surgical pearls and all those things. Even it's too
how do we decide who's the right patient? You know,
doctor Williams alluded to, you know what we call patient selection.
But that's continuously being refined, right because you're always learning
(22:24):
new things, right science, That's the thing. Science is like,
you continuously learn, and that's what's allowing us to become
a much better company and for the product to be
much more effective in the marketplace. So we really took
that we'll call it March seventh when we receive the approval,
(22:45):
and then we immediately did another round of financing, and
then we ordered resterilizable instrument sets. We got all the documentation,
pulled together, all the quality management system stuff together, and
November seventh, twenty twenty three, here in New York City,
(23:07):
doctor Williams was the first surgeon to ever implant the device.
Speaker 1 (23:12):
It's fun stuff and so basically, you know that the
initial launch from that was the March. First patient was November.
How was that initial launch maybe from November, let's say
November twenty twenty three, the first twelve months until the
end of twenty twenty four.
Speaker 4 (23:32):
One.
Speaker 1 (23:32):
Maybe we'll start with the patient outcomes. What were you
seeing with these patients off the bat after they were
doing done with these procedures.
Speaker 2 (23:42):
Yeah, I mean, I think it's worth it to mention
although the overture implant was a new implant, the concept
was not. So when patients asked like, oh, like, you know,
what's the history of usage, you could you could accurately
point to Arthur's surface because even though the the way
(24:04):
you put it in was different, essentially exact same concept.
So so that was the framework that I kind of
framed it to patients, like, hey, listen, updated implant. We
have a stable of surgeons who sort of live in
this in this in this world, help with the development.
We think it's better. So you know, listen, you're you're
you're being honest with them about it being new, but
(24:24):
also contextually framing it for them clinically. So and the
response was like overwhelmingly positive. I mean, people shockingly like
surgeon inventors. They and I think HSS is a good
platform for me because it is the kind of final
stop for these kind of things. But the take on
message was I had already done over three thousand Osikono
(24:46):
allograph transplants, so I knew putting in the spacers worked
different surface a little bit, but you could make an argument,
which is why we did it this way, is that
you put someone's human piece of tissue into like a
fifty year old's knee. Not the most friendly environment, right,
(25:07):
just because of that catabolism we talked about. But you
put in a piece of titanium. That's the same concept
as a total except it's just more limited, smaller. So
the early results were honestly, like shockingly great. Like the
interesting anecdote is what I found was people were fantastic
(25:30):
for the first three months and then you get a
bunch of people come back at four months with swollen
knees because they just had this I call it this
irrational exuberance because they start thinking, oh, I haven't been
pain free in years. So I have to kind of
counsel them about, you know, a slow ramp up and
understanding that that inflammation that we talked about it earlier
still around. But listen, high class problems.
Speaker 1 (25:53):
I mean, I was about to say, it sounds like
they want to run a marathon after getting sucre do. Yeah,
And so you mentioned about the fifty year old patients.
That kind of the is that the patient pool that's
kind of narrowed down for selection of focal plasty or
is it a more complicated approach, this deciding who gets
who's best suited for it.
Speaker 2 (26:12):
Yeah, you know, I'm always careful to pigeonholes. So just
to throw out some examples, I think the youngest patient
that has got an overture and plant I believe was
twenty five. But this was a facian who failed one
of these allographs that I just mentioned. So for these
big holes and knees you don't have, they're no great options.
(26:34):
So and I will tell you he loves me. He's running,
you know, despite me telling him it so to be careful.
So so you know, it really kind of depends on
the problem. But I said, if you were thinking like
the early arthritic, it's probably thirty five to sixty five,
just depending on the findings on the ground, well aligned
knee like I said, normal ish BMI body mass index.
(26:58):
And quite frankly, you want to have some meniscus right,
you don't want to be apps in the meniscus because
again it's not a big, structurally bulky implant. It's just
meant to kind of put you back in line, get
rid of the potholes, so to speak, make things smooth,
and a need that's otherwise relatively normal.
Speaker 1 (27:16):
Yeah, and then James, you were talking about a sterilized set,
but my understanding is that there's also a single use set.
Is that something that you developed during this process in
the initial launch phase.
Speaker 4 (27:33):
Yeah.
Speaker 5 (27:33):
You know, the Orthopedic Space had kind of shot itself
in the foot business wise because a lot of these
bigger companies were so focused on selling implants that they
got to a point where they said, hey, you buy
these implants or do a certain volume of implants, and
we will basically let you have or let you borrow
(27:54):
these instrument sets for free. So the Space got into
this whole legit sticks nightmare of having to get resterlizable
sets and a restertizable set. Just so you know, with us,
with the small volume that we initially ordered for a
limited market release, it costs about twenty six thousand dollars.
Speaker 4 (28:14):
Each, right, I mean that's a car.
Speaker 5 (28:17):
So you're limited by the number of resterilizable sets you
have in terms of how many cases you can do
we'll call it simultaneously.
Speaker 4 (28:25):
Right, So.
Speaker 5 (28:28):
You know this this concept of well, let's take that back,
let's see how we can win that war back, right,
Because a lot of the cases now, especially with this.
I mean you asked a question earlier to doctor Williams.
Is this a procedure that can be done in a day?
Can the patient come in and then leave the same day? Absolutely,
So you're starting to see a lot of these cases
(28:48):
now go out to the amblatory surgery centers, right. So
a single use instrument kit is perfect for these facilities
because they don't have the big SPD or sterilization sisting
departments that an HSS has, that an NYU has, you
know that a KAISER has. Still it doesn't make a
lot of economic sense for them, but you know they
(29:10):
obviously have more overhead and more capacity to as a
surgery center they run lean. The other thing too, is
is it takes out all the complications in the operating room.
You know doctor Williams can attest to this, but you
want to take out as many variables as possible during
a case, and so having a single use kit we
(29:31):
just literally peel pack open and you can have a
backup for that as well. But peel pack open and
you don't have to guess which ones am I going
to use for this case? You know, based on the size,
I know exactly what I'm gonna use because the sizer
that I used told me is going to be in
our case A twenty two and a half by thirty five.
So I'm going to pull that set, open it up,
and here we go. So it's going to make even
the case more efficient.
Speaker 1 (29:53):
Yeah, and then so yeah, less inventory management things like that.
Speaker 4 (29:56):
Yeah.
Speaker 1 (29:57):
Yeah, it actually sounds like you're almost putting the foot
in the door for that reversal, as you said, winning
back that war. And even you know, maybe some of
the larger ORTHO companies would take note and be able
to see how we can make it more single use
cases like that again.
Speaker 4 (30:12):
Yeah, exactly.
Speaker 5 (30:12):
And you know there is a way to well call
it economize it as well or monetize it, right, because
you're you're basically giving these things for free. Here's here's
a funny story. We had a we got a call
from a surgeon out in Chicago. He's at Rush University Hospital,
and he said, hey, look, I got a case here
in two days. Do you think you guys can get
me an instrument two instrument sets for the case. Yes,
(30:35):
we can absolutely do that. So we looked up how
much it would cost to ship that, right, and you've
got to do next day because they have to have time.
Speaker 4 (30:42):
To sterilize it to get it ready.
Speaker 5 (30:45):
And it was five hundred and fifty dollars to ship
that from from.
Speaker 3 (30:51):
LA to Chicago. Yeah, okay, right, and.
Speaker 4 (30:54):
Sure we could do that.
Speaker 5 (30:55):
But then just for the fun of it, I just
went on American Airlines dot com AA dot com and
I said, I wonder how much it would cost for
me to do a round trip for a flight tomorrow.
And it was four hundred and thirty dollars, right, So
you know, I basically said, fine, I'm going to actually
be in the case. I'm going to book the ticket
and I'm just gonna take the sets with me at
(31:18):
cheaper than UPS or you know, FedEx.
Speaker 3 (31:21):
Right.
Speaker 5 (31:22):
So it's really interesting how you can try and change
the game. And we did this over at xcoment. I
think that was one of the allures of xment. We
had all singuise peel pack kits for hand surgery and
it actually it did really well also because of COVID.
At COVID there was no SPD department, there was none
of this, so you just had to drop off the
(31:42):
instrument sets and they loved it.
Speaker 4 (31:44):
That helped us but that really opened.
Speaker 5 (31:46):
My eyes to the power of a singuse instrument kit
in the space. And I think a lot of other companies,
I mean, this is not a secret. A lot of
the other companies are really trying to get there. It's
just how do you get there?
Speaker 4 (31:57):
Right? And you just gotta could happen.
Speaker 3 (32:00):
Yeah, I hear you.
Speaker 4 (32:02):
Yeah, all right.
Speaker 1 (32:03):
So obviously HSS and you talk about Rush University in Chicago,
but you also talked about the ASC setting. So how
have you built the commercial infrastructure to be able to
reach some of the top tier hospitals in the country
but also those ASC settings that you know, this seems
like a perfect outpatient procedure for sure.
Speaker 5 (32:24):
Well, we initially started off the and I alluded to
this earlier, but we had a limited market release. And
the limited market release consisted of eighteen to twenty maybe
twenty five surgeons that were reputable, that had experienced that
were peppered throughout the country. A lot of them were
you know, doctor Williams colleagues that he had great relationships
(32:47):
with and had great conversations with about this idea, right,
and they all understood the mission. The missionaire is there's
got to be something for patients when the biology just
doesn't work anymore, right, and let's try and build this implant.
So we started off with those surgeons, right, and we
did it a little bit differently.
Speaker 4 (33:08):
So if you think about an.
Speaker 5 (33:10):
Orthopedics company or a medical device company that wants to
get out and proliferate in the marketplace, they come up
with the idea, they get it FDA cleared or they
get the approval, and then they start building operations and
do all that stuff, and then they go out and
they call their distributor network of friends. Right, so you know,
I remember this guy he covered the state of New Jersey.
(33:32):
This guy he covered the state of Texas, and they
did a really great job and they know all the surgeons.
Speaker 4 (33:36):
Well, it was different for us.
Speaker 5 (33:38):
Because we already had relationships through doctor Williams, through doctor Bay,
through some of my past experiences that were surgeons that
these actually these distribuers actually wanted to have business with. Yeah,
so we actually asked those surgeons first, who would you
(33:59):
like to support you? And that's how we initially started
our network distributors. And then from there, you know, as
we got more confident, you know, we surpassed one hundred cases.
We said okay, now now it's game time. Now we
can go and we can start going beyond that trusted
inner concentric circle is going to say, Okay, here are
(34:20):
the things that we need to fix.
Speaker 4 (34:21):
Here are the things that are good.
Speaker 5 (34:22):
Here are the things that you know, we really need
to consider, you know, all those things that you do
in a limited market pleace. So now we could expand
beyond that. And that's really what we're trying to do
with these single use kits as well, because the resentilizable sets,
those were a limiting factor.
Speaker 1 (34:36):
Yeah, and just the you know, actually, one of the
things that I'm curious about with all of that, with
the single use sets is you know, when I'm thinking
of total knee replacements, I'm thinking of you know, high
volume and you have high turnover and you're trying to
you know, you have multiple especially top tier institution like HSS,
you have multiple rooms that you're doing multiple procedures, and
(34:59):
you're you know, many these cases can probably be what
less than an hour once you actually have the incision open,
maybe even less.
Speaker 2 (35:05):
Oh, it's it's and so and so.
Speaker 1 (35:08):
Is that One of the things with the single you
set is that you can make this procedure a very
highly efficient procedure as well, and just kind of building
the volume game is not the right way to think
about it, but you know, you're trying to treat as
many patients as possible with the technology. So is that
is this single use product the way of the future
(35:31):
or is this is there other things that you're working
on to kind of be able to streamline the procedure.
Speaker 2 (35:37):
Well, you know, trends and healthcare now are moving away
from impatients days hip replacements need replacements are done as outpatients. Uh,
James alluded to it. I just want to bring it
back up the trays and just the instruments require for
these these these cases typically certainly for totally they're massive,
(36:00):
and acs just don't have the storage capacity or reprocessing
capacity to do high volume. And you're right, like people
should think of the operating room as a hospital resource.
It's probably their most valuable resource. It's the highest amount
of renumeration for time spent in the entirety of the system.
So the more you can go through and run cases through,
(36:22):
the more economically viable you are. So any adjunct instrumentation methodology,
what have you that is going to be you know,
well integrated and befitting of an ASC in this market
is going to be a winner. So there are some
things that we did on the insertions side that are
(36:43):
very innovative and very proud of it. We got a
great you know, James conceived of it, our R and
D team put it together. It's it's very satisfying, and
we're coming out with those like just about right now
with some and it allowed us to do some modifications
on the on the early instrument designs that I think,
you know, the natural process of any company. But but yeah,
(37:08):
if you're not set up for ambulatory uh environment in
this market, that's that's that's not great.
Speaker 3 (37:16):
Yeah.
Speaker 1 (37:17):
And then you know, we were talking about the operating
rooms being the money makers for the hospitals. Is he
and you also mentioned that this is kind of similar
to a UNI or a partial knee replacement. Is it
reimbursed the same way because it's kind of considered technically
a UNI.
Speaker 2 (37:33):
Short answer Short answer is yes, Okay, short answer is yes.
The there a couple of codes for unis. One is
for one service, the others for two. I mean, this
is a unique compartment of arthroplacy indicated for both a
fema and tibia. They have been some with just the femur,
which is, you know, an off label indication, but again
one that uh I anticipate will have a hot high
(37:57):
likelihood of utilization in that in that circumstance, the specific
diagnosis of osteo chondritis disscants, that's that twenty five year
old patient. Those can be really big, debilitating, structurally challenging
type cases. And ultimately, in case the public wonders like
(38:17):
what is off label uses? Off label use means that
you and your doctor decided that this is a good
idea for you, and that you understand it's not technically
what the FD said. We don't push that. But ultimately
there are codes for both of those. So clearly it's
been in the ether before. Ye and they and they,
you know, they renumerate pretty pretty well.
Speaker 3 (38:39):
Yeah.
Speaker 1 (38:39):
Actually, the biggest one I see in my personal point
of view, is in the diabetes market, and there's insulin
pumps that are not labeled for type two, but you're
seeing the endochronologists still prescribing them because they see the
benefit of insulin pumps for all diabetic patients, whether it's
type one or type two. Doing insulin, so I get
the off label. I think what they say is that
(38:59):
you're not technically allowed to market that you can do that,
But then the doctors could just still do it if
they think it's still right.
Speaker 2 (39:05):
You know, it's a it's an interesting discussion. I'm glad you.
I love that analogy because you know, off label sounds
like illegal, yeah, right, which I just always have to
caution people. It's you know, at the end of the day,
doctors have a lot of leeway with regards to treating disease,
and the biggest innovations, quite frankly, come from these types
(39:27):
of cross references, cross cross usages that maybe were not
the original intent. FDA's main job is to regulate and
to make sure patients are safe. So which which which
we which we uh, you know support fully. But but
at the end of the day, the overture system is
so fungible and and it's just got broad application to
(39:50):
all sorts of Carliss problems that that we we think
it's a it's a it's a listen, it's the right
end plan at the right time.
Speaker 3 (39:58):
Yeah.
Speaker 1 (39:59):
And you know, with that implant, the I'm thinking of
the competitive landscape. I mean Arthur's surface doesn't sell their
product anymore. Is there anyone else out there doing focal
plasty or is it are you? Did you find that
initial niche step in the osteoarthritis treatment paradigm?
Speaker 5 (40:19):
Currently we are the only ones right now that have
FDA clearance outside of Arthur's Surface.
Speaker 4 (40:28):
I know.
Speaker 5 (40:28):
Doctor Williams alluded to some of the noted differences between
our implant and Arthur's surface, and do you do you
mind if I add a couple of points?
Speaker 3 (40:37):
Oh? Absolutely, Yeah.
Speaker 5 (40:39):
So our implant is a monolithic implant, meaning it's not
two pieces. Okay, okay, it's just one piece. And doctor
Williams shared that we have a base plate it's porous titanium,
and that titanium has natural characteristics or attributes where the
bone wants to grow into it, right, yeah, And it
(40:59):
was manufactured very low profile. And the reason why we're
able to do that is because three D printing or
what you know, I guess professionals called additive printing is
now able to do that with titanium. They were not
able to do that five ten years ago. So you know,
by utilizing that technology to do this, we're able to
make it low profile, because we don't want to reinvent
(41:24):
the staircase. We just want to be a stare in
that whole staircase. We want to provide surgeons with many
tools for what they believe is the right approach for
the patient and what the patient is going through. So
that's that titanium base plate and then the titanium nitride coding. Sure,
it's gold, and you know, it's a fun color for us,
(41:46):
but the titanium nitride is a harder surface, right, has
a lower coefficient of friction. So that's why it works
for us, because titanum is too soft. Yeah, okay.
Speaker 4 (41:57):
And then with the poly.
Speaker 5 (41:59):
You know on the opposing tibious it's the same base plate,
but it has the poly on the on the table side,
which is a plastic, but it's highly cross linked, and
it's highly cross linked for where right, Yeah, and then
we added vitamin E to it because we want to
protect it from oxidation. Oh okay, yeah, So it's a
(42:20):
highly cross linked vitamin E injected poly.
Speaker 3 (42:23):
Yeah.
Speaker 4 (42:24):
Right.
Speaker 5 (42:24):
And so those are some of the things that make
us different to Arthur Surface. Arthur Surface also, as I
alluded to earlier, it's two pieces. It's like a dental implant.
You put in the screw which is yeh, cobalt chrome
with a titanium spray on it.
Speaker 4 (42:40):
And has a cap.
Speaker 5 (42:41):
Yeah okay, yeah, whereas the are the overture is just
a one step process.
Speaker 1 (42:46):
Which once you got it all sounds like you're doing.
You're filling a cavity with a mini connect exactly.
Speaker 5 (42:52):
So you know, you kind of asked earlier, how do
you describe our procedure to somebody who can't see anything?
It is just into this, right, It's basically like a
dental cavity. Right, You're basically going in, You're just treating
that area. Rather than cutting everything out. You're trying to
spare as much of that tooth or that bone as possible.
(43:12):
So you just spot treating, right, And our implant was
designed to be able to spot treat, but it was
designed to do that without foregoing the opportunity of going
to the next stair in the staircase if necessary, if
the cavity spreads or the carlage defect spreads. Am I
kind of describing that, right, Doc Williams.
Speaker 1 (43:35):
There we go very nice and then so I mean
I have to imagine then that some of the large
cap competitors are interested in this type of technology, and
so anytime I have a small private company on, I
always ask what their protective moat is when it comes
to kind of patent protection. So how is your patent
protection to kind of fend off some of these large cap.
Speaker 5 (43:56):
Yeah, I mean that was one of the things that
we did earlier. You know, we're working with a very
reputable firm specifically in the space called Kenobe Martins. They're
based in Orange County. Work with them several companies. So
you know, in situations like this, you want to go
with the best, right And I'm sure you know many
people have their opinion of the best, but for us,
(44:17):
and at least in terms of where we are, these
guys have proven that they're good. So we have patents
pending on not only implant but also now with the
singouse instrument kits, right, So so we're good there. We
also have trademarks. So obviously our branding and our name
and all that stuff's trademarked even internationally, but we have
(44:42):
also I know, we were using focal plasty just like
it was a you know, common term now, but that's
something that is trademarked by overture as well. Doctor Williams
is the one who came up with it, I think,
at least in our circle. But yeah, focal plasty because
you know, obviously there's arthroplasty and vocal plastic and this
is a way that we thought we could describe the process.
Speaker 4 (45:04):
So the us p t O awarded that for us.
Speaker 1 (45:07):
All right, do I have to pay you guys licensing
fees for saying focal plasty times?
Speaker 2 (45:12):
Just slide on that.
Speaker 1 (45:15):
Oh yeah, And so then kind of just then looking
at you know, you guys are I know you guys
are on your in the air initial launch of the
vocal plasty of the single use. But in the future,
how are you envisioning this or expanded indications for this
type of technology. Yeah, I'll start with you, mister doctor Williams.
Speaker 2 (45:36):
Well, I mean I think, uh, obviously, if we have
efficacy in the knee, which is one of the most
frequently arthritic joints are hit knee and ankle, and then
a lesser degree shoulder and elbow, great toe arth right,
it's a big problem. Right. So so basically, if we
(45:59):
can continue to demonstrate efficacy in the knee, and you
wanted to expand you would just expand to other joints.
The the the idea of minimal bony resection and low
profile resurfacing is a winner. It just is because you're
essentially not trying to cut out a joint and rebuild
(46:22):
a joint. You're just going into the native joint and
filling in a hole. And and that is a you know,
thesis that can be applied over and over again, just
germane to the unique geometry whatever joint you happen to
be talking about. Yeah, so so that that's kind of
(46:42):
what I had imagined. And and listen, maybe you'll make
maybe you'll make a bigger implant. Maybe you'll make one
that that has a little bit more coverage in some
of the areas. For example, the pateel frameral joint is
another area that that we have an approved in plant for.
We haven't launched it because we want to kind of
deal with the way being part of the tibia feral
part of the joint, but that that clearly is another
(47:05):
sort of area that we're sort of interested in going
in because that's that's that quite frankly big problem in women.
So if you have arthritis in front of union and
makes all those fun things we talked about tennis, pickleball,
skiing really difficult. So so that that's in the offing.
So I would think like the teleferal joint expansion, other
(47:25):
joint expansion makes sense over the over the lifetime of
the company. But listen, I think we're a young company
and you want you want to hit with some wins, right,
So so my plan as an academic is to you know,
now that now now that we have a volume of cases,
we're coming up on two years kind of minimum time.
(47:46):
That's when you can really start to publish and and
and and present validated peer reviews sort of studies on
the efficacy which which will be important for us moving forward.
Speaker 1 (47:55):
Is it safe to think that in five years, you know, I,
you know, you an ESPN dot com would talk about
an ex player game and arthroscopic procedure done. Well, I
be able to see in the article that why player
got a focal plastic procedure done?
Speaker 2 (48:09):
You know, it's I'm going to use a very specific example,
I believe actually I'm not going to say the name
because I don't know if he announced it, but there
is a there is an NBA player who has played
NBA games who had a hip resurfacing procedure not the
same but similar, and he you wouldn't know anything. I
(48:33):
believe there are a couple of tennis players who've had
it as well, So we are on the precipice of it.
But my approach is the leader of the limited release
group has been like, when you're starting with a relatively
new implant like this, you want wins in regular people.
You don't start with Lebron James and someone who you
(48:53):
know is going to, you know, take their two hundred
and forty found frame and run up and down ninety feet.
So so I and I have that kind of practice
like I have. I have a professional athlete tertiary me practice.
So it's coming. But I think, you know, you want
to demonstrate efficacy and under normal loads, and then as
your experience grows and you see durability and efficacy, you
(49:15):
just expand on that.
Speaker 5 (49:17):
I think, you know, the other really cool stat is,
you know, twenty seven million people have signs of early
osteoarthritis with that are over the age of forty five, right,
and it's growing right because we're changing patient population, right,
(49:37):
you know. I like to use this illustration but when
we were growing up, you know, Blanche and Rose and
Dorothy from Golden Girls were fifty year olds.
Speaker 3 (49:47):
Right.
Speaker 5 (49:47):
Today a fifty year old is Jennifer Aniston. Right, it's
a totally different patient population. Look at the clothes that
we're wearing. Look at how sports and you know, an
active lifestyle has really traded you know, our culture, not
just the United States but obviously globally. So patients are
also doing things differently, Like I don't remember my dad,
(50:11):
you know, because I'm forty eight. I don't remember my
dad at forty eight doing anything besides like golf. But
you know, here I am still trying to play soccer
and I'm you know, running and doing all kinds of stuff.
So medicine also has to follow the patient population how
it changes, right, So I think that's another thing that
we really need to take into consideration in terms of
(50:32):
where this thing is going. So sure it's good for
the younger Lebron James's and whatever, you know, we'll see
in years to come, but there's a whole other group
of patients that really need this.
Speaker 1 (50:45):
Yeah, yeah, that's it sounds like early early Indians for
you guys. But James and doctor Williams. Thank you so
much for joining us today. I appreciate you guys coming
in and telling the story.
Speaker 4 (50:56):
Yeah, our pleasure.
Speaker 2 (50:58):
I love the overture story.
Speaker 3 (51:00):
Well there we go. That's gonna be the title of it.
Speaker 1 (51:04):
And thank you to our listeners for tuning in today.
We hope you join us for future episodes. If you'd
like to stay up to date, you can click the
subscribe button on Spotify or your favorite streaming platform. Take care,
So welcome to another exciting episode of the Vanguards of
Healthcare series. My name is Matt Hendrickson, the medical technology
analyst at Bloomberg Intelligence, which is the in house equity
research platform of Bloomberg LP. We are pleased to have
Overture Orthopedics with us today, including CEO James Kim and
doctor Riley Williams, Chief of Sports Medicine at HSS. Overture
(00:39):
is a privately held medical device company that is developing
focal plasty, or a type of knee resurfacing system for
osteothritis in the knee. James and doctor Williams, thank you
both for joining us today.
Speaker 2 (00:52):
Thank you happy to be here.
Speaker 1 (00:54):
And doctor Williams, I might start with you because as
I was reading your bio ahead of this episode, I
didn't help but think of Bill Hayter from the movie
train Wreck. Now, is that a right or wrong observation?
Speaker 2 (01:08):
Yeah, that is technically a correct observation. I will add
in the fact that I was consulted by the producers
of that movie with regards to the roles and responsibilities
of a team physician. So yes, there is some activities.
Speaker 3 (01:23):
Okay, so I'm gonna say yes to that.
Speaker 1 (01:26):
All right, Well, then why don't you know people who
have never seen train wreck before? I don't want them
to think that you're the one drinking all the time.
So why don't you tell me about your current role
at HSS.
Speaker 2 (01:37):
Yes, so I've been at I've been at Hospital for
Special Surgery HSS for thirty two years. I started there
in nineteen ninety three as a resident and a fellow
in nineteen ninety seven, and I started my practice in
nineteen ninety eight. My primary objective when I started there
was to start a program in cardlyge repair. So for
(02:01):
those who are unaware, cartilage is the spongy and to
the bone which he roades away. So technically, when you're
carlige starts the road, you have arthritis. And in the
nineties there really weren't a whole lot of options for
affected patients, so it could have really bad consequences for say,
folks that maybe you know tour their acl or tor
meniscus when they were twenty. Now they're forty and they
(02:23):
were too young for knee replacement surgery. But we're certainly
in need of some help. So that that's been basically
the professional sort of engine of my career if you
will as a n surgeon.
Speaker 1 (02:37):
Okay, that's very cool. And then James, your background is
more in the private company side, So walk us through
your path to kind of where you got to with
overture today.
Speaker 4 (02:49):
Sure.
Speaker 5 (02:50):
So I went to a good business school, got my
MBA at USC two thousand and four, and decided, do
WAN want to go to entertainment, which a lot of
USC students do, or do I want to go into
this area called healthcare where you know, when we're talking
about baby boomers and you know it's going to be
a market that continues to grow. So you know, it
(03:12):
was an opportunity for me to go and join a
smaller company that was looking into medical innovations, looking into
healthcare and how we can make it even better for
this huge population growth, right the baby boomers. So went
in and I've been a part of not only big
companies such as Johnson and Johnson, Algam Medical, Cardinal Healthcare
(03:35):
most recently Acumed, but I've also been a part of
four other small companies that we took to the next level.
Speaker 1 (03:42):
Yeah, and so that's kind of one of the things
that you have, that background of being able to you know,
take and expand private companies. What was your first of
you with overture? How did you get involved with them?
Speaker 4 (03:58):
Sure?
Speaker 5 (03:59):
Well, so for those of you who don't know, Hospital
for Special Surgery is a very special and unique place,
right It really is a hub for a lot of
medical innovations, specifically for orthopedics and sports and medicine. So
you end up working with a lot of the surgeons
who are at HSS, and so you know, I've built
(04:24):
a lot of friendships. And funny enough, we were at
a mutual friend's birthday party in New York City, a
very well known surgeon named Edwin Sue and doctor Williams
and I and another surgeon, doctor Hayn Bae, the other
surgeon co founder. The three of us sat there instead
of talking about hey, doctor Williams has this idea. At
(04:48):
this point, doctor Bay was getting ready to, I guess
take a company called Engaged to the Next Level, and
I was doing that with a company called Xcement, which
was enhanced. So timing just kind of aligned, and you know,
did a little bit of research and I saw okay, well,
so you know, the early Austria arthritis market, especially for
(05:12):
cardiage repair and the knee is about you know, one
point five billion dollars. You know, in twenty thirty one,
it's probably going to grow to about six six point
five billion. So there is a ton of opportunity. The
space has been very driven by like biological options, but
(05:33):
you know, there probably is a place for something where
when biology fails, but you don't want to go to
a full, partial new replacement of total new replacement. I'll
that doctor Williams talk a little bit more about that,
but you know, the market dynamics, the opportunity to work
with doctor Williams and doctor Bay and just really build
this thing was was super attractive for me, right and
(05:56):
you know I basically work with them to put some
of the bolts in place. But I did tell them, look,
I've got to finish things out because Acumen is going
to acquire us, and you know, let's get the we'll
call it like the liquor license, which is the FDA approval.
Speaker 4 (06:12):
Yeah, you know, before you know, I come on full time.
Speaker 5 (06:16):
It will raise money and we'll do these things, but
it just it doesn't feel right to come in and
take a salary as a CEO until we are able
to generate sales.
Speaker 1 (06:24):
Yeah, and that's you know, that's a good way to
approach it. But then, so doctor Williams, and you sound
like the brainchild for focal plasty and this technology. Why
don't we just start with, you know, the landscape of
how to treat osteoarthritis, because you know, when I'm thinking
about you and you were talking, James, you were talking about,
(06:45):
you know, the one point five billion dollar market currently
I'm thinking of you know, ten fifteen million patients who
have osteoarthritis, but really only seven hundred thousand or so
have a total knee replacement each year, so leaves a
good thirteen fourteen million patients who are not ready for
that treatment yet. So while could you provide just a
(07:08):
kind of a brief overview of how you treat those
patients through the progression of the disease?
Speaker 2 (07:14):
Right, Yeah, that's interesting. Well, listen, I think I'm old
enough to have witnessed the development application and quite frankly
durable outcome of total knee replacements, So we'll start there.
Total knee is basically resurfacing all the surfaces of the knee.
It's a big procedure, but one that is effective at
(07:38):
reducing pain. However, if you dig beyond the surface level
and start asking patients about function and functionality. It's not great.
And we live in a time now where where exercise
and mobility are sort of key life drivers for quality
of life as well as longevity. So people really don't
(08:01):
like knee replacements. So that's seven hundred thousand number. If
you really look at it, it's going to be six
fifty six hundred. People really don't want a knee replacement.
So that's where really we come in because you know,
in the time since I started practice in ninety eight,
there have been all sorts of biologic options, you know,
(08:24):
growing cells and putting them on a patch, or coming
up with a plug made from the skeletons of starfish,
you know, ostecono allographs, which are donor pieces of corlage,
which I've done thousands of, And largely there is this
sweet spot that exists between people who are too far
(08:46):
gone for a biologic option, and that's mainly because what
happens in our knees as we get older, there's an imbalance,
and the imbalance tilts towards breakdown. We call it catabolism.
So it's really hard to put a patch with some
cells in it in someone's knee who's like that and
expected it's going to grow into something. So all we
(09:08):
did with the the focal plasty sort of approach was
to say, just like you intimated earlier, you know, feeling,
you're feeling a cavity, you're feeling a tooth. There there
is a role for that type of technology right when
you really just can't grow anything in a knee, but
(09:29):
that the objective findings of disrepair are limited and it's
typically load associated, and and and uh, there's just such
a enthusiasm for these limited approach you know. The overture
system is technically a unique compartmental orthoplasty. It is a
(09:53):
minimalist unique compartmental orthoplasty. But the the incidents and application
of unit compartmental technology is exponentially rising since twenty ten,
while TKR is going down, So we fall that's the
reason for the name overture. We're at the beginning, right,
And Overture is designed in a way that it allows
(10:15):
you step by step to maybe avoid a total need
because it's so bone sparing that technically you could do
a more formal bone resecting type unicompartmental earthplace if this
one should fail or your disease progress to a point
where you need it that next level.
Speaker 1 (10:33):
Yeah, and maybe let's just step a take a step
further into why total knee replacement is such a or
considered such a last resort. And my thought is that
because once you start doing a total need replacement, you're
cutting everything around the bone, including ligaments and cartilage and everything.
(10:54):
So walk us through, like why just having to do
a hacks off removing everything is not the best treatment
for these patients.
Speaker 2 (11:02):
There are two real focal points to make about that,
not to make a complicated. Number One, arthritis is the
erosion of cartilage, bone on bone, right, that's what that means,
and that hurts because you don't have the cushion. But
what people don't realize is that that bone on bone
rubbing creates particles in the knee, and most of these
knees are inflamed angry knees. So when you go in
(11:25):
and you do this, like you said, this hack saw
and it really is quite a quite an aggressive surgery.
Effective surgery, but aggressive. There's always this exacerbation or winding
up of that inflammatory response, which which quite frankly, can
result in some stiffness or feelings of tightness and just
sort of chronic swelling that that just takes people a
long time to get better from. So that's that's that's
(11:48):
problem one. Problem two is you mentioned it now, I
want to call it out. You are replacing the inner ligaments,
the antire crucied ligament, and the poster crucied ligament of
the knee with knee replacement, and you're replacing it with
a post. So you can imagine golf, skiing, tennis, pickleball,
(12:08):
all the things that people as a kind of age
out of other types of exercises tend to get into.
That makes that rotatory component just feel unnatural. And that's
the big downside of it. So the reason the unis
are much more prevalent now is because those aren't sacrificed.
You retain all of your normal ligamenture, tendons and everything.
(12:30):
All you're doing with these resurfacing type strategies is to
replace the missing surfaces with new surfaces. So it's it's
it really is a targeted you know, hence the name
focal plastic type of type of approach.
Speaker 1 (12:46):
Okay, let's let's dive into that focal plastic because how
does the implant. I mean, this is one of those
things where we're on a podcast, so it's it's you know,
you have to be you have to describe the visual components,
but walk us through the design of the product itself.
Speaker 3 (13:02):
What does it look like?
Speaker 1 (13:03):
And you know what, how does the procedure look Maybe
not getting total need because we talked about kind of
you know, totally is the hacking. We're trying to talk
about focal being more of a mainly invasive procedure, but
compared to a UNI or to the partial knee replacement,
how does that differ, and including things like how is
the image, what type of imaging do you need to use?
(13:25):
Is it just simply X ray or do you need
to have a CT scan? And you know, just the
process of you know, patient from going from day one
saying I have knee pain to gain the focal plasty
and then post procedure, how soon can they get back
out and doing their running or golfing or skiing.
Speaker 2 (13:42):
Yeah, all valid. So first thing I'd say is most
patients who are ideally suited for this procedure have normal
X rays and it's largely an MRI diagnosis because MRI
is more sensitive. So you can see more. Uh. The
reason I bring up the normal X rays is because
with this particular procedure, we're not replacing meniscus, we're preserving it.
(14:04):
We're not you know, substantively rebuilding and they we're just
resurfacing worn surfaces of cartilage. So, uh, you want to
have good alignment, you want to have a you know,
a reasonable weight profile, things like that. Those are all
kind of played to it being successful. But once you
find a patient who has say some eroded carlage, and
(14:25):
that can be anything from as small as ten millimeters
up to about forty top to bottom on the on
the con dile or the end of the femur, the
thing that you walk on, so that's round, almost like
a cone, and then the tivious flat like a like
like you know, like the floor in the room. So uh,
the the overture implant, basically on the femur comes in
(14:46):
two varieties. They're there their gold it's like a gold
filling that was picked purposely. Their titanium, so they have
a tin nitrate cover. Then they have a tiny titanium
body and then what we call a a boning growth
bottom which looks porous and the reason we did that
that way is because ideally you like the implant to
(15:07):
bond to bone so that you can do all those
sports that you talked about, all the running impact stuff.
And then on the tibial side, it's actually a polyethylene
or high density plastic surface that's around and if you
took your thumb and just wiped it over the top
of the tibia surface after a procedure like this, you
(15:28):
shouldn't be able to tell a difference between you know,
where the implant starts and where the surface begins.
Speaker 1 (15:33):
Very nice, and then once the procedure is done. I
guess the way I can ask this is this the
same day procedure. Are they able to leave the hospital
for sure?
Speaker 3 (15:43):
Yeah?
Speaker 1 (15:43):
For sure?
Speaker 2 (15:44):
Yeah yeah. I mean to do a resurfacing of the
tibian femous probably about a forty to forty five minute
outpatient procedure, small incision, you know, crutches for maybe four
or five days. As soon as you start feeling reasonable,
you can start to walk on it. Cadence would be
(16:04):
something like you know, PT twice a week for six weeks.
I think at the end of two weeks most people
are like like pleasantly surprised, it's not very uncomfortable. By
six weeks, they're super happy because there's an achy pain
that comes with this type of a diagnosis that immediately
upon putting the implant in is relieved. So once the
(16:26):
haze of the surgery sort of passes through, which again
not a bad surgery, but you know, two weeks in,
I think most people are like, wow, okay, they're very optimistic,
and as they're working their way through the therapy, I
usually I usually see very happy, sort of like uber
optimistic patients at that six week mark.
Speaker 1 (16:44):
Yeah, and walk me through your design versus kind of
some of the predicate designs out there, because you did
get five to ten K, so you had to use
a predicate and Arthur's Surface, which I think was acquired
by Anika four or five years ago. I don't think
that product is still on the market. So what was
kind of the the the con or the you know,
(17:09):
the you know, what was missing with that device that
you were able to be able to alleviate in your design.
Speaker 2 (17:16):
You know, I'm glad you asked that because I was
a big fan of the Arthur Surface conceptually, was not
a big fan of it practically, and not to get
too much in the weeds, but the the way by
which you you fixed the implant on the femur, you know,
there was some principles involved there in development of it.
(17:38):
There was a screw and there was like a c
taper interface with the implant. It was just weird, like
I just didn't understand, and I should say my colleagues
didn't either like why it was that way. And then
on the tibia you had to do this kind of
weird like retrograde saw and you ha to pull it down.
It was very imprecise and will my my clinical results
(18:02):
with the Arthur Service were very good. I just never
got a comfort level with the way it was put
in and I suspect that that probably had something to
new with its with its overall utilization, however, really good idea, right.
So so when COVID started UH and we were not
operating basically to get back to what James was talking about,
(18:27):
I was involved with the engagement plant just as a
as a late investor and utilizer, and I thought, you know,
it's time to make hay On this is this is
the time to do it, if we're going to do it.
So I used that that eight weekhiatus. We had to
really kind of set down the basis of forming a company.
Speaker 1 (18:43):
Yeah, so basically one of the I thought what I
took away from that is that there was like a
retrograde drilling or cutting that took place.
Speaker 3 (18:50):
What was the biggest what was the biggest.
Speaker 1 (18:51):
Design feature in overture that kind of you know, eliminated
that cutting difficulty.
Speaker 2 (19:00):
So the the the main design improvement we made with
our implant was going back to principles of arthoplasty firm
early fixation. It's a partial cementation process with pegs which
the Arthur serface did not have, so we added that.
Then the bone end growth would allow some stability. So
(19:23):
it's just basically as you walk on the implant, it
helps with bony healing, like that's what you want. And
then on the tibia as a as a as a
carlist transplant surgeon, I knew for years that you could
detach an insertion of the meniscus and put it back,
and when you do that, you've got a beautiful view
of essentially the anterior four fifths of the of the
(19:46):
tibia interest so typically where the disease is. So that
was the change. It was what we call an antigrade
approach as opposed to a retrograde, which which again is
a very simple arthoplastic principle.
Speaker 3 (19:57):
Yeah, that just comes.
Speaker 1 (19:58):
I feel like that just comes from twenty five thirty
years of experience doing that type of work as your
cartilage repair to begin your career. And so that gets
us to the five ten K. And here now, James,
welcome back. When you had this conversation with Riley and
the other you know, doctors as they were beginning this design,
(20:21):
were you expecting this five ten K to come as
quickly as it did or was it? Were you ready?
Were you antsy and ready to go?
Speaker 5 (20:30):
You know, I think it was an unknown. The Arthur's surface,
which you mentioned earlier, that was the predicate device. So
you know, you just kind of look at history and
when you do submissions, you know, if you have a
predicated device that's already out in the marketplace and has
clinical data, which it had a lot of published clinical data,
you know, it almost seemed like a slam dunk.
Speaker 4 (20:51):
It was just a matter of when. Yeah, so I
think we had.
Speaker 5 (20:53):
Submitted it, doctor Williams. I think it was late maybe
it was November.
Speaker 2 (20:59):
Of twenty twenty two.
Speaker 5 (21:02):
And we were abas in Las Vegas. I still remember
March twenty twenty three and we get a phone call
at four am. You know, hey, it's five teen k cleared, right,
And so that's when the excitement really started happening. You know,
this is it's really interesting because I actually also launched
(21:25):
the product that was the longest ever reviewed by the
FDO was thirteen years.
Speaker 3 (21:30):
Wait, what device was that?
Speaker 5 (21:31):
That's an anatomically shaped breast implant for patients to have
breast reconstructions.
Speaker 3 (21:35):
Okay, that took thirteen years.
Speaker 5 (21:36):
Thirteen years. And again I had nothing to do with
the submission. I had nothing to do with except that
I just kept board. And then they said I got
a paper and said, hey, we're launching this thing. So
it was really exciting to get the notice. And we
just knew that since we already had we'll call it
our stable of surgeons who were ready to starting this device.
(22:01):
They were already trained, they already knew all the mechanics
behind it. Obviously, there's still a learning curve. We're still
trying to refine the surgical technique and you know, figure
out surgical pearls and all those things. Even it's too
how do we decide who's the right patient? You know,
doctor Williams alluded to, you know what we call patient selection.
But that's continuously being refined, right because you're always learning
(22:24):
new things, right science, That's the thing. Science is like,
you continuously learn, and that's what's allowing us to become
a much better company and for the product to be
much more effective in the marketplace. So we really took
that we'll call it March seventh when we receive the approval,
(22:45):
and then we immediately did another round of financing, and
then we ordered resterilizable instrument sets. We got all the documentation,
pulled together, all the quality management system stuff together, and
November seventh, twenty twenty three, here in New York City,
(23:07):
doctor Williams was the first surgeon to ever implant the device.
Speaker 1 (23:12):
It's fun stuff and so basically, you know that the
initial launch from that was the March. First patient was November.
How was that initial launch maybe from November, let's say
November twenty twenty three, the first twelve months until the
end of twenty twenty four.
Speaker 4 (23:32):
One.
Speaker 1 (23:32):
Maybe we'll start with the patient outcomes. What were you
seeing with these patients off the bat after they were
doing done with these procedures.
Speaker 2 (23:42):
Yeah, I mean, I think it's worth it to mention
although the overture implant was a new implant, the concept
was not. So when patients asked like, oh, like, you know,
what's the history of usage, you could you could accurately
point to Arthur's surface because even though the the way
(24:04):
you put it in was different, essentially exact same concept.
So so that was the framework that I kind of
framed it to patients, like, hey, listen, updated implant. We
have a stable of surgeons who sort of live in
this in this in this world, help with the development.
We think it's better. So you know, listen, you're you're
you're being honest with them about it being new, but
(24:24):
also contextually framing it for them clinically. So and the
response was like overwhelmingly positive. I mean, people shockingly like
surgeon inventors. They and I think HSS is a good
platform for me because it is the kind of final
stop for these kind of things. But the take on
message was I had already done over three thousand Osikono
(24:46):
allograph transplants, so I knew putting in the spacers worked
different surface a little bit, but you could make an argument,
which is why we did it this way, is that
you put someone's human piece of tissue into like a
fifty year old's knee. Not the most friendly environment, right,
(25:07):
just because of that catabolism we talked about. But you
put in a piece of titanium. That's the same concept
as a total except it's just more limited, smaller. So
the early results were honestly, like shockingly great. Like the
interesting anecdote is what I found was people were fantastic
(25:30):
for the first three months and then you get a
bunch of people come back at four months with swollen
knees because they just had this I call it this
irrational exuberance because they start thinking, oh, I haven't been
pain free in years. So I have to kind of
counsel them about, you know, a slow ramp up and
understanding that that inflammation that we talked about it earlier
still around. But listen, high class problems.
Speaker 1 (25:53):
I mean, I was about to say, it sounds like
they want to run a marathon after getting sucre do. Yeah,
And so you mentioned about the fifty year old patients.
That kind of the is that the patient pool that's
kind of narrowed down for selection of focal plasty or
is it a more complicated approach, this deciding who gets
who's best suited for it.
Speaker 2 (26:12):
Yeah, you know, I'm always careful to pigeonholes. So just
to throw out some examples, I think the youngest patient
that has got an overture and plant I believe was
twenty five. But this was a facian who failed one
of these allographs that I just mentioned. So for these
big holes and knees you don't have, they're no great options.
(26:34):
So and I will tell you he loves me. He's running,
you know, despite me telling him it so to be careful.
So so you know, it really kind of depends on
the problem. But I said, if you were thinking like
the early arthritic, it's probably thirty five to sixty five,
just depending on the findings on the ground, well aligned
knee like I said, normal ish BMI body mass index.
(26:58):
And quite frankly, you want to have some meniscus right,
you don't want to be apps in the meniscus because
again it's not a big, structurally bulky implant. It's just
meant to kind of put you back in line, get
rid of the potholes, so to speak, make things smooth,
and a need that's otherwise relatively normal.
Speaker 1 (27:16):
Yeah, and then James, you were talking about a sterilized set,
but my understanding is that there's also a single use set.
Is that something that you developed during this process in
the initial launch phase.
Speaker 4 (27:33):
Yeah.
Speaker 5 (27:33):
You know, the Orthopedic Space had kind of shot itself
in the foot business wise because a lot of these
bigger companies were so focused on selling implants that they
got to a point where they said, hey, you buy
these implants or do a certain volume of implants, and
we will basically let you have or let you borrow
(27:54):
these instrument sets for free. So the Space got into
this whole legit sticks nightmare of having to get resterlizable
sets and a restertizable set. Just so you know, with us,
with the small volume that we initially ordered for a
limited market release, it costs about twenty six thousand dollars.
Speaker 4 (28:14):
Each, right, I mean that's a car.
Speaker 5 (28:17):
So you're limited by the number of resterilizable sets you
have in terms of how many cases you can do
we'll call it simultaneously.
Speaker 4 (28:25):
Right, So.
Speaker 5 (28:28):
You know this this concept of well, let's take that back,
let's see how we can win that war back, right,
Because a lot of the cases now, especially with this.
I mean you asked a question earlier to doctor Williams.
Is this a procedure that can be done in a day?
Can the patient come in and then leave the same day? Absolutely,
So you're starting to see a lot of these cases
(28:48):
now go out to the amblatory surgery centers, right. So
a single use instrument kit is perfect for these facilities
because they don't have the big SPD or sterilization sisting
departments that an HSS has, that an NYU has, you
know that a KAISER has. Still it doesn't make a
lot of economic sense for them, but you know they
(29:10):
obviously have more overhead and more capacity to as a
surgery center they run lean. The other thing too, is
is it takes out all the complications in the operating room.
You know doctor Williams can attest to this, but you
want to take out as many variables as possible during
a case, and so having a single use kit we
(29:31):
just literally peel pack open and you can have a
backup for that as well. But peel pack open and
you don't have to guess which ones am I going
to use for this case? You know, based on the size,
I know exactly what I'm gonna use because the sizer
that I used told me is going to be in
our case A twenty two and a half by thirty five.
So I'm going to pull that set, open it up,
and here we go. So it's going to make even
the case more efficient.
Speaker 1 (29:53):
Yeah, and then so yeah, less inventory management things like that.
Speaker 4 (29:56):
Yeah.
Speaker 1 (29:57):
Yeah, it actually sounds like you're almost putting the foot
in the door for that reversal, as you said, winning
back that war. And even you know, maybe some of
the larger ORTHO companies would take note and be able
to see how we can make it more single use
cases like that again.
Speaker 4 (30:12):
Yeah, exactly.
Speaker 5 (30:12):
And you know there is a way to well call
it economize it as well or monetize it, right, because
you're you're basically giving these things for free. Here's here's
a funny story. We had a we got a call
from a surgeon out in Chicago. He's at Rush University Hospital,
and he said, hey, look, I got a case here
in two days. Do you think you guys can get
me an instrument two instrument sets for the case. Yes,
(30:35):
we can absolutely do that. So we looked up how
much it would cost to ship that, right, and you've
got to do next day because they have to have time.
Speaker 4 (30:42):
To sterilize it to get it ready.
Speaker 5 (30:45):
And it was five hundred and fifty dollars to ship
that from from.
Speaker 3 (30:51):
LA to Chicago. Yeah, okay, right, and.
Speaker 4 (30:54):
Sure we could do that.
Speaker 5 (30:55):
But then just for the fun of it, I just
went on American Airlines dot com AA dot com and
I said, I wonder how much it would cost for
me to do a round trip for a flight tomorrow.
And it was four hundred and thirty dollars, right, So
you know, I basically said, fine, I'm going to actually
be in the case. I'm going to book the ticket
and I'm just gonna take the sets with me at
(31:18):
cheaper than UPS or you know, FedEx.
Speaker 3 (31:21):
Right.
Speaker 5 (31:22):
So it's really interesting how you can try and change
the game. And we did this over at xcoment. I
think that was one of the allures of xment. We
had all singuise peel pack kits for hand surgery and
it actually it did really well also because of COVID.
At COVID there was no SPD department, there was none
of this, so you just had to drop off the
(31:42):
instrument sets and they loved it.
Speaker 4 (31:44):
That helped us but that really opened.
Speaker 5 (31:46):
My eyes to the power of a singuse instrument kit
in the space. And I think a lot of other companies,
I mean, this is not a secret. A lot of
the other companies are really trying to get there. It's
just how do you get there?
Speaker 4 (31:57):
Right? And you just gotta could happen.
Speaker 3 (32:00):
Yeah, I hear you.
Speaker 4 (32:02):
Yeah, all right.
Speaker 1 (32:03):
So obviously HSS and you talk about Rush University in Chicago,
but you also talked about the ASC setting. So how
have you built the commercial infrastructure to be able to
reach some of the top tier hospitals in the country
but also those ASC settings that you know, this seems
like a perfect outpatient procedure for sure.
Speaker 5 (32:24):
Well, we initially started off the and I alluded to
this earlier, but we had a limited market release. And
the limited market release consisted of eighteen to twenty maybe
twenty five surgeons that were reputable, that had experienced that
were peppered throughout the country. A lot of them were
you know, doctor Williams colleagues that he had great relationships
(32:47):
with and had great conversations with about this idea, right,
and they all understood the mission. The missionaire is there's
got to be something for patients when the biology just
doesn't work anymore, right, and let's try and build this implant.
So we started off with those surgeons, right, and we
did it a little bit differently.
Speaker 4 (33:08):
So if you think about an.
Speaker 5 (33:10):
Orthopedics company or a medical device company that wants to
get out and proliferate in the marketplace, they come up
with the idea, they get it FDA cleared or they
get the approval, and then they start building operations and
do all that stuff, and then they go out and
they call their distributor network of friends. Right, so you know,
I remember this guy he covered the state of New Jersey.
(33:32):
This guy he covered the state of Texas, and they
did a really great job and they know all the surgeons.
Speaker 4 (33:36):
Well, it was different for us.
Speaker 5 (33:38):
Because we already had relationships through doctor Williams, through doctor Bay,
through some of my past experiences that were surgeons that
these actually these distribuers actually wanted to have business with. Yeah,
so we actually asked those surgeons first, who would you
(33:59):
like to support you? And that's how we initially started
our network distributors. And then from there, you know, as
we got more confident, you know, we surpassed one hundred cases.
We said okay, now now it's game time. Now we
can go and we can start going beyond that trusted
inner concentric circle is going to say, Okay, here are
(34:20):
the things that we need to fix.
Speaker 4 (34:21):
Here are the things that are good.
Speaker 5 (34:22):
Here are the things that you know, we really need
to consider, you know, all those things that you do
in a limited market pleace. So now we could expand
beyond that. And that's really what we're trying to do
with these single use kits as well, because the resentilizable sets,
those were a limiting factor.
Speaker 1 (34:36):
Yeah, and just the you know, actually, one of the
things that I'm curious about with all of that, with
the single use sets is you know, when I'm thinking
of total knee replacements, I'm thinking of you know, high
volume and you have high turnover and you're trying to
you know, you have multiple especially top tier institution like HSS,
you have multiple rooms that you're doing multiple procedures, and
(34:59):
you're you know, many these cases can probably be what
less than an hour once you actually have the incision open,
maybe even less.
Speaker 2 (35:05):
Oh, it's it's and so and so.
Speaker 1 (35:08):
Is that One of the things with the single you
set is that you can make this procedure a very
highly efficient procedure as well, and just kind of building
the volume game is not the right way to think
about it, but you know, you're trying to treat as
many patients as possible with the technology. So is that
is this single use product the way of the future
(35:31):
or is this is there other things that you're working
on to kind of be able to streamline the procedure.
Speaker 2 (35:37):
Well, you know, trends and healthcare now are moving away
from impatients days hip replacements need replacements are done as outpatients. Uh,
James alluded to it. I just want to bring it
back up the trays and just the instruments require for
these these these cases typically certainly for totally they're massive,
(36:00):
and acs just don't have the storage capacity or reprocessing
capacity to do high volume. And you're right, like people
should think of the operating room as a hospital resource.
It's probably their most valuable resource. It's the highest amount
of renumeration for time spent in the entirety of the system.
So the more you can go through and run cases through,
(36:22):
the more economically viable you are. So any adjunct instrumentation methodology,
what have you that is going to be you know,
well integrated and befitting of an ASC in this market
is going to be a winner. So there are some
things that we did on the insertions side that are
(36:43):
very innovative and very proud of it. We got a
great you know, James conceived of it, our R and
D team put it together. It's it's very satisfying, and
we're coming out with those like just about right now
with some and it allowed us to do some modifications
on the on the early instrument designs that I think,
you know, the natural process of any company. But but yeah,
(37:08):
if you're not set up for ambulatory uh environment in
this market, that's that's that's not great.
Speaker 3 (37:16):
Yeah.
Speaker 1 (37:17):
And then you know, we were talking about the operating
rooms being the money makers for the hospitals. Is he
and you also mentioned that this is kind of similar
to a UNI or a partial knee replacement. Is it
reimbursed the same way because it's kind of considered technically
a UNI.
Speaker 2 (37:33):
Short answer Short answer is yes, Okay, short answer is yes.
The there a couple of codes for unis. One is
for one service, the others for two. I mean, this
is a unique compartment of arthroplacy indicated for both a
fema and tibia. They have been some with just the femur,
which is, you know, an off label indication, but again
one that uh I anticipate will have a hot high
(37:57):
likelihood of utilization in that in that circumstance, the specific
diagnosis of osteo chondritis disscants, that's that twenty five year
old patient. Those can be really big, debilitating, structurally challenging
type cases. And ultimately, in case the public wonders like
(38:17):
what is off label uses? Off label use means that
you and your doctor decided that this is a good
idea for you, and that you understand it's not technically
what the FD said. We don't push that. But ultimately
there are codes for both of those. So clearly it's
been in the ether before. Ye and they and they,
you know, they renumerate pretty pretty well.
Speaker 3 (38:39):
Yeah.
Speaker 1 (38:39):
Actually, the biggest one I see in my personal point
of view, is in the diabetes market, and there's insulin
pumps that are not labeled for type two, but you're
seeing the endochronologists still prescribing them because they see the
benefit of insulin pumps for all diabetic patients, whether it's
type one or type two. Doing insulin, so I get
the off label. I think what they say is that
(38:59):
you're not technically allowed to market that you can do that,
But then the doctors could just still do it if
they think it's still right.
Speaker 2 (39:05):
You know, it's a it's an interesting discussion. I'm glad you.
I love that analogy because you know, off label sounds
like illegal, yeah, right, which I just always have to
caution people. It's you know, at the end of the day,
doctors have a lot of leeway with regards to treating disease,
and the biggest innovations, quite frankly, come from these types
(39:27):
of cross references, cross cross usages that maybe were not
the original intent. FDA's main job is to regulate and
to make sure patients are safe. So which which which
we which we uh, you know support fully. But but
at the end of the day, the overture system is
so fungible and and it's just got broad application to
(39:50):
all sorts of Carliss problems that that we we think
it's a it's a it's a listen, it's the right
end plan at the right time.
Speaker 3 (39:58):
Yeah.
Speaker 1 (39:59):
And you know, with that implant, the I'm thinking of
the competitive landscape. I mean Arthur's surface doesn't sell their
product anymore. Is there anyone else out there doing focal
plasty or is it are you? Did you find that
initial niche step in the osteoarthritis treatment paradigm?
Speaker 5 (40:19):
Currently we are the only ones right now that have
FDA clearance outside of Arthur's Surface.
Speaker 4 (40:28):
I know.
Speaker 5 (40:28):
Doctor Williams alluded to some of the noted differences between
our implant and Arthur's surface, and do you do you
mind if I add a couple of points?
Speaker 3 (40:37):
Oh? Absolutely, Yeah.
Speaker 5 (40:39):
So our implant is a monolithic implant, meaning it's not
two pieces. Okay, okay, it's just one piece. And doctor
Williams shared that we have a base plate it's porous titanium,
and that titanium has natural characteristics or attributes where the
bone wants to grow into it, right, yeah, And it
(40:59):
was manufactured very low profile. And the reason why we're
able to do that is because three D printing or
what you know, I guess professionals called additive printing is
now able to do that with titanium. They were not
able to do that five ten years ago. So you know,
by utilizing that technology to do this, we're able to
make it low profile, because we don't want to reinvent
(41:24):
the staircase. We just want to be a stare in
that whole staircase. We want to provide surgeons with many
tools for what they believe is the right approach for
the patient and what the patient is going through. So
that's that titanium base plate and then the titanium nitride coding. Sure,
it's gold, and you know, it's a fun color for us,
(41:46):
but the titanium nitride is a harder surface, right, has
a lower coefficient of friction. So that's why it works
for us, because titanum is too soft. Yeah, okay.
Speaker 4 (41:57):
And then with the poly.
Speaker 5 (41:59):
You know on the opposing tibious it's the same base plate,
but it has the poly on the on the table side,
which is a plastic, but it's highly cross linked, and
it's highly cross linked for where right, Yeah, and then
we added vitamin E to it because we want to
protect it from oxidation. Oh okay, yeah, So it's a
(42:20):
highly cross linked vitamin E injected poly.
Speaker 3 (42:23):
Yeah.
Speaker 4 (42:24):
Right.
Speaker 5 (42:24):
And so those are some of the things that make
us different to Arthur Surface. Arthur Surface also, as I
alluded to earlier, it's two pieces. It's like a dental implant.
You put in the screw which is yeh, cobalt chrome
with a titanium spray on it.
Speaker 4 (42:40):
And has a cap.
Speaker 5 (42:41):
Yeah okay, yeah, whereas the are the overture is just
a one step process.
Speaker 1 (42:46):
Which once you got it all sounds like you're doing.
You're filling a cavity with a mini connect exactly.
Speaker 5 (42:52):
So you know, you kind of asked earlier, how do
you describe our procedure to somebody who can't see anything?
It is just into this, right, It's basically like a
dental cavity. Right, You're basically going in, You're just treating
that area. Rather than cutting everything out. You're trying to
spare as much of that tooth or that bone as possible.
(43:12):
So you just spot treating, right, And our implant was
designed to be able to spot treat, but it was
designed to do that without foregoing the opportunity of going
to the next stair in the staircase if necessary, if
the cavity spreads or the carlage defect spreads. Am I
kind of describing that, right, Doc Williams.
Speaker 1 (43:35):
There we go very nice and then so I mean
I have to imagine then that some of the large
cap competitors are interested in this type of technology, and
so anytime I have a small private company on, I
always ask what their protective moat is when it comes
to kind of patent protection. So how is your patent
protection to kind of fend off some of these large cap.
Speaker 5 (43:56):
Yeah, I mean that was one of the things that
we did earlier. You know, we're working with a very
reputable firm specifically in the space called Kenobe Martins. They're
based in Orange County. Work with them several companies. So
you know, in situations like this, you want to go
with the best, right And I'm sure you know many
people have their opinion of the best, but for us,
(44:17):
and at least in terms of where we are, these
guys have proven that they're good. So we have patents
pending on not only implant but also now with the
singouse instrument kits, right, So so we're good there. We
also have trademarks. So obviously our branding and our name
and all that stuff's trademarked even internationally, but we have
(44:42):
also I know, we were using focal plasty just like
it was a you know, common term now, but that's
something that is trademarked by overture as well. Doctor Williams
is the one who came up with it, I think,
at least in our circle. But yeah, focal plasty because
you know, obviously there's arthroplasty and vocal plastic and this
is a way that we thought we could describe the process.
Speaker 4 (45:04):
So the us p t O awarded that for us.
Speaker 1 (45:07):
All right, do I have to pay you guys licensing
fees for saying focal plasty times?
Speaker 2 (45:12):
Just slide on that.
Speaker 1 (45:15):
Oh yeah, And so then kind of just then looking
at you know, you guys are I know you guys
are on your in the air initial launch of the
vocal plasty of the single use. But in the future,
how are you envisioning this or expanded indications for this
type of technology. Yeah, I'll start with you, mister doctor Williams.
Speaker 2 (45:36):
Well, I mean I think, uh, obviously, if we have
efficacy in the knee, which is one of the most
frequently arthritic joints are hit knee and ankle, and then
a lesser degree shoulder and elbow, great toe arth right,
it's a big problem. Right. So so basically, if we
(45:59):
can continue to demonstrate efficacy in the knee, and you
wanted to expand you would just expand to other joints.
The the the idea of minimal bony resection and low
profile resurfacing is a winner. It just is because you're
essentially not trying to cut out a joint and rebuild
(46:22):
a joint. You're just going into the native joint and
filling in a hole. And and that is a you know,
thesis that can be applied over and over again, just
germane to the unique geometry whatever joint you happen to
be talking about. Yeah, so so that that's kind of
(46:42):
what I had imagined. And and listen, maybe you'll make
maybe you'll make a bigger implant. Maybe you'll make one
that that has a little bit more coverage in some
of the areas. For example, the pateel frameral joint is
another area that that we have an approved in plant for.
We haven't launched it because we want to kind of
deal with the way being part of the tibia feral
part of the joint, but that that clearly is another
(47:05):
sort of area that we're sort of interested in going
in because that's that's that quite frankly big problem in women.
So if you have arthritis in front of union and
makes all those fun things we talked about tennis, pickleball,
skiing really difficult. So so that that's in the offing.
So I would think like the teleferal joint expansion, other
(47:25):
joint expansion makes sense over the over the lifetime of
the company. But listen, I think we're a young company
and you want you want to hit with some wins, right,
So so my plan as an academic is to you know,
now that now now that we have a volume of cases,
we're coming up on two years kind of minimum time.
(47:46):
That's when you can really start to publish and and
and and present validated peer reviews sort of studies on
the efficacy which which will be important for us moving forward.
Speaker 1 (47:55):
Is it safe to think that in five years, you know, I,
you know, you an ESPN dot com would talk about
an ex player game and arthroscopic procedure done. Well, I
be able to see in the article that why player
got a focal plastic procedure done?
Speaker 2 (48:09):
You know, it's I'm going to use a very specific example,
I believe actually I'm not going to say the name
because I don't know if he announced it, but there
is a there is an NBA player who has played
NBA games who had a hip resurfacing procedure not the
same but similar, and he you wouldn't know anything. I
(48:33):
believe there are a couple of tennis players who've had
it as well, So we are on the precipice of it.
But my approach is the leader of the limited release
group has been like, when you're starting with a relatively
new implant like this, you want wins in regular people.
You don't start with Lebron James and someone who you
(48:53):
know is going to, you know, take their two hundred
and forty found frame and run up and down ninety feet.
So so I and I have that kind of practice
like I have. I have a professional athlete tertiary me practice.
So it's coming. But I think, you know, you want
to demonstrate efficacy and under normal loads, and then as
your experience grows and you see durability and efficacy, you
(49:15):
just expand on that.
Speaker 5 (49:17):
I think, you know, the other really cool stat is,
you know, twenty seven million people have signs of early
osteoarthritis with that are over the age of forty five, right,
and it's growing right because we're changing patient population, right,
(49:37):
you know. I like to use this illustration but when
we were growing up, you know, Blanche and Rose and
Dorothy from Golden Girls were fifty year olds.
Speaker 3 (49:47):
Right.
Speaker 5 (49:47):
Today a fifty year old is Jennifer Aniston. Right, it's
a totally different patient population. Look at the clothes that
we're wearing. Look at how sports and you know, an
active lifestyle has really traded you know, our culture, not
just the United States but obviously globally. So patients are
also doing things differently, Like I don't remember my dad,
(50:11):
you know, because I'm forty eight. I don't remember my
dad at forty eight doing anything besides like golf. But
you know, here I am still trying to play soccer
and I'm you know, running and doing all kinds of stuff.
So medicine also has to follow the patient population how
it changes, right, So I think that's another thing that
we really need to take into consideration in terms of
(50:32):
where this thing is going. So sure it's good for
the younger Lebron James's and whatever, you know, we'll see
in years to come, but there's a whole other group
of patients that really need this.
Speaker 1 (50:45):
Yeah, yeah, that's it sounds like early early Indians for
you guys. But James and doctor Williams. Thank you so
much for joining us today. I appreciate you guys coming
in and telling the story.
Speaker 4 (50:56):
Yeah, our pleasure.
Speaker 2 (50:58):
I love the overture story.
Speaker 3 (51:00):
Well there we go. That's gonna be the title of it.
Speaker 1 (51:04):
And thank you to our listeners for tuning in today.
We hope you join us for future episodes. If you'd
like to stay up to date, you can click the
subscribe button on Spotify or your favorite streaming platform. Take care,
Host
Jonathan Palmer
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