December 5, 2024 • 45 mins
Sequel is combining the experience of its four co-founders to develop the next generation of insulin pumps, aiming to provide better delivery capabilities, CEO Alan Lotvin tells Bloomberg Intelligence. In this Vanguards of Health Care podcast episode, Lotvin sits down with BI analyst Matt Henriksson for an in-depth interview on the path insulin pumps have taken over the past 50 years to close in on a truly automated delivery system. They also discuss Sequel’s development of its twiist delivery system, designed to better titrate insulin injected into the body, and its strategy for commercial launch in 2025.
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Episode Transcript
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Speaker 1 (00:21):
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 with us
today Alan Latvin, co founder and CEO of Sequel, a
privately held medical device company that is developing the Twist
(00:43):
automated insulin delivery system. Alan, thank you for joining us today.
Speaker 2 (00:47):
My pleasure, Thanks for having me and.
Speaker 1 (00:50):
So Alan, ye know you have had a robust career
in the healthcare space. So why don't we start with
just your career path that has gotten you to first
getting into the diabetes space, and then SQL SQL the company,
and then just you know, some of the paths that
(01:11):
connected you with some of the other co founders for
SQL sure, So.
Speaker 2 (01:17):
Just it was a little bit of a securitiest path.
By by way of background, IM an interventional cardiologist practice
in the New York area for about five years, doing
a lot of stent placement, angipastays, all sorts of intracronary interventions,
and obviously a lot of those patients had diabetes. I
left practice because I was really interested in population health
(01:38):
management and what we then called big data, and ultimately
found my way into the pharmacy industry and particularly the
pharmacy benefit management industry, which I thought was fascinating because
you had a real time data set and it was
a data set of what actually went into the body
in the way of medications versus what someone wanted to
(01:59):
get paid for, and so I thought that was really
an interesting place to pursue those two passions. Found out
that I was, you know, pretty I enjoyed it. It
was pretty good at it. And my career through the
PBM industry was largely in specialty pharmacy and disease management,
so disease management you know, diabetes, hypertension, things like that,
(02:20):
and the specialty pharmacy drugs that are ten thousand to
a million dollars a year, and I helped build two
of the larger ones in the country, most recently starting
in twenty thirteen or so at CVS Specialty and then
for the last three years up until I left in
twenty twenty three, I was the president of CBS Caremark,
(02:43):
the largest PBM, and through that really saw how important
and impactful the costs associated with diabetes were. To employers.
But also because you see this entire, this huge database
of people using insulin, using other agents for diabetes, you
(03:04):
get to see all the gaps in therapy and all
the gaps in care, and all the opportunities to improve care,
whether it's through better anti diabetes therapy, better insulin therapy,
but also through better supportive therapy like antihypotensial. So that's
sort of how I got through to like real interest
in diabetes. While I was at CVS, I met Dean
(03:28):
cam In, one of the original inventors of the first
wearable diabetes insulin pump, which is just a fascinating story
and of itself, on another project we were working on together,
and as I got to learn more and more about
the things Dean was working on, I became more and
more intrigued by this device because it has some truly
(03:49):
unique technology that allows for what I expect to be
really clinically relevant opportunities to help people living with diabetes.
So as I was ready to transition out as CVS
after you know, eleven years there, twenty seven years in
big companies, I I you know, work with Dean and
(04:13):
some of our other founders who I had met along
the way and we decided to form a company around
around this device. We called the company Sequel and the
device twit.
Speaker 1 (04:22):
Interesting and yeah, I mean I think partnering with Dean
and you know his it was called the auto syringe
pump was the first one he made. Correct, that's correct, correct,
And but that was also almost fifty years ago when
that came out, and you're talking about, you know, this
(04:43):
gap in treatment for these patients. Walk us through maybe
those last fifty years or so, because the gap has closed,
but it's not as quick as people were hoping for
for developing what is now called the automated insulin delivery system.
(05:03):
So maybe we can just you know, dive in. First,
is you know why these diabetic patients need to inject
themselves with insulin day in and day out, and then
you know what are some of the technology advances that
have taken place over those fifty years before we've gotten
to kind of the current technology.
Speaker 2 (05:22):
Sure, so focus first on why people with diabetes need insulin.
So we're going to focus mostly on type one. Type
two patients are also become insulin dependent, and we can
talk about those. But there are two really two different
mechanisms so they're essentially different diseases in a lot of ways.
So type one diabetes used to be called juvenile onset diabetes,
(05:48):
though it can certainly come on in adulthood, is an
autoimmune disease, meaning that it's a disease where the body's
own immune system attacks the specific cells and the pancreask
called beta cells that make insulin. So those people are
absolutely dependent on exogynists insulin from outside in order to survive.
(06:12):
And we knew that insulin would would allow people to
not develop the acute problems associated with diabetes, and we've
learned that better insulin management, or better glucose management, prevents
the long term sequillite. So for the longest time, the
principal ways that you would get insulin were either injections,
(06:36):
daily injections, and often that would be multiple injections. You'd
measure your blood glucose with a fingerstick, so you'd prick
your finger, measure some blood, and then give yourself a
certain amount of insulin. Over time, people realize that this
idea of having a small dose of insulin all the
time was important. So two ways that that became a veil.
(07:00):
One was through insulin pumps, like the autos range and
oogly pumps and other ones. And the other was what
are called basil insulins long acting insulins LANTIS was one
of the first ones. So those for really from like
(07:21):
nineteen seventy four until probably you know, early two thousands,
all of the insulin pumps on the market worked virtually
the same way. They have a high precision motor that
turns the lead screw which pushes a plunger on a syringe,
and and you know, it was perfectly adequate for maintaining
(07:44):
you know, people, you know, in a reasonable level, and
it was an alternative to to these basil insulins. It
didn't change really the need for boluses. Over time, people
started developing the ability to bowl us off the pump,
where you would you would manipulate the pump in such
a way that they would start to put insul it.
(08:04):
It would give a hot it would give a literally
a bowl as a shot of insulin. What what started
to make the difference in terms of these automated insulin
delivery systems was the development of glucose monitoring. And if
you think about an automated insulin delivery system, it has
three pieces to it. It has the glucose monitor, it
(08:26):
has the algorithm or control system, and then the insulin
delivery device, and they all three work together to to
to deliver insulin in and like any system it's there,
it's only as good as the weakest length. And for
a long time the challenges were with us with the
continuous glucose sensors, and you know, Dean would tell you
(08:50):
that he expected that technology to advance, you know, so
that by the early two thousands or late nineties, certainly
we would have automated insul delivery systems. It turned out
to be a much more difficult problem, both measurement problem
and processing problems, so that we really didn't have great
sensors until you know, the twenty tens. And then as
(09:12):
the sensors got better, people started building algorithms to drive
these insulin delivery devices. And sort of in those twenty
late twenty teams who started to see the evolution of
these automated insulin delivery devices. There was also sort of
a different pumping technology developed in the early two thousands
(09:34):
with Insult and the omnipod, which was a slightly different
mechanism of delivering insulin. Well fast forward to we'll call
it twenty twenty three, and there were a number of
automated insulin delivery systems on the market. They clearly demonstrated
that they were better than what are called multiple dealy injections,
(09:58):
where people would give themselves into injections, but they still
had they still had it was still a very unmet market.
And why do I think it was an unmet market. Well,
it was an unmet market because despite the fact that
the ADA technically in twenty twenty four said that all
patients who are insulin dependent should use an AID system,
(10:21):
only about thirty seven percent of people in the United
States actually are. And of the people who are using
an AID system, between anywhere between five and fifteen percent
of them will will will change every every year. So
to me, that just speaks to an unmet need in
the market for new technology. There's all sorts of reasons
(10:46):
why these systems don't meet all the needs of patients,
and there's no one one answer. So Dean, observing the
evolution of the CGM market, said, you know what, I
know all the limitations of the of the existing pumps,
of the existing it's own delivery devices, and and he
(11:08):
believed that having a new technology that that you know,
basically the first new delivery technology in twenty years, would
allow for for better outcomes and better closed loop control
of for people living with diabetes. Now, I should say
(11:29):
that was his vision. We still have to prove a
lot of this. We We've done a lot of work
with the technology, but you know, we haven't launched into
people yet, so we still have a lot of work
to do. But that was his vision. That's why he
spent so much time and effort on building this really
incredible technology that you know, we believe and hope answers
(11:50):
a lot of the issues with respect to why people
why the market is relatively unsatisfied.
Speaker 1 (12:00):
Interesting and so you know, there was actually a second
component you brought in there about actual insulin delivery results
because you know what, you know, the transition that I've
seen over the last ten years working deeply into the
space and then going back to my history lesson over
the past fifty years, is that the theme has been
(12:23):
to make these devices smaller so it's less of a
burden to wear, and it's no longer you know, holding
a walkman or walkman sized device with a big canular tube.
It's that transition. But you're also saying that even with
the improvements in the design, there's still improvements that are
(12:45):
needed in the actual delivery of the insulin. Did I
take is that? Is that a correct takeaway?
Speaker 2 (12:50):
I took from you that that that is correct? I
think the again, wear ability, I think is an important
part for people. Capacity of the device right can hold
enough to last three days is an important piece. But
there are there are Everyone who uses these devices knows
(13:13):
that even though they're better, they have better results than
than delivering insulin. They have they have some challenges, and
some of those challenges have to do with the the
inability of the current crop of devices to let you
know when insulin delivery is interrupted in a physiologically relevant timeframe.
(13:39):
And so because of the way these devices work, they
sense blockages and occlusions what by by pressure building up,
and that takes a fair amount of time. The twist
system is different. Right. We we directly measure how much
insulin we deliver every time we give an impulsion or
(14:01):
a micro shot, every single time. And so if if
if we give a micro shot and we measure zero,
well we know there's a problem. Now Obviously, we don't
alarm instantly, because that would be foolish because sometimes people
are just they've rolled over or But in the in
the instructions for use in our i FU, it says
(14:25):
we we alarm up to nine times faster than any
of the devices on the market.
Speaker 1 (14:32):
We have.
Speaker 2 (14:34):
We there was an article published in the in the
I Triple E Journal, which is an engineering journal, which
looked at an apples to apples comparison of the existing
devices on the market, and they kind of replicated that
and said, well, the TWIST device will alarm five to
twenty five times faster. And what we plan on doing
(14:57):
is as we as we get on the market is
demons straight that when our pump tells you that you're
getting insulin, you are in fact getting insulin. Then when
you're not getting insul we will let you know in
a timeframe that is that is physiologically relevant with respect
to avoiding high glucose.
Speaker 1 (15:14):
Yeah, okay, And so then it's so basically what you're
seeing as a problem that can be easily fixed or
get be fixed with the right technology is that the
current pumps don't alert the patient soon enough and therefore
they're not getting the right insulin dosage. In so it
(15:35):
sounds like they're getting less insulin than they're expecting to
and so their blood glucose levels are higher than what
they're targeting. And so basically then by the time they
see their blood glucose, let's say, get to above one
hundred or two one hundred and twenty five, then that's
the point where it's probably was you know, could have
(15:56):
been addressed sooner. Correct, So I.
Speaker 2 (15:59):
Would say a little bit diff So what happens is
because it can take hours for people to for these
pumps to alarm, your blood sugar can be three or
four hundred, at which point it's it's it becomes a
much more significant problem than just oh my human love
and A and Z is going to be high. At
three or four hundred in type one, you can be
(16:20):
in what's called DKA. You could easily end up hospitalized
for for high blood sugar. So you know, these things
are it's it's more of a safety issue. And when
you talk to when you talk to patients who have
chosen not to use a device an AID system despite
the fact and again I want to emphasize for your listeners,
(16:40):
AID systems, all of them, they're they're safer and more
overall better results than multiple doses of insulin. Having said that,
there is still opportunity to make them better, and that's
why we're on West where we're coming to the market.
But when you talk to people who have chosen not
to use it, one common reason that you get is
(17:02):
when I inject myself with my insulin pen, I know,
I got insulin in, and I'm afraid to go to
sleep and have an occlusion or something bad happen overnight
and wake up, you know, with extreme hyperglycemia, high blood sugar.
So that that's one of the reasons that we're trying
to one of the one of the we'll call it
(17:23):
a challenge problems we're trying to solve, or or concerns
we're trying to address.
Speaker 1 (17:28):
Okay, and so you know, let's let's dive into your
twist aid system a little deeper. What is the technology
that is allowing you to be able to do those
kind of checks and then essentially then turns into allowing
you to do microdoses? Is that correct?
Speaker 2 (17:49):
Yeah? So so so the microdoses are more like there
are more a function of how we deliver the insulin
and other other pumps give small doses as well, but
we differently as we we measure each and every one,
and because we measure each and everyone, we sort of
I'll explain it to you a second. We're able to
(18:10):
very quickly tytrate to where you want to be. So
so the way we measure, we measure insulin is really
it's beautifully elegant. So I'm going to give you a
very very quick, no more than one minute, physics lesson.
So we'll start with Isaac Newton. Isaac Newton kind of
(18:30):
described the physics of almost every musical instrument, and he
realized that every musical instrument is a mass that vibrates,
which in turn vibrates the air. So think about plucking
a guitar string, or blowing across a red or banging
a drum. You know, a mass the skin, the red
(18:52):
or the string moves, It moves the airwaves. The airwaves
hit your ears and you hear it. Isaac Newton couldn't
figure out how a pipe organ worked like a church organ.
It took two hundred years for a guy named Heinrich
Chmhols to figure it out. And what he realized was
a pipe organ works the way if when you were
(19:12):
a kid if you blew across a coke bottle or
a beer bottle and made a tone, and then you
drank a little bit of the coke or the beer
and blew across and made another lower tone. He realized
that his seminal observation was that air was both the
thing that was vibrating and what was being vibrated. And
(19:34):
so when you do a lot of complicated mathematics, and
if you have a rigid cylinder like a coke bottle,
or a rigid two like a coke bottle, it turns
out that the only thing that matters is the height
of the is the height of the air column, right,
And so the air column is higher, you make a
lower tone. Of the air column is shorter, you make
(19:55):
a higher tone. And so what we basically did was
build a tiny little chamber like a coke bottle into
the twist pump, we blow a series of frequencies across it.
We do some very complicated mathematics, and we're able to
see the size of the chamber. So now what happens
is when I'm ready to give insulin, I measure before
(20:19):
insulin in the chamber. I open a valve and insulin
flows in and a deformable membrane moves, and I measure again,
and then I let the insulin flow into the patient
and I measure a third time. And when I do that,
I can subtract the last measurement from the from the
second one, and that's how much insulin I gave. And
(20:41):
we can measure that at fifty nano leaders of precision,
fifty billions of a leader of position. It's it's insane
because you know, when when you're when you're using sound
waves that are very high frequency, it has very high resolution,
sort of like X rays, and you know, the higher
the frequency the X rays, the better the resolution. That's
(21:04):
how we measure, and then what we the next thing
we do is we we then adjust the time interval
between doses. So if someone wanted to give zero point
one units and an hour, for example, we would divide
that into twelve doses. We would figure out about how
much each dose should be, and then if we were
a little bit over on one micro impulse, we would
(21:26):
we would instead of waiting a minute for the next microdose,
we might wait a minute, we might wait a minute
and four seconds. And if we were a little bit
under because we're always going to be you know, very
very close plus or minus five percent. Well, we'll wait
a minute shorter. So what happens is, whereas all pumps
on the market are are accurate to plus or minus
(21:48):
five percent at the end of three days, in shorter timeframes,
they have a lot more variability. Because we were able
to measure what we're giving, we can we can reduce
that variability substantially. And again, you know, you could say, well,
big deal. We think over time that's and we'll be
(22:08):
able to demonstrate over time that that makes a difference
with algorithms, but we have to prove that. But where
it really makes a difference right now is I can
measure very quickly whether you're occluded or not, because if
I gave less than I expected by more than a
certain amount, you know, if I'm fifty percent or sixty
percent or eighty percent less than I expected, there's an
(22:29):
inclusion in the system somewhere.
Speaker 1 (22:31):
Yeah. I actually I'm very interested to dive a little
bit deeper now into.
Speaker 2 (22:37):
You know, you you.
Speaker 1 (22:38):
Talked about the you know, let's call it the trifecta
of insulin delivery, where you need a CGM, you need
a algorithm and you need the pump. My understanding previously,
maybe a little bit naive, was that, you know, the
CGM had the sensor reading, that's the lucos level readings
(23:01):
from that CGM then goes to the algorithm. The algorithm
does the number crunching, and then those results then go
to the insulin pump, and the insulin pump delivers it.
Let me start first with what is the algorithm that
you're using for your pump.
Speaker 2 (23:19):
So we're using an algorithm that's that's essentially derived from
the tidepool loop algorithm, okay, which was an algorithm developed
in actually in the do it yourself community. People engineers
who are whose children often were living with diabetes built it.
So it was built you know, by people living with
(23:41):
diabetes for people living with diabetes.
Speaker 1 (23:45):
Yeah, and but that that that's what that did receive
FDA approval sometime last year. Correct, So even though it's
a do it yourself, it is a FDA approved algorithm.
Speaker 2 (23:56):
So that that's correct. So what what? And to be
very precise, there is a version of the algorithm that
was we'll call it an air quotes frozen and that
version was cleared by the FDA as part of what
are called the interoperability Interoperability Standards for use with ai
(24:16):
D systems. Okay, and so the algorithm that we're using,
we're using the FDA cleared version of the algorithm, and
we're continuing to work with tide Pool on on on
enhancing that.
Speaker 1 (24:28):
Okay, And that's that. But that then then so that
goes to then the second part of my question and
kind of my initial understanding about insulin pumps almost being
passive and allowing the algorithm to make the decision of
how much insulin and when to deliver that insulin. But
it sounds like the design of Twist now is allowing
(24:51):
some communication to go back to the algorithm and say, hey,
we may have delivered a little bit too much or
too little in this last my crow dose. We're gonna
have to change the time of the next frequency or
the amount next time. Is that something that is novel
with the TWIST design?
Speaker 2 (25:13):
I think I think I would think about it differently.
Which is which is the the the algorithm and the
pump together and the CGM they comprise a control system,
and a control system has a lot, you know, think about.
I'll think I'll give you an example of a control system.
So you get in the shower, and you an old
(25:36):
fashioned shower and it's got two knobs, and you want
to make it, you know, the temperature that's comfortable. And
you get in and it's too cold, so you turn
up the hot water. The response isn't immediate, right, because
you got to the valves, got to open more. Hot
water's got to come from the basement, and you overshoot
(25:57):
almost always, you'll overshoot. Now it's too hot, so now
turn the hot down or you turn the cold up
one of the two, and over time, you you you
kind of you, you slowly get that to the temperature
you want. Well, imagine you're in an old house and
while you're trying to do that, you know someone's you know,
turning on the dishwasher or flushing a toilet. So the
(26:19):
water it's always changing. And so that's that's what what's
going on in this system. So control systems can get
out of whack really quickly. And so the and I'm
not an engineer, but you put certain filters in the
control system that that that blow down that response so
(26:39):
that you don't overreact or underreact, right, because in case
of overreacting and insulin you would get hypoglycemia low blood
sugar and the case of underreacting you get hyperglycemia. That
because the twist system is a little bit more responsive,
(27:00):
we can we will be able to empisodes, be able
to tweak the coefficients such that and the filter is
such that we have less of less of a delay,
less of a concern because the reproducibility is there, so
it's less to say about you know, kind of feedback
back and forth. Though knowing for an algorithm to know
(27:23):
that it gave x amount of insulin and know that's
in fact how much it was was actually given is
again I think something new that will that that algorithm
engineers will be able to incorporate into into their evolutions
of their algorithms. Okay uh.
Speaker 1 (27:42):
And then for the rest of the form factor itself,
how is it differentiated from kind of other options that
are out there, either if it's a durable pump or
if it's on the body.
Speaker 2 (27:55):
Where So just just one last one last point on
on algorithms. But that's I think that I think the
fact that this was made by people with diabetes, it
really has there's some very unique aspects of the tide
Pool algorithm. One is it has the lowest set point,
So if you want to be aggressive about lowering your
blood sugar without suffering, without the risk of more hypoglycemia,
(28:19):
you can set your this algorithm to target the lowest
blood sugar of any algorithm on the market. The second
thing I think that it does, it's really remarkable. It's
very very personalizable if you want to, you don't have to,
but it does something that I think in the GLP
one era is really important, which is if you sit
down and you think you were going to eat forty
(28:41):
carbohydrates at a meal that you took your GLP one
and you only eat twenty, you can retroactively reset the
carb count and the algorithm will update to give you
less insulin. So it does require so much consistency in
how you eat or or accuracy. So it's really a
some nice features.
Speaker 1 (29:01):
Yeah, and especially the saying the load target, because I
know other algorithms that they're they're in the process of
trying to lower the target glucose level without having the
risk of going into that hypo, because the hypo is
a much more acute risk compared to the long term
ramifications of hyperglycemia. So that's that's a good good point.
Speaker 2 (29:25):
To know, that's absolutely correct and and and yeah, absolutely.
Speaker 1 (29:29):
Correct and so yeah, so them just going back to
the form factor, I mean, when I'm thinking of a
durable pump, when I'm thinking of an ont of body
where where where does twists fit in that spectrum?
Speaker 2 (29:42):
From an on body wear perspective. We've tried to create
it a device that creates maximum flexibility for people, so
you can wear it on your body. It's the only
wearable device that holds three ccs or three hundred units
of insulin. You can tuck it in a pocket, you
can move it around without losing insulin, so that if
(30:04):
you know, if you're wearing different clothes or different styles
of clothes, you can easily change how you're wearing the
Twist pump. And again, you don't lose insulin every time
you move it. You you have to move the the
insertion site for the for the canula, but you don't
(30:24):
lose insulin. So we kind of like that, and we
think with a short canula, short teather, it's it's equally
wearable to anything else that's on the market, but with
the ability to see the site to understand what's going
on the site also will give us in the future,
(30:47):
we're going to look for the opportunity of extended wear
and and again being able to see the site and
see that it's not leaking and not irritated, we think
is an important part of that. But it's really about flexibility.
It's about wearing and using the device the way you
want to use said.
Speaker 1 (31:01):
And so then you you have FDA approval for this device,
but you're you're still working on the development for your
US commercial launch. So what is the strategy around that launch.
Speaker 2 (31:16):
Yeah, so, so we are UH finalizing our our sensor
partnerships and UH that's really the driver of our launch
timing right now. We we plan on launching what we've
told people and I think we're still comfortable with it
is in the beginning of next year. Our intent is
(31:39):
to really have a fairly aggressive UH rollout throughout the
course of the year and and and make the device
widely available, you know, across all the major UH uh
UH centers and territories by the by the middle of
(31:59):
the of the of the year, with with clinical trainers
in the field and sales reps in the field that
at that point, you know, starting in the first quarter
and you know, ramping up through the call them you know,
early part of the third quarter.
Speaker 1 (32:17):
Okay. And then so you know, one of the other
things too, is you mentioned at the very beginning your
time at CVS and as you know, we're you know,
your specialty in the PBM sector. How would will this
product be available through the pharmacy channel the same way
some of the other kind of on the body where
(32:37):
pumps are.
Speaker 2 (32:38):
Yeah, this was this is going to be exclusively available
through the pharmacy channel, okay. And we really thought through
kind of the the the pricing strategy to make sure
that we created the lowest list price that would benefit
people living with diabetes and users, and you know, made
(33:01):
sure that we had a net price that was effective
for payers.
Speaker 1 (33:05):
Okay. And then you're also targeting the type one population first, Well,
how do you see that opportunity potentially expand over the years.
You know, you talked about AID you know, the penetration
rates currently in the high thirties, maybe potentially low forties.
(33:25):
How do you expect that penetration rate to kind of
accelerate over time?
Speaker 2 (33:31):
Yeah? So I'm again, you know, what did yogi berra say,
you know, making predictions, especially about the future as hard.
I don't know. I would imagine that over the next
I look, let me say not, I imagine I hope
that over the next three to four years that we
can get that forty percent number into the high seventies.
Speaker 1 (33:54):
Yeah, that would that would that would you know? And
you know, this is kind of what we're talking about
the transition from MDI, which you know, you're saying that, yes,
the patient knows that they're getting insulin delivered at that point,
but all the burdens of you know, having to repetitively
inject yourself transitioning to these pumps where you're kind of
(34:18):
having that ease, but it's also you know, you're also
there's some uncertainty about if that the canule is actually
gained the insulin delivered, and as you improve that portion
of the insulin delivery system over time, you should be
able to get that penetration rate up.
Speaker 2 (34:36):
I think that's right. I think I think a lot
of things are going to be sort of operating together.
I think sort of new technology is certainly going to
make a difference. I think continued work and demonstration of
of better outcomes. I think, like everything else in medicine,
you know, it does take a long time for things
to move from we know they make a difference to
(34:57):
being broadly clinically available, so you know, in some ways,
I think the end of chronology community is moving faster
than not some other some other parts of healthcare. But yeah,
I think it's a combination of a surety of delivery,
ease of use, ease of access through the pharmacy channel
as more as more devices become available to the pharmacy channel.
(35:21):
Algorithms that allow you to do or not do what
you want but without making you feel trapped into something
you can't control. I think are all all things that
are going to help expand the expand the market.
Speaker 1 (35:35):
Yeah, and the the other thing too that I'm taking
away from this too is that there's still a plenty
of opportunities with patients who are still using syringes instead
of patients who are using other automated insulin delivery systems
and are going to transition over to your technology.
Speaker 2 (35:53):
I think definitely there's a group of people who are
using multiple doses of insulin and insulin that are going
to move to our device because it addresses a concern.
The concern maybe they want to wear something, but they
need three hundred units of influence for three days, a
concern maybe you know, confidence and delivery. I also think
(36:13):
that there are some people who are going to look
at it and go, you know what, I really like
this idea of a waterproof on body where that you
know that I'm okay with being able to see the side.
I like having a tether. I like being able to
move the side around. But I really want something I
don't have to take off when I go to the beach,
or I don't take off and I take a shower.
Those sorts of things I think makes a difference to people.
Speaker 1 (36:33):
Yeah. Yeah, And then you know the other thing too
with just any commercial launch as well, is just the
manufacturing capacity. How have you, you know, putting on you know,
transitioning from kind of the scientific and the engineering head
to the CEO hat. What are the steps that you
need to kind of ramp up manufacturing between now and
(36:53):
kind of first quarter twenty twenty five when these launches
could initially begin, and then kind of further in twenty
twenty five as you ramp up.
Speaker 2 (37:03):
So we have two operating lines right now that are
making well actually four two that are making the reusable
part of the system, two that are making the disposable cassettes.
They're making commercial product now in anticipation of lawn. We
(37:24):
have a third sort of high volume automated line. These
lines are automated, but there's one transfer step high volume
automated line that is we're taking delivery on shortly and
that should be available and I don't know, sometime in
(37:45):
twenty twenty five. And then we have a fourth line,
also a very very high volume line that's currently in development.
So we've essentially invested in capacity well in advance of
needing it at we can we can we can meet
our anticipated needs.
Speaker 1 (38:04):
Yeah, and so then beyond that too, you know, when
you look beyond the launch in twenty twenty five, that's
a lot on your plate. But you know, as we're
looking beyond even that, what are some of the other
developments in progress at SEQL, And you know, I'm thinking
of things with you know, Type two patients, you know,
(38:24):
the development that we're seeing with kind of pre pre
filled like insulin syringes or cartridges. And then lastly, I
mean some of the technology can also be translated into
other drug delivery, and I'm curious if that's a step
that SQL has been considering.
Speaker 2 (38:45):
Right, So, so a lot of good questions in there.
So first, we are very interested in Type two. I
think again this this at the ability of this device
to hold three hundred units is important. Uh, And we
have some really interesting kind of next generation that would
allow us to hold even more which in the same size,
(39:06):
in the same form, fact which I think for Type
two will be really important. We're going to be starting
a a cuindical trial and Type two next year, so
Type two is really important. We also have a proprietary
infusion set that we're we're bringing through the FDA for clearance.
It's a it has some unique features with respect to
(39:29):
the material and the actual insertion methodology that we think
is going to be really, really, really cool. But a
little too early to talk about. Your question about prefilled
cartridges is one that we're actively exploring. It has some
it has some challenges and a timeline and how you
(39:52):
do that, you know quickly because you have to demonstrate
stability obviously and safety. But you know, definitely on our
radar screen is something that would make the experience for
people and with diabetes better. And then to your point
about other drugs, it's, uh, this, we do think there's
a lot of opportunity for other for other drugs, particularly
(40:14):
any any scenario where there's a physiologic parameter we can
measure and then alter the drug dose in response to
that parameter, we think is a really interesting opportunity. So
we're looking at a number of those those products.
Speaker 1 (40:34):
That's interesting. Actually one of the description of the pre
filled cartridges and you talked about the stability, is that
the stability of the insulin staying in the dispenser, the syringe,
the cartridge, and is that kind of maybe one of
the biggest hurdles for all of these companies right now,
(40:55):
is that making sure that the insulin that's in there
is you know, almost reproducible and providing the same benefit throughout.
Speaker 2 (41:05):
So insulin is a notoriously finicky molecule, and we know
that you can store insulin and glass. I think what
we're you know, most of the of the devices are
using some form of plastic, Okay, So to to to
(41:26):
have to you have to demonstrate to the FDA that
that the having the insulin in contact with a plastic
versus glass for a longer period of time than you know,
a week, a month, whatever, doesn't do anything to degrade
effectiveness of the insulin or otherwise create issues. So it's
(41:47):
just a it's just a matter of doing the work,
is really what it takes.
Speaker 1 (41:51):
Yeah, and that's that's the interesting thing that you know,
it's always just you don't connect the dots about why
you can't transition from insulin, and it really just it's fascinating.
It's just simply the difference between glass and plastic.
Speaker 2 (42:04):
That's certainly one of the issues, right. I mean, if
someone had if someone had proven that X, Y and
Z plastic could store insulin safely for for two years,
then you know, everyone would use that plastic. But no
one has done that or or and if they have,
it hasn't been coome widely available to you know, because
of intellectual property, which is which is which is fine?
Speaker 1 (42:25):
Yeah uh and then yeah, Ellen, I think we'll just
you know, we'll close out this episode. You know, you
talked about your career path that's gotten you to where
you are now as CEO a SQL. You've learned a
lot during those times, especially at CBS. Now it's helping
you with the pharmacy channel. I'm curious if there was
(42:47):
a book that you've read, either recently or a while back,
that's also has influenced you during your career path.
Speaker 2 (42:56):
Yeah. So I'm a pretty voracious reader, So I read
a lot and so on any given day. Uh, you know,
there are more, you know, there's a lot of books
that I think have been very helpful to me in understanding,
you know, leading teams and and and how to you know,
(43:17):
inspire organize kind of work that are really there's there's
too many to name because it's really it's it's you know,
you kind of go through all of the the literature,
but from a business perspective, and probably the single most
impactful book I've ever read is either Double Digit Growth
by Michael Tracy, which just gives you a really good
(43:40):
framework for thinking about how to drive growth in multiple
areas and how to make sure you're not missing anything.
So that and probably Jim Collins Good to Great are
probably the two best business books I've read that I
think contributed to helping me kind of stay focused and
stay stay you know, you know, in particular, Good Degree
(44:01):
keeps you keeps the things that are most important to
your business from the center.
Speaker 1 (44:07):
Yeah, and especially the double digit one too, because of
the fact that in medtech, I mean it's especially for
a smidcap medtech or a private health medtech name, having
that double digit revenue growth is so important for your
next round of financing whenever that comes down the road.
So being able to maintain that is definitely an important
(44:29):
aspect of it. But Alan, I thank you for joining
us today. I've thought it was a great conversation.
Speaker 2 (44:36):
I really enjoyed it, great questions and no, I particularly
love when podcasts always look for book recommendations because it
always helps me find the next great book to read.
Speaker 1 (44:46):
And likewise, I know my wife doesn't like me buying
all these books, but I always enjoy them as well.
Thank you to our listeners for tuning in today, and
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 favorites Freeman platform. Take
care
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 with us
today Alan Latvin, co founder and CEO of Sequel, a
privately held medical device company that is developing the Twist
(00:43):
automated insulin delivery system. Alan, thank you for joining us today.
Speaker 2 (00:47):
My pleasure, Thanks for having me and.
Speaker 1 (00:50):
So Alan, ye know you have had a robust career
in the healthcare space. So why don't we start with
just your career path that has gotten you to first
getting into the diabetes space, and then SQL SQL the company,
and then just you know, some of the paths that
(01:11):
connected you with some of the other co founders for
SQL sure, So.
Speaker 2 (01:17):
Just it was a little bit of a securitiest path.
By by way of background, IM an interventional cardiologist practice
in the New York area for about five years, doing
a lot of stent placement, angipastays, all sorts of intracronary interventions,
and obviously a lot of those patients had diabetes. I
left practice because I was really interested in population health
(01:38):
management and what we then called big data, and ultimately
found my way into the pharmacy industry and particularly the
pharmacy benefit management industry, which I thought was fascinating because
you had a real time data set and it was
a data set of what actually went into the body
in the way of medications versus what someone wanted to
(01:59):
get paid for, and so I thought that was really
an interesting place to pursue those two passions. Found out
that I was, you know, pretty I enjoyed it. It
was pretty good at it. And my career through the
PBM industry was largely in specialty pharmacy and disease management,
so disease management you know, diabetes, hypertension, things like that,
(02:20):
and the specialty pharmacy drugs that are ten thousand to
a million dollars a year, and I helped build two
of the larger ones in the country, most recently starting
in twenty thirteen or so at CVS Specialty and then
for the last three years up until I left in
twenty twenty three, I was the president of CBS Caremark,
(02:43):
the largest PBM, and through that really saw how important
and impactful the costs associated with diabetes were. To employers.
But also because you see this entire, this huge database
of people using insulin, using other agents for diabetes, you
(03:04):
get to see all the gaps in therapy and all
the gaps in care, and all the opportunities to improve care,
whether it's through better anti diabetes therapy, better insulin therapy,
but also through better supportive therapy like antihypotensial. So that's
sort of how I got through to like real interest
in diabetes. While I was at CVS, I met Dean
(03:28):
cam In, one of the original inventors of the first
wearable diabetes insulin pump, which is just a fascinating story
and of itself, on another project we were working on together,
and as I got to learn more and more about
the things Dean was working on, I became more and
more intrigued by this device because it has some truly
(03:49):
unique technology that allows for what I expect to be
really clinically relevant opportunities to help people living with diabetes.
So as I was ready to transition out as CVS
after you know, eleven years there, twenty seven years in
big companies, I I you know, work with Dean and
(04:13):
some of our other founders who I had met along
the way and we decided to form a company around
around this device. We called the company Sequel and the
device twit.
Speaker 1 (04:22):
Interesting and yeah, I mean I think partnering with Dean
and you know his it was called the auto syringe
pump was the first one he made. Correct, that's correct, correct,
And but that was also almost fifty years ago when
that came out, and you're talking about, you know, this
(04:43):
gap in treatment for these patients. Walk us through maybe
those last fifty years or so, because the gap has closed,
but it's not as quick as people were hoping for
for developing what is now called the automated insulin delivery system.
(05:03):
So maybe we can just you know, dive in. First,
is you know why these diabetic patients need to inject
themselves with insulin day in and day out, and then
you know what are some of the technology advances that
have taken place over those fifty years before we've gotten
to kind of the current technology.
Speaker 2 (05:22):
Sure, so focus first on why people with diabetes need insulin.
So we're going to focus mostly on type one. Type
two patients are also become insulin dependent, and we can
talk about those. But there are two really two different
mechanisms so they're essentially different diseases in a lot of ways.
So type one diabetes used to be called juvenile onset diabetes,
(05:48):
though it can certainly come on in adulthood, is an
autoimmune disease, meaning that it's a disease where the body's
own immune system attacks the specific cells and the pancreask
called beta cells that make insulin. So those people are
absolutely dependent on exogynists insulin from outside in order to survive.
(06:12):
And we knew that insulin would would allow people to
not develop the acute problems associated with diabetes, and we've
learned that better insulin management, or better glucose management, prevents
the long term sequillite. So for the longest time, the
principal ways that you would get insulin were either injections,
(06:36):
daily injections, and often that would be multiple injections. You'd
measure your blood glucose with a fingerstick, so you'd prick
your finger, measure some blood, and then give yourself a
certain amount of insulin. Over time, people realize that this
idea of having a small dose of insulin all the
time was important. So two ways that that became a veil.
(07:00):
One was through insulin pumps, like the autos range and
oogly pumps and other ones. And the other was what
are called basil insulins long acting insulins LANTIS was one
of the first ones. So those for really from like
(07:21):
nineteen seventy four until probably you know, early two thousands,
all of the insulin pumps on the market worked virtually
the same way. They have a high precision motor that
turns the lead screw which pushes a plunger on a syringe,
and and you know, it was perfectly adequate for maintaining
(07:44):
you know, people, you know, in a reasonable level, and
it was an alternative to to these basil insulins. It
didn't change really the need for boluses. Over time, people
started developing the ability to bowl us off the pump,
where you would you would manipulate the pump in such
a way that they would start to put insul it.
(08:04):
It would give a hot it would give a literally
a bowl as a shot of insulin. What what started
to make the difference in terms of these automated insulin
delivery systems was the development of glucose monitoring. And if
you think about an automated insulin delivery system, it has
three pieces to it. It has the glucose monitor, it
(08:26):
has the algorithm or control system, and then the insulin
delivery device, and they all three work together to to
to deliver insulin in and like any system it's there,
it's only as good as the weakest length. And for
a long time the challenges were with us with the
continuous glucose sensors, and you know, Dean would tell you
(08:50):
that he expected that technology to advance, you know, so
that by the early two thousands or late nineties, certainly
we would have automated insul delivery systems. It turned out
to be a much more difficult problem, both measurement problem
and processing problems, so that we really didn't have great
sensors until you know, the twenty tens. And then as
(09:12):
the sensors got better, people started building algorithms to drive
these insulin delivery devices. And sort of in those twenty
late twenty teams who started to see the evolution of
these automated insulin delivery devices. There was also sort of
a different pumping technology developed in the early two thousands
(09:34):
with Insult and the omnipod, which was a slightly different
mechanism of delivering insulin. Well fast forward to we'll call
it twenty twenty three, and there were a number of
automated insulin delivery systems on the market. They clearly demonstrated
that they were better than what are called multiple dealy injections,
(09:58):
where people would give themselves into injections, but they still
had they still had it was still a very unmet market.
And why do I think it was an unmet market. Well,
it was an unmet market because despite the fact that
the ADA technically in twenty twenty four said that all
patients who are insulin dependent should use an AID system,
(10:21):
only about thirty seven percent of people in the United
States actually are. And of the people who are using
an AID system, between anywhere between five and fifteen percent
of them will will will change every every year. So
to me, that just speaks to an unmet need in
the market for new technology. There's all sorts of reasons
(10:46):
why these systems don't meet all the needs of patients,
and there's no one one answer. So Dean, observing the
evolution of the CGM market, said, you know what, I
know all the limitations of the of the existing pumps,
of the existing it's own delivery devices, and and he
(11:08):
believed that having a new technology that that you know,
basically the first new delivery technology in twenty years, would
allow for for better outcomes and better closed loop control
of for people living with diabetes. Now, I should say
(11:29):
that was his vision. We still have to prove a
lot of this. We We've done a lot of work
with the technology, but you know, we haven't launched into
people yet, so we still have a lot of work
to do. But that was his vision. That's why he
spent so much time and effort on building this really
incredible technology that you know, we believe and hope answers
(11:50):
a lot of the issues with respect to why people
why the market is relatively unsatisfied.
Speaker 1 (12:00):
Interesting and so you know, there was actually a second
component you brought in there about actual insulin delivery results
because you know what, you know, the transition that I've
seen over the last ten years working deeply into the
space and then going back to my history lesson over
the past fifty years, is that the theme has been
(12:23):
to make these devices smaller so it's less of a
burden to wear, and it's no longer you know, holding
a walkman or walkman sized device with a big canular tube.
It's that transition. But you're also saying that even with
the improvements in the design, there's still improvements that are
(12:45):
needed in the actual delivery of the insulin. Did I
take is that? Is that a correct takeaway?
Speaker 2 (12:50):
I took from you that that that is correct? I
think the again, wear ability, I think is an important
part for people. Capacity of the device right can hold
enough to last three days is an important piece. But
there are there are Everyone who uses these devices knows
(13:13):
that even though they're better, they have better results than
than delivering insulin. They have they have some challenges, and
some of those challenges have to do with the the
inability of the current crop of devices to let you
know when insulin delivery is interrupted in a physiologically relevant timeframe.
(13:39):
And so because of the way these devices work, they
sense blockages and occlusions what by by pressure building up,
and that takes a fair amount of time. The twist
system is different. Right. We we directly measure how much
insulin we deliver every time we give an impulsion or
(14:01):
a micro shot, every single time. And so if if
if we give a micro shot and we measure zero,
well we know there's a problem. Now Obviously, we don't
alarm instantly, because that would be foolish because sometimes people
are just they've rolled over or But in the in
the instructions for use in our i FU, it says
(14:25):
we we alarm up to nine times faster than any
of the devices on the market.
Speaker 1 (14:32):
We have.
Speaker 2 (14:34):
We there was an article published in the in the
I Triple E Journal, which is an engineering journal, which
looked at an apples to apples comparison of the existing
devices on the market, and they kind of replicated that
and said, well, the TWIST device will alarm five to
twenty five times faster. And what we plan on doing
(14:57):
is as we as we get on the market is
demons straight that when our pump tells you that you're
getting insulin, you are in fact getting insulin. Then when
you're not getting insul we will let you know in
a timeframe that is that is physiologically relevant with respect
to avoiding high glucose.
Speaker 1 (15:14):
Yeah, okay, And so then it's so basically what you're
seeing as a problem that can be easily fixed or
get be fixed with the right technology is that the
current pumps don't alert the patient soon enough and therefore
they're not getting the right insulin dosage. In so it
(15:35):
sounds like they're getting less insulin than they're expecting to
and so their blood glucose levels are higher than what
they're targeting. And so basically then by the time they
see their blood glucose, let's say, get to above one
hundred or two one hundred and twenty five, then that's
the point where it's probably was you know, could have
(15:56):
been addressed sooner. Correct, So I.
Speaker 2 (15:59):
Would say a little bit diff So what happens is
because it can take hours for people to for these
pumps to alarm, your blood sugar can be three or
four hundred, at which point it's it's it becomes a
much more significant problem than just oh my human love
and A and Z is going to be high. At
three or four hundred in type one, you can be
(16:20):
in what's called DKA. You could easily end up hospitalized
for for high blood sugar. So you know, these things
are it's it's more of a safety issue. And when
you talk to when you talk to patients who have
chosen not to use a device an AID system despite
the fact and again I want to emphasize for your listeners,
(16:40):
AID systems, all of them, they're they're safer and more
overall better results than multiple doses of insulin. Having said that,
there is still opportunity to make them better, and that's
why we're on West where we're coming to the market.
But when you talk to people who have chosen not
to use it, one common reason that you get is
(17:02):
when I inject myself with my insulin pen, I know,
I got insulin in, and I'm afraid to go to
sleep and have an occlusion or something bad happen overnight
and wake up, you know, with extreme hyperglycemia, high blood sugar.
So that that's one of the reasons that we're trying
to one of the one of the we'll call it
(17:23):
a challenge problems we're trying to solve, or or concerns
we're trying to address.
Speaker 1 (17:28):
Okay, and so you know, let's let's dive into your
twist aid system a little deeper. What is the technology
that is allowing you to be able to do those
kind of checks and then essentially then turns into allowing
you to do microdoses? Is that correct?
Speaker 2 (17:49):
Yeah? So so so the microdoses are more like there
are more a function of how we deliver the insulin
and other other pumps give small doses as well, but
we differently as we we measure each and every one,
and because we measure each and everyone, we sort of
I'll explain it to you a second. We're able to
(18:10):
very quickly tytrate to where you want to be. So
so the way we measure, we measure insulin is really
it's beautifully elegant. So I'm going to give you a
very very quick, no more than one minute, physics lesson.
So we'll start with Isaac Newton. Isaac Newton kind of
(18:30):
described the physics of almost every musical instrument, and he
realized that every musical instrument is a mass that vibrates,
which in turn vibrates the air. So think about plucking
a guitar string, or blowing across a red or banging
a drum. You know, a mass the skin, the red
(18:52):
or the string moves, It moves the airwaves. The airwaves
hit your ears and you hear it. Isaac Newton couldn't
figure out how a pipe organ worked like a church organ.
It took two hundred years for a guy named Heinrich
Chmhols to figure it out. And what he realized was
a pipe organ works the way if when you were
(19:12):
a kid if you blew across a coke bottle or
a beer bottle and made a tone, and then you
drank a little bit of the coke or the beer
and blew across and made another lower tone. He realized
that his seminal observation was that air was both the
thing that was vibrating and what was being vibrated. And
(19:34):
so when you do a lot of complicated mathematics, and
if you have a rigid cylinder like a coke bottle,
or a rigid two like a coke bottle, it turns
out that the only thing that matters is the height
of the is the height of the air column, right,
And so the air column is higher, you make a
lower tone. Of the air column is shorter, you make
(19:55):
a higher tone. And so what we basically did was
build a tiny little chamber like a coke bottle into
the twist pump, we blow a series of frequencies across it.
We do some very complicated mathematics, and we're able to
see the size of the chamber. So now what happens
is when I'm ready to give insulin, I measure before
(20:19):
insulin in the chamber. I open a valve and insulin
flows in and a deformable membrane moves, and I measure again,
and then I let the insulin flow into the patient
and I measure a third time. And when I do that,
I can subtract the last measurement from the from the
second one, and that's how much insulin I gave. And
(20:41):
we can measure that at fifty nano leaders of precision,
fifty billions of a leader of position. It's it's insane
because you know, when when you're when you're using sound
waves that are very high frequency, it has very high resolution,
sort of like X rays, and you know, the higher
the frequency the X rays, the better the resolution. That's
(21:04):
how we measure, and then what we the next thing
we do is we we then adjust the time interval
between doses. So if someone wanted to give zero point
one units and an hour, for example, we would divide
that into twelve doses. We would figure out about how
much each dose should be, and then if we were
a little bit over on one micro impulse, we would
(21:26):
we would instead of waiting a minute for the next microdose,
we might wait a minute, we might wait a minute
and four seconds. And if we were a little bit
under because we're always going to be you know, very
very close plus or minus five percent. Well, we'll wait
a minute shorter. So what happens is, whereas all pumps
on the market are are accurate to plus or minus
(21:48):
five percent at the end of three days, in shorter timeframes,
they have a lot more variability. Because we were able
to measure what we're giving, we can we can reduce
that variability substantially. And again, you know, you could say, well,
big deal. We think over time that's and we'll be
(22:08):
able to demonstrate over time that that makes a difference
with algorithms, but we have to prove that. But where
it really makes a difference right now is I can
measure very quickly whether you're occluded or not, because if
I gave less than I expected by more than a
certain amount, you know, if I'm fifty percent or sixty
percent or eighty percent less than I expected, there's an
(22:29):
inclusion in the system somewhere.
Speaker 1 (22:31):
Yeah. I actually I'm very interested to dive a little
bit deeper now into.
Speaker 2 (22:37):
You know, you you.
Speaker 1 (22:38):
Talked about the you know, let's call it the trifecta
of insulin delivery, where you need a CGM, you need
a algorithm and you need the pump. My understanding previously,
maybe a little bit naive, was that, you know, the
CGM had the sensor reading, that's the lucos level readings
(23:01):
from that CGM then goes to the algorithm. The algorithm
does the number crunching, and then those results then go
to the insulin pump, and the insulin pump delivers it.
Let me start first with what is the algorithm that
you're using for your pump.
Speaker 2 (23:19):
So we're using an algorithm that's that's essentially derived from
the tidepool loop algorithm, okay, which was an algorithm developed
in actually in the do it yourself community. People engineers
who are whose children often were living with diabetes built it.
So it was built you know, by people living with
(23:41):
diabetes for people living with diabetes.
Speaker 1 (23:45):
Yeah, and but that that that's what that did receive
FDA approval sometime last year. Correct, So even though it's
a do it yourself, it is a FDA approved algorithm.
Speaker 2 (23:56):
So that that's correct. So what what? And to be
very precise, there is a version of the algorithm that
was we'll call it an air quotes frozen and that
version was cleared by the FDA as part of what
are called the interoperability Interoperability Standards for use with ai
(24:16):
D systems. Okay, and so the algorithm that we're using,
we're using the FDA cleared version of the algorithm, and
we're continuing to work with tide Pool on on on
enhancing that.
Speaker 1 (24:28):
Okay, And that's that. But that then then so that
goes to then the second part of my question and
kind of my initial understanding about insulin pumps almost being
passive and allowing the algorithm to make the decision of
how much insulin and when to deliver that insulin. But
it sounds like the design of Twist now is allowing
(24:51):
some communication to go back to the algorithm and say, hey,
we may have delivered a little bit too much or
too little in this last my crow dose. We're gonna
have to change the time of the next frequency or
the amount next time. Is that something that is novel
with the TWIST design?
Speaker 2 (25:13):
I think I think I would think about it differently.
Which is which is the the the algorithm and the
pump together and the CGM they comprise a control system,
and a control system has a lot, you know, think about.
I'll think I'll give you an example of a control system.
So you get in the shower, and you an old
(25:36):
fashioned shower and it's got two knobs, and you want
to make it, you know, the temperature that's comfortable. And
you get in and it's too cold, so you turn
up the hot water. The response isn't immediate, right, because
you got to the valves, got to open more. Hot
water's got to come from the basement, and you overshoot
(25:57):
almost always, you'll overshoot. Now it's too hot, so now
turn the hot down or you turn the cold up
one of the two, and over time, you you you
kind of you, you slowly get that to the temperature
you want. Well, imagine you're in an old house and
while you're trying to do that, you know someone's you know,
turning on the dishwasher or flushing a toilet. So the
(26:19):
water it's always changing. And so that's that's what what's
going on in this system. So control systems can get
out of whack really quickly. And so the and I'm
not an engineer, but you put certain filters in the
control system that that that blow down that response so
(26:39):
that you don't overreact or underreact, right, because in case
of overreacting and insulin you would get hypoglycemia low blood
sugar and the case of underreacting you get hyperglycemia. That
because the twist system is a little bit more responsive,
(27:00):
we can we will be able to empisodes, be able
to tweak the coefficients such that and the filter is
such that we have less of less of a delay,
less of a concern because the reproducibility is there, so
it's less to say about you know, kind of feedback
back and forth. Though knowing for an algorithm to know
(27:23):
that it gave x amount of insulin and know that's
in fact how much it was was actually given is
again I think something new that will that that algorithm
engineers will be able to incorporate into into their evolutions
of their algorithms. Okay uh.
Speaker 1 (27:42):
And then for the rest of the form factor itself,
how is it differentiated from kind of other options that
are out there, either if it's a durable pump or
if it's on the body.
Speaker 2 (27:55):
Where So just just one last one last point on
on algorithms. But that's I think that I think the
fact that this was made by people with diabetes, it
really has there's some very unique aspects of the tide
Pool algorithm. One is it has the lowest set point,
So if you want to be aggressive about lowering your
blood sugar without suffering, without the risk of more hypoglycemia,
(28:19):
you can set your this algorithm to target the lowest
blood sugar of any algorithm on the market. The second
thing I think that it does, it's really remarkable. It's
very very personalizable if you want to, you don't have to,
but it does something that I think in the GLP
one era is really important, which is if you sit
down and you think you were going to eat forty
(28:41):
carbohydrates at a meal that you took your GLP one
and you only eat twenty, you can retroactively reset the
carb count and the algorithm will update to give you
less insulin. So it does require so much consistency in
how you eat or or accuracy. So it's really a
some nice features.
Speaker 1 (29:01):
Yeah, and especially the saying the load target, because I
know other algorithms that they're they're in the process of
trying to lower the target glucose level without having the
risk of going into that hypo, because the hypo is
a much more acute risk compared to the long term
ramifications of hyperglycemia. So that's that's a good good point.
Speaker 2 (29:25):
To know, that's absolutely correct and and and yeah, absolutely.
Speaker 1 (29:29):
Correct and so yeah, so them just going back to
the form factor, I mean, when I'm thinking of a
durable pump, when I'm thinking of an ont of body
where where where does twists fit in that spectrum?
Speaker 2 (29:42):
From an on body wear perspective. We've tried to create
it a device that creates maximum flexibility for people, so
you can wear it on your body. It's the only
wearable device that holds three ccs or three hundred units
of insulin. You can tuck it in a pocket, you
can move it around without losing insulin, so that if
(30:04):
you know, if you're wearing different clothes or different styles
of clothes, you can easily change how you're wearing the
Twist pump. And again, you don't lose insulin every time
you move it. You you have to move the the
insertion site for the for the canula, but you don't
(30:24):
lose insulin. So we kind of like that, and we
think with a short canula, short teather, it's it's equally
wearable to anything else that's on the market, but with
the ability to see the site to understand what's going
on the site also will give us in the future,
(30:47):
we're going to look for the opportunity of extended wear
and and again being able to see the site and
see that it's not leaking and not irritated, we think
is an important part of that. But it's really about flexibility.
It's about wearing and using the device the way you
want to use said.
Speaker 1 (31:01):
And so then you you have FDA approval for this device,
but you're you're still working on the development for your
US commercial launch. So what is the strategy around that launch.
Speaker 2 (31:16):
Yeah, so, so we are UH finalizing our our sensor
partnerships and UH that's really the driver of our launch
timing right now. We we plan on launching what we've
told people and I think we're still comfortable with it
is in the beginning of next year. Our intent is
(31:39):
to really have a fairly aggressive UH rollout throughout the
course of the year and and and make the device
widely available, you know, across all the major UH uh
UH centers and territories by the by the middle of
(31:59):
the of the of the year, with with clinical trainers
in the field and sales reps in the field that
at that point, you know, starting in the first quarter
and you know, ramping up through the call them you know,
early part of the third quarter.
Speaker 1 (32:17):
Okay. And then so you know, one of the other
things too, is you mentioned at the very beginning your
time at CVS and as you know, we're you know,
your specialty in the PBM sector. How would will this
product be available through the pharmacy channel the same way
some of the other kind of on the body where
(32:37):
pumps are.
Speaker 2 (32:38):
Yeah, this was this is going to be exclusively available
through the pharmacy channel, okay. And we really thought through
kind of the the the pricing strategy to make sure
that we created the lowest list price that would benefit
people living with diabetes and users, and you know, made
(33:01):
sure that we had a net price that was effective
for payers.
Speaker 1 (33:05):
Okay. And then you're also targeting the type one population first, Well,
how do you see that opportunity potentially expand over the years.
You know, you talked about AID you know, the penetration
rates currently in the high thirties, maybe potentially low forties.
(33:25):
How do you expect that penetration rate to kind of
accelerate over time?
Speaker 2 (33:31):
Yeah? So I'm again, you know, what did yogi berra say,
you know, making predictions, especially about the future as hard.
I don't know. I would imagine that over the next
I look, let me say not, I imagine I hope
that over the next three to four years that we
can get that forty percent number into the high seventies.
Speaker 1 (33:54):
Yeah, that would that would that would you know? And
you know, this is kind of what we're talking about
the transition from MDI, which you know, you're saying that, yes,
the patient knows that they're getting insulin delivered at that point,
but all the burdens of you know, having to repetitively
inject yourself transitioning to these pumps where you're kind of
(34:18):
having that ease, but it's also you know, you're also
there's some uncertainty about if that the canule is actually
gained the insulin delivered, and as you improve that portion
of the insulin delivery system over time, you should be
able to get that penetration rate up.
Speaker 2 (34:36):
I think that's right. I think I think a lot
of things are going to be sort of operating together.
I think sort of new technology is certainly going to
make a difference. I think continued work and demonstration of
of better outcomes. I think, like everything else in medicine,
you know, it does take a long time for things
to move from we know they make a difference to
(34:57):
being broadly clinically available, so you know, in some ways,
I think the end of chronology community is moving faster
than not some other some other parts of healthcare. But yeah,
I think it's a combination of a surety of delivery,
ease of use, ease of access through the pharmacy channel
as more as more devices become available to the pharmacy channel.
(35:21):
Algorithms that allow you to do or not do what
you want but without making you feel trapped into something
you can't control. I think are all all things that
are going to help expand the expand the market.
Speaker 1 (35:35):
Yeah, and the the other thing too that I'm taking
away from this too is that there's still a plenty
of opportunities with patients who are still using syringes instead
of patients who are using other automated insulin delivery systems
and are going to transition over to your technology.
Speaker 2 (35:53):
I think definitely there's a group of people who are
using multiple doses of insulin and insulin that are going
to move to our device because it addresses a concern.
The concern maybe they want to wear something, but they
need three hundred units of influence for three days, a
concern maybe you know, confidence and delivery. I also think
(36:13):
that there are some people who are going to look
at it and go, you know what, I really like
this idea of a waterproof on body where that you
know that I'm okay with being able to see the side.
I like having a tether. I like being able to
move the side around. But I really want something I
don't have to take off when I go to the beach,
or I don't take off and I take a shower.
Those sorts of things I think makes a difference to people.
Speaker 1 (36:33):
Yeah. Yeah, And then you know the other thing too
with just any commercial launch as well, is just the
manufacturing capacity. How have you, you know, putting on you know,
transitioning from kind of the scientific and the engineering head
to the CEO hat. What are the steps that you
need to kind of ramp up manufacturing between now and
(36:53):
kind of first quarter twenty twenty five when these launches
could initially begin, and then kind of further in twenty
twenty five as you ramp up.
Speaker 2 (37:03):
So we have two operating lines right now that are
making well actually four two that are making the reusable
part of the system, two that are making the disposable cassettes.
They're making commercial product now in anticipation of lawn. We
(37:24):
have a third sort of high volume automated line. These
lines are automated, but there's one transfer step high volume
automated line that is we're taking delivery on shortly and
that should be available and I don't know, sometime in
(37:45):
twenty twenty five. And then we have a fourth line,
also a very very high volume line that's currently in development.
So we've essentially invested in capacity well in advance of
needing it at we can we can we can meet
our anticipated needs.
Speaker 1 (38:04):
Yeah, and so then beyond that too, you know, when
you look beyond the launch in twenty twenty five, that's
a lot on your plate. But you know, as we're
looking beyond even that, what are some of the other
developments in progress at SEQL, And you know, I'm thinking
of things with you know, Type two patients, you know,
(38:24):
the development that we're seeing with kind of pre pre
filled like insulin syringes or cartridges. And then lastly, I
mean some of the technology can also be translated into
other drug delivery, and I'm curious if that's a step
that SQL has been considering.
Speaker 2 (38:45):
Right, So, so a lot of good questions in there.
So first, we are very interested in Type two. I
think again this this at the ability of this device
to hold three hundred units is important. Uh, And we
have some really interesting kind of next generation that would
allow us to hold even more which in the same size,
(39:06):
in the same form, fact which I think for Type
two will be really important. We're going to be starting
a a cuindical trial and Type two next year, so
Type two is really important. We also have a proprietary
infusion set that we're we're bringing through the FDA for clearance.
It's a it has some unique features with respect to
(39:29):
the material and the actual insertion methodology that we think
is going to be really, really, really cool. But a
little too early to talk about. Your question about prefilled
cartridges is one that we're actively exploring. It has some
it has some challenges and a timeline and how you
(39:52):
do that, you know quickly because you have to demonstrate
stability obviously and safety. But you know, definitely on our
radar screen is something that would make the experience for
people and with diabetes better. And then to your point
about other drugs, it's, uh, this, we do think there's
a lot of opportunity for other for other drugs, particularly
(40:14):
any any scenario where there's a physiologic parameter we can
measure and then alter the drug dose in response to
that parameter, we think is a really interesting opportunity. So
we're looking at a number of those those products.
Speaker 1 (40:34):
That's interesting. Actually one of the description of the pre
filled cartridges and you talked about the stability, is that
the stability of the insulin staying in the dispenser, the syringe,
the cartridge, and is that kind of maybe one of
the biggest hurdles for all of these companies right now,
(40:55):
is that making sure that the insulin that's in there
is you know, almost reproducible and providing the same benefit throughout.
Speaker 2 (41:05):
So insulin is a notoriously finicky molecule, and we know
that you can store insulin and glass. I think what
we're you know, most of the of the devices are
using some form of plastic, Okay, So to to to
(41:26):
have to you have to demonstrate to the FDA that
that the having the insulin in contact with a plastic
versus glass for a longer period of time than you know,
a week, a month, whatever, doesn't do anything to degrade
effectiveness of the insulin or otherwise create issues. So it's
(41:47):
just a it's just a matter of doing the work,
is really what it takes.
Speaker 1 (41:51):
Yeah, and that's that's the interesting thing that you know,
it's always just you don't connect the dots about why
you can't transition from insulin, and it really just it's fascinating.
It's just simply the difference between glass and plastic.
Speaker 2 (42:04):
That's certainly one of the issues, right. I mean, if
someone had if someone had proven that X, Y and
Z plastic could store insulin safely for for two years,
then you know, everyone would use that plastic. But no
one has done that or or and if they have,
it hasn't been coome widely available to you know, because
of intellectual property, which is which is which is fine?
Speaker 1 (42:25):
Yeah uh and then yeah, Ellen, I think we'll just
you know, we'll close out this episode. You know, you
talked about your career path that's gotten you to where
you are now as CEO a SQL. You've learned a
lot during those times, especially at CBS. Now it's helping
you with the pharmacy channel. I'm curious if there was
(42:47):
a book that you've read, either recently or a while back,
that's also has influenced you during your career path.
Speaker 2 (42:56):
Yeah. So I'm a pretty voracious reader, So I read
a lot and so on any given day. Uh, you know,
there are more, you know, there's a lot of books
that I think have been very helpful to me in understanding,
you know, leading teams and and and how to you know,
(43:17):
inspire organize kind of work that are really there's there's
too many to name because it's really it's it's you know,
you kind of go through all of the the literature,
but from a business perspective, and probably the single most
impactful book I've ever read is either Double Digit Growth
by Michael Tracy, which just gives you a really good
(43:40):
framework for thinking about how to drive growth in multiple
areas and how to make sure you're not missing anything.
So that and probably Jim Collins Good to Great are
probably the two best business books I've read that I
think contributed to helping me kind of stay focused and
stay stay you know, you know, in particular, Good Degree
(44:01):
keeps you keeps the things that are most important to
your business from the center.
Speaker 1 (44:07):
Yeah, and especially the double digit one too, because of
the fact that in medtech, I mean it's especially for
a smidcap medtech or a private health medtech name, having
that double digit revenue growth is so important for your
next round of financing whenever that comes down the road.
So being able to maintain that is definitely an important
(44:29):
aspect of it. But Alan, I thank you for joining
us today. I've thought it was a great conversation.
Speaker 2 (44:36):
I really enjoyed it, great questions and no, I particularly
love when podcasts always look for book recommendations because it
always helps me find the next great book to read.
Speaker 1 (44:46):
And likewise, I know my wife doesn't like me buying
all these books, but I always enjoy them as well.
Thank you to our listeners for tuning in today, and
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 favorites Freeman platform. Take
care
Host
Jonathan Palmer
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