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March 20, 2025 51 mins

Cardiac monitoring “is a space that hasn’t seen disruption or innovation for 50 to 60 years, and we’re trying to disrupt that with our AI-powered Zio platform,” iRhythm CEO Quentin Blackford tells Bloomberg Intelligence. “And really, the focus is on how do we enable an earlier, more accurate diagnosis while reducing the workflow effects for our physicians?” In this episode of the Vanguards of Health Care podcast, Blackford sits down with BI analyst Matt Henriksson to talk about iRhythm, how its Zio-platform technology powered by its AI network allows patients to be monitored without disrupting their everyday lives, and how its clinical data could support a more proactive screening of patients to find arrhythmias before a catastrophic adverse event occurs.

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Episode Transcript

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Speaker 1 (01:28):
Welcome to another 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 Quentin Blackford, CEO.

Speaker 2 (01:43):
Of I Rhythm, a medical device company that is a
key leader in the long term cardiac monitors to detect arrhythmias.
You can dive deeper into the company and its financials
by typing in IRTC equity go on your Bloomberg terminal. Quentin,
thank you for joining us today.

Speaker 3 (02:00):
Matt, thanks for having me. It's good to be back
with you guys.

Speaker 2 (02:02):
It is great to have you back as well. And
so maybe why don't we just start with a quick
recap of where i Rhythm has gone over the past
twelve months since we last spoke, and kind of including
maybe a quick summary of what i Rhythm does for
those listeners who are new to the story.

Speaker 3 (02:21):
Sure, so, I think for those who are less familiar
with Irythm, we're a digital healthcare company that's focused really
on transforming the way that cardiac arrhythmia detection and management
is being done currently. Right this is a space that
hasn't seen disruption or innovation for nearly fifty to sixty years,
and we're trying to disrupt that with our AI powered

(02:43):
Zeo platform. Zeo is the name of our product, and
really the focus is on how do we enable an earlier,
more accurate diagnosis while reducing the workflow effects for our
physicians and providing a much faster pathway to outcome for
the patient. We focus really around clinical efficiency, healthcare system

(03:07):
resource reduction, but also clinical accuracy, and I think you
see that in the data that surrounds our product. We
know that positions will agree with us ninety nine percent
of the time when they're utilizing our product, which I
think stands on its own in terms of our place
in the market. Nobody can compete with that. When you
think about twenty twenty four in particular, it was a

(03:29):
super strong year for US. We delivered twenty percent revenue
growth on the full year. We saw momentum in the
business grow every single quarter. As a matter of fact,
the fourth quarter we put up twenty four percent revenue growth.
So we were excited by the momentum that continues to
build in the marketplace, in and around our product, and
it also is validation of our strategy to really push

(03:51):
the prescribing of the product up the care pathway into
primary care and these value based care programs, which I'm
sure we'll get further into. But we were also sided
with some of the progress on the international side. We
launched into four new EU countries. We got regulatory approval
for our product into Japan, which will launch here in
twenty twenty five, bringing the first AI powered cardiac arrhythmia

(04:15):
solution into that market, so we're very excited with that.
It was a year that was marked with a lot
of strategic partnerships and advancement towards our three to five
year vision of where we're trying to go. We had
a tremendous collaboration that we were able to ink with
Epic and the Aura platform, which i think will open
many doors. We were able to come together with Bionteleisins,

(04:37):
which will allow us to expand our platform and go
well beyond just cardiac monitoring into the future, which I'm
sure we'll get into as well. And then we made
tremendous progress on the financial side, Matt as well. We
saw the financial profile of our company continue to improve
we drove our gross margins from early in the year
in the mid sixties to be in just above seventy

(04:57):
percent by the time we exited the year, and we
drove another four to five hundred basis points of improvement
in our just a debitop profile as well, excluding a
one time IPR and D non cash charge that we took.
So a terrific here for us in twenty twenty four
one that we were very pleased with. But also just
the startup where we're trying to go as we head
into twenty twenty five.

Speaker 4 (05:18):
Yeah, a lot to dive in there.

Speaker 2 (05:20):
But what caught my attention first is just how the
industry has been slow to change over the several decades
of being able to monitor these patients.

Speaker 4 (05:33):
Why don't we just set the.

Speaker 2 (05:36):
Background of how these arrhythmia patients have traditionally been monitored
before the introduction of ZO and these long term cardiac monitors.

Speaker 3 (05:51):
Sure, so, the traditional method for monitoring is really a
Holter monitor that I mentioned has been around fifty sixty
years without any real disruption or innovation in and around it.
And we can think about a Halter monitor, you're usually
monitoring a patient for somewhere between twenty four to forty
eight hours. The challenge with that approach is that most

(06:13):
cardiac arrhythmias are episodic, and so if a patient's not
experiencing an arrhythmia in those twenty four to forty eight hours,
you're not going to find it with a traditional Hulter monitor.
And that's where we've really tried to change the entire industry.
With a longer duration of monitoring going out to fourteen days,
the data would tell us that you're going to find
most arrhythmias between day five and say day eight, So

(06:37):
you've got to have a longer duration of monitoring to
ultimately get to a diagnosis for that patient. And that's
exactly what we're doing, and it's why the market's moving
very quickly away from a traditional Ulter monitor to a
patch based solution like our own, where you can get
longer duration monitoring. And we hold seventy percent of that

(06:57):
patch based market, so we've got a very strong position
and we're having a lot of progress, making a lot
of progress in flipping the way that these technologies are
being used to look for these arrhythmias. If you think
in the past, you know most arrhythmias, Halter monitors are
being prescribed in a reactive setting. Right A patient shows

(07:17):
up and they've got some sort of symptom tied to
the cardiac arrhythmia. Maybe it's a lightheadedness, maybe there's a
fainting spell. They're blocking out, and so you put a
Hulter monitor on them. Work flipping the script to be
much more proactive and targeting populations that are high risk
of arrhydmia is in getting a patch onto them much
earlier and then finding those rhythmias before there's ever any

(07:40):
sort of catastrophic events downstream. And a big part of
enabling that is really really getting up the care pathway,
if you will, to where the product is getting applied,
and that's a big part of our strategy. We targeted
the cardiologists the EPs out of the gate when we
designed and put the product into the market, and they

(08:01):
are the biggest voice of support for us, and we
will always focus on that segment. But we've made the
products so easy to use and so accurate that we're
moving further up the care pathway into primary care where
we can reach many, many more patients much earlier in
their care journey and.

Speaker 2 (08:18):
So that brings us to know your ZEO platform. And
just you know, a couple thoughts I had while you
were explaining kind of the cons of the Holter monitor.
And you know, it's a two day where essentially while
yours is up to fourteen days even longer for some
of your other products.

Speaker 4 (08:40):
But what it.

Speaker 2 (08:41):
Prevents a doctor from just prescribing Ahlter monitor seven straight times,
so two days, and they prescribe a second one for
two days, and they prescribe a third one for another
two days.

Speaker 4 (08:53):
Is it just the.

Speaker 2 (08:54):
Form factor, is just a burning for the patients, or
is it just the accuracy of kind of those separate
readings isn't good enough to be able to do that?
Or is there a cost component to it? And then
turning to the ZO patch itself, you know, intuitively a

(09:14):
longer ware would detect more data points, but you also
just you talked about your AI and your neural networks
further aiding the accuracy. So how does that play into
the overall platform of being able to detect these arrhythmias?

Speaker 3 (09:30):
Sure? So, I you know, I think back to your
the original question there with respect to why not just
prescribe a Whulter monitor over and over and over again. Well, one,
these are incredibly clunky devices, right, and they're applied in
the physician's office and then they're set home with the
patients and they come back into the physician's office to
have the data downloaded and understood. The problem is most

(09:54):
of these are twelve lead EKGs and a lead falls
off here or there, or two leads fall off, three
leads fall off, and you get a lot of noise
in the signal. So getting having a clean signal in
what you're analyzing is very very important. And with a
Hulter monitor, you can imagine you could wear it for
twenty four to forty eight hours, and if a position
wanted just to prescribe that again and have a patient

(10:16):
were at another twenty four to forty eight hours, they've
got to come back into the office. They've got to
haven't reapplied, they've got to have the data downloaded, you know,
the device white clean from a data perspective, and then
started back up again for that next twenty four to
forty eight hour period. So it's incredibly cumbersome for a patient,
incredibly cumbersome for a position's office. They don't have the
capacity to see that same patient multiple times over in

(10:39):
a short period of time, and it becomes incredibly costly
to the payer system, right because every time you're prescribing
that alter, you're seeking reimbursement for it. So the cost
of that sort of a model becomes prohibitive. It would
become far more expensive than just say using a single
patch like our own for fourteen days. The thing that

(11:01):
really allows us to stand out is when our patients
wear our product for fourteen days, which is generally what
we're prescribed for. If it's prescribed for fourteen days, our data,
and keep in mind we've now served ten million patients
in our history, our data would tell us that those
that are prescribed for fourteen days are going to wear

(11:22):
it on average thirteen point eight days of the fourteen days.
So the analyzable wear time is incredibly high, which means
we're capturing every single heartbeat over that period of time
with very very little noise in the signal. We'll get
on average nearly two million heartbeats per patient per wear period.
And then our AI can run against that large amount

(11:45):
of heart rhythm data and identify where the rhythmis are at.
And I think this is where we really stand out.
We know that when AI runs across that data coming
off the strip and we publish into a report or
are recommended findings for the position, they will follow those
findings ninety nine percent of the time and that's how

(12:06):
they make their diagnosis. So we have a very high
correlation of position agreement to our AI generated report that
leads to a very high degrade of accuracy in the diagnosis.
Alter monitors are nowhere close to that. We've heard you know,
anywhere around you know, fifty to sixty percent accuracy versus

(12:27):
you know what ours is at ninety nine percent. And
there's a lot of data out there now that stands
behind this. The Camelot study that was put into the
marketplace well over a year now demonstrated very clearly, looking
at a historical data set coming out of CMS nearly
three hundred thousand patients, it showed the Zeo XD product

(12:48):
at the time going up against other competitive products in
the marketplace that we were able to glean out of
as data set, and it showed very clearly that Zeo
far and away was a superior product. It was a
faster time to diagnosis, there's a higher diagnostic yield, and
it led to a much lower retest rate that was
required in this patient population, all of which generates meaningful

(13:12):
value back for the health system. So a lot of
data points out there that would articulate the power of
this technology. But you do still have halter monitors out
there in the market as we've worked to transform kind
of the entire industry.

Speaker 2 (13:27):
So I mean, just to summarize that, it sounds like
it's the Zeo patch is a one shot at goal
versus multiple less accurate shots with While you're saying be
more burdensome to just the physician's office and staff, correct.

Speaker 3 (13:48):
No question, even to the point where Mattam if the
physician's office would like to rather than having a patch
placed on a patient in their office, they can prescribe it,
can send it directly to the patient's home, the patient
can put it on themselves at home and wear it
for the fourteen days. We get a lot of feedback
from patients that once I put it on, I don't

(14:09):
even realize I'm wearing it any longer. Right, It's become
such a small profile and in a lightweight product that
folks don't even realize they're wearing it, which is why
we get ninety eight percent you know, analyzable time out
of the fourteen day work period, which is super critical
of finding us rhythmus.

Speaker 2 (14:25):
Yeah, and then you know there's other companies that have,
you know, cardiac monitors similar to Zeo, but during a
wave of M and A into large cap diversified medtech companies,
they kind of got lost in the shuffle and we
don't hear as much updates from them. So what are

(14:45):
your views of the kind of the competitive landscape over
the past couple of years, you know, as you are
launching your product you're talking about you know, during your
fourth quarter call, one million patients have been prescribed the
Zeo monitor in twenty twenty four. I mean, how's the
competitive landscape looking or changing over those couple of years.

Speaker 3 (15:07):
We certainly saw some activity in the space, you know,
three years ago or so, as we saw you know,
Boston get involved with the Prevenice acquisition. We saw Barty
get acquired by hill Ram now part of Baxter, and
Fillips with their biot sell product line. Those are three
primary competitors in the marketplace. What I would say is,

(15:32):
you know, we we certainly are aware of them, but
I think we're at a point where we compete very
well for those accounts when we go head to head.
And I would tell you in twenty twenty four we
saw the largest portion of competitive conversions towards Zeo. As
a matter of fact, I believe coming into twenty twenty four,
we probably had somewhere around sixty eight percent market share

(15:53):
of the long term patch market. I think we exited
twenty twenty four above seventy percent. Think we were back
in a share gain position despite the significant market share
that we already hold. And I think what that is
is folks see the power of a patch based technology
relative to a wholeter monitor. A competitor might get to

(16:15):
that account before we do. They might try a competitive product,
but then they look for the best solution in a
patch based solution, and ultimately they find their way to Zeo.
And I think we've got many data points in twenty
four that indicate folks will ultimately come our way. And
I think we're now at a very exciting time in
our sort of company's journey to where we have the size,

(16:39):
We have the scale and the capabilities that if a
large ID in a large network of accounts wants to
make a full conversion over to a single platform like Zeo.
We now have the size and scale where we can
convert an entire network over and support them, whereas you know,
two years ago we couldn't really do that, right, So,

(17:00):
I think there's just been a lot of evolution in
our in our growth and our scale and our maturity.
That's allowing us to really compete aggressively. And that's a
big part of why we saw matter our growth rate
over the course of twenty four accelerate every single quarter.
The number of new accounts that we on boarded was
an all time record nearly every quarter of the year,

(17:21):
but certainly for the full year, and that was in
both our monitor business and our our at business, where
we have a much smaller market share, but it's a
big strategic focus.

Speaker 2 (17:31):
For Yeah, and you know, we'll jump into that the
mobile cardiac telemetry in a couple of minutes, but I
just want to finish up with you know, we talked
about the Camelot data, but there was also a lot
of data presented at the end of last year. I mean,
there was some data presented at hr X, and then

(17:51):
I think there was five studies at AHA. We could
probably spend the whole hour just talking about those studies.
But what were some of your takeaways from those studies
that you know we're kind of presented last quarter.

Speaker 3 (18:07):
Well, one of the things you're going to find unique
to algorithm is that we invest heavily in our clinical data.
We feel very strongly that our product, our platform, our
capability ought to be able to stand on its own
and the data behind it should articulate its superiority relative
to any other offering in the marketplace. And so we

(18:29):
let the data speak for itself. And the data is tremendous.
You know, there's over one hundred and twenty five peer
reviewed studies that are out there, more than forty independent
peer reviewed publications that stand by and the value of
Zeo being best in class, and so we're excited by that,
you know, Camelot, we spoke a little bit about again
sort of head to head analysis looking at a historic

(18:52):
CMS data set of over well not over, but nearly
three hundred thousand patients that articulated the superiority of our product.
You would be able to find the Examine study that
was published which identified the fact that we were able
to identify nearly three times more non sustained particular tachycardia

(19:12):
or n SBT, which is a very high risk of rhythma,
particularly in younger athletes and adult than a traditional ulter monitor.
So the data points continue to sort of accrue in
the favor of our method of monitoring, which I think
is going to continue to drive volumes in our direction.

(19:33):
I think one of the things that I get most
excited about is when people think about our market. A
lot of times they look at the existing number of
ambulatory cardiac monitoring tests being prescribed, say in the US
as an example, which is right around six and a
half million tests, and that's how they define our market.
I think of our market very differently. I think of

(19:53):
our market as being nearly twenty five to twenty seven
million patients that are showing up in primary care today
with cardiac palpitations, already identified in their medical records and
noted or using say the n STOP study that looked
at a population profile of you know, if you're a

(20:14):
female over the age of seventy five, male over sixty five,
or male or femail over fifty five with a comorbid
condition like type two diabetes or obesity, the likelihood of
having a rhythm in that population was nearly twenty five percent.
And so you start to put those things together and
you get to a market opportunity that's closer to twenty
five to twenty seven million patients. But to find those,

(20:35):
I believe, you have to be up in primary care
and you have to start to identify where those patients exist.
And so one of the studies that I was most
excited about was the Eversona study that was published at AHA,
which started to draw the correlation between these comorbid disease
states of type two diabetes as an example, or COPD
or CKD, and we can look at the medical history

(20:58):
of these patients and we can see, based upon different
markers in their medical history, whether or not they likely
have an arrhythmia or not. And the reality is, when
you get into those populations, so many of these folks
have no idea that they have in arrythmia, but we
can see in the data that they most likely do.
Now we can begin to put a patch on those
patients proactively and find the arrhythmia before they ever have

(21:23):
a downstream catastrophic event like a stroke or they end
up in the er because they had a sinkable event
and they passed out and they fell and they broke
a limb. That's a game changer, and that's how we're
going to open the market up to serve the twenty
five to twenty seven million people that are out there
that have arrhythmias that are completely unaware of it. And

(21:43):
you know, in some of these early pilots, it's quite remarkable.
But when we target a population that we believe have
in arrhythmias through our AI capabilities, we're finding, you know,
north of eighty percent of those folks we put a
patch on actually do in fact have an arrhythmia. So
being able to turn that dial to such a an

(22:03):
accurate diagnosis is quite remarkable, and I think it is
how we will open up the market.

Speaker 2 (22:09):
So and then just that that that last study, the
ever Sana study that was that was so basically it
was analyzing what the cost is for treating a patient
with arrhythmias versus the cost of a patient without arrhythmias.
And then what the conclusion was was that the patients

(22:34):
who don't have arrhythmias but may have the comorbidities and
then get you know, a zeopatch to see if they
do have arrhythmias, and if they do have arrhythmias, then
you know, you do the initial treatment for them. Those
cumulative costs are still less expensive than what a a

(22:55):
traditional patient with arrhythmias would incur throughout their treatment paradigm.
Is that kind of the right way to think about.

Speaker 3 (23:05):
Yeah, you're down the right path. I mean, really, what
we did was we said, let's let's go look at
these large disease states. Let's take type two as an example,
and let's start to look into the data and identify
when did a type two diabetic patient who has an arrhythmia,
when did they first find out if they had an

(23:26):
arrhythmia or not? Can we see that in the data?
And as we started a dig, we found that a
good number of type two diabetics first learned that they
had in arrhythmia because they were visiting the er. And
when you look at the codes that were being used
in that er visit, they were primarily around cardiovascular aid
related events like a stroke or some sort of sinkable

(23:49):
event that led to a fall in a fracture. And
so you looked at those two events and you said,
you know, if we knew that that patient had an
arrhythmia before they got to the point that they had stroke,
we probably could have helped avoid that, and we don't
have to bend that curve very very significantly to dramatically
reduce the cost of caring for that population. So we said,

(24:11):
how do we find those patients who unfortunately are ending
up in the er with these catastrophic events. How do
we find them earlier diagnosed the arrhythmia that is present
but they just have no idea, and begin to treat
them earlier to prevent those catastrophic events. And that's what
we were able to do with AIS, identify where those
patient populations were at, and then proactively get patches onto

(24:35):
that population that we highly suspected had in arhythmia. And
what we found in these pilot early pilots was that
nearly eighty one percent of the patients that we put
a patch on did in fact have an arrhythmia. So
if we could just keep one patient out of the
er and avoid a stroke, we have significantly reduced the
cost of care. When we looked at these two cohorts

(24:57):
of folks who had an arrhythmia versus folks who didn't
know that they hadn't ridden and got diagnosed in the er.
And we know that the cost of caring for that
that patient is at least two times higher than the other.
We know the hospital stays are two to five days
longer uh than the other. So there's tremendous cost benefit

(25:18):
in this approach. The question is how do you find
these patients? And that's the AI algorithms that we're building
to to go find them. We've got a pilot that's
going right now in COPD. We know there's similar opportunity
in c KD. So more excited about this. I think
it's going to move the needle in a meaningful way,
but we're on the very early early stages of it.

Speaker 2 (25:40):
Yeah, and you know it goes back to you know,
you guys have the data set that you know can
be able to use this AI functionality to be able
to find these trends you know easier and you know,
more efficiently than you know some other companies potentially could.
But then you know you're talking about then you know,

(26:00):
the transition though, seems to be from kind of the
cardiologists and the EPs to the primary care physicians to
be able to get to let's say that additional twenty
one million, I'm counting the six point five million tests
twenty seven million. What are the steps to be able
to reach out to those primary care physicians. Is it

(26:23):
a salesforce expansion, is there marketing awareness? Just what is
your strategy for being able to get you know, build
that additional twenty one million patient opportunity.

Speaker 3 (26:37):
Yeah, it's a great question. We get that one a lot.
I do not have a strong desire to go out
and build a massive salesforce to knock on the door
of every primary care physician that's out there. That's not
going to be our approach. We're going at this in
two different ways. One is, we are in a vast

(26:59):
majority of the large IDNs that sit out across the
United States, and most of our relationships in those id
ins are with the cardiologist and the EP the electrophysiologist.
But those cardiologists and EPs experience themselves a significant backlog
in being able to see their own patients. They don't

(27:20):
have the capacity to see sort of the patients that
are coming their ways. In many cases, a patient is
waiting four to five to six months to even see
a cardiologist or an EP. And so in these large
networks that we're already in, we're actually leveraging our relationship
with the cardiologist in the EP to have them bring
primary care into the prescribing pattern for the patient. And

(27:43):
you can't go out in the field any longer and
have a dinner with one of these large accounts and
your core customer being the cardiologist or the EP without
them asking to also bring their primary care physicians with them.
And they're beginning to push the prescribing up the care
pathway into primary care. And over the course of twenty
four we saw that over fifty percent of all of

(28:05):
our large ideas that we do business with now have
a prescribing primary care physician within them. And when we
see the prescribing move up the care journey to primary
care ultimate, the entire account begins to grow at a
very attractive rate. And the reason for that is if
you're prescribing a ze earlier in the care pathway, you're

(28:25):
now using the tool as I like to describe sort
of as a rule in or a rule out tool.
If there's an rhythmia present and you're likely going to
rule them in and send them onto cardiology or EP,
or if there's nothing present there. You might send them
down a completely different journey and keep them out of
the cardiology or EP office where they're not going to
be able to help them. So you're starting to solve

(28:46):
a meaningful capacity challenge within these networks. But what we
find is when we do find the arrhythmia in primary
care and we rule that patient in and send them
onto cardiology, usually that cardiologist or EPs now spending time
with a much more qualified patient if you will, that
should be seeing them, which might lead to more procedures,

(29:07):
and then you're monitoring post procedure, so you're getting more
volume out of that account, and the overall growth begins
to show up very very nicely. So that's one approach
that we're going in at. The other approach, and the
one that is really getting a lot of traction for us,
is going at these large national primary care networks. Many

(29:28):
of these large networks the likes of a one Medical
or a Signify or an Oak Street, and you can
go down the list. They're very national in their approach.
Many will sit with payers and sort of take risk
to manage a particular population. They'll capitate that and if
they can manage the cost of caring for that population

(29:49):
in a better way they get to keep the margin.
These accounts, these large national primary care accounts, realize the
value of finding a rhythmy is earlier in the care journey,
that the earlier they can find them, the better they
can control the downstream cost and avoid some of these
large catastrophic events. And so there's a very keen interest

(30:09):
to proactively identify where these patients exist within their network
and get patches on those patients. And over the course
of twenty four you know, we've seen a couple of
these large national primary care accounts actually become some of
our largest customers in the business. So that's the other
approach that we're taking to open up primary care. My

(30:31):
data would tell us that between those two approaches, we
can probably reach sixty five percent or so of total
primary care physicians in the US. I think is word
of mouth continues to grow around the ease of being
able to prescribe this product and get a diagnosis with
such a high degree of accuracy. I think word of
mouth will spread across the other call it thirty five

(30:53):
percent of the population. You're going to see more and
more primary care wanting to do this, but our focus
on that, you know, call it sixty five percent. It's
going to keep us plenty busy here for the next
couple of years.

Speaker 4 (31:03):
Yeah.

Speaker 2 (31:03):
And you know, it's interesting that you talked about solving
the problem of, you know, the capacity constraint that these
cardiologists and EPs are facing, and it's you know, I
think you nailed the hammer on the nail there.

Speaker 4 (31:21):
The fact that you're able to be.

Speaker 2 (31:23):
Able to screen these patients before getting into the cardiologists
and removing the task for the cardiologists to do the
screening themselves. It feels like that goes a long way,
and they're patient efficiencies.

Speaker 3 (31:34):
It's huge, man. And it's even to the point where
with our digital platform that we've created, and we are
so focused on integration into our accounts, we won't workflow
to be as seamless as possible. We've made it as
easy as a primary care physician can prescribe our ZEO,
patient wears it, we generate the report, we put the

(31:55):
report right back into our digital platform, and a cardiologist
without for having seen a patient can go into that
platform and pull down that report and they know pretty quickly,
now do I need to spend time with this patient
or not. And so the workflow efficiencies that we're we're
driving are just they're tremendous. And I think you know
right now, given capacity constraints, given trying to reduce the

(32:16):
cost of the overall burden of healthcare, we've got a
perfect tool to get after this.

Speaker 4 (32:24):
Yeah.

Speaker 2 (32:25):
And you know, one of the things that I feel
like most of this conversation so far has been on
is the Zeo Monitor patch. But you also have your
new Mobile Cardiac Telemetry or new Zeo MCT device in
the works. So maybe why don't we start quickly with

(32:45):
just for those new to the story, what is the
difference between the Zeo Monitor and this new Zeo m
c T product that it should be in the market
in the near future.

Speaker 3 (33:00):
Yeah, So if you look at our product portfolio today,
we have what we call Zeo Monitor and zo AT.
Zo AT will ultimately be replaced by zo MCT, so
we can step through that. But I think it's important
Zeo Monitors is our workhorse product today. You know, it's
ninety percent of our revenue stream and it's you know,

(33:25):
it carries seventy percent market share, so it's had incredible success.
Zoat if you compare it to Zeo Monitor, it's essentially
the same war period. You're wearing it for fourteen days,
but rather than being blinded during that fourteen day period,
a patient who wears this, we're sending data off of
the device through a connected device up into the cloud,

(33:48):
and we're monitoring that patient more routinely, you know, over
the course of the war period. So if we see
an arrhythmia taking place in a particular day, we're going
to notify that position and that patient in the moment
to say, look, you know you need to you might
want to look into this or here's what's happening right
And it's not real time monitoring, but it's a notification somewhere,

(34:11):
you know, around an hour or so. So there's more
sort of frequent feedback as you're wearing this over the
fourteen days that ZAT product we brought to market after
Zeo Monitor. If you look at you know that competitive
space that that's what they call the MCT space, the
mobile Cardiac telemetry space. We only have about call it

(34:33):
roughly twelve percent market share in that space compared to
the seventy percent market share we have in the blinded
monitoring space. And the biggest players in MCT are the
folks like you know, biotel preventers as an example, we
believe there's a tremendous opportunity to gain significant share in

(34:53):
that market. As a point of reference, every ten points
of market share gained would be somewhere around one hundred
million dollars of incremental annual revenue for US in the
MCT space. But again, we only have twelve percent market
share today. The challenge or the reason for that is
the product isn't isn't as competitive as it needs to be.

(35:16):
So when we're competing in the MCT space, our competitors
are enabling monitoring out to thirty days, which is very
important to our positions. Their solutions enable a downgrade capability,
which is, you know, if the MCT device is prescribed
and a payer ultimately denies it, they can downgrade it
into an event recorder and still you know, get reimbursement

(35:41):
for that versus our solution. If the MCT device is
ultimately denied by a payer and it's already on the
patient for a day or two, we can't downgrade it
into anything. They just simply got to take it off,
which a lot of our positions don't want to have
to deal with with that scenario. And nearly seventy percent
of all MCT procedures require you know, prior approval to

(36:03):
seek reimbursement or to get reimbursement. So we are in
the process as we speak of developing and getting on
file with the FDA here in the third quarter of
this year our new MCT device that will extend the
duration well beyond the fourteen days that we have today
in our ZAT product. It will enable the downgrade capability

(36:24):
as well and really put us on par even allow
us to surpass based upon our algorithm accuracy, these competitive
products that sit in the market. And what excites me
most is we're already in these accounts with our Zeo
monitor product. It's just because our AT product isn't quite

(36:44):
competitive enough. These same physicians are already doing business with
will prescribe a competitors MCT product, And we hear all
the time when you get an MCT product that's at
least competitive with your competitors, will make that switch. And
so I think there is a real opportunity to gain
meaningful share there. I don't expect we're going to get
seventy percent market share in the MCT space, but if

(37:06):
we can take our twelve percent to twenty five percent
or even thirty percent, you know, there's one hundred to
two hundred million dollars of annual revenue sitting there for
us to go get, and that's that's what we're after.

Speaker 2 (37:18):
I really caught onto just the downgrade feature because it's
like you said, it sounds like the doctors sometimes tend
to shoot first and ask questions later with the MCT product,
and we'll put the patch on before they actually get
pay or approval. So I think that's that's an interesting

(37:39):
new feature for the MCT, so then they don't have
to worry about that. Just with the FDA though, and
you're talking about submission with it. Part of that process though,
is that is your FDA remediation steps you talked during
the fourth quarter call about, you know, the timeline for

(38:00):
mid twenty twenty five still seems to be on track.
It sounds like you're checking all the boxes. You're responding
to the FDA's queries about having docutioner and documents in
or any follow up questions they may have. So I'm
not expecting more information from you than what you gave

(38:22):
during the call. But actually the one that catches my
attention though, is that we're in a new presidential administration
right now, and they're going through government agencies with a
machete at this point, have you noticed any differences in
your interactions with the FDA, say, before January twentieth and

(38:44):
post January twentieth.

Speaker 3 (38:45):
I can't give you any specific examples of how we've
seen our interactions change with them, so I think it's
too early to speak to that. However, we're certainly aware
of of all the noise in and around the space,
you know, the impacts with in CDRH as an example

(39:07):
from a personnel perspective, we hear of them. I'm certain
some of those folks you know have been impacted that
have been working, you know, our example of remediation. However,
I also know, you know, the the folks who are
leading that effort at the FDA, who are primary contacts,
and the folks that we interact with the most, they
are absolutely still there and continue to engage with us

(39:30):
as they always have. So I don't know how to
read into sort of some of the recent governmental actions
around the agency just yet. What I can say is
we're doing everything within our power to deliver on what
we said we were going to do by when we
said we were going to do it, and frankly even
go above and beyond that. You know, when when the

(39:52):
FDA came in last year Midsummer and we received a
few four to three observations out of that, we made
it very clear to the FDA and to our company
that that was going to be our top priority to
remediate those matters. But not only was that going to
be our top priority, we were going to commit ourselves
to go above and beyond even what the FDA was

(40:14):
asking for and really completely rebuild the quality management system
of our company. And that's something that we're on track
to do, and we'll have done by the end of
twenty twenty five. We will have addressed the FDA's remediation
specific activities by the mid part of this year in
twenty twenty five, and then there's activities we committed to
do on our own to go above and beyond even

(40:36):
what they were focused on, and those will be wrapped
up by the end of twenty five. So we're controlling
what we can control. Matt, I can't give you any
specific examples just yet of how impacts would or could
be felt. I think we're just going to have to
monitor it as we go. Well.

Speaker 2 (40:52):
I also think it's interesting that you're taking the opportunity
to fully invest to go above and beyond what the
FDA wants. What caught my attention though, was with the
twenty twenty four twenty twenty five guidance that you provided,
you commented that, you know, slightly negative free cash flow

(41:13):
this year and then that could potentially be positive in
twenty twenty six. I'm just curious, given the investments that
you're making to go above and beyond the FDA thing,
would your cash flow free cash flow have been positive
this year if you excluded those investments that you're making
into the you know, the remediation programs.

Speaker 3 (41:37):
It would have been Matt. You know, we're so close
to break even at this point in time. There are
some investments we're making outside of FDA remediation, for sure,
to address the infrastructure of our company and allow us
to scale efficiently for years to come. But you know,
there's north of fifteen million dollars being spent on FDA
specific remediation activities that, once completed, will go away, and

(42:01):
I do suspect that, you know, outside of these efforts,
that we would have been pretty casual positive, you know,
probably a year sooner than what we're sort of indicating now,
which is twenty six. Yeah.

Speaker 2 (42:12):
And you know, it's investments to make the foundation for
the you know, the future launch of this product. So
those investments make sense. And then you know, other investments
that I'm assuming that I RHITHM is making is in
the international expansion. You talked about launching in four EU
countries last year. Correct me if I'm wrong. I believe

(42:32):
they're Austria, Netherlands, Spain and Switzerland. But how how is
that launch going? And now how many your EU countries
are you in currently?

Speaker 3 (42:42):
Yeah? So the four that you rat it off or
that are correct, those are the four countries that we
stepped into within the EU, and and those are the
only four countries in the qu that we are currently in.
We're in the UK as well. The UK was our
initial sort of beach head into the international market, and
you know, I've been incredibly pleased with the momentum from

(43:04):
a unit volume perspective in that UK market. We're navigating
through some you know, public reimbursement matters there and look
to get a public rate established in a not too
distant future. But volumes there have been tremendous and the
uptake in the product has been tremendous, So good progress.
Happy with where we're at in these four EU countries

(43:24):
as well. Out of the gate. It's very early, but
I clearly see the uptick in and adopts the product
and the excitement around the Zeo platform. I think that
the next one that sort of gets me most excited
is Japan. You know, this is the second largest market
in the world. I mentioned earlier as we kicked off

(43:45):
our discussion today that we saw regulatory approval come through
for Japan late last year. We're in the process of
seeking reimbursement for that product as we speak, and we'll
see where that goes hopefully not too distant future here,
but second largest market one and a half million tests
being prescribed per year in an aging population. That that

(44:06):
I think we can really disrupt with the first AI
sort of you know AI solution that is in that
cardiac rhythm monitoring space. There just is anything else like it,
and you know, you look at the Japanese art rhythm society.
You look at the names of positions around the table
in the way that they carry, clearly they believe in

(44:28):
zero and they're excited to get it to the market.
So I expect we'll be in market in Japan and
sort of around the year, and we're excited to see
where that can go.

Speaker 4 (44:40):
Interesting.

Speaker 2 (44:40):
And then you know, actually, one of the things that
I'm curious about the reimbursement, I kind of in my
mind think about the trials and tribulations that I Rhythm
went through in twenty twenty and twenty twenty one getting
you know, a permanent CMS code. I was curious if
there was any learnings from that experience that we're able

(45:04):
to be provided in the steps to get the Japanese reimbursement.
But also now my follow up question is you talk
about the one point five million tests being done in
Japan already. Is that being reimbursed differently? Is that just
is that simply not a patch pump or I'm sorry,

(45:24):
not a patch pump, but just a cardiac patch and
so so basically is it a new technology reimbursement code
or is it each product has to be reimbursed separately.

Speaker 3 (45:36):
I think that's what we're still working through matter or
looking to hear back right, Is it a brand new
code given the fact that we got high medical needs
designation specific to ZEO and not specific to patch based monitoring,
does that, you know, does that create a different code
for ZEO in particular relative to to the entire market

(45:57):
right now? There really isn't you know, sort of patch
solutions in the market. There are wholter monitors in the market,
and that's how they're reimbursed. I think, you know, it's
such a new technology and just a differentiated approach to
that market that you know, it's going to be interesting
to see how they want to set up reimbursement for it.
The other thing is, you know, it's a it's a

(46:21):
market that has a lot of loyalty to it, loyalty
to that product and companies that maybe these positions have
been using for a while, loyalty to the local Japanese
manufacturer versus say, somebody coming in from the United States.
And so we have to think through all those different
aspects and make sure that we step into this in
the right way and that we got the right people

(46:42):
involved and that we're building the right relationship. So we'll
monitor that as we go, But again we're excited by it.
You know, I don't think it's a big needle mover
for us in twenty twenty five, we've said it's about
two million dollars of revenue for us in terms of
what we're expecting, but I think the long term potential
the market it is just incredibly exciting.

Speaker 2 (47:02):
Yeah, and you know, you're kind of still in the
early innings for arrhythmias, but it is currently just the
only disease state that the patches being able to detect
for a disease state. As we just look at ambulatory

(47:23):
monitoring in the next five years, what other fields could
potentially benefit from this technology.

Speaker 3 (47:30):
Yeah, that's an exciting one. You know, my vision for
I Rhythm and for our platform is to go far
beyond just cardiac monitoring. It was a big part of
why we license the technology from Biointellescence in the mid
part of twenty twenty four. That allows us to now
bring onto our single platform off the chest things like

(47:51):
PPG alongside our existing EKG signal that allows us to
get to things like puls like symmetry, SPO two, lovel monitoring, hypertension,
heart rate, variability, respiratory rate. You know, you can go
down the whole list, but ultimately, I think it gets
us to a point where we can monitor nearly every
vital sign right off of a single product being worn

(48:14):
on the chest. And I think that is where this
space is going to go, particularly as we get further
up the care pathway to primary care. I think we
start to earn the right to look for more disease states,
if you will. And so the first one we're most
likely to step into is is sleep. We've got some
things moving around sleep. We know that eighty percent of

(48:34):
folks who have a FIB have obstructive sleep AVENA. If
we can make it so easy to identify cardiac arrhythmia
is in the primary care physician's office, can we make
it as easy as just simply you know, hitting a
bon a button on the Zeo Suite digital platform that says, hey,
I want to look for sleep disease as well, and
through software on our integrated platform, now have the monitor

(48:58):
that the patient's wearing begins identify whether or not sleep
diseases present alongside a cardiac rhythm or not, or monitor hypertension,
you know, while they're wearing the patch, and I think
that excites me very much in terms of what I
think we can do through that primary care channel and
start to give answers into the healthcare system very very

(49:19):
early for these patients and frankly, you know, give answers
in a matter of weeks, three to four weeks to
get an answer around these multiple disease states versus having
to wait four to five to six months to go
see a specialist in these different areas to get an answer.
And so I think we can completely disrupt this whole space.
And if we get it right, I think there's a

(49:40):
real opportunity that we can sort of accelerate the move
out of the hospital into the home. I think, you know,
there's so much we can do to monitor patients as
we see them leave the hospital from a vital signed perspective,
monitor for early deterioration, get a nurse in to see
that that patient rather than having to bring them all

(50:02):
the way back to the hospital readmit them, and the
hospital bear these incredible cost of readmission. I think we
can bend that curve in a tremendous way. So getting
to a single platform that can monitor all of these
different sensing capabilities and modalities. I think it just opens
up so many future opportunities for us and net excises.

Speaker 2 (50:24):
Yeah, no, it sounds like it could be a potentially
exciting next few years. Quentin, thank you so much for
joining us today. I always appreciate hearing your story.

Speaker 3 (50:34):
Man, thanks for having us. It's exciting times and we
have a lot of fun telling the story and wet
on a lot of work to do, but I think
the opportunity is just incredible, So thanks for having us.

Speaker 2 (50:45):
Yeah, absolutely, And thank you to our listeners for tuning
in today. We hope you enjoyed us For future episodes,
and if you want to stay up to date, please
click the subscribe button on Spotify or your favorite streaming platform.

Speaker 4 (50:55):
Take caresses and bases US bases
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