So it's a real pleasure to welcome
back the old friend Dr Michael Flynn

second from Abbott Labs Abbott says
that the labs are a bit longer but.

So Michael did his kind
of a Georgia Tech life or

did his bachelor's degree his
master's degree in his Ph D.

in C.E. here at Georgia Tech
specializing in mems work for his Ph D.

at around the same time or during his
graduate work he was the number two

employee at cardio memes a small startup
that came out of Marc Allen's work here.

And that then kind of made it big and got
bought out by a company called St Jude and

then that got bought out by Abbott So
that's where he is today where he was

director of Product Development he's on
the technology is going to talk about he

has eight patents to his name and
he's also a member of the external

advisory board for the Southeastern
nanotechnology infrastructure corridor or

scenic which is the and see I note
here at Georgia Tech so Michael.

Thank you.

It's.

Thanks David

it's a pleasure it's a pleasure to be here
I was talking to David earlier when I got

here I think it was about ten years ago
when I had the privilege to come speak

to an audience just like this about where
we were what Cartman's was doing and

what were our challenges at the time and
so

today I've got a presentation that's going
to be similar but will be different you

know one of the things that I was thinking
about when Amy reached out to me and said

Write an abstract about what you're going
to talk about I thought about what could I

present that was different at least for
me because I've been doing this for

a really long time I've been working on
this product for about seventeen years now

and I wanted to tell a story
from a different perspective and

so certainly today the story for
carbon is not so much about can we do it

which is really the challenge we face back
in two thousand and eight but what can we

do with it what what can society do
with it and so before I start I'm

going to talk a little
bit about context and.

In my field or in the Med Device field
standard of care is something that is so

in a lounge it has a legal term and
I won't go into into that but

center of care really means what's kind
of common knowledge in terms of how you

take care of patients and in the space
that I'm in we're really interested in

improving the lives of patients with heart
failure or other disease states that's

what Abbott specializes in and
specifically for me it's interested in how

do you improve the lives of patients that
have chronic diseases and so that's why

I want to talk about today in that story
and that chronology I want to talk to you

about Cardi man's where it came from how
we struggled what was our chronology and

hopefully give you a glimpse into the real
life of what a start up goes through and

what it takes to make a product
a commercial viable product and

we start with one quick example this is
something many of you are very familiar

with I'm sure and that's hypertension
hypertension is high blood pressure.

Many of you.

Probably already know that one way to
manage high blood pressure is to measure

your blood pressure this is common
knowledge this is been around for

a very long time.

The technology for measuring blood
pressure has been around for

a long time if I look at you know
when this figure in the monitor was

developed it was eighty
nine hundred six so

we were measuring blood pressure as far
back as a thousand nine hundred six and

this has become common knowledge in fact
nowadays there's a lot of technologies for

measuring your blood pressure at home
smart devices that measure blood pressure

or you can go in a pharmacy and
sit in a booth and

they'll measure your blood pressure this
is what we consider today standard of care

it took a long time to get there this is
not something that happened overnight

if you think about the monitors at home
you know they started playing around

with these devices back in one
thousand nine hundred eighty S.

That's when the first monitors started
showing up at your house to measure blood

pressure and they're still not quite as
accurate as we'd like them to be but that

risk benefit analysis that all physicians
have to do is just about right for

this device it's not nearly as invasive as
some other devices but it it gets the job

done let me give you another example
that we're all very familiar with this

is probably not as old as hypertension but
it's been around for a long time and

that's that bts this is a chronic disease
that they back to the Egyptian area

where they were describing a lot of
the symptoms that we see today most of you

already know that the way you manage their
bodies is by measuring blood glucose and

then you go since allin this is
a common cycle feedback loop and

how you manage this chronic disease and
the technology has been advancing for

the last four decades to work today and
this is kind of a shameless plug for

Abbott really.

They develop a patch with a reader and

it will give you continuous
monitoring every blood glucose.

And you know the the technology has
been seeking ways in to minimize

how invasive The technology is
the reduction of blood pricking and and

all these sorts of monitors and advances
but the core knowledge of what you do and

what it's what is useful has been
around for quite some time and

it's taken about four decades to get to
where this common knowledge of treatment

is not even question you guys already
know this this is this is very familiar

so I want to talk about heart failure and
this is a disease it's very complex it's

not a very simple disease there's
a lot of causes of heart failure.

This is straight out of
the American Heart Association and and

they list over here all the different
ways in which can lead to

heart failure some of them are genetic
some of them could be coronary disease

it could be diet it could be a variety
of factors and it's a complex disease

because there's no single answer it's
not like diet bts where you just.

Treat with insulin it's not like high
blood pressure where you just measure

blood pressure and then you just try
to lower the blood pressure there's

a lot of co-morbidities and a lot of
other factors that play into it but

what was striking to us was what
is the standard of care for

her today and so this is straight
out of the guidelines you know there

are societies in the medical industry
that get together and they look at all

the greatest literature and publications
and trials and they establish what

the standard of care should be are there
are there guidelines for medication or

treatment of different diseases and
every few years they get together and

they update these this one is from two
thousand and thirteen I believe and

most of the guidelines for heart failure
are related to symptom management so

when you think about for a minute in those
two examples I gave you the symptoms for

diabetes the symptoms for high blood
pressure with high blood pressure

it's really a asymptomatic disease you
don't feel any really different but

it leads to stroke and it leads to other
catastrophic events and we don't wait for

those patients to get to where they have
a stroke or they have catastrophic events

to manage their conic disease same thing
with diabetes you know you don't wait for

somebody to get hypoglycemic before you
start to treat them or manage them but

in heart failure that's exactly what we
do today that's been the standard of care

along you monitor weight you
look at symptoms how do you feel

you feel you feel better do you feel worse
that's been the standard of care and

then there's a variety of drugs
I mean a cocktail of drugs I

didn't list them there's too many to list.

This is how you treat the disease
as well as some devices so

here's where we start to get interested in
what's going on in the industry what kind

of devices that we have.

Well in in the medical guidance you've got
really three devices that they offer up

one is I C.D.'s The other one
is C.R.T.'s so cardiac reason

can is a recent conversation therapy is
really a way to remodel the heart and

that's electrical aspects I.C.B.M.'s
are really about different relation

in controlling electrical circuits and

then if you get really really sick you're
really only left with two options you

can get a pump an artificial pump which
is really advancing in the last decade at

least in terms of a viable option
instead of transplant transplant is a.

Is is a procedure that is limited in
resources and so that's always going

to be a limitation of transplants is the
number of little hearts to transplant so

the pump industry needs to catch up in
terms of the invasive aspect of it and

the risk factors that are associated with
it but this is the standard of care that's

provided and none of these are really
dealing with what's at the heart no pun

intended of heart failure just to
take a step back if we look at where

heart failure is coming from you know one
of the striking things about our history

is that over the last several years at
least since the one nine hundred eighty S.

the med industry has been a great
job of reducing coronary disease so

this is cholesterol This is heart attacks
and way back then it lead led to death and

now we're keeping a lot of these patients
alive reducing coronary disease but

at the same time there's
this funny correlation with

the increase occurrence or prevalence of
heart failure so this is this is one one

interesting piece of information if you
look at heart failure in the U.S. and

how we treat it today in terms
of the cost in Medicare.

These are this is a plot of all
the hospitalizations that occur

in the United States I think this data is
probably from the early two thousand and

ten two thousand and eleven era but

it's striking you know the disease and
the prevalence of it in the U.S. and

then globally it's it's similar you know a
lot of the countries in Europe in Asia and

South America have have similar
hard pill or disease conditions

just to give you some facts about
the prevalence of this disease is about

six million people in the United States
today with heart failure there's about one

million hospitalizations every year and
if you go to Medicare Medicaid and

you look at the budget the number one line
item budget is going to be management of

heart failure when you book it all
the expenses in the United States we spend

more money on heart failure and anything
else in this country so it's a huge

the seas it's a big problem so when I want
to make sure that I convey that message.

Again if we go back to the guidelines of
care you know they subdivide heart failure

and different levels or stages and then
they classify into class one two three and

four with class one being essentially
these are classifications of symptoms so

in class one you may have heart failure
but but you have no symptoms you

can't really tell that you have heart
failure in class two Are you starting to

see some symptoms common therapies for
this is going to be C.

or T.
or is inconsistent

resynchronize they found therapy sorry and

then in class three and four is where
you really start to get get sick and

this is where more intervention needs to
take place and there's a huge opportunity

even today in these areas if you
if you look at a cross-section

of heart failure usually they're
classified into two sector segments.

Heart failure would preserve ejection
fraction ejection fraction is just

a measure of how much blood the heart
pumps and what we'll talk about you know

what are the key characteristics of heart
failure things that we care to monitor and

manage but preserve ejection fraction is
basically a way of measuring the amount

of blood that your pumps that your heart
pumps out every time it beats and for

this segment there's not a lot of devices
if you look at it on the med device space

you know most of it is just medical
therapy and looking at symptoms so

there's there's opportunity
there reduced ejection fraction

these are patients whose heart is
really failing in the sense that it's

it's not producing a lot of volume of
blood to your circulatory system and

this is where a lot of devices have
seen a lot of success with C.R.T.'s

through this class of heart failure
all the way done down the pumps and

so this is where this is where we come
in this is where cardio memes originated

we were looking at how do we take
how do we take this opportunity and

improve the lives of these patients so

if we go back and
look at the definition of heart failure

it's really the weakening of the heart
your heart is a pump It pumps blood.

This is a system that cares
about pressures and volumes and

if I show you a quick C.G.I. here and
hopefully you're not going to disturb

the heart we're really looking about
the seqlock cycle of pressure in

volume in the heart and so
it was striking to us was why is nobody

paying attention to these key parameters
within the heart pressure and

volume Why is nobody measuring key aspects
of the heart that could help you manage

this disease because at the end of the day
either you're trying to improve the volume

output of the heart because it's been
reduced because of the disease state or

you're trying to measure and monitor
the pressures if they get too high or

too low leads to different
aspects of the disease that.

So why not hear more dynamic sensors and

this is where wireless man sensors came
into play and this is where all really

start my talk about Cardi memes where we
are and where we want to go in the future.

So you'll see this light come up a few
times in the talk it's going to give

a chronology of of Cardium is what we
were founded in two thousand and one and

is my introduction eluded to I've
been a Georgia Tech all my life.

And I'm still a Georgia Tech if we
show you a show you a map soon but.

We were founded in two thousand and
one by two individuals one was when he

was a cardiologist and he was interested
in solving a lot of these cardiovascular

diseases by finding new technology
he was an intrapreneur at heart and

he really caught on to
this idea of memes and

he was seeking a partner to
help him solve this problem and

one of the unique things we had here at
Georgia Tech that Dr Allen's were team was

working on was at the time we call him
nonstandard men so mostly polymers and

doctors ceramics just a variety of
things including pressure sensors and

this became very attractive to Jay and
they met a few times in two thousand and

by two thousand and
one the company was founded.

And that's where I came in I was a young
kid working for Mark Allen at the time.

In fact in two thousand I was just
a research assistant I wasn't even grad

school yet and I had told Mark I was
interested in in joining his his

program and I was interested in startups
I was interested in all these things and

it really was a very
fortunate opportunity for me

that the company was starting at the time
I was going to begin my graduate career.

So when I say I've been a tech all my life
it's because it's true in these little

circles reflect you know the different
homes that car has had over the years

we started out over on Tenth Street to see
if we can find the lasers that this guy.

For in a in a cubit are called A.T.C.

they're still around believe A.T.C. still
in fifth Street if I'm not mistaken so

we moved with them from Tenth Street down
to fifth street over at Tech Square and

we stayed there a couple of years and then
when we graduated from the incubate or

space we build our own space over here and
the E.P. which is right down the street

shadows of Coca-Cola on the other side
of the train tracks as we like to say.

And as it was it was strategically
done that way you know part

of the reason Card event has
always been so close to detect

it because of the wonderful resources
that this institution has and

the research that was already ongoing
here not just for pressure sensors but

the vast availability of tools and
technology that comes with the place and

so I've got a short slide here I stole
these images from the I and website but

this was key to our success and
as Dr Brand knows and as David knows we've

we've always been a partner with with your
attack because we know the value that

the institution provides to us in terms of
access to tools that we would never dream

of buying or be able to be capable of of
acquiring without having access to them so

this is this is been a key aspect
of the success of our company.

Back in the early two thousand we were
looking for sensors that could measure

pressure at very high temperatures these
were target engine sensors it was a DARPA

research program I was a second graduate
student joining the program to continue on

the research that a previous student was
working on in terms of this technology and

our goal was How hot can
we measure pressure and

we got about a thousand degrees C.

and then that's when Carvins came in and
we diverted all our efforts to migrating

the technology from turban engines
to working inside the body and

this took some time but
it's not an original concept so

this is where I want to give you guys
perspective as to how long things take in

how hard it is to come up with truly
novel ideas today but if you if you

keep working at it from a different point
of view a different angle you will achieve

a novel idea what needs to be done but
this is a paper from Collins dating back

to one thousand nine hundred seven
where hitting columns answers back and

he called them to nominate because these
devices essentially have a frequency tone

that varies with pressure and that that
concept of that device has been around for

very long time I think that what we
were able to do is take the fabrication

technology that we learned here
George attack and apply it to

this type of technology so when cardinals
was founded we have one goal and

that was let's prove that we can actually
use this commercially we didn't start with

heart failure we actually started
with a different application.

That application was a domino Arctic
aneurisms this is a disease state it's

another chronic disease state the symptoms
are not something that you would know or

feel so if you happen to have an aneurism
you wouldn't know it you can't feel it and

these are any reasons in your
abdomen this is a disease state that

usually happens in elderly and in told
maybe the mid one nine hundred ninety S.

there wasn't a lot of knowledge
around this disease state so

there wasn't a lot of screening being done
and the result is fairly catastrophic if

you're if you're a or diverse then you can
bleed to death fairly fairly quickly and

so the industry came up with a solution
they said well why don't we just reply

the inside of your aorta and
that was a reasonable solution.

It's less invasive The alternative to this
approach is to do surgery so you could you

major surgery this is it has great success
unfortunately it's very catastrophic

during the surgery itself and recovery is
very difficult so a less invasive approach

was this think graffing one problem with
the same craft is that they can leak or

there's other vessels as you see in this
cartoon they can feed blood into the areas

I'm the prevent you from excluding the
systemic blood flow into this aneurism and

high pressure in this aneurism is what
leads to the rupture so we were clever and

we thought why not just take a sensor in
there and measure the pressure to monitor

the health of this aneurism and ensure
that they can keep the pressure slow and

this is what we set out to do in
the early two thousand so I I brought up

a slide from two thousand and
eight because this is where we were and

the goal of that presentation was to give
some insight as to what does it take to go

from research and institutionally to
detect to a true commercial product and

this is still true today it took us about
five years as when we first commercial as

a product.

And then the second generation
came out two years later

we spent the first four years
really developing in understanding

the technology how to use it how
to apply it characterizing it.

A lot of the things that we don't tend to
do in academia when I when I did my thesis

you know success was measured
by can I make the prototype and

can I demonstrate with some data that
it does what I think it's going to do

when you try to do a commercial product
now you have to get the reliability and

reproducibility of those results and

there's a man a tremendous amount of
energy that's needed to get to that and so

this is a very generic cycle of what
it took us to get to that product for

the you have no abdominal your take on
your ism sensor and we started out with.

Initial development so we had a look at
all the bio compatibility aspects animal

implants and if you're in the biomed
engineering department these

are all be familiar things that you're
probably learning in school today.

A lot of bench testing so reliability
was was king making sure that when we

implant this device into a patient we knew
exactly how it was going to perform and

how it was going operate this was just
demonstration of technology this is

this is just getting feasibility so
we had we had published literature

at the beginning of this era in terms of
understanding what we what could be done

we had demonstrated what could
be done commercially and

that's what this whole area was about
then we wanted to product development and

this is an engine term for
where you really start to convert from

feasibility proof of concept to
commercialize product manufacturing and

so a lot of the manufacturing
procedures were developed here and

in the Med space that comes
with a lot of documentation

half my life is documentation we have
to document everything we do and

if if you don't document it then
it doesn't really exist that's at

the point of view essentially there's
several industries like that aerospace

military in defense have very similar
standards in terms of documentation

everything's got to be documented so
we spent a good bit of time establishing

that documentation that package
that we give to the F.D.A.

so they can actually approve the product
and then we launch the product we learned

a lot of things here one was what does
it take to make these men sensors

commercialize them and then implant them
in the patients there's a lot of learning

that happened during that timeframe we
also got credibility with the F.D.A.

We were newcomers they didn't know who we
were this was new technology in the space

wireless measurement of intra body

metrics had never been done
before not like this not in

the permanent implant so
we needed to demonstrate to the F.D.A.

and to ourselves that we could do it and
that's what this exercise was about this

was all before heart failure so
now we're here seven years later.

So from concept an idea to demonstrating
proof of technology in concept in

a commercially viable application one key
about this application was at the approval

there's different ways to get F.D.A.
approval One is through premarket approval

process which is very lengthy usually
you're trying to prove efficacy and

safety and it's a fairly large
clinical trial and it takes many years

another one is called The Five think A and
this is where you you essentially

claim that there's other predicate
devices like yours in our case for

this application it was a catheter to
measuring pressure inside the energies and

just before you seal the aneurism they
would pull that catheter tube out but

it was an acute use so acute means
just temporary during the procedure

not long term use and we managed to get
that kind of labeling and get approval and

that was fairly quick for for
a product like ours we knew that for

heart failure it was going to be a full
clinical study we had to show efficacy in

evidence of the product so bring back
this light again now we were ready to

pursue this application and

one interesting thing that came about
is we were at the first ones to pursue

this application actually Metron it
had a device called the Chronicle and

from the late one nine hundred ninety S.

into the early two thousand they were
pursuing a pressure sensor that was

similar to a pacemaker it would have what
they call an industry a can with a lead

that fit into the ventricle and it would
measure pressure in the ventricle and

that was really the first trial of trying
to measure pressure inside the heart

with a device and so we learned a lot from
their clinical study and we specifically

targeted this class of patients for
a reason the reason was the rate of

hospitalization was high so when you're
trying to prove some scientific evidence

in medicine you want to have a lot of
opportunity to prove that in the sense

that it'll minimize your clinical study
if you don't want to have a study that

several thousand patients large you
need to find a patient population and

where the occurrence of event of things
that you're trying to look for Happens

fairly high and so this patient population
was key in the sense that they weren't so

sick that they're needing advance
they're appease but they're not so

healthy that the rate of occurrence of
what you're looking for is too low and

what we were looking for
was hospitalizations.

So what happens to these patients
is when they're hospitalized and

this is if you think of this
is heart function versus time

every time they're hospitalized it's
causing damage to the heart and so

prevention of the hospitalization was
a key aspect of our technology and

what we were seeking to demonstrate
scientifically in our clinical study so

it wasn't as simple as can we measure
pressure it was demonstrate that

there's a value in measuring this pressure
and that was a bar set by the F.D.A. and

it's not common I think it's typically for
a diagnostic device usually you're just

demanded to prove that you can make
the measurements accurately in precisely

not demonstrate actual value but
the F.D.A.

is point of view was this is going to
revolutionize how we perform therapy in

these patients and so you have to show
that there is some benefit positive

benefit in the therapy that's provided
not just that you measure pressure and so

our bar went from you know a diagnostic
tool to now almost a therapy.

If you think about what's happening to
these patients you know the the thesis

behind why we were interested in measuring
pressure is we call this our wedge but

if you look at the right side this is
essentially the event so this is when

the patient has been hospitalized you're
being rushed to the emergency room

this is time zero and
this is what you're trying to prevent and

standard of care was looking at waits and
symptoms this is where we still live

today a lot of clinics today that manage
heart failure ask about your weight and

ask about your symptoms and you're very
very close within a week or less than

a week of potentially being hospitalized
if you're waiting this long before you

take action action is change of medication
change in lifestyle change in diet

these types of things that can prevent
you from getting getting hospitalized

in literature we already knew that feeling
pressures within the heart again this is

a pump that he would an Amex matter so
what was interesting to us and what's

interesting to me is why is it taken so
long for the industry to recognize what

the key variables are in managing symptoms
or chronic diseases of the heart and

why haven't we done anything about it but
we knew that he would and

I make aspects of the heart were key and
actually leading indicators

to the disease that we're trying to manage
and prevent and so Metron it knew this and

they actually published some
information relating to this this

this is actually Dr Adamson who's our
medical director today but at the time he

was a practicing cardiologist managing a
lot of heart failure patients and he had.

A lot of knowledge of you know what
these patients lived through and

how to best manage them and they were
looking for a tool they thought Metron X.

to A would be it unfortunately their
device did not meet their primary endpoint

so then they joined up with cardio
memes and they were part of R.P.I.

is in our clinical study and

we set out to demonstrate that if you
manage the patients with pressure so

this is now the variable they
using to adjust your medication or

just how you manage the disease that you
can prevent prevent this from happening.

Our product is developed
over the last ten years and

it really is is formulated from three
different aspects are really for

a lump one into the top
tier the the sensor and

delivery system is the way we get the
sensor into the body there's an external

readout electronics that we use to
measure patients pressure every day but

ultimately what the physician really cares
about this is really neat and they get all

excited about this but really the
information is what they're looking for

this is information they never had this is
the feedback that they need so many of you

guys went through engineering in undergrad
and you probably went into systems and

controls and you probably could not
imagine trying to develop any kind

of system without feedback or control and
that's really essentially what we're

trying to provide the physician it's
feedback a feedback loop of information to

manage these patients
the sensor is a sensor and

this is a cartoon of how it operates and
it's a very simple concept.

And the simplicity dates back to when we
were trying to measure pressure and high

temperature you know when we were thinking
about how do I measure it five hundred C.

A thousand C.

most of the things we had at the time
tools would probably melt or

not function appropriately and so
it really limited was limited us to design

space that was purely a materials problem
how can I make these materials into shape

that give me a signal electrical signal
that I can read out and ultimately what

that led to was a inductive capacitive
resident circuit that varied with

pressure and so here's a cartoon of what
that looks like if you have a you could do

this with a very an inductance or varying
capacitance I think for us capacitance was

easier to vary than inductance but
it really doesn't matter the tone of this

device or the frequency varies with
pressure and we can measure that using and

inductively coupled system
this was really hard to do.

Some of the simplest things are sometimes
the hardest things to do but

that's I think part of the the need
aspect of the technology and

its reliability is the fact that it's so
simple so you know we looked at a lot

of literature back in the day and it's in
and when I was doing my graduate work in

ma'am it's always very easy to complicate
things but sometimes it's best to

take the harder road in simplify keep keep
thinking what is the simplest thing I can

create that will solve the problem because
ultimately more complex tends to mean

more more problems or more reliability
issues that's not always true but that's

that's a guiding principle we had enough
a lot of we had so we had no batteries.

We didn't want to limit the longevity of
the implant batteries today are advancing

significantly and I'm certain in the
future we're going to have batteries in

these devices but initially we didn't want
to go that route because of reliability as

well as the active circuit aspect of it we
wanted to keep it as simple as possible as

reliable as possible so that was a guiding
philosophy and then that pushed a lot

of the complexity into the externally
Tronics one of the unknown aspects of

Cardi memes is that the electronics is
is just as neat from a engineering and

technology point of view as the sensor
is in terms of its ability to measure

inductively couple devices from many
inches away if you look at most are if ID

tag books you know they're measuring with
an inch a few centimeters away from those

those devices in our case we're measuring
within the body which is which is

a challenge if you think about our body
being fluid being a conductive body it's

difficult for R.F. to penetrate the body
you have to go into very low frequency and

to achieve those of
frequencies you have to scale

the device so when you're when
you're dealing purely with

geometries in materials size and
frequency or are counter to each other

so we set out to demonstrate.

Efficacy for this device we had shown we
could measure pressure in the industry and

that was through our abdominal
Eric aneurism sensor

next we had to go show what can
we do with this product and

it turns out that since there was no
product like ours before this is when you

demonstrate the greatest amount of gains
in these types of disease management so

we were able to show a thirty three
percent reduction in hospitalization for

this patient population and that might
not seem like a lot in other areas but

in the Med Device where usually you're
trying to gain five percent ten percent

where these these percentages are large
thirty three was unprecedented for

this industry they had they had no other
device or technology or even therapy

that was achieving this level of
reduction for the entire cross-section So

when I showed you that graph of heart
failure and we had preserve the Jackson

fraction versus reduce the direction
practice these are different phases

of heart failure different types of heart
failure we show this across the board for

all devices and and it wasn't
a surprise to us because at the end of

the day as I mentioned heart failure
is about volume and pressure and

so giving insight into what's going
on inside the body was key for

these physicians to be able to
improve prove these patients live so

that gets us to just last year where
we got approval in two thousand and

fourteen this was a great day for us and

that led to our acquisition St Jude
commercial as a product and

then we were acquired
by Abbott last year and

now the goal is to to see where
we can take the technology so

I'll show you this graph this is a.

Very simple graph of clinical evidence if
you work in the Med space you know this is

the challenge that we're faced with today
after you've demonstrated that it just

works so all along for the last seventy
years we've been trying to show how

the product works we can measure pressure
it's actually reliable and you can do

something beneficial about it and if you
go to the American Heart Association or

any other association is in a chronic
disease they usually have a guideline and

they also have a guideline as to how they
weigh the different types of scientific

evidence for those disease states and
they break it down into little level

of evidence which the best starts at
the top and works its way down so

you've got many trials many populations
usually many companies many

competitors lots of information rich pool
of information associated with disease

management a single study with
limited populations is next and

then typically below that
is expert opinions or

case studies at an individual clinic so
this is this is the level of evidence

that's needed and then they've got
a classification for the risk benefit and

so obviously we want to be up here and
not down here and

where we are today is where a single
data point right there essentially we've

done one study with very high risk
the benefit demonstration and

so the goal the challenge for
us our perspective today is not so much

can we do it but what can we do with it
and change the mindsets of individuals and

become common knowledge or standard of
care so with that I open the Ford any

questions I'd I can talk about this
stuff all day long been doing it for

a long time and if we want to go into
the more technical aspects of the product

into more biomedical aspects of
the product that be I'd be happy to do so

thank you thank.

Yes.

All.

That.

Sure.

Is.

He's here.

With.

Me.

You know.

Why.

Some.

Research.

Which is you know really.

If you know what is it.

That you have who.

Is.

I risk.

Well.

I mean it's it's not easy and
there's not a simple answer in and for

me at least my from my career is partly
luck so it's what I was doing and

what we were working in and I wasn't going
to forego an opportunity to go work for

a startup when I was starting my graduate
work at the time we had no idea what it

was going to succeed or fail like every
other startup certainly their field of

of medical devices had an easier
time in capital funding

in the early two thousand I think today
it's a much riskier proposition and

I think it be a lot harder today
potentially for us to have survived.

In terms of the space you know
their sensors if I look back and

I'm happy that we ended up
where we did because I think.

The type of work that we do is very
inspiring you know actually helping

patients we get the visit with a lot of
patients we get to hear their stories and

that's very very impactful much more so
than any of the other industries or

certainly our phones or
cars all this technology is

filled with memes devices in fact there's
been an explosion of men's use and.

It's far more exciting today than it
was back when I was starting which

most people don't even know what
the word meant standard for.

At least I did and I never heard
it before so it was a little bit

of stroke of luck it was honestly the
vision that our founders had you know and

I I started with them on that ride
in stayed with it all along but

I don't know that we could have predicted
any of the factors that you described in

terms of we didn't know prospectively.

What challenges we were going to meet we
just knew that the work was valuable and

that it had meaning and so
you know that's part of the story is

if you believe in something and
you find something

to be valuable you need to stick with it
it takes a long time in the mid space and

you need to come in that with your eyes
wide open in terms of the potential

longevity that you're signing up for
because nothing happens quick we're not

going to be like an Instagram we're not
going to be like these apps today that

turn over into a billion dollar
industry in a matter of a couple years.

But at the end of the day
we're very rewarding and

that's probably the most
satisfying part about it yes.

Yes

So the way the device works is the sensor
is a purely passive resonant circuit

and when you're not energizing it with
our efforts it's purely dormant so

the electronics has the job of
energizing it within our field and

our frequency is a band of thirty or
thirty seven megahertz

that was a sweet spot for us in terms of
how low can I get the frequency because I

want to penetrate deep into the body yet
how small can I make the device if you

want lower frequency to have to make it
larger or find greater energy density so

you start thinking about how dielectric
material you start thinking about.

High permeable materials in terms of
ferrites or are magnets of things

of that nature but then you also have to
worry about stability and longevity and so

for us you know we felt like let's not
deal with materials that potentially could

be unstable over time let's go with an air
core coil let's do an air gap capacitor

and that limited limited us in terms of
what size and dimension great so that sets

that now you have to go making electronics
the way the electronics works is

it has two antennas really one is
to transmit and one is to listen or

receive and it works a lot like sonar so
if you think of sonar you you paying

it sends a wave out and then the
reflectance back is what you listen for

and certainly tronic says that very
very fast the the ring down time if

you think about the ring going over
resonator is within a few microseconds so

one hundred thousand times a second
we're saying we're pinging and

listening to the sensor and it's through
near field inductive coupling so

that's that's how the device works
the electronics has a phase lock

loop that once it locks on to that
frequency it'll phase like loop onto it

now it can track it as it's moving
across the pressure gradient.

Yeah and at the time the idea was well
we can always upgrade the externals but

the implants permanent I like to use
a stent as a you know stents put in they

never get removed or sensor gets implanted
and it's never going to come out.

Of the pulmonary vasculature.

You know.

You know.

You know great question so
the first question goes back to

you know in the original design
concept we thought about what are all

the key aspects of the cardiac cycle
that that you would be interested in and

if you if you're familiar with the heart
there's a left side of the heart which is

pumping blood to your body and the left
ventricle is a main is the main aspect of

the heart that pumps all the blood to the
body and one of the first areas the blood

goes to as it goes out of your heart to
your arms your head and your feet and so

one of the risks of putting any devices in
the left in trickle lead to stroke and so

when we're doing kind of this respond
if it analysis of where to measure and

what the measure and what could be the
potential risks or the safety aspect of

our product that conversation came into
play a lot in terms of where do we go so

we said well the left side is kind of
risky at the end of the day because

our device is is not it's not like

a leader like a pacemaker lead where
if the anchor making isn't fails or

something happens it's not going
anywhere it's going to stay tethered

whereas our device is not tethered so
we excluded the left and

trickle then we thought about the right
men trickle what about what about that

device here and that seemed to make more
sense to us the right side is a lot safer

it's a lot lower pressure it can lead
to the same value of information maybe

you know that most doctors care about
left in trickle or pressure but

that's a lot riskier area to be in so we
said well let's give them right matricular

pressure and see if we can demonstrate
the same information there.

And when we went through a risk benefit
analysis one of the feather modes was well

if it dislodges it's going to end up
in your lung like an embolism and so

we said why don't we just have
a controlled delivery into the lung and

then we won't have to worry about
it failing into the lung and

I say that tongue in cheek but that's kind
of the thought process that evolved into

let's see if we can pursue a sensor there
it's also out of the way in the pulmonary

artery you get a lot of similar
information that you're looking for

from the pulmonary artery
same value of information

that you would get from the right side
adventure go for the right atrium.

Without being in the way
of other devices so

precluding them from getting say leads or
other implanted devices as well as

a lot safer from a profile of a device and
when you're a diagnostic you know F.D.A.

is more tolerant to risk when
you're providing therapy but

if you're truly a diagnostic device their
tolerance to risk is much lower and so

we have to consider that So that's that's
the first one the second question was.

Yes so the measurement that's
a an interesting thing when to doctors and

in we were telling him about getting
readings every day the first thing he says

I don't want so much they have nothing
now they don't want to be flooded with

information later so we had to find the
right amount of data that would suit them

today we measure about eighteen seconds so
we get a couple of breaths so

you can see their respiratory
cycle as well as their heart rate

in the reading that we collect it it
takes eighteen seconds plus another.

Been or two to get the information and
transmit it to the database and

we ask them to do that once a day and
that's that's more than sufficient for

what we need to prove in our clinical
study certainly you could think about

getting more data getting less data but
if you know the day where label showed was

that one reading a day of about a few
minutes is more than enough to get

the benefit that we've demonstrated so
there's kind of this balancing of

how much is enough and what benefit can
you get out of it and you go back you.

You know that's a good
business question and

certainly there's no magic eight ball for
that you know I think what I learned from

watching my managers as I was coming
up through the ranks in card humans and

the strategy they deployed is that at
the end of the day what they look for

is they look for
individuals of character you know and.

Most of the time if they've had a solid
education which you would get Georgia Tech

or any other high institution then you're
looking for What's Your character like

can they learn do they have appetite for
learning because you can't usually train

train that an individual so you know for
Certainly we made many mistakes and.

But we also were very fortunate to have
a lot of great individuals working in our

company and certainly this was
a team effort I get to go around and

present about cardio but certainly
this was not necessarily my baby or

my own thing it was a huge team effort
that led to our success all along the way

initially with developing the technology
later with performing a clinical study

it's very difficult for startups to do
a full premarket approval study and

then now in the commercialization aspect
of it leveraging all these big companies

budgets as well as sales force to go and
promote and deliver the product so

I'd say today when I hire when I look
at individuals that we want to keep for

longevity you know how do I
assess their character and

that's really the biggest measure of
whether they're going to turn out to be

a really good employer or
not let me go here in the coming.

Yeah and certainly all the wearables
today are becoming you know a big key

aspect they're now making
their way into med.

Certainly if you look at Apple in their
watch they're looking at a lot of

medical applications by measuring
telemetry from their watch and

they're not the only ones but
that's really one of the biggest ones

I'd say that Abbott's going to be very
interested in trying to integrate

our sensing knowledge of making implants
with a lot of their other technologies

that they have in terms of you know one
of the things that Abbott got when they

bought St Jude is they have a huge
portfolio now of cardiovascular disease so

Abbott had a lot of stents and
wires and catheters and

St Jude had a lot of the cardiac
rhythm and management products which

are the I C D C R T's as well as the pumps
and they also had Party members so

now Abbott's well positioned to to
really lead lead that space and

heart failure they have a product for
just about every aspect of heart for

their disease so now for us it's about
growing party members and getting to that

standard of care getting for the agencies
that that define how you care for

a patient to list pulmonary
pressure sensing devices and

that takes time you have to build up the
evidence but also integrating some of that

across across the boundaries beyond
that you know you can imagine

all the different spaces in the body where
pressure is going to be key it's not just

in the cardiovascular system and so then
it's going to be about the appetite for

Abbott and or other competition to pursue
those areas certainly we're not we're not

alone competitions coming and so that
will To me that's exciting because that's

a sign that we're we're doing
the right thing let me.

Just.

Like.

Yeah yeah.

Yeah I mean.

So there's always going to be
a desire to do more things and

with more things you have to have more
levers to be able to do such things so

one of the limitations of this
technology is as a standalone sensor for

just measuring pressure where we measure
it does a great job the moment you start

thinking about how do I have it integrate
with other devices or other things

now it's very challenging because if it's
trying to communicate with another implant

now it's on the onus of the implant to
carry all the electronics and the R.F.

power to talk to a device which is not
miniaturize it will proceed at this time

as well as other other metrics that
that are interesting to monitor.

So so now for us now that we understand at
least internally in my development team

we understand very well what does it take
to measure pressure inside the body or

what is it what does it take to measure
anything really inside the body.

Well how do we expand that to other other
things and how do we do more with it and

terms of integrating to other devices for
collecting different data sets and

for that we're going to need we're
going to need more variables to to

to the design space that are beyond
just geometry chemistry and

materials which is a great job for
what we're doing but

in the long run it's going to be
a limiting factor for us moving forward in

our sense is that if we don't do it
somebody else is going to so we're looking

at a variety of different aspects for not
just energy density in a passive way so

how do we how do we capture more if
energy to then do more things with.

But then there's always
this hanging aspect of well

you can also store energy in
the device through a battery and

why not consider that as well so I think
I think it's coming unfortunately and so

we have to be in front of it or
we're going to be behind you know.

Yeah yeah they're very expensive.

Yeah so

that's a that's a that's
a problem that all P.M.A.

or even any clinical study is going to
face in terms of how do they insure and

Roman because you know you write
a protocol which is you tell the F.D.A.

Here's what I want to do here's how I want
to do it here's how many people I need to

do it with statistically to show and prove
with power the effects that I'm trying to

show and so then they sign off and say
Yeah and they say OK No Now go do it and

certainly consent is a big
aspect of clinical trials in for

that we had to hire a whole clinical
department that was experienced in doing

that achieving consent you're not always
going to get consent from all patients

most of the time in technology like ours
where it's never been done before you're

going to be paying for the procedures are
you going to be paying for the trial and

so for us that was a huge cost aspect
of of the business and we had to raise

capital to pursue that and there's
different ways of pursuing capital and and

certainly there's a lot of external forces
that drive the way capital swings so I

don't know if this answering your question
but you know the cost of the patient

wasn't necessarily the first thing on
their mind because they're not paying for

it out of pocket for them it's
more this is a study that's never

been proven before in my willing to take
the risk in being part of this study or

not it's an unfortunate thing that a lot
of these patients are very very sick and

so they're they're really sick and
tired of feeling that way and

a lot of them are very open minded in
terms of trying trying different things

and so for us that was a benefit in terms
of enrollment but it still took us about

three years then roll all of the patients
that we wanted to as about five hundred

fifty patients and and it's a slow
process at the end of the day all right.

Thank you thanks.