Speaker.

Michael Leavitt

while he was a joy

actually working pressure sensors.

I think it was while we're

showing our first

ration reduction.

Thanks.

That afternoon.

So a lot of familiar faces and
all these grounds pretty good.

I mean he writes a lot.

So you're so my talk today should
be fairly short not going to

focus on a lot of technical detail.

I'd like to go telling the story
of how card was found there

progression and how they launched
the first product into the market.

So it's going to be a top level overview
of cardio memes and then kind of

a little bit of history and progression of
product development for our first product.

Here's an outline of the talk.

Give me an introduction to quality memes
for those of aware who cardigans might be.

And give you some technology overview.

That's in the target applications that
we might be interested in specifically

cardiovascular applications also talk
a little bit about the device concept

a slight technical information here but
not a lot and

I'll show you a little movie about what an
implant procedure looks like and this is.

Media Technology overview and
then I go into

introducing product development
which is for our first product.

We spent several years developing
the technology introducing it into

the marketplace and then launching
a first product and I'll conclude.

So little history and cardio memes.

It was founded in remember
two thousand and seven.

That's about the time I was going to take
as a grad student right before I joined

go to Tech there was another student here
who had been doing research in wireless

pressure sensors for turban engines and
there was some intellectual property that

was developed in that research and
in the direction of Dr Mark Allen.

So license that technology in April
two thousand and one and pretty soon

after that once we had some intellectual
property operations began in Atlanta.

Some of you might have
been familiar with A.T.C.

that said
Vance Technology Development Center and

they were located over on Tenth Street
back in two thousand and one and

that's well office was there some other
companies that went through that incubator

space such as mine spring and
several other companies.

That in Cuba or space is owned or
funded by the state of Georgia and

they located it right here next to do
tech to try to leach out technology

develop companies that found businesses
and then generate revenue for the state.

Through the income in taxes and
employment.

So that's the motivation
of the computer space.

Some other point information
in cardigans history.

Was that we were located next to George
attack and that was very important for

us because we were developing technology.

It was an immense space and that requires
very specific tools that we had to use and

it was very important for
us to be located next the M.R.C. to be

able to leverage a lot of these tools to
do our our development and our research.

Many of you that work on there
have probably run into a few

cardigans employees.

For the positive or negative.

Maybe.

Several years after we started
operations we graduated from a.

After a while you better space
wants you to hatch and grow and

become your own company
move out in your own space.

So in two thousand and
five we graduate and

we move to Texas where very
nice facilities over there and

in November of two thousand and
five we commercialize our first product so

you can see from the time we started
operations to two thousand and five.

There's a lot of work that had to be done
for this company to grow and develop and

introduce its technology
into the marketplace.

There's a new building
now down North Avenue

called the technology enterprise
park right next to Coca-Cola and

that's where we moved to
the life sciences building and

there's two current companies there cardio
mamzer and a company called Atiya and

that's where we're currently located
it's about one or two miles from here.

And soon after that in two thousand and
seven we started clinical trials for

our second product.

And I'll talk a little bit about
the strategy in the company and

choosing different applications in
the direction they chose to go.

I would say that this clinical trial that
we're currently in is probably the next

biggest step in the company's history and
discuss some details about that overall

the company has raised close to ninety
million dollars over the last six or

seven years and we've grown to about one
hundred twenty employees eighty five of

those are here in Georgia the remainder
are scattered throughout the U.S.

or kind of a direct sales force team.

So let me introduce
the founding fathers of cardio.

Dr J. and Dr Mark Allen first
started having discussions about

party members probably in two thousand and

they were both interested and leveraging
memes technology for the medical industry.

Doctor got have had problems
that he needed solutions for

and he thought that some of the technology
that Dr Allen was developing were

the correct solution for those problems.

So they came together and they started
thinking about all the possibilities of

what they could do with this company.

And one of the obvious things that
the medical industry needs is to be

able to measure pressure.

There's a lot of areas.

In your body where pressure
is a critical parameter and

I felt like that was a very good start for
a company to initiate and

be able to grow and
develop into various other areas.

So the goal was to take some of this
high temperature turban technology and

migrated over to the medical space.

Like I said there's a lot of different
areas where measuring pressure is

important and it can help in therapeutics
or in management of diseases and

I've just listed a few of them here
such as hydrocephalus hypertension and

truculent pressure in obesity now have
a leper stopping bands that can go around

and it's important for them to be able
to measure pressure there as well

you probably you ology
gastro Knology orthopedics.

And the rest I left cardiovascular
applications to the very end.

Because that was the main
focus of cardio memes there's.

Either in there's a lot of need for
pressure monitoring in

cardiovascular applications either because
they're catastrophic to the patient or

just the sheer volume of patients that
exist that need better management.

So the company chose that is
the primary focus of a to start.

There are some reasons for that.

No I'll discuss those in a little bit.

If you look at patient opportunity.

So again I'm talking about
you know why the company's

deciding to go in the space why
they're looking to go in this area.

If you look at patient
opportunity you can see that.

At the bottom here you have aneurisms and

I'm talking about abdominal
your take on yours and

these are and you reasons in your abdomen
usually right below your belly button.

An aneurism there's a bulging of Yoda.

And that's a disease where
the vessel wall keeps weakening and

it keeps ballooning out until it
potentially could burst and if it burst.

You could bleed to death.

Very quickly.

So there's some catastrophic
events that could happen to

patients if they're not monitored and
managed properly but

the overall population space is somewhat
small compared to some of the other areas.

You know if you move up the ladder you
can see that cardiac surgery disses for

when you're doing open heart surgery.

The heart the cardiovascular
system is excessive.

You can implant devices at that point if
you needed to heart failure is a disease

where over a progression
of time the heart begins to

weaken the cardiovascular system begins to
weaken and it's not as an efficient pump.

So when your heart is not
as efficient as it can be.

You start to see all kinds of different
side effects you start to build up fluid

in your lungs you have shortness of breath

organs are tissue you don't get
all the blood that they need and

then moving up to the largest
application which is hypertension and

that affects you know over sixty five
million people in the United States.

So the strategy for carbons was to take
any reasons initially because it was a.

Disease in which
catastrophic events occur.

So there's an a demand for a product or
a new technology in that space.

The F.D.A. was very eager to see new
technology being developed in that area.

And Cardenas felt like that was a
strategic location to start to be able to

develop the technology introduce it in the
marketplace and get its foothold in this

wireless diagnostic space and
there's not a lot of competition

as far as wireless implantable devices in
the body in this at this time frame and

so it was important for card humans to
try to develop technology quickly and

be able to get it approved through the
F.D.A. and in this space we're aneurisms

It's called AAA is for
short a domino to Kenya isms that space.

The F.D.A. was looking for solutions.

So we could commercialize a product
in two thousand and five and

that's where we introduced the technology.

Currently we're doing clinical
trials in heart failure.

And this is a lateral or an improvement
in the market size from a business point

of view as far as reaching
larger patient populations.

You know to develop better technology and

overall generate more revenue for
the company.

So let's talk about heart.

Well your first and then all on move on.

It's a progressive disorder
which damages the heart and

the cardiovascular system like I said.

And it manifests itself in
various different side effects

such as fluid in your lungs
shortness of breath and so forth.

Like I said it afflicts over
five million Americans.

It represents about fourteen
percent of Medicare beneficiaries

that have congestive heart failure and
the impact of all of this of all these

patients require a management is that it's
about a six billion dollars expense for

just hospitalizing these patients.

And it's one of the most
common reasons for

being hospitalized in
the United States right now.

So the yes the minutes for
two thousand and seven for expenditure.

Managing these patients is you know
close to thirty three billion dollars So

there's a lot of need for
better management of these patients

in general cardio is trying
to develop technology.

For diagnostics and then hopefully

in the future they can start developing
technology just doesn't do diagnostics but

actually provides an active role
in the management of patients.

Perhaps drug delivery etc But
you've got to start in one area and

then progress further and
so the technology for

diagnostics is somewhat limited in
in the medical space right now.

Doctors don't have a lot of
information that they can use.

From within the patient where
continuous monitoring is being done.

Of the patient whether they're home
whether they're mobile moving around

not just diagnostics in the hospital.

So that's that's the technology that
current is trying to bring and introduce.

If you look at that the devices
themselves the companies

interested in developing miniature
sensors for wireless communication and

obviously they strategically chose
to go in a passive route but

ultimately we're not going to be limited
to just passive sensors there are some

clear advantages as to
ride passive devices.

Proved to be useful in this area and
I'll talk about that in a little bit.

So the technology itself the sensors
don't have any batteries or

power sources they're purely
powered through our energy.

Program the implants and the patient so
there's not a lot of sensors that

are permanent implanted in the patients
currently a lot of diagnostics is done

through scanning or
imaging of patients whether it be C.T.

scan or M.R.I.
or they come into the hospital and

they get acutely measured
without be through catheters or

surgical approach is that's how they're
diagnosing a lot of these diseases.

There's not continuous
measurement of the patients.

So for the concept itself.

The way the device operates
is is pretty simple and

it's very easy to understand and
I've got a couple of

images here that explain the conceptual
operation of the device.

The sensor itself is a L.C.
resonant circuit and

most of you should be familiar with what
that is but it's basically an inductor and

capacitor when you join these two
together they form a resonator.

And it's going to have a resident
frequency and in the field.

The man's If you're able to fabricate
these capacitors on mechanical

deformable plates.

Now you can trans do some
of that mechanical change

into an electable change so in this case.

If you apply pressure to
the deflecting membranes now

you're capacitance is
variable in your circuit.

And you cannot really obviously change
the resonant frequency of your device so

that's the basic operation.

If you place your device in a loop
antenna Now you get magnetic up and

you get magnetic field interaction
between the sensor and the intent up and

you're able to measure
the impedance impedance change due

to this resonant circuit
being in your loop antenna.

So if you monitor this impedance and

you apply a hydrostatic
pressure on your sensor.

Now you're going to measure the resonant
frequency change due to pressure.

And that's the basic
operation of the device.

In practice or in practical terms like
to use this analogy everybody is pretty

familiar with diabetes and
in the marketplace.

There's commercials and devices and

a lot of works been done to try to be
able to measure blood glucose because

that's a critical parameter and be able
to manage diabetes in a similar fashion.

For heart failure or many of these
cardiovascular diseases measuring

into cardiac pressure or pressure
inside some organ inside your lungs.

Is critical parameter to be
able to manage these diseases.

So the technology is really for

providing real time monitoring
vital information and that there

is a promise for reducing hospitalization
of patients improving the patient's

quality of life and delivering more
efficient and cost effective health care.

So I think the patients are interested
because their overall health health care

and lifestyle has improved insurance
companies are happier because they

are spending a lot less money in trying to
manage these patients and the doctors have

improved diagnostic tools you know one
of the things that everybody's probably

familiar with his other open loop
systems are closed loop systems and

managing hard for their patients right now
is an open system the way they manage them

is they provide the medication for example
to try to monitor their cardiovascular

system try to improve cardiac output and
improve the efficiency of how their organs

are working but they don't have a feedback
loop to tell them how good or bad.

They're improving the management
of this patient and

so cardigans wants to provide a diagnostic
tool a way to be able to monitor

continuously monitor these patients and
get a little clip here.

That shows you how the overall procedure
is done for one of these implants.

So another important aspect of

the technology is that it's designed to be
minimally invasive and what that means is

that you don't have to have open
surgery to be able to implanted device.

We want to leverage catheter
based delivery systems.

Which is basically tailor bean aside.

Tubes for a better word that can be
inserted through your arteries through

your veins to be able to deliver your
devices in the in the desired locations.

So for heart failure obviously we want
to measure into cardiac pressure.

So we need to take the sensor and

deliver it near the heart or as close
to the pulmonary artery as possible.

And we do that you insert a catheter near
the growing there's probably a small

incision that can be made and
this allows for a catheter to be inserted.

So now you have access
to the being inside and

I don't know if it's showing up very
strong but you can see here is your aorta.

And there's the venous side.

And I'll talk about why that mean
the side is being chosen in this case.

Just a second.

So the axis of sight would be able to
guide your catheters all the way to

the heart or the side of implant and
the easiest way the doctors have time to

do this for this type of procedure
is basically to allow blood flow

to direct you all the way to the point
where I order so on the side blood is

coming back to the heart and then it's
going to be pumped into the lungs.

So what they want to do is
with the air balloon basically

generate a sail and they'll sail
this air balloon all the way up

into the heart and
into the point of the artery so now.

Now you've accessed the pulmonary
artery and this is I say with the East

but you know primarily you're allowing for

blood flow to go back to the direction
in which your balloon is going.

This is a common practice some of
the matter heard of a salon dance

catheterization there's a procedure
in which a doctor is able to do

insert a catheter of this type and
measure their right or

left heart cardiac pressure in or.

Diagnosed whether you're you have heart
failure or other cardiovascular diseases.

So this procedure in itself is not new
problems than develop this procedure this

is something that exists out in the field
already and we're just leveraging on it

to be able to access a site where
we want to implant our sensor.

Once you're catheters achieve the site and
so you see that we've gone past the heart

and we're actually in this pulling
artery branch and that's an anatomy for

in layman's terms what that is is from
the heart the pulmonary goes into

the lungs and it just branches out into
thousands and hundreds of smaller and

smaller arteries and that's ultimately
what oxygenates your blood.

And one of the reasons
we chose this site is

actually through some of the product
development they were doing at the time.

Obviously like I said into cardiac
pressure is an important key parameter for

managing this disease.

So the obvious question to be well right
and to implant your device in the heart

and then conceptually that
was the original intent.

We were thinking of similar to
pacemaker leads they get screwed in

into the side wall of the heart.

Usually it's back a little bit

and posit here a lot of pain to make at
least and to come in this area here and

get implanted somewhere on this wall or
down at this part.

And in anatomy this is the right ventricle
and this is the left ventricle the right

ventricle receive units of blood and
then it pumps it out

into the lungs from the Long as it comes
back into the left ventricle and then it

gets pumped out to the rest of your body
so it goes out the aorta zero to here.

These are the main arteries that go to
your to your hands and to your brain and.

This main trunk goes down and

it follows your spine and
it feeds blood to the rest of your body.

So this is the left ventricle is really
where the doctors care to measure into

a cardiac pressure.

This is the main parameter that they're
trying to monitor and investigate for

managing these patients but there are some
drawbacks in putting devices in this place

and one of the major drawbacks
is if there's a failure mode for

your device the first place.

Something will go to is up your artery and
probably up in your brain and

cause a stroke.

So it's an obvious place where you
want to measure but you don't want to

put your device there because you
can cause serious serious effects.

So the next best place is
the right ventricle and doctors

can correlate very well the pressure
from the right side to the left side.

So it's equally good spot
to place a device and

that's why a lot of pacemaker leads and
so forth are put here.

If you generate clots or things start to
attach to your sensor and then come off or

if the device itself happens
to dislodge the first place.

Everything is going to
go is now in your lungs.

If you get a clot in your long it's
probably not as serious as if you

get a clot up into your brain also
pacemaker leads are attached they got no

where to go for our device because it's a
permanent implant it has no wires it has.

Nothing other than its own mechanical
fixation to wherever you're implanting it.

You need to be cognizant of some of
the failure modes that can happen during

the planning is the vice and when we were
doing product development we said well

one of the things that could happen is if
your attachment mechanism fails the first

place your sensors are going
to go is into your long.

And then we started considering Well why
can't you just measure pressure there and

is it equally useful to the patients and
so that's how we ended up.

Developing a product that implants
essentially no long as it's in your

pulmonary artery it's down a second or
third branch of the pulmonary artery.

So what you say will be
a little air bubble all the way

down there plenty artery.

You can sort of guide wire and
guide wires exactly where.

That sounds like it just
helps guide other devices.

So you can see there's
a guide wire right here.

Now you're able to insert because
the most pressure sensor.

It's a pretty basic delivery system
when I mean basic is we try to

keep everything as simple as possible
when you're designing medical devices.

Doctors are accustomed to certain
tendencies are accustomed to

certain technologies and
they expect a certain feel for things and

one of the things that you want to be from
a marketing perspective is not disrupt

what they're accustomed to being able to
do in a procedure or lengthen the time

of a procedure or make them have to
learn external extraneous amounts of

steps to be able to use your product
because they'll just stop using it.

So from a delivery system point of view
the sensor which is not easily see yet

but it's basically attached to a catheter
catheter has a couple of lumens

in which to have the wires are used.

Tell the wires basically secure the sensor
to the catheter until you're ready to

deliver it.

So to deliver the sensor
it's actually pretty simple.

You just pull some wires from
the back of the catheter and this.

Basically extracts those to have
a buyers that are holding your sensor.

Now the sensor is free from the catheter
at this point blood flow is going to

push the sensor slightly down into one of
the bifurcations of the pulmonary artery.

And it's guts and

anchoring mechanisms that prevent
it from going downstream too far.

One of the things you want to do
is you want to prevent the sensor

from going too far down a branch because
then you can block blood flow but

at the same time you
want to be high enough so

you can measure the pressures
that you're trying to monitor.

Once that's not on you able
to extract the catheter and

now at any given time the patient can
take readings from the hospital or home.

So for heart failure
the the idea is we want to give.

Continual monitoring of
real time pressure for

the patient so the patient actually
gets to take home a chronic system.

It's a small box about
a foot by half a foot and

this can sit in their nightstand and they
can monitor their pressure they can lay

down or
sit up system that contains our intent.

And that's able to wirelessly communicate
with the sensor This information is then

monitored by this box and then transmitted
via wireless connection or internet.

To a central database that cardigans
houses all the patient information and

the doctors are now able to access
that through the Internet so

that gives them a very significant
tool to be able to monitor to manage

these patients this particular product
is currently in the clinical trials and

so you know we're probably about
halfway through a clinical trials we

hope to commercialize this product
in two thousand and nine and

be able to provide better care and
management of these patients.

So obviously there's a lot of different
system components that come into play and

developing this technology.

The obvious one is the implant itself and
there's a lot of years of research that

went into developing this type of
technology but there's other areas.

So when you're thinking about relating
that to research that you do here as well

as myself I experience the same thing you
spend a lot of time researching in an area

and really understanding what are the
potentials of what you're researching but

in order to in order to be able to
bring that into a product or be able

to market this product there's a lot of
different things that have to happen and

you've probably heard a lot of discussions
that relate to developing a system.

And developing the device for

their being able to understand its
reliability its manufacture ability.

And it's reproducibility So
from a system standpoint there's a lot of

other development that has to happen
beyond just doing the research the pure

research of how the sensor operates how
to improve this design and so forth.

There's an entire telemetry
system that could be developed.

There was an implant there's a catheter
system that had to be developed for

this device to be implanted there was
a procedure in the medical field that

had to be understood and then developed
to be able to implant the device.

There's a whole information technology
that had also be developed to be able

to manage that information and transmit
it efficiently back to the doctors.

So the next part of my talk
here is kind of going to go

into an example of the first
product a card was developed.

And discuss a little bit about the
progression and the different things and

activities that had to occur to be able to
go from a research project that myself or

a previous student was doing
here at Georgia Tech and

transition it over to the product or
medical field.

So the concept itself for

a lot of this pressure sensors is not
new it's been around for a long time.

In fact most ideas today are now it's
hard to come would come up with new

ideas today a lot of ideas existed way
before we were here and our job is to

figure out what are better ways in
which we can implement these ideas.

So back in one thousand
nine hundred sixty seven.

Collins published a journal paper for

implantable Sesar sensors for
physiological parameter measurements and

these are very small handmade passive L.C.
resonant circuits

that he was implanting into the eye of
rabbits to measure ocular pressure and

so he was able to demonstrate early on
the capabilities of this technology.

It took a long time between this

technology which he was doing he was
winding these quotas by hand and

mounting them on the whole American
membranes to create these devices.

It took quite a while for.

There's technology to go to reach
the men side and man stands for

micro mechanical systems where they
started looking at using silicon membranes

and solder about quotas to develop
wireless pressure sensors and over

several years from the one thousand nine
hundred to the one nine hundred ninety S.

that technology was developed in total.

Dr Allen and his group started developing
some of these devices for high temperature

applications in which they were looking
not just that the concept itself but how

do you reliably make a passive resonant
circuit operate in harsh environments.

You know turbine engines are operating
at very high temperatures and

there's not a lot of things you can put
in there so that really limits your

design space into what kind of circuitry
you can put in your device and

what kind of materials you can use.

And they came about with a concept

that leverage to sort of make packaging
technology which obviously it's

ceramic it can withstand
certain temperatures and

this concept to be able to design a sensor
and so some of the key parameters and

that some of the key aspects as to why
that seven Tahj is are the device ends

up being self packaged You know many of
you might be developing their circuits or

memes components silicon I C's or
other substrates and there's

usually not a lot of concern for what
the packaging needs to be of these devices

mostly you're focused on the operational
performance how can I improve it.

Or maybe the process in
developing these components but

when you want to take a component to
market it when you want to try to sell it.

You've got to try to package it and so
you've probably heard a lot of energy talk

about well you've got to develop packaging
and packaging is very important and

this concept the critical thing
is that the device is built

on its packaging substrate.

So a lot of those are joined together
a lot of the difficulties that come with

taking a device and
finding a suitable package for it

are eliminated by being able to just build
it on your actual package material itself.

So from the initial conception.

There's a lot of work that has to be done
some of that work was done here detect and

you look at understanding the fundamental
principles of the device operation so

there's electromagnetic
effects of the device.

You've got a passive L.C.

resonant circuit operating now
within its packaging substrate.

And this is now immersed
in a loss the media.

So there are some electromagnetic effects
that are happening to this device which

are going to alter or
change the behavior of your device.

And for a product to really exist.

You can have drift and you can have
a lot of these side effects that happen

that most of the time you're not that
interested in as far as doing research

you care more about understanding
the fundamental physics of the device.

How does that impact a product.

There's obviously some mechanical or

modeling that has to be done of the device
you can develop an analytical definition

and then you can create circuits
to try to model all this.

This is a lot of the fundamental
research that was done here at

Georgia Tech to be able to understand.

Conceptually how these devices perform.

Then comes fabrication and
fabrication technology so.

You know in one thousand nine hundred
sixty seven the concept of these wireless

sensors was being conceived.

But at the time they didn't
have the telemetry they don't

have the computer processing
power that we have today and

they obviously didn't have the fabrication
technology that we have today.

So another important aspect of being
able to develop this technology was

the availability of new fabrication
technology and most of you're familiar

with men and microfiber cation
which is a product of the I.C.

industry being able to use batch
fabrication and a lot of semiconductor

processing to create small mechanical and
electrical devices that

really a lot us to miniaturize
the devices that we're trying to implant.

So the last aspect of the design

that I want to discuss which
was important in being able to.

Transfer this research into a product
were some of the advantages in the design

when you're talking about implanting
sensors either in turbine engines or

in a human body.

Both are equally harsh environments.

You know turbine engines get very hot and

it's very difficult to create
devices to operate in there.

The human body is no less
forgiving you have a chemistry.

That's operating in there
you have to be compatible.

Obviously you can't do any
harm to the patient either so

that really limits the space
in which you can operate and

what the Founding Fathers thought was
an advantage in this technology was.

The sensor itself is primarily very simple
you have an L.C. resonant circuit so

you have you don't need a lot of materials
you don't need a power supply or

batteries you don't need active
circuitry to be able to design and

fabricate this device and that's very
important because it gives you a lot of

stability in the design
as far as performance.

You know one of the things that we care
to minimize is the drift rate of these

devices.

Obviously all transducers drift and
it's how much can you limit that drift to

the transducer so for applications where
you're looking at implanting in the body.

You're not going to have access to be
able to keep calibrating your transistor

over and over and

over again it will you really have to
design a lot of stability into the device.

So with the concept of
the pressure transistor being so

simple it allows you to really build in a
lot of stability and a lot of reliability.

So passive really means that you don't
have batteries you don't have I.C.

circuits you don't have
a lot of complexity.

Well it buys you a lot of features.

It also generates a lot of complexity
of things that could go wrong.

So for an implant that's going to last for
the rest of your life.

The last thing you want to do
is to have malfunctions or or

poor operation of your device.

Like I demonstrated before men's
fabrication really gave us

a lot of options in terms of
what we could fabricate and

how much we could miniaturize the device.

And then wireless is obvious.

To be useful in the medical field and for

it to be used as a diagnostic tool it
needs to be wireless so that we use it.

Telemetry system and
the majority the complexity as far as how

the wireless system works
is contained in the box.

It's outside the body.

And that's great because from a technology
point of view you can keep upgrading this

as much as you want to you can replace it.

It can break.

You can develop new models.

While the implant itself fundamentally
hasn't changed and it has

a high reliability and life lifetime for
that for the patient which is critical.

So to develop from research a product.

There's a couple of things that
had to happen for Cardenas for

the very first product.

Obviously that was the concept and
in literature.

You can go back to the one
nine hundred fifty S.

or one thousand nine hundred six to find
examples of this type of technology but

like I said before they had
limited fabrication and

they had limitations in their telemetry.

So then there's a scientific research and
if you look at the first product.

We had elaborate sensually two Ph D.

graduate work that was done here at
Georgia Tech intellectual property here to

take that amount about more than ten
years of work that was done here

at Tech looking at the sensor technology
in developing that technology.

Once you have some of this you can go into
what I call initial product development

and I call it Initial because this
technology didn't exist in the market

space there was no passive
wireless medical telemetry systems

out in the market space so not only
did we have to develop the product but

we also had a car about that technology
and introduce it into the marketplace.

So in the initial product development.

You're doing very
fundamental definitions of.

For example frequencies of operation we
had a carve out a space in the F.C.C. and

say well this in the F.C.C. This is what
our medical industry is going to operate.

You know in the thirty or so make a range.

We had to develop specs for
the sensor the.

A lemon tree and a catheter so
that they would all work together.

None of this existed at the time so that
that had to occur over a period of time.

And then you could actually move into

general product development where
you have very specific needs and

very specific targets that you're trying
to meet you can develop the product itself

and that translates to really into a lot
of bench testing and process development

because you want to sell a product even
understand it's manufacturability you need

to understand its processes and you need
to be able to reproduce the results that

you've demonstrated doing research and
it's all initial conception of the device.

And then comes the rest of the burden
that's applied to a medical device company

which is proving safety and
then achieving approval.

So if we were producing cell phones.

We could stop here and
launch our product but

since we're trying to operate in the
medical space there's a lot more work that

has to be done to be able to
commercialize a product and

that involves product safety that
could be bio compatibility M.R.I.

safety you know a lot of these
patients need to have imaging done and

then the last thing you want to do is have
this device be under such huge Mainak

forces that it could tear tissues
apart if it be later so you know now

you can go to malas and they have these
automatic to figure later so if something

happens they might use one of those on you
you don't want your device to impact that.

As well as you don't want those types of
systems to impact your device either.

As a yard that specific absorption rate

that's basically avoiding
microwaving your tissue.

So we have to ensure that
because our system operates

in a frequency band that we're not.

Radiating R.F. energy that's going to
damage any kind of tissue in your body

then you have animal implants
where you try to leverage

safety concerns such as safety concerns
localized to the implant itself

you look at the tissue around
the implant and you look at.

You know are the animals getting feeble.

Are they showing any signs of ever so
facts and

then finally you're able to
go into clinical trials and

this might start outside the United States
and then transition in the United States.

So it's a long period of time.

Between just developing
the concept in the device and

then being able to market
it into the product.

So once you've finally achieved F.D.A.

approval now you can
commercialize your product.

So I'm going to go quickly through
an example of our first product and

that was for a democratic aneurisms
the problem itself is that the aorta which

is right in front of your spine right
here in front of your your belly button.

There's a disease in which this
vessel weakens and it balloons out.

So the treatment.

You have two options for treatment.

One is surgical in which they
implant the graft the other one

is noninvasive in which they
implant a stent graph and

this is done through a catheter in
which now you have a new lining.

And the purpose of this
treatment is to block any

blood flow into your aneurism
to minimize its expansion.

So obviously.

Carvins was interested in this kind of
treatment because it's minimally invasive

that expands a number of patient
population that you can treat And

so once you have your sensor implanted
next to this think graph you

can monitor this aneurism over
the life span of the patient.

So our goal was to be able to be a
diagnostic tool for an existing treatment.

Some of the problems
with this treatment and

so what was the need for quality
members to create this diagnostic tool.

Well this is a preferred
method of treatment because

the doctor can surgically implant this
graph the problem is the surgery itself

a lot of these patients are elderly
they have other complications and so

this is a very traumatic surgery for
the patient.

This is a lot less traumatic and so

there's a lot more patients that
can receive this treatment but

it's not perfect it has a other problem
such as leaks there in the graft itself or

other vessel was feeding the aneurism So
there's a lot potential there's a.

A lot of potential for this and
years in the keep growing.

And that really drove the F.D.A.

to find new technologies to be
able to monitor these patients.

So I created a very simple matrix here and
it's not a complete matrix but

it gives you an overview of what I talked
about before you know you need to be able

to bench test your product for many
different things whether it be performance

performance to its capital
because it needs to be delivered.

There's other things that products need to
be tested for such as ship testing shelf

life testing and need to be
sterilized in order to be sterile so

you've got to validate that whole process
and then the electrical safety aspects

related to that for a medical device
product that's implantable you

also have to look at Bio compatibility and
so there's a lot of predefined tasks that

your product has to undergo to be able
to meet the guidance regulations.

There's a lot of animal studies
that need to be done and

then finally there's a human studies for

this particular device we looked at
the eighty four patient pivotal study.

And we had twelve sites and multiple
countries and up to date we've had up to

four years of follow up since
the first implant that we've ever had.

So we generated kind of a very
basic timeline of what it took for

us to go from an idea that Dr Yadav and

Dr Alan were conceding to the point where
you launched a product and there's.

There's this initial part what I call
initial take now technology development

where you're carving out that space for
an entirely new product or

a new device that doesn't exist yet in the
marketplace and so there's a lot of work

that's going on in either developing the
sense or developing the delivery system.

Understanding the medical device
aspects of the product and

then we do the product development
where you do some of the trials and

then finally you can launch a product and
I've listed here

launch of a second generation probably
because I want to show how the cycle time.

Quick.
Improves once you've done all of this

legwork and you kind of defining
the foundation for a new industry.

Once you do that you're able to quickly
leverage on everything you've done in

the past to be able to generate a new and
improved product or products for

other spaces so

in the beginning I showed a slide that had
various many different pressure sensing

applications now we can leverage this
to be able to develop that technology.

So here's a summary of the product
development as I mentioned before you know

the initial research was started
back in the late sixty's and

then it continued at various different
institutions including Georgia Tech.

Then it went on to new technology
development where we had to introduce and

develop the technology for
a new market space.

And then we went into product development
and I want to emphasize that for

product development.

Obviously you have to have a prototype
you have to have the device and

the concept figured out.

But that doesn't end the work and
usually that's where you and

most of your research projects is
once you've achieved the conceptual

the prototype and the functionality of
the device once you've characterized it

whether it be a process or
a device itself.

That's normally where you end up for a
product development you must continue and

you have to do design optimization process
development manufacturability becomes

important because there's been
a lot of very creative and

neat designs for
members devices out in the world but

one of the major flaws they have is that
they are very difficult to manufacture or

they're such complex devices that it would
be very difficult or it's a barrier to

get those to market so designed for
manufacturability becomes very important

when you're thinking of research projects
that you would like to commercialize later

on I mentioned there's product safety and
performance that has to be understood.

And then finally able to
commercialize your product.

So I concludes my presentation for today.

I'd like to thank all of you.

And I like to think Dr David got paid for

inviting me to speak at
a seminar Thank you.

I think in the medical industry what
happens is that some of the bigger

companies and up consuming a lot of
the smaller companies for Carty memes.

They their strategy is twofold one
they do all their development so

they hire all the engineers you know for
the medical aspects for the electrical

engineering on the telemetry side and
for the engineering on the sensor side.

You know we probably twenty or
thirty engineers all in each space

working to develop the technology
they want their standard technology.

So we don't farm out the design then
another struck the strategic point

the company did was they wanted to hire
their own direct sales and marketing team.

And that was to be able to
precisely control the marketing and

distribution of the product.

So I wouldn't say it's common but

for our industry it seemed like a very
good strategic strategy strategy to be

able to market on product and get our own
direct sales force as well as design.

Well the only thing that we do from
out is that the manufacturing of it.

Once we develop the process sees We don't
manufacture it ourselves we contract

manufacture most of
the manufacturing steps and

that is that's I think a common
trend nowadays is to outsource

foundry work such as men's devices at the
foundry just because of the capital that's

required to create a clean room and
so forth.

It

was all private funding.

Say about half and
half between venture capitalists and

then private companies and their research
in developing sections of the private

companies interested in our technology and
want to know to fund our work so I

think there's been very limited government
funding most of has been private funding.

But one last point on
that it was important.

I didn't mention it.

But both Dr J. as well as Dr Allen.

Were previously experienced in start
up companies Dr De out of created and

your guard which was sold to Johnson and
Johnson and

Dr Mark Allen had radio on
which was a micro media company

that was acquired by buyout so
both of them having experience and

generating started companies was was
critical in the initial stages of being

able to raise capital and grow
the company to what it's become today.

This was how we test our sensors.

There's lots of different
testing that we have to do.

There's there's a testing for design
validation and we have a new concept and

then there's testing for
the product itself.

Each device is basically
measuring calibrated uniquely so

use the price as a calibration curve for
that transducer that is generated.

And each patient then gets that
information to be able to monitor their

sensor that translates
frequency response to pressure.

Well the testing is all done as part

of the manufacturing process as far as
performance testing so functional testing.

You know frequency to pressure
performance and so forth.

There's a lot of in process testing that's
done to ensure quality of the product

as well as unsure functional aspects

of the product as well as the final
callup what we call the calibration.

Code of the product which specifies for
that specific transducer

what its response is going to be
once you implanted in the patient.

There's a very minimal amount of testing
that's done or what I call testing.

There's a calibration is done
to set the mean pressure.

But as far as the sensitivity
the device that that's not affected so

that's all measured ahead of time
during the manufacturing process

is the answer your question.

Yeah there's a lot of different aspects
that we had to consider in the design.

As far as you know what's going to
impact the performance of our device and

I just mentioned a few but there's because
it's an R.F. system and it's got parasitic

inductance and parasitic capacitance
that could be coming from anywhere.

We have to shield the device electrically
shield it from that environment so

you know blood insane Lino very
last the media that can really

increase the amount of losses in your
train your L.C. resonant circuit and

the main drawback to that is that you
won't have sufficient energy being

transmitted absorbed by the sensor because
of data losses that are surrounding it.

So that's one aspect of it then
there's a little growth over

the device for our particular device.

I didn't mention this before but
it's actually silicone coated and

that's silicone not silicon and

that's a polymer where a lot of these
tissues really don't want to stick to.

So there's not a lot of what we've noticed
with all our devices from the very

beginning is that there's not a lot of
growth that wants to stick to there's

not no clots or anything forming on them
and then lastly what you look at is.

So it's a pressure transducer if you
do have growth or tissue that come.

As to your form of the membrane you want
to make that very rigid very stiff and

relative comparison to what could grow
on your sensor so I remember things

are mechanically very stiff we only
deflect in the matter of micron or

sub Micron ranges because it's so stiff.

So are some of the gaps that we
generate between these capacitors or

under a micron for
some of our devices just to make it so

stiff that anything that could grow on it
would not alter its performance in that

sense this question Did
you have a question.

So the first question was how do we make
it so that there's no adverse effects

to the implant itself first step is to
just choosing the right material so

that there's a list of materials that have
been known to be biocompatible already and

so obviously you want to choose from that
list and then you make sure that any

combination of those materials don't have
an adverse effect on the patient as well.

So you go through a lot of
bio compatibility studies and

animal studies to look
at tissue reaction or

extraction studies where you're looking
at you know what's coming off as your

particular it is their bio burden it's
attached to my devices in manufacturing.

But the first step is obviously
choosing the right materials and for

our devices they're made a few
silica pure glass basically and

you know glass is a very by compatible or
very stable materials and

as I mentioned before the device is
many factures into the package itself so

the glass that is the sensor is
the package and it's also the mechanical

structure that's pressure sensitive
it's all united in integrated and one.

Then it's coated with silica.

That's a very common implantable material.

And so that's how we ensure that
it doesn't affect the patient.

As far as chloride arteries I'm not
really sure what your question is

you mean would the device cause clots or
if the arteries already collided.

Yeah I guess if I understand the question
correctly for the abdominal Eric any

reason for example which is it can
be a sack as large as my fist.

So I can grow very large when they
put in a stink Raphe the stink

graph itself is basically new piping for

blood flow to happen so
once you get you a clue where you Xclusive

this any reason from blood flow things
start to cry relate things start to get.

Not solid but not blood either it's kind
of this in-between state and so the sensor

that we implant there happens to be
a clot in blood and other body fluids.

But because it relies on hydrostatic
pressure it doesn't really matter that

there's soft tissue or these other
things all intimately the hydrostatic

pressure surrounding it is going
to make that membrane deformed.

So it shouldn't really affected.