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ceocfointerviews.com
March 21, 2016
The Most Powerful Name in Corporate News
New Multifunction Applanation Device Which Can Be Used
as a Risk Assessment Tool in the Management of Glaucoma and
Vascular Disorders
CEOCFO:
Dr Falck, what is the basic concept at Falck Medical?
Dr Falck:
To
develop innovative and disruptive technologies that fulfill
particular needs in the medical care marketplace. We are
currently working in eye care, where we are introducing the
Falck Medical Multifunction Tonometer, the FAT1 device. The FAT1
device was recently cleared by the Food and Drug Administration
for multiple indications. These indications allow the device to
be used for the management of a wide range of eye related
conditions which include glaucoma, diabetes, macular
degeneration and vascular disorders. The technology also has
applications for primary care practitioners and we are
developing a device for that market as well.
CEOCFO:
It is a pretty wide category in both areas. How do you vet a
technology? How do you know when what you are looking at really
has the potential to work?
Dr Falck:
That is a
good question. It is all based upon determining need, examining
what technologies exist, and then discovering what the
inadequacies of those technologies are. The goal is develop
technologies that improve on the standard of care and add
revenue to the bottom line.
CEOCFO:
Are you able to look at what people might be working on as
well? Is it possible to include that in the vetting process?
Dr Falck:
It is
somewhat. You can look at patents. You can look at provisional
applications that have been filed. You can participate in
research meetings and see what papers are being presented. The
way that I approach a given technology is to determine how it
was developed, what was the scientific basis of it, what were
the identified inadequacies of it or the inadequacies that users
in the marketplace have identified. When we develop a product
that represents a significant technological advance, we file the
IP, and protect the technology.
CEOCFO:
What are you focusing on today?
Dr Falck:
The Falck
Medical Multi-Function Tonometer (FAT 1) deals with the
inadequacies of the current means of which intraocular pressure
is measured. Intraocular pressure is a risk factor for the
development of glaucoma. There is a valve that exists within the
eye which is called the trabecular meshwork. That valve
regulates the intraocular pressure. All forms of glaucoma except
one are due to dysfunction of the trabecular meshwork. The FAT1
device can perform an in-office procedure called Tonography to
assess the function of the trabecular meshwork. That data can be
used to assess risk and also be used to prescribe and manage
therapy. For example, you can prescribe a therapy or perform a
surgical procedure and use the device to assess treatment
response.
CEOCFO:
When you are at the ophthalmologist and they say they are
testing for glaucoma, what are they measuring?
Dr Falck:
They are
measuring the intraocular pressure (IOP). However that is not
enough. It is known and established that intraocular pressure
varies throughout the day. Multiple studies have demonstrated
that in those eyes with glaucoma that are not currently being
treated, the IOP was in the normal range at the time it was
measured. The trabecular meshwork is where the problem exists;
therefore it is important to have a device that can assess the
function of the trabecular meshwork. There is another issue that
must be discussed. Intraocular pressure varies with the cardiac
cycle; it is higher during systole and lower when the heart is
at rest during diastole. All current devices that are used to
measure IOP do not account for this variation. So they are not
providing accurate and complete data. The FAT1 device measures,
records and displays the variation in IOP that occurs with the
cardiac cycle.
CEOCFO:
How are you actually doing the measurement? What is the
device able to read and how?
Dr Falck:
The
device is measuring the outflow of the clear fluid called
aqueous humor through the trabecular meshwork. In eyes with
glaucoma outflow is impaired, or decreased which results in
elevated IOP. The data demonstrating this was compiled during
the FDA clinical trials.
CEOCFO:
Where are you in the process of commercialization?
Dr Falck:
We have
been cleared by the FDA to go to market. We are currently in the
manufacturing phase and distribution will begin in the second
quarter of 2016. We have identified independent medical device
distributors throughout North America that will be selling the
device in their respective geographic areas.
CEOCFO:
Is the ophthalmology community aware or will you be
introducing something that most ophthalmologists do not know
about at all?
Dr Falck:
Most
ophthalmologists and optometrists have not been exposed to the
technology. It will be a process of education, but once they
understand that the device will improve the quality of care,
prevent transmission of infectious disease and add revenue to
their bottom line they will embrace it. From the FDA clinical
trial research studies and independent research studies done at
Tufts School of Medicine, we have white papers that validate and
demonstrate the clinical utility of the technology. Keep in mind
this is the only single device ever cleared by FDA with these
clinical applications.
CEOCFO:
There is so much on every doctor’s plate, How do you jump out
and get the attention?
Dr Falck:
The eye
care community is technology driven. We like technology that
will give a better handle on preventing and managing eye
disease. When you have a new technology which is disruptive,
innovative, improves the quality of care, prevents transmission
of infectious disease and adds revenue to the bottom line they
will embrace it.
CEOCFO:
How did that happen? Is it because there has been a lot of
innovation in ophthalmology? Is it a mindset of
ophthalmologists?
Dr Falck:
Yes,
there has been a lot of innovation in eye care because sight is
a precious and necessary sense if one is to maintain
independence. If you talk to the average person and you ask them
what sense they find to be the most important they will always
say their sight. People fear going blind. Therefore we must be
driven to develop innovative technologies that allow us to
prevent blindness.
CEOCFO:
Where does cost of the equipment come in? Is there a question
of reimbursement using this test as compared to what is being
done today?
Dr Falck:
The exact
market price has not been set yet. But it will be set at
a price point that every eye care practitioner can afford. We
have been very efficient in producing the technology and have
maintained our targeted cost efficiencies. Some of the tests the
FAT1 device performs will generate revenue, so over time the
device will pay for itself.
CEOCFO:
What else is on the agenda for Falck?
Dr Falck:
The FAT1
device can perform a test called ophthalmodynamometry, which is
an assessment of the pressure in the central retinal artery. The
central retinal artery provides blood flow to the eye and is a
branch of the internal carotid artery. The major cause of stroke
is disease in the internal carotid artery; a narrowing due to
atherosclerosis. Due to normal vascular physiology, a reduction
in central retinal artery pressure can be a sign of disease in
the internal carotid artery. During the clinical trials we were
able to save the life of a young woman who had an undiagnosed
internal carotid artery aneurysm. FMI will be moving into the
primary care marketplace with a device that they will be able to
use.
CEOCFO:
Would you be moving into cardiac arena as well or should
problems be caught earlier at the primary level?
Dr Falck:
Yes, a
portable version is being developed that any primary care
doctor, family practice physician, vascular surgeon, or
cardiologist can use.
CEOCFO:
Does the medical community understand the correlation, but
have just never been means, or do primary care physicians need
direction that this can exist and that the relationship does
exist?
Dr Falck:
There
will be a process of education. The exciting part about this is
that from a public health point of view we need to move towards
preventing the vascular event. For example, right now before
someone will get a vascular workup, they must either have had a
stroke, a mini-stroke called a TIA, significant signs of carotid
artery disease, or temporary blindness called amaurosis where
a piece of cholesterol plaque breaks off the internal carotid
artery, and lodges in the central retinal artery.
CEOCFO:
Are the tests easy for a doctor to do?
Dr Falck:
The
device was designed so that the tests can be done by a nurse, a
medical assistant an ophthalmic assistant, or optometric
assistant.
CEOCFO:
Are you funded for the steps you would like to take? Are you
seeking investments or partnerships?
Dr Falck:
FMI is
self-funded, privately held and at this time has the capital
required to bring the product to market.
CEOCFO:
Would you like to remain self funded?
Dr Falck:
FMI would
entertain collaboration with outside entities that would serve
to benefit and promote the technology.
CEOCFO:
What have you learned throughout the process on the business
side that gives you confidence you can accomplish your goals?
Dr Falck:
The FAT1
device raises the standard care, enhances public safety and adds
revenue. It would be difficult to understand on a rational basis
why a licensed practitioner would decline the use of this
technology.
CEOCFO:
Will you be selling equipment or a device? Are there
disposables that you would be offering with it? What is the
business model?
Dr Falck:
With all
of the current existing tonometer devices that measure
intraocular pressure there is a documented serious risk of
transmission of infectious disease. It is well known that tears
contain infectious prions in those with Mad- Cow disease, the
HIV virus in those with AIDS and the type A, B, or C virus in
those with Hepatitis A, B or C. The problem is it cannot be
determined who is infected, some are carriers who do not
manifest the signs of the disease. The Centers for Disease
Control, the FDA and other independent researchers investigated
and dertermined that the tip of the contact tonometer devices,
which touches the eye cannot be completely sterilized. To
respond to this problem the manufacturers have developed tip
covers. But there use is not required. The devices can still be
used without changing the covers or even using the covers.
Non-contact air puff tonometers are also a potential source of
infectious disease. The air puff aerosolizes the tears which are
now infectious airborne particles, which are inhaled. With the
FAT1 device the contact tip must be changed between each
patient. The device has an internal patented detection system
that allows the device to determine whether a prism has been
used previously. The tonometer tip is a fixed used disposable.
The tip must be changed before the device will allow a
measurement on another individual. It is an absolute barrier and
eliminates the risk of infectious disease transmission from one
individual to another.
CEOCFO:
In addition to being better, is it safer!
Dr Falck:
In
addition to being better it is safer. It is important that the
public be protected against the risk of transmission of
infectious disease.
CEOCFO:
How do you deal with some of the frustration surrounding the
time it takes to get a device to market?
Dr Falck:
Commitment to the vision you have for your product and
persistence are necessary to overcome all the obstacles on the
path to the marketplace.
CEOCFO:
There are so many companies and so many ideas in the health
community. How does Falck Medical offer a meaningful
breakthrough?
Dr Falck:
The FAT1 device raises the standard of care. It eliminates the
risk of disease transmission from one individual to the next, it
measures intraocular pressure throughout the cardiac cycle,
capturing the increase in intraocular pressure that occurs with
systole, it allows the user to assess the function of the
trabecular meshwork, providing a tool that can be used for
glaucoma management and the ophthalmodynamometry function
has potential for vascular status assessment.
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