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 Robert
Thatcher
Chief Executive Officer
4C Medical Technologies
Interview conducted by:
Lynn Fosse, Senior Editor CEOCFO Magazine, Published – July 31, 2017
CEOCFO: Mr. Thatcher, what is 4C Medical?
Mr. Thatcher:
4C Medical is an early stage medical device company focused on
therapies for structural heart disease and, specifically, the treatment
of mitral regurgitation today and tricuspid regurgitation in the future.
CEOCFO: What is problem with mitral
regurgitation?
Mr. Thatcher:
In the United States alone, there are about 3.5 million people in
any given year that suffer from moderate to severe mitral regurgitation
(MR). MR occurs when the mitral valve, located between the left
ventricle and the left atrium, does not close properly and allows blood
in the left ventricle to leak back into the left atrium. Over time, MR
creates clinical issues such as arrhythmias, pulmonary hypertension, and
heart failure. When patients get to the severe stage of mitral
regurgitation and they are over 75 years of age, about 50% of those
patients die within two years.
CEOCFO: Is it easily identifiable by
doctors?
Mr. Thatcher:
It is easily identifiable, but unfortunately, it is not easily
fixed. About half of those 3.5 million patients with moderate to severe
MR are not surgical candidates. Because they are so sick, they may not
survive the traumatic open-heart surgery required today to replace or
repair the mitral valve. They are on medical management until they pass
away, so it is not a good option. If you could fix the valve in a less
invasive procedure, then you could prolong the patient’s life and
improve their health status.
CEOCFO: What have you figured out at 4C
Medical Technologies to make a difference?
Mr. Thatcher:
We have a really new and novel design. There are other companies at
the same stage that we are in. All of those companies have devices that
reside in the native mitral annulus and then protrude down into the left
ventricle. When you do that, you create significant clinical and
technical issues. First of all, unlike other valves, the mitral valve is
very uniquely shaped with asymmetrical annulus and irregular-shaped
leaflets, so trying to size the valve to fit that native annulus is
problematic. Secondly, when you go down into the ventricle, you create
other clinical problems like obstruction of the left ventricular outflow
tract, the path where the blood goes from the ventricle into the aorta.
If you close that path and prevent blood from entering the aorta, it is
not a good thing. It can also damage the chordae tendineae, the little
parachute string-like structures that hold the native mitral valve
leaflets to the papillary muscles in the ventricle. When you destroy the
chordae, the ventricle begins to negatively remodel and patients go into
heart failure at a faster rate. What we do that is completely different
from what anybody else is doing is we reside 100% in the left atrium
above the native annulus and therefore have no interference in the
ventricle. Moreover, we are not relying on a perfect fit in the mitral
annulus. We literally, by design,
eliminate these
known issues
that others
are facing
today.
CEOCFO:
Why did you look to put it there and why have others not done
so?
Mr. Thatcher:
I always tell people it is like wheels on luggage; until someone came up
with the idea it was not obvious. It was obvious in retrospect but not
obvious prospectively. For hundreds of years we did not have wheels on
luggage.
CEOCFO:
How does it work?
Mr. Thatcher:
It is basically a Nitinol stent-like structure shaped in the form of a
ball. Nitinol is a unique shape memory alloy and it can be delivered in a
very collapsed position and once it is deployed, it remembers its shape and
springs back up into the ball shape. In the middle of the ball is a short
little chimney where the artificial heart valve is placed. Our valve is
placed above the native valve that is still working to some degree, and
prevents the MR.
CEOCFO:
What have you done so far to prove it works?
Mr. Thatcher:
We are use the porcine model as our animal model. The most recent device
design was tested in chronic thirty-day animals. They survived to thirty
days and have really good hemodynamic functions, meaning we prevent the MR.
There was not paravalvular leakage around our technology. There was not
thrombus or blood clots and there was no obstruction of the pulmonary veins.
We documented at sacrifice that we have endothelialization of the stent
frame, meaning the native heart tissue is growing over the stent frame and
incorporating it into the heart muscle. We are two quarters ahead at this
time. We were not expecting to have two successful chronic animals until the
end of this calendar year. We are very pleased with the results that we have
had to date and are in the process of setting up our first formal meetings
with the FDA to plan out our first-in-human, early feasibility study in the
United States.
CEOCFO:
When you have spoken with people in the medical
community, what has been the response?
Mr. Thatcher:
The response has been delight, shock, and surprise that this design
eliminates all the known clinical and technical issues that others are
facing today. Most of the other companies are doing what they call a
transapical delivery. This is a minor surgery, starting with a thoracotomy
and sticking the device through the apex of the heart and then implanting
it, which is very traumatic to these patients who are already sick. Our
technology will be able to be delivered transseptally. It will be delivered
through a groin stick in the low pressure venous side, up into the inferior
vena cava and across the septum of the heart. It will be a simple delivery
procedure, likened to the coronary stent implants that we have
today.
CEOCFO:
With so many recalls of devices, how do you
insure as you go forward, it is going to stand the test of time? Are there
extra steps you see needing to take as you continue?
Mr. Thatcher:
The FDA has a pretty rigorous requirement in terms of testing so that
you know the stent frame is not going to fracture, you know the valve is
going to work, and those test conditions are conducted at the upper end of
what you would see in the human model. Once you are at the point where you
are doing your human clinical trials and eventually commercializing the
technology, there are significant quality systems that are also part of the
FDA requirements that have a lot of checks and balances in place to make
sure that the product is not only performing well but it gives you the
chance to improve the design at time of approval.
CEOCFO:
Are you seeking funding, investment or
partnerships?
Mr. Thatcher:
Right now, we are finishing our A Round of financing, and that will be
up to eight million dollars in financing. That should be closed out by July
this year. As we speak, we are starting our process on the B Round of
financing, which will be about fifteen million dollars and targeted to close
around the first quarter of 2018. That will give us the financing that we
need to initiate the early feasibility study in the U.S.
CEOCFO:
What do you know from past experience about the
process about the industry?
Mr. Thatcher:
I have been in the medical device industry since 1981, so I know quite a
bit about the history of innovation and the changes not just in technology
but also in the regulatory agencies and the reimbursement agencies. I know
that innovation comes through early stage companies like 4C Medical. There
are very few examples of big, strategic medical device companies innovating.
Most of their growth is through acquisitions, so small startup companies
like 4C Medical are critical to innovation in the U.S. and the rest of the
world.
CEOCFO:
What have you learned not to do when bringing a
product to market or getting funding?
Mr. Thatcher:
I think the number one thing to do from a funding side is to talk to
everybody. Sometimes you have people with preconceived notions that a
certain group of investors may not be the right fit. You have to talk with
everybody because you do not know what has changed in their models. Then in
terms of bringing products to market, understand that there will be speed
bumps that you hit and that you have to be flexible and able to adjust when
those things happen. Knock on wood, we have had very few speed bumps so far,
but the one thing that we know for sure is there will be speed bumps and
then you just address those and move forward.
CEOCFO: You mentioned another potential product or use. Could you tell us
more about where else you can go?
Mr. Thatcher: Mitral
regurgitation has a significant prevalence in the United States alone.
Tricuspid regurgitation occurs at about half of the rate of MR. The
tricuspid valve resides between the right ventricle and right atrium. Our
technology is, with a few geometry changes, also suited for that
application. Focus, focus, focus, so first thing’s first which is getting
our mitral valve technology into clinic trials before we start working on
the tricuspid regurgitation application.
CEOCFO: Why pay attention to
4C Medical Technologies now?
Mr. Thatcher:
In the history of medicine, there have been very few true disruptive
technologies. What we see right now in the MR space is people taking what
they have learned in transcatheter aortic valve replacement and trying to
transfer that to mitral regurgitation in the mitral valve. This approach is
fraught with major clinical and technical issues. What we are doing is
completely different and wildly disruptive. It will allow treatment of a
broader patient population, leading to quicker enrollment in our early
feasibility clinical study. There are a lot of patients that are very sick
and dying. At the end of the day, that is what we are here to fix, the MR
disease state and to give patients the highest quality of life for the
remainder of their life.
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“There are a lot of patients that are very sick and dying. At the end of the
day, that is what we are here to fix, the MR disease state and to give
patients the highest quality of life for the remainder of their life.”-
Robert Thatcher
4C Medical Technologies
Contact:
Robert
Thatcher (612) 600-8951
rthatcher@4CMed.com
4C Medical Technologies
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Mitral Regurgitation Treatment, 4C Medical
Technologies, Transcatheter MR Replacement Technologies, Heart Disease
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(MR) that Eliminates Placement and Fixation Problems associated with
Conventional Transcatheter MR Replacement Technologies, CEO Interviews 2017,
Medical Device Companies, Treatments for Mitral Regurgitation, MR, Mitral
Regurgitation management, causes of arrhythmias, pulmonary hypertension, and
heart failure, mitral valve, Nitinol stent, minimally invasive therapies for
structural heart disease, Transcatheter Valve Therapies, supra-annular,
atrial-only fixation technology, supra-annular implant, Treatments for Heart
Disease, 4C Medical Technologies Press Releases, News |
