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International begins marketing ComfortScan system
internationally as an adjunct to mammography -- Enters final stages of U.S. FDA
submission, review and approval
Medical Equipment & Supplies
DOBI Medical International, Inc.
1200 MacArthur Blvd.
Mahwah, NJ 07430
Phillip C. Thomas
President and Chief Executive Officer
Interview conducted by:
Lynn Fosse, Senior Editor
May 19, 2005
Phillip C. Thomas, President and Chief Executive Officer
Phillip C. Thomas co-founded and serves as Chief Executive Officer and board member of
DOBI Medical International, Inc. Mr. Thomas had been the Chief Executive Officer and a
director of DOBI Medical Systems since December 1999. Previously, Mr. Thomas served as the
CEO of Dynamics Imaging, Inc., a corporation from which DOBI Medical acquired its
technology and other non-financial assets. Over the past 25 years, Mr. Thomas has
held a number of public and private high-technology senior executive positions. Mr.
Thomas received his B.A. degree from Brigham Young University and has completed executive
development courses at Harvard Business School and Stanford Business School.
DOBI® (Dynamic Optical Breast Imaging) Medical International was founded to
develop and commercialize innovative imaging technologies to improve the diagnosis of
cancer and other diseases. Currently, the company is developing the
ComfortScan system, a noninvasive, nonionizing device designed to provide unique
diagnostic information to assist physicians in better identifying and diagnosing breast
cancer. In addition, the company has developed the ComfortView reading
software designed to help physicians analyze angiogenesis and assess breast disease. Both
the ComfortScan system and ComfortView software are currently the subject of a U.S.
clinical trial in progress.
Thomas, what was your vision when you started DOBI?
Mr. Thomas: Our original vision came out of the fact
that every hour in the United States, five or six women die of breast cancer, twenty-four
hours a day, seven days a week. That in combination with the fact that mammography, which
is the most common form of breast cancer diagnosis, is about a 40-year-old technology. I
felt we could do better than that and I set out to do that.
has happened over time?
Mr. Thomas: For the last seven years, we have refined
our approach for identifying the key signs that are associated with the presence of
[breast] cancer. This is in the area of the blood supply that has been shown to feed
malignant tumors, which is known as angiogenesis. In theory, angiogenesis is required for
a tumor to grow beyond the size of, say an eraser on the end of a pencil. A tumor this
size will most likely not kill you, especially if it is a breast tumor. But when it
develops a new blood supply and its own capability for sustained growth through
angiogenesis, it becomes more dangerous. In the later stages, tumors such as this can
become life threatening and start to metastasize to other parts of the body.
is the ComfortScan system and how does it detect it?Mr.
Thomas: We know that angiogenesis is new blood vessel development and those
blood vessels have certain characteristics. They are ill formed; they are very interwoven
and chaotic in their structure as well as leaky. Therefore, we take advantage of
this physiological phenomenon along with the scientific knowledge that we have relative to
the metabolic rate of malignant tumors. Malignant tumors have four times the metabolic
rate compared to normal tissue in our bodies. So now, you have a malignant tumor that is
consuming oxygen very quickly; blood vessels that are leaky and very chaotic in their
structure surround it. With our ComfortScan system, we place the breast on a soft
panel with red light and pass the light through the breast, which interacts with the blood
vessels that are angiogenic in nature. We also put a slight amount of pressure on the
breast, which allows us to momentarily reduce the flow of new blood into the angiogenic
area around the tumor and slow the exit of blood from that same area. Therefore, at the
time that the test is done, we are measuring the amount of light passing through the
breast, we are also watching as the tumor is consuming oxygen in the angiogenic area.
This is called the de-oxygenation cycle. As we place external pressure on the
breast while passing light through, the angiogenic area starts to appear in our images.
The ComfortScan system takes 2.5
2 images per second over a 5 45-second time cycle. It
begins scanning as the light passes through the breast, then we apply the pressure, and
then we relieve the pressure. We see changes in light absorption over time that correspond
to subtle changes in breast vasculature in response to the applied pressure. A colorized
image of the breast is displayed in which different colors represent areas of increased or
decreased light absorption. Temporal changes in light absorption associated with the
de-oxygenation cycle have a different appearance than normal tissue. The dynamic images
can reveal the presence of angiogenesis. When you identify angiogenesis, you often
have malignancy. We see a bell curve that would be indicative of the presence of
angiogenesis, and the oxy/de-oxy cycle that is common with malignant tumors. The resulting
image shows the outline of the breast with light passing through normal areas of the
breast with minimal absorption, but like in carrying the angiogenic areas of the breast,
absorption is a darkened area of the breast because those blood vessels are blocking the
light from coming through, and the absence of light is darkness. Now we have a dynamic
image, which means we have a series of images and it is revealing of the presence of
angiogenesis. When you detect angiogenesis, you often have malignancy.
CEOCFOinterviews: Why is
that more effective than mammography?
Mr. Thomas: Mammography is very effective for women
forty and above, for identifying the anatomy changes taking place in the breast when a
tumor is growing inside the breast. We are the physiology part of the equation. With
mammography, you can see anatomical change. The ComfortScan system provides new data
that is physiological, so now you have anatomy and combined with complementary physiology
in a quick, inexpensive test for the first time.
you marketing it as an adjunct because it is easier to gain acceptance that way?
Mr. Thomas: We have had many discussions with the FDA
and their recommendation is that we market it as an adjunct in order to begin the
establishment of the new modality. Their recommendation is to take an incremental approach
where we would be an asset to aid in improving the diagnosis by having mammography
identify possible lesions while our capability would indicate whether there was a
concurrently suspicious area of angiogenesis present. Over time as physicians become more
reliant on this new information, we will be exploring expanded uses for the device as
additions to the FDA approvals that we are currently working toward. Expanded uses are
foreseen with high-risk women who have dense breasts because of age or size of the breast
or perhaps because they have been on hormone replacement therapy. Mammography has a more
difficult time identifying lesions or anatomy from other natural parts of the breasts,
which are sort of camouflaging the presence of the lesion because of the density in the
is your product in use now?
Mr. Thomas: In the fourth quarter last year, we began
limited shipments to a few international locations. We do not have FDA approval at this
time, but we are well underway in a trial supporting our FDA Pre-market Approval
submission. We are working on the final step of the approval process, but until we have
that, we cannot market the system in the United States. We have the CE mark, which means
we can market the ComfortScan system in Europe. In addition, we are an ISO 9000 company
and we have the ability to sell the product overseas in certain specific locations.
CEOCFOinterviews: How is
ComfortScan be received?
Mr. Thomas: The excitement is building overseas. There
have been a number of small studies that have recently been completed and results will be
published on those studies in the near future. People in the medical community are
starting to understand the real world of angiogenesis. They understand also that
ultrasound and mammography cannot take advantage of the angiogenic process in terms of
identifying malignancies. What DOBI Medical has is a new technology that more and more
people are becoming excited about because it is the classic, faster solution that
compliments an existing modality. Therefore, you do not have to throw away the equipment
that you have an investment in, but you have a new tool that aids in providing new data
that has not been very readily available.
is the financial picture of DOBI?
Mr. Thomas: The announcement that we made recently was
the successful completion of a $10.5 million private placement with a number of
institutions that we have been talking to and briefing about the company for several
weeks. We are in our last step in our FDA submission process, so we have earmarked a
significant amount of dollars for 2005, for completing the clinical trial that is required
as the last step in our FDA premarket approval effort. At the same time, additional funds
from this particular raise will go to continue to improve our patent portfolio as well as
continue to build our international presence from a sales and marketing perspective. We
have made the investment in a small manufacturing facility, and the resources that are
needed to build devices for sales, are now in-place, as well as building devices for our
FDA clinical study. Therefore, 2005 will be a year of clinical studies, both here in the United
States and abroad. That will help to build additional shareholder value. The cash from
this financial round will carry us well into the first half of 2006.
mentioned attacking cancer in general; where do you go down the road?
Mr. Thomas: According to the Angiogenesis Foundation in
Cambridge, Massachusetts, over seventy different diseases are related to angiogenic
activity. What the world is starting to understand more completely is the dynamic nature
of our internal vascular system. We see a lot of vascular change as women go through
pregnancy, and when we are wounded, angiogenesis is a factor in wound healing. There are
many different diseases and conditions where angiogenesis is a factor. We see our intended
use expanding as our product design evolves into three key areas. In the context of breast
cancer, we currently see it used as an adjunct to mammography. Secondly, we potentially
see it used as a broad-based imaging tool which physicians could use to monitor women at
high risk for the disease, as we get through further FDA efforts to obtain that particular
approval. Lastly, we see a very big opportunity in the area of therapy monitoring. What I
mean by this is the pharmaceutical industry is spending literally hundreds of millions of
dollars on new drugs designed to attack the blood supply feeding a tumor as a means of
eradicating cancerous tumors of all types, not just in the breast. We initially would see
ourselves as a unique and possibly unparalleled method of tracking the effectiveness of
some of these therapies, but our focus today is in the area of breast cancer.
are the challenges going forward?
Mr. Thomas: We know that whenever anything new comes
into the medical marketplace, it faces a certain degree of skepticism. That is probably a
healthy skepticism in most cases. We have an obligation and responsibility to obtain
strong valid clinical data from reputable sources and to be able to present that data in
reputable conferences and seminars where that information is up for challenge and
examination. We are prepared to do that; we are working with some very good institutions
in the U.S. and abroad to generate strong, medically relevant clinical data that will help
others the medical community feel comfortable about the new technology. There is a bit of
a missionary effort and educational effort involved. We feel comfortable that we are doing
the right things to go forward and provide credible clinical data and clinical results
that will help people understand the advantages and potential of this new
closing, why should potential investors be interested and what should they know that
perhaps they do not realize when they first look at the company?
Mr. Thomas: I think that investors should realize that we
have an extraordinary team of entrepreneurial people with focus and integrity. We
are committed to advancing ComfortScan and working with the FDA to do so. The FDA is
a healthy endeavor in terms of trying to make sure this is a legitimate technology with
medical merit. They put you through a lot, but it is actually for our own benefit as
we get through this because it strengthens our position in the marketplace, and it
provides a core of clinical data to familiarize physicians with use of the ComfortScan
s use. Investors, I would think, would want to pay attention to how well
things are going in the FDA submission approval process and be mindful that even after we
get an FDA approval, which never can be guaranteed, that the market is going to take some
time to be trained and educated about this modality. As we advance through these
milestones, we should see real interest in this new modality because it has the potential
to fundamentally change and positively impact breast and other cancer diagnosis.
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