DOBI Medical Systems
DOBI Medical Systems, headquartered in Mahwah, NJ,
is a technology-based medical device company that has developed
a unique, accurate, and potentially lifesaving means for the
improved diagnosis of cancer through the detection of vascular
changes associated specifically with malignant tumors.
Our first application of this technology has been to develop
an adjunctive tool to mammography - a key diagnostic imaging
modality widely used to aid in the diagnosis of breast cancer.
While mammography has long been considered an important tool
for breast cancer detection, it has been shown to have numerous
limitations. The process is often painful, it irradiates the
patient, is limited in its ability to identify breast cancer
in its earliest stages, and most importantly, is often unable
to differentiate malignant from benign tumors.
While still the most common tool for detecting breast cancer,
the mammogram also has limited applicability to millions of
women under the age of 40 and women on hormone-replacement
therapy, due to the lack of contrast in x-ray images of dense
breast tissue. The American Cancer Society estimates that
5 to 10 percent of mammography tests are abnormal or inconclusive,
necessitating further testing that can be painful, invasive,
Our Dynamic Optical Breast Imaging (DOBI) System (the
ComfortScanTM System) is a noninvasive, non-ionizing
medical-equipment product designed to assist physicians in
the detection of breast cancer at the earliest stages of development
- earlier than is possible using mammography alone. We are
able achieve this on a cost-effective basis by providing new,
image-based, physiological information never before available.
Our vision for the future is to introduce a new standard
in vascular imaging worldwide. And our immediate goal is to
reduce the incidence of invasive intervention in the breast
cancer diagnostic process. To these ends we are building a
fully integrated medical device company whose focus is the
development and commercialization of a new generation of angiogenesis-based
imaging systems. Such imaging systems are intended to offer
more accurate screening, diagnosis, and monitoring of most
The DOBI System is designed to alert physicians to
the first indication of breast cancer by detecting angiogenesis,
which in turn facilitates the differentiation between benign
and malignant breast tumors. Once we have completed the final
process to gain FDA approval (4 modules of 5 have already
been reviewed and accepted), DOBI Medical Systems can move
ahead to provide a new diagnostic resource for physicians,
service providers and scientists; cost savings to third-party
payers; a positive impact on breast health; and, finally,
improved quality-of-life for women around the world. Ultimately,
we expect clinical trial data and market usage to engender
confidence in our technology to the extent that it will be
adopted worldwide as a breast cancer screening tool.
Frequently Asked Questions (FAQs)
What is a DOBI System and how much does it cost?
The DOBI System is an advanced digital-imaging system
that uses high-intensity light-emitting diodes (LED's), gentle
external pressure, a low-noise charged-coupled device (CCD)
camera, and proprietary image-processing algorithms to highlight
areas of vascular development common to malignant tumors in
the breast. The technology is based on detecting tumor angiogenesis,
the growth of a dense network of tiny blood-filled capillaries
that surround a cancerous tumor. Initially, the Company will
introduce the DOBI System as an adjunct to x-ray mammography.
Pricing is expected to be competitive with analog mammography
systems and ultrasound devices, but it should market at about
a third of the price of the new digital mammography systems.
How does it work?
The DOBI System's high-intensity light-emitting diodes
transmit near-infrared light through the breast, recording
one image per second via a CCD camera for approximately 45
seconds. As the red light encounters the angiogenic (and thus
potentially malignant) region of the breast, it is absorbed
by the higher-than-normal concentrations of hemoglobin in
that area of the breast, in contrast to the normal portions
of the breast. As a result, the DOBI System focuses on dynamic
functional imaging (i.e., what is occurring within the tissue
in near real-time) rather than a singular morphological image
(i.e., a static anatomical snapshot showing physical details
at a single point in time) such as those created by mammography.
What is angiogenesis and why is it important?
Angiogenesis is the growth of new blood vessels in the
body, a type of vascular change. It is an important, natural
process that occurs both in health and disease. Angiogenesis
occurs in the healthy body for healing wounds and for restoring
blood flow. The healthy body controls angiogenesis through
a series of "on" and "off" switches, maintaining
a perfect balance between these angiogenesis modulators. However,
in a diseased state, the body loses control over the angiogenesis
process. Angiogenesis-dependent diseases result when new blood
vessels either grow excessively or insufficiently. Excessive
angiogenesis occurs in the development of cancers. New blood
vessels feed the cancer, allowing a tumor to grow up to 16,000
times in size (sometimes in a matter of weeks). At the same
time, cancer cells escape into the circulation via the blood
vessels and lodge into other organs (via metastasis).
According to the most recent scientific research from the
Angiogenesis Foundation, angiogenesis is associated with virtually
every type of cancer known. Furthermore, angiogenesis is an
underlying indicator in more than 70 conditions, including
cardiac disease, arthritis, AIDS, ophthalmic and skin diseases,
as well as other solid tumors. Angiogenesis can also impact
surgical incisions, trauma-related injuries, and ulcers that
rely on the angiogenic process for healing. The Angiogenesis
Foundation estimates that more than 500 million cases of angiogenesis-based
disease are currently afflicting patients in the western world.
DOBI Medical's technology is built on its ability to accurately
identify angiogenesis non-invasively - thus providing a new
tool to assist physicians in the detection of virtually all
cancers, including breast cancer.
How is this helpful in diagnosing breast cancer?
Research by the U.S. and international scientific communities
has documented the process of angiogenesis as it occurs in
the development of breast cancer. In fact, breast cancer mortality
has been highly correlated to, and has the highest amount
of evidence for, angiogenesis dependency. All solid breast
tumors become clinically relevant once they recruit their
own blood supply. Angiogenesis occurs when cancerous breast
tumors are only one to two millimeters in size. By contrast,
breast cancers that are detected when they are 10 millimeters
in diameter already contain more than one billion cancer cells.
Recent developments in optical imaging technology and image
processing make it possible to identify minute vascular changes
within a growing cancer in the breast when it is still in
its earliest stages. Once detected, the changes constitute
a unique vascular profile that can indicate the presence of
breast cancer before a cancerous lesion is discernible by
most conventional means. A generally accepted principle in
medicine is that earlier detection leads to earlier treatment,
which in turn presents a better prognosis for cure. For a
more detailed discussion, go to the "angiogenesis"
section on this website.
What is going on at DOBI Medical now?
Currently, we are in the process of obtaining FDA approval
for the ComfortScanTM to be used as an adjunctive
testing device supplemental to mammography. We have consciously
selected this initial use for the technology because 1) breast
cancer is the most prevalent type of cancer with the highest
amount of evidence for angiogenesis-dependency; 2) there is
a significant market need; and 3) a shorter, less-expensive
timeframe to FDA approval is anticipated for an adjunctive
However, we intend to use the confidence and market acceptance
gained from this initial application to broaden the DOBI System's
applicability. Although there is no assurance of final FDA
approval, we are developing a next-generation application
for the device as a broad-based screening tool for breast
In addition, we believe that our technology has high potential
in the area of therapy monitoring, allowing physicians and
pharmaceutical companies to monitor the effectiveness of anti-angiogenic
drugs. We also plan to expand testing into other areas where
angiogenesis is an underlying indicator of disease, such as
cardiac disease, arthritis, AIDS, ophthalmic and skin diseases,
as well as other solid tumors.
Where do you stand with the FDA now?
In August 2000, we received FDA review and acceptance
of our five-step Pre-Marketing Application (PMA) submission
plan. The first data module of the plan was submitted and
accepted shortly thereafter, followed by acceptance in 2001
of Modules Two and Three. Module Four was submitted and accepted
in 2002. A clinical test of approximately 1,200 patients will
complete the fifth and final module of the Company's PMA.
What is the goal of the clinical trial?
The successful completion of the trial will enable the Company
to meet its goal of obtaining FDA approval and entering the market
as quickly as possible. The Company continues to work closely with
the FDA and has already begun submitting data regarding the DOBI
Where is the DOBI System being tested?
We have an excellent group of highly regarded medical
institutions that either have been or are testing the DOBI
System including The Hospital San Carlos (Madrid, Spain),
The European Institute of Oncology (Milan, Italy), Gustave
Roussy Institute (Paris, France), the Cancer Institute of
New Jersey, Columbia Presbyterian Hospital in New York City,
and Massachusetts General Hospital in Boston. For more information,
see our "clinical" section on this
Can I get a DOBI Scan?
Currently, the testing program is restricted to those
women who are part of our research program at pre-selected
sites. However, at such time as FDA approval is granted, your
doctor would be able to direct you to an appropriate breast-imaging
center with a DOBI System and tell you whether a DOBI Scan
is right for you.
What sets the DOBI System apart from other techniques?
As in many natural processes, such as vision, multiple
sensors are often combined to produce improved results. By
combining the imaging capabilities of the DOBI System (which
produces images of vascular change or physiological elements
of the breast) with structural or morphological images of
the breast, physicians will have breast cancer diagnostic
information that has never before been so readily available.
A next-generation version of the DOBI System (which would
combine the diagnostic capabilities of ultrasound, x-rays,
or other imaging modalities, with the DOBI System's capabilities)
would offer an advanced process that would considerably improve
the current potential of breast cancer screening and diagnosis.
We expect to see the application of this new diagnostic capability
to other cancers, as well as to many additional diseases of
the human body affected by angiogenesis. Such application
would not only be instrumental in the monitoring of the effectiveness
of treatments for many diseases but also may help to identify
disease at the earliest possible stages by targeting its angiogenic
If the DOBI System is good at differentiating benign from
malignant tumors in the breast, can it be used for other,
Currently, the Company is in the process of obtaining
FDA approval for its first application as an adjunctive testing
device supplemental to mammography. However, DOBI Medical
intends to use the confidence and market acceptance gained
from this initial application to broaden the DOBI System's
applicability. Although there is no assurance of FDA approval,
the Company intends to develop a next-generation application
for the device as a broad-based screening tool for breast
and other types of cancer.
In addition, the Company believes its technology has high
utility in the area of therapy monitoring, allowing physicians
and pharmaceutical companies to monitor the effectiveness
of anti-angiogenic drugs. Furthermore, the Company plans to
expand testing into other areas where angiogenesis is an underlying
indicator of disease, such as cardiac disease, arthritis,
AIDS, ophthalmic and skin diseases as well as other solid
tumors. The Company also believes its technology may have
a potential role in assessing surgical incisions, as well
as trauma-related injuries and ulcers, which rely on the angiogenic
process for healing.
Does the Company have a CE Mark or ISO certification?
The Company received its CE Mark Apr 12, 2000, for the
DOBI System and ISO 9001 certification for the Company in
How can I follow the progress of the Company?
visit us here at igaot.pt. We will regularly update the site
with DOBI Medical Systems news and activities.
Investigational Device: Limited by Federal Law to Investigational Use Only.
Copyright ©2000-2001 DOBI Medical Systems All Rights Reserved.