The DOBI ComfortScanTM System
The DOBI ComfortScanTM System is an advanced digital-imaging
system that uses high-intensity light-emitting diodes and
gentle external pressure to highlight areas of vascular development
common to malignant tumors in the breast. The DOBI technology
is based on detecting tumor angiogenesis, or vascular change,
the process whereby a cancerous growth surrounds itself with
a dense network of tiny blood-filled capillaries. These vascular
"feeding tubes" provide oxygen and nutrients to
active tumors and are unique physiological "markers"
that reveal the presence of cancer.
Angiogenesis is a natural occurrence in the body. In cases
where cancer is involved, the growth of new blood vessels
occurs around, and in support of, a malignant tumor. This
process is vital, since without it, these tumors remain small
and harmless. When a woman discovers a lump within her breast,
it has likely been developing for a number of years, as cancerous
tumors often take many years to become palpable.
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.
If the light encounters an angiogenic (and thus potentially
cancerous) region of the breast, it is absorbed by the higher-than-normal
concentrations of hemoglobin in that area of the breast. It
thus appears on the DOBI image in marked contrast to 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. These unprecedented images provide the physician
with new, physiological information which may be associated
with cancer development.
The initial application of ComfortScanTM is as
an adjunct to mammography and physical exam. The DOBI System
has been designed and tested to show that it provides substantially
higher levels of specificity in detecting benign lesions within
the breast, thus 1) reducing the number of false positives
generated by current techniques; and 2) potentially avoiding
a high number of breast biopsies or other downstream testing.
The DOBI System may have the potential to increase screening
sensitivity when used in conjunction with mammography.
The DOBI System has the potential to provide many improvements
over currently available imaging technologies in the areas
of accuracy, speed, comfort, safety, convenience, ease of
use, and system and scan costs. The Company has 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
time frame to FDA approval is anticipated for an adjunctive
Dynamic Functional Imaging
The DOBI ComfortScanTM System is based upon a platform technology
called Dynamic Functional Imaging. ComfortScanTM is sensitive
to dynamic volumetric changes in blood and changes in deoxyhemoglobin.
Both of these changes are commonly found in malignant tumors.
The System is able to measure these changes by applying a
uniform pressure to the breast. The change in pressure is
believed to trap blood in the tortuous angiogenic structures
that form around the tumor. This trapped blood gets deoxygenated
up to four times faster than normal tissue. The System displays
the effects of the changes in volume and/or changes in deoxyhemoglobin
over time. These changes show up in the images as low light
levels because of greater light absorption. Normal or benign
tissue, which has normal vascular structures and a slower
metabolic rate, does not absorb as much light and thus has
a higher light level than malignant tissue.
Future Uses for the DOBI System
The Company fully expects that, over time, clinical trial
data and market usage will engender confidence in its technology
to the extent that the marketplace will adopt its widespread
use as a diagnostic screening tool for women with an identified
high risk for breast cancer. This use can likely develop significantly
faster in certain foreign countries where current mammographic
techniques are more flexible due to a number of factors including
financial constraints, concern over radiation, and other considerations.
The DOBI ComfortScanTM System can be an exciting resource
for underserved or developing countries since it is transportable,
has no special environmental or power requirements, and uses
no expensive or bulky film cassettes or chemicals. Images
can be stored locally and sent electronically to other locations
for collaborative readings or analysis. Thus, ComfortScanTM
can be transported to non-urban areas and the images gathered
there could be sent electronically and read at remote central
locations if local radiological expertise is limited.
"Seeing" the presence of angiogenesis in the body
opens the door to many potential opportunities for the Company's
technology. The latest research indicates that angiogenesis
is found in many significant disease states, including rheumatoid
arthritis, adult blindness, and others. Thus, future uses
of DOBI technology may be for many other diseases as well
as cancer. Furthermore, therapeutic monitoring is considered
a near-term application of the DOBI Medical technology. The
Company has begun a series of discussions with select pharmaceutical
firms to investigate these opportunities.