Imaging
Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS) a pioneer in laser
optical breast imaging systems, announced that Professor Eric Milne, M.D.,
IDSI Director of Clinical Research, has contributed to a comprehensive new
book, "Cancer Imaging: Lung and Breast Carcinomas," edited by Professor
M.A. Hayat.
Professor Milne's chapter, "Breast Dose in Thoracic Computed
Tomography," examines the risks of inducing breast cancer as a result of
the ionizing radiation received during CT exams of the thorax and upper
abdomen. Citing results stemming from his original 1992 study, which
demonstrated that large doses of ionizing radiation, equivalent to the dose
from 15 to 60 mammograms, are absorbed by the female breast as a result of
each chest CT exam, Milne suggests that referring physicians should
carefully weigh the clinical necessity for thoracic scans in female and
pediatric patients and cautions against the use of CT scans as a screening
procedure for lung cancer, coronary artery calcification, or pediatric lung
disease.
"The number of CT scans performed per year, for every 1,000 persons,
has increased enormously in the USA over the last five years," Milne
explains. "We now hold the world record at 172.5 scans for every group of
1,000 people. A conservative estimate of the carcinogenic effects of this
massive irradiation would indicate an increase of 16,000 breast cancers."
Commented Tim Hansen, IDSI President and CEO: "We believe that imaging
the angiogenesis process using lasers not only presents new information to
the diagnostician, but also avoids adding to the patient's cumulative
carcinogenic radiation dose. As Dr. Milne notes, physicians should be aware
of the dose consequences and examine alternatives that are available."
The book, which will be published by Elsevier, is currently in press.
About Imaging Diagnostic Systems, Inc.
Imaging Diagnostic Systems, Inc. has developed a revolutionary new
imaging device to aid in the detection and management of breast cancer. The
CTLM(R) system is a breast imaging system that utilizes patented continuous
wave laser technology and computer algorithms to create 3-D images of the
breast. The procedure is non-invasive, painless, and does not expose the
patient to ionizing radiation or painful breast compression. CT Laser
Mammography (CTLM(R)) is designed to be used in conjunction with
mammography. It reveals information about blood distribution in the breast
and may visualize the process of angiogenesis, which usually accompanies
tumor growth.
Imaging Diagnostic Systems is currently collecting data from clinical
sites for the future filing of an FDA Premarket Approval (PMA) for the
Computed Tomography Laser Mammography (CTLM(R)) system to be used as an
adjunct to mammography. The FDA has determined that the Company's clinical
study is a non-significant risk (NSR) investigational device study under
812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR
812). The CTLM system is limited by United States Federal Law to
investigational use only in the United States. The CTLM system has received
other registrations including CE, CMDCAS Canadian License, China SFDA, UL,
ISO 9001:2000, ISO 13485:2003 and FDA export certification.
As contemplated by the provisions of the Safe Harbor section of the
Private Securities Litigation Reform Act of 1995, this news release may
contain forward-looking statements pertaining to future, anticipated, or
projected plans, performances and developments, as well as other statements
relating to future operations. All such forward-looking statements are
necessarily only estimates or predictions of future results or events and
there can be no assurance that actual results or events will not materially
differ from expectations. Further information on potential factors that
could affect Imaging Diagnostic Systems, Inc., is included in the Company's
filings with the Securities and Exchange Commission. We expressly disclaim
any intent or obligation to update any forward-looking statements.
www.imds
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