Imaging Diagnostic Systems CT Laser Mammography (CTLM(R)) System Featured at the 94th Annual Radiological Society of North America (RSNA) Conference
Imaging Diagnostic Systems logo. (PRNewsFoto/IMAGING DIAGNOSTIC SYSTEMS)
FT. LAUDERDALE, FL UNITED STATES
FORT LAUDERDALE, Fla., Dec. 1 /PRNewswire-FirstCall/ -- Imaging Diagnostic
Systems, Inc., (OTC Bulletin Board: IMDS), a pioneer in laser optical breast
imaging, announced today that a recent study on CTLM is one of the featured
scientific abstracts at RSNA 2008, November 30th - December 5th. Dr. Jin Qi,
a radiologist at the Tianjin Medical University Cancer Institute and Hospital,
Tianjin, China, was selected for her paper, "CTLM as an Adjunct to Mammography
in the Diagnosis of Patients with Dense Breasts." Dr. Qi is attending RSNA
with IDSI and will be present at the company's exhibit.
Her study, which evaluated CTLM as an adjunct to mammography in women with
heterogeneously or extremely dense breast tissue, found that CTLM could
successfully distinguish malignant from benign lesions in dense breasts. The
system's imaging capabilities were not affected by tissue density in breasts
and could provide information about angiogenesis in malignant and benign
breast lesions.
Women who were scheduled for biopsy were first evaluated with mammography
to classify breast density and then examined by the CTLM system. The CTLM
examination was performed subsequently with mammography. The findings were
then compared to mammography alone, the CTLM system alone, and CTLM and
mammography adjunctively. Sensitivity, specificity, and positive predictive
values were calculated by using standard methods. Among the extremely dense
breast patient population, the sensitivity of mammography alone was 34.40%.
CTLM alone resulted in a sensitivity of 74.40%, and mammography plus CTLM
produced a sensitivity of 81.57%. The specificity of mammography alone was
90.48%; CTLM alone, 71.00%; and mammography plus CTLM was 72.22%.
In the heterogeneously dense breast patient population, the sensitivity of
mammography alone was 68.29%; CTLM alone was 85%; and mammography plus CTLM
resulted in a sensitivity of 95.34%. The specificity of mammography alone was
85%. CTLM alone was 61% and mammography plus CTLM was 55.26%.
"When CTLM was used as an adjunct to mammography in heterogeneously dense
breasts and extremely dense breasts the sensitivity increased significantly,"
Dr. Qi stated. "This study suggests that in clinical practice, adding CTLM in
dense breasts may be useful."
Following the study's presentation at RSNA, it will be released in China,
where it will be used to help market the CTLM system throughout the country.
The CTLM system has completed registrations including the CE Mark, CMDCAS
Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export
certification.
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. The company
is currently engaged in clinical trials for the FDA Pre-market approval
application submission.
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.
For more information, visit our website: www.imds.com
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.
