Imaging
Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS) announced today that
clinical trials of the CT Laser Mammography (CTLM(R)) system have commenced
at a number of US university medical centers. IDSI will collect clinical
data through a non- significant risk (NSR) device study.
"As previously reported, we will be scanning patients using the latest
version of the CTLM system," commented Deborah O'Brien, Senior Vice
President of Imaging Diagnostic Systems. "Following data collection and
analysis, we intend to submit a Premarket Approval application to the FDA
for the use of CTLM as an imaging adjunct to conventional diagnostic
mammography. CTLM has the potential to fill an important role in improving
the accuracy of current breast cancer detection methods and in improving
patient management. We are partnering with prestigious institutions, using
an experienced clinical study management firm, working with leading
regulatory consultants, and using our best efforts to ensure successful
clinical trials."
"We are also moving forward in our global commercialization efforts. We
held our first International CTLM Users Meeting in April. Many of our
international users have gained useful experience and collectively have
scanned over 7,000 breasts. IDSI recently participated in the European
Congress of Radiology, where several of our luminary partners presented
clinical studies," O'Brien added.
The Company will continue to provide periodic updates of its progress
on current initiatives, including the US PMA process, by way of shareholder
letters, press releases, and other public filings. The locations of the
clinical trials will not be disclosed so that the study members may
participate without publicity or distraction.
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for
its Computed Tomography Laser Mammography (CTLM(R)) system to be used as an
adjunct to mammography. The Company's PMA application will be submitted in
its entirety at the completion of the data collection and review process.
The FDA has determined that the Company's clinical investigation is a non-
significant risk (NSR) investigational device study because it does not
meet the definition of a significant risk (SR) device under 812.3(m) of the
investigational device exemptions (IDE) regulation (21 CFR 812). The
CTLM(R) system is the first patented breast imaging system that utilizes
state-of-the- art laser technology and patented algorithms to create 3-D
images of the breast. It is a non-invasive, painless examination that does
not expose the patient to radiation or require breast compression. Imaging
Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian
License, China SFDA approval, UL listing, ISO 9001:2000, ISO 13485:2003
certification and FDA export certification for its CT Laser Mammography
system.
Please visit Imaging Diagnostic Systems' website at:
imds
for additional information.
In conjunction with 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
projected plans, performances and developments, as well as other statements
relating to future operations. All such forward-looking statements are
necessarily only estimates of future results and there can be no assurance
that actual results will not materially differ from expectation. Further
information on potential factors that could affect Imaging Diagnostic
Systems, Inc., is included in the Company's filing with the Securities
Exchange Commission. We expressly disclaim any intent or obligation to
update any forward-looking statements.
Imaging Diagnostic Systems, Inc.
imds
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