SALT LAKE CITY, June 16 /PRNewswire-FirstCall/ -- TechniScan,
(OTC Bulletin Board: TSNI) a medical device company engaged in the
development and commercialization of an automated 3D breast
ultrasound imaging system, today announced that it has launched a
clinical study in Rochester,
Minn., its third new clinical site to commence in the last
five months.
TechniScan's Warm Bath Ultrasound (WBU) system is designed to
capture three-dimensional images of the breast as a woman lies
prone on a table and state-of-the-art ultrasound technology is used
in a warm water tank to image the breast anatomy. Its revolutionary
new method of imaging produces information and whole breast images
that are not available with traditional reflection ultrasound or
whole breast ultrasound systems presently on the market.
To date, TechniScan has scanned over 800 women in clinical
studies in Salt Lake City and
Ogden, Utah as well as
Orange and San Diego, California. These past clinical
studies focused on key factors like image quality, repeatability,
and establishing protocols for testing baseline values for positive
and negative predictive capabilities of the system.
According to Dr. John Klock,
TechniScan's chief medical officer, the most recently completed
clinical work continues to support that refraction-corrected
reflection images highlight connective tissue features within the
breast, whereas the speed-of-sound images show fibroglandular,
ductal and terminal lobular units with high resolution.
Image consistency and reproducibility, whether it is weeks,
months or a year between exams, are critical to support precise and
reliable assessment of breast lesions. Clinical studies in
San Diego recently evaluated the
ability of the system to reliably reproduce images from the same
woman.
"We have clearly demonstrated that the system can reliably
reproduce images based on reflection and sound transmission and
that those images will have significant clinical utility," said
David Robinson TechniScan's president and CEO.
"Volumetric whole-breast imaging provides a substantial
practical advantage over conventional very-small-field-of-view
sonography. We are greatly aided by the ability to produce
repeatable whole-breast comparisons – left to right and present to
past. These comparisons are the nuts and bolts of breast imaging,
by any modality," said Michael
Andre, Ph.D., adjunct professor of radiology and director of
medical physics at University of California,
San Diego School of Medicine.
Building on this prior clinical work, the current clinical
studies in Freiberg, Germany,
San Diego and Rochester will involve at least 500 women with
various types of breast lesions. Major objectives of the
12-month study will be to compare WBU to conventional breast
sonography and MRI as well as to examine the WBU system's ability
to differentiate between normal, benign and malignant breast
tissue. These clinical studies in the U.S. are funded by a Small
Business Innovation Research Grant (SBIR) from the National Cancer
Institute.
TechniScan's current study sites include the University Medical
Center Freiburg in Germany, Moores
UCSD Cancer Center, and the latest clinical study site in
Rochester, Minnesota as well as
limited imaging studies that support product development in
Genoa, Italy and Salt Lake City, Utah.
"Overall we expect to image another 600 or more patients in our
clinical program over the next 6-12 months," said Robinson. "These
studies will provide us with critical information about the
clinical utility and application of the WBU capabilities."
"The feedback that we are receiving from our scientists and
radiologists at our study sites gives us good reasons to remain
cautiously optimistic," said Klock.
Researchers involved in the studies will also utilize
TechniScan's groundbreaking imaging network, which provides them
with the ability to archive, store, and retrieve WBU images and
relevant medical records and to collaborate with other research
sites.
"Our vision is to begin to create a database of thousands of
breast images as well as the underlying and related image data,"
said Robinson. "With complete anonymity, women can contribute their
mammograms, breast MRI's and WBU images along with related
pathology and other information to provide researchers around the
world an unprecedented opportunity to study breast cancer.
TechniScan's imaging network will also allow timely and efficient
collaboration of patient's records for her medical team's use. The
concept is simple, yet revolutionary within the medical system and
represents a key competitive advantage of the TechniScan
system."
About TechniScan
TechniScan, Inc. is a medical device company engaged in the
development and commercialization of a non-invasive imaging tool
designed to provide physicians with automated ultrasound images of
the human breast. TechniScan's WBU imaging device is limited by
U.S. law to investigational use unless, and until, cleared by the
FDA. For more information, please visit
www.techniscanmedical.com.
Forward Looking Statements
Certain statements in this press release that are not
historical facts are "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such statements may be identified by the use of words such as
"anticipate, "believe," "expect," "future," "may," "will," "would,"
"should," "plan," "projected," "potential," "intend," and similar
expressions. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause the
actual results, performance or achievements of TechniScan, Inc.
(the "Company") to be materially different from those expressed or
implied by such forward-looking statements. The Company's future
operating results are dependent upon many factors, including risk
factors discussed in the Company's periodic filings with the
Securities and Exchange Commission, which are available for review
at www.sec.gov, including the Company's Annual Report on Form 10-K
filed on March 22, 2010. The Company
undertakes no obligation to update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
Press Contact: Tracy
Harden, TechniScan Medical Systems, (801) 994-2968,
tharden@tsni.com
SOURCE TechniScan
