Plastic and Reconstructive Surgery Publishes Clinical Trial Results of Ultrashape(TM) Non-Invasive Body Contouring System


YOQNEAM, Israel and SAN RAMON, California, September 6 /PRNewswire/ --

- UltraShape Demonstrates Measurable Durable Results After a
Single Treatment

Clinical trial results using the UltraShape(TM) Contour I, the first
clinically proven non-invasive focused ultrasound solution for body
contouring, are published in the September issue of the industry-leading
peer-reviewed Plastic and Reconstructive Surgery (PRS), the Journal of the
American Society of Plastic Surgeons.

The study "Body Contouring by Non-Invasive Transdermal Focused
Ultrasound: Safety and Efficacy of the Contour I Device in a Multi-center,
Controlled, Clinical Study" demonstrates measurable and durable body
circumference and fat thickness reduction after only a single UltraShape
treatment. The published study can also be accessed online at
http://www.plasreconsurg.com.

"With UltraShape finally there is a nearly painless, non-invasive, no
downtime body contouring option that gives durable results," said Steven
Teitelbaum, M.D., lead investigator for UltraShape's multi-center controlled
clinical trial, and Assistant Clinical Professor of Plastic Surgery at the
David Geffen School of Medicine at UCLA. "The system precisely delivers
focused ultrasound energy strong enough to destroy fat cells but leave
neighboring tissue unharmed."

"UltraShape's clinical findings demonstrate the safety and clinical
effectiveness of the procedure which has been adopted by physicians all over
the world," said Rodger Stewart, President and Chief Executive Officer of
UltraShape Inc. "To date, over 40,000 treatments have been performed and we
expect that number to continue to rapidly increase as global market adoption
of the technology continues."

"Published clinical results in a prestigious journal like Plastic and
Reconstructive Surgery, further validate the promise of UltraShape for
non-invasive fat cell lysis and body contouring using its unique focused
ultrasound technology," said Jeffery M. Kenkel, MD, FACS, Vice Chairman and
Professor of Plastic Surgery at the University of Texas Southwestern Medical
Center, and Chairman, UltraShape North America Medical Advisory Board.
"What's more, UltraShape's patented real-time tracking and guiding technology
allows for consistent energy delivery to ensure uniform, smooth body
contouring results-a breakthrough in itself considering contour
irregularities can be a common side effect of other methods of body
contouring."

More About the Multi-Center, Single Treatment Study

The clinical trial described in Plastic and Reconstructive Surgery was
conducted in five centers (two in the U.S., one in the U.K., and two in
Japan) and included a total of one hundred and sixty-four (164) healthy
patients. One hundred and thirty-seven (137) patients were treated with a
single treatment; twenty-seven were untreated (control group). The study
included treatment of the following areas of the body: abdomen, flanks, and
thighs. The study demonstrated a mean circumference reduction of 2 cm after a
single treatment of localized fat deposits. No statistically significant
weight loss was observed during the 84 day follow-up period. Therefore, the
reduction in circumference was attributed to the treatment, not to weight
loss. No clinically significant elevation of serum lipid profiles or changes
in blood and urine tests were seen. Liver ultrasound was performed before and
after treatment and there were no treatment induced changes to the liver. No
serious adverse events were observed.

About the UltraShape CONTOUR I

The UltraShape Contour I system, based on patented focused ultrasound
technology, is the first scientifically and clinically proven non-invasive
body contouring solution for both men and women. The device produces
mechanical, non-thermal, acoustic effects which targets and selectively
destroys fat cells, leaving surrounding critical structures such as skin,
blood vessels, nerves, and connective tissue intact. The UltraShape procedure
is guided by proprietary real-time tracking and guidance technology designed
to deliver smooth, uniform body contouring results. The software guarantees
adherence to a pre-determined treatment algorithm minimizing risk of contour
irregularities, a common side effect of liposuction. The UltraShape procedure
is performed during a convenient, "walk-in, walk-out" session carried out in
an office-based environment; it requires no anesthesia or sedation, and the
vast majority of patients report no pain or discomfort. After treatment,
patients immediately resume their daily routines with no need for maintenance
treatments. The UltraShape procedure is available in 47 countries and over
40,000 patient treatments have been performed worldwide with high patient
satisfaction. The UltraShape Contour I received the CE Mark in 2005 and a
medical device license from Health Canada in 2007.

About UltraShape

UltraShape is redefining aesthetic medicine by developing, manufacturing 
and marketing innovative non-invasive technologies for body contouring. The
company is dedicated to providing clinically proven safe and effective
solutions that enhance the lives of patients worldwide. The UltraShape
proprietary non-invasive body contouring technology is based on focused
ultrasound that targets and selectively disrupts fat cells without affecting
surrounding structures. Founded in 2000, UltraShape is a privately held and
venture backed company with offices in the United States, Israel, France,
United Kingdom, and Italy. The UltraShape Contour I system is not cleared by
the FDA for marketing in the United States. For more information visit
http://www.ultrashape.com.

Contacts:

    Abigail Marks
    UltraShape
    +972-4-909-9260
    abigail@ultrashape.com
 
    Paula Moggio
    FischerHealth
    +1-310-577-7870x151
    pmoggio@fischerhealth.com
 
    Jessica Fishman
    Gitam Porter Novelli
    +972-3-576-5798
    jessica@gitam.co.il

© PR Newswire Association LLC.

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