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



    UltraShape Demonstrates Measurable Durable Results After a Single
Treatment

    SAN RAMON, CALIF. & YOQNEAM, ISRAEL, September 6 /CNW/ - 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
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, M.D., 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 target and selectively destroy
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
www.ultrashape.com.




For further information:

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

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