Lasers in Surgery and Medicine and Plastic and Reconstructive Surgery
Publish Clinical Trial Results that Demonstrate Definite, Measurable Results
of the UltraShape CONTOUR I
YOQNEAM, ISRAEL & SAN RAMON, CALIF., April 9 /CNW/ - Results of an
independent clinical trial showing the efficacy of the UltraShape CONTOUR I,
the first clinically proven non-invasive solution for body contouring, will be
published in the April issue of Lasers in Surgery and Medicine, the journal
for the American Society for Laser Medicine & Surgery. The study "Body
Contouring by Non-Invasive Transdermal Focused Ultrasound" demonstrates that
multiple treatments using UltraShape CONTOUR I as a non-invasive method for
reducing unwanted fat deposits produce a 100% response rate with a mean
reduction in fat thickness of 2.28 +/- 0.80 cm and a mean reduction in
circumference of 3.95 +/- 1.99 cm.
"In the past, the only way to achieve dramatic improvement in body
silhouette was by removing local fat deposits through liposuction or other
more invasive surgical procedures. Those procedures, however, have major
drawbacks," explained Javier Moreno-Moraga, M.D., lead investigator from the
Instituto Medico Laser in Madrid, Spain. "What we have found through this
study is that the use of focused ultrasound using the UltraShape CONTOUR I
system in appropriate patients could be considered the non-invasive, no
downtime alternative to conventional liposuction for people who choose not to
or cannot undergo more invasive approaches to body contouring."
This published study comes on the heels of the publication of
multi-center controlled clinical trial results, which are currently available
as an Advance online article at www.plasreconsurg.com, the Web site for
Plastic and Reconstructive Surgery(R), the Journal of the American Society of
Plastic Surgeons. This trial included 164 patients and showed measurable and
durable results, after only a single UltraShape treatment. These results will
be published in the September issue of the journal.
"The UltraShape CONTOUR I has been scientifically demonstrated to produce
definitive, measurable circumference and fat thickness reduction in a single
treatment without pain or downtime. It has also been shown to selectively
target fat without harming surrounding tissues," said Steven Teitelbaum, M.D.,
lead investigator for UltraShape's multi-center controlled clinical trial.
"Publication of clinical studies in two premier peer-reviewed journals
showing dramatic results echoes the experience many physicians outside the
U.S. have seen performing the UltraShape(R) procedure in their practices,"
said Rodger Stewart, President and Chief Executive Officer of UltraShape Inc.
More About the Multiple Treatment Study
The independent multiple treatment clinical trial published in Lasers in
Surgery and Medicine included 30 patients that underwent three treatments at
30 day intervals using the UltraShape CONTOUR I. The study included treatment
of the following areas of the body: abdomen, flanks, thighs, knees and
pseudo-gynecomastia. Results showed 100% response rate with no adverse effects
on patients following the three treatments. The study also demonstrated a mean
fat thickness reduction of 2.28 cm and a mean circumference reduction of 3.95
cm. As a control, weight loss was monitored to ensure results were not due to
About the UltraShape CONTOUR I
The UltraShape CONTOUR I system, based on patented focused ultrasound
technology, is the first clinically proven non-invasive body contouring
solution for both men and women. It is designed to target and disrupt fat,
leaving surrounding structures such as skin, blood vessels, and nerves intact.
The UltraShape procedure is guided by proprietary real-time tracking and
guidance software 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
which is a highly technique-sensitive surgical procedure. 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 and there is
no need for maintenance treatments.
The UltraShape CONTOUR I system received the CE Mark in June 2005 and is
currently distributed in 45 countries outside of the United States. Over
30,000 commercial treatments have been performed worldwide with high patient
UltraShape Inc., founded in 2000, is a privately held and venture backed
company that develops, manufactures and markets innovative, non-invasive
solutions for the aesthetic medical field. The UltraShape expert team is
dedicated to the development of cutting-edge body-contouring technology in a
mission to enhance patients' self-image and sense of well-being. The
UltraShape CONTOUR I, the first clinically proven non-invasive body contouring
solution, received the CE Mark in June 2005 and is currently distributed in 45
countries outside the United States. Over 30,000 commercial treatments have
been performed to-date.
The concept behind the company's platform technology was developed by Ami
Glicksman, M.D., a plastic surgeon and Yoram Eshel, Ph.D., MBA, a medical
physicist who teamed up to marry the aesthetic clinical experience of the
doctor and the expertise in high power focused ultrasound of the physicist.
UltraShape adheres to the highest scientific and quality standards and is
ISO 13485: 2003 certified. The company has worldwide 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, please visit www.ultrashape.com.
For further information:
For further information: UltraShape Abigail Marks, +972-4-909-9260
firstname.lastname@example.org or FischerHealth Amanda McNulty Sheldon, 310-577-7870
x173 email@example.com or Porter Novelli Dariela Roffe,