The results of the clinical trial using the UltraShape (TM) Contour I, first clinically proven non invasive focused ultrasound solution for body contouring, are published in the Journal of the American Society of Plastic Surgeon.

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 in the website of the Association.

"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."

"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" 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.

About the Study

The study included treatment of the following areas of the body: abdomen, flanks, and thighs. Comparing two groups of patients from a total of 164, 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.

 Results after one session treatment

About the UltraShape CONTOUR I

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, one of risk of other procedures as 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 but still not cleared by the FDA for marketing in the United States.

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