Healthcare Industry News:  Transdermal 

Devices

 News Release - September 6, 2007

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

YOQNEAM, Israel and SAN RAMON, California, September 6 (HSMN NewsFeed) -- 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.


Source: UltraShape

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