Press Release

Independent Clinical Trial Finds Dramatic Improvements in Body Contouring using UltraShape™ CONTOUR I
4월 9일, 2007

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, May 2, 2007 - 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®, 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® 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 weight loss.


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 July 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 satisfaction.


About UltraShape

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 July 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.


Contact

Abigail Marks, UltraShape
abigail@ultrashape.com
+972.4.909.9260

Amanda McNulty Sheldon, Fischer Health
asheldon@fischerhealth.com
+1.310.577.7870 X173

Dariela Roffe, Porter Novelli
dariela.roffe@porternovelli.co.uk
+44.207.853.2234