Sanctuary Medical Aesthetic Center Treats First Patient In Investigational Study Of Ultrashape
Oct 13, 2008 – Boca Raton, Florida- Sanctuary Medical Aesthetic Center announced today the first treatment performed at its center for the IDE (Investigational Device Exemption) study of the UltraShape® Contour PlusTM, the first non-invasive fat reduction and body contouring device using non-thermal selective focused ultrasound. Due to its expertise in advancing aesthetic technology and goal to provide measurable, long-lasting results for its patients, SMAC was selected as one of six centers in the United States, and the only center in Florida, to participate in the study. “We have witnessed a growing demand for non-invasive procedures for measurable fat reduction for body contouring. We are excited to participate in this groundbreaking study to evaluate the ability of the Contour Plus to selectively target and break down fat cells through non-thermal, acoustic effects,” said Dr. David Goldberg, cosmetic dermatologist and co-director of SMAC. The revolutionary technology of the Contour Plus is supported by the Contour I platform, which is currently available outside the U.S. and has been shown in pre-clinical and clinical studies to target and selectively breakdown fat cells, while protecting vital structures such as skin, blood vessels, nerves, and connective tissue. As it incorporates advanced technology, the Contour Plus is intended to provide a non-invasive, fat reduction and body contouring solution for men and women alike. About The UltraShape® Contour Plus™ IDE Study The UltraShape Contour Plus IDE study will enroll patients at six centers in the United States. The primary endpoint will be an objective, quantifiable fat reduction assessment. UltraShape intends to submit the pivotal study results to the U.S. Food and Drug Administration (FDA) in a premarket approval (PMA) submission. The study builds upon positive clinical studies conducted with Contour I including two peer-reviewed published studies. The first study, a multi-center worldwide study, was published in the industry-leading peer-reviewed Plastic and Reconstructive Surgery, “Body Contouring by Non-Invasive Transdermal Focused Ultrasound: Safety and Efficacy of the Contour I Device in a Multi-center, Controlled, Clinical Study,” Teitelbaum, et al. The study demonstrated measurable and durable body circumference and fat thickness reduction after only a single UltraShape treatment. The second study, an independent clinical trial showing the efficacy of multiple treatments with the UltraShape Contour I, published in Lasers in Surgery and Medicine, “Body Contouring by Non-Invasive Transdermal Focused Ultrasound,” Moreno-Moraga, et al. The study, using Contour I as a non-invasive method for reducing unwanted fat deposits, produced a 100 percent response rate with a mean reduction in fat thickness of 2.28 cm, and as much as 3.94 cm, and a mean reduction in circumference of 3.95 cm, and as much as 10 cm. The study demonstrated definitive, measurable results of the UltraShape system. [Patients interested in obtaining more information on the study should contact Krystie Lennox, Sanctuary Medical Aesthetic Center, at 561-886-0970]. About the UltraShape® Contour Plus™ The UltraShape Contour Plus system, an investigational device in the U.S., is based on the Contour I platform and incorporates patented focused ultrasound technology. Contour I, which is authorized for marketing outside the U.S., is the first non-invasive fat reduction and body contouring device for both men and women. The device is designed to produce mechanical, non-thermal, acoustic effects which target and selectively disrupt fat cells, leaving surrounding critical structures such as skin, blood vessels, nerves, and connective tissue intact. The UltraShape procedure is available in 60 countries and over 60,000 patient treatments have been performed worldwide with high patient satisfaction. The UltraShape procedure is guided by proprietary real-time tracking and guidance technology designed to deliver smooth, uniform body contouring results. The software provides a pre-determined treatment algorithm designed to minimize 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. After treatment, patients immediately resume their daily routines with no need for maintenance treatments. The UltraShape Contour I received the CE Mark in 2005 and a medical device license from Health Canada in 2007. The Contour Plus system is an investigational product limited by U.S. law to investigational use only. About SMAC Sanctuary Medical Aesthetic Center (SMAC) is the hub of South Florida’s commitment to revolutionary wellness and rejuvenation. Our unrivaled physician-led team of specialists treats virtually every area of the body with the latest in science-based beauty and age management techniques. The center features Jason Pozner, M.D., Kurt Wagner, M.D., and Christine Haugen, M.D., and celebrated cosmetic dermatologist David Goldberg, M.D., all armed with the most advanced technologies to promote beauty and health. 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, United Kingdom, Italy, and France. The UltraShape system is not approved by the FDA for marketing in the United States. For more information visit www.ultrashape.com.