YOQNEAM, Israel and SAN RAMON, California, June 12 /PRNewswire/ --
- Study Will Evaluate Safety and Effectiveness of Contour Plus(TM) Device
UltraShape(R), a global leader in non-invasive fat reduction and body contouring, today announced the commencement of its pivotal IDE (Investigational Device Exemption) study to evaluate Contour Plus(TM), the first non-invasive device for fat reduction and body contouring using non-thermal selective focused ultrasound.
The next generation Contour Plus is based on the Contour I platform, which is available outside the U.S. and has been shown in pre-clinical and clinical studies to target and selectively break down fat cells, leaving surrounding critical structures such as skin, blood vessels, nerves, and connective tissue intact.
Contour Plus incorporates advanced technology to reduce treatment time and is intended to provide a non-invasive, fat reduction and body contouring solution for both men and women.
"This is a ground-breaking study for the aesthetics field. The Contour Plus has the potential to be the first system to create a durable, measurable fat thickness reduction," said Jeffery M. Kenkel, M.D., F.A.C.S., lead investigator, Vice Chairman and Professor of Plastic Surgery at the University of Texas Southwestern Medical Center, and Chairman, UltraShape Medical Advisory Board. "I believe the UltraShape study will demonstrate the ability of Contour Plus to selectively target and break down fat cells through non-thermal, acoustic effects."
"This IDE study signifies a landmark milestone for our company and huge potential for UltraShape to lead an industry breakthrough and become the first non-invasive treatment for measurable fat reduction for the purpose of body contouring in the United States," said Rodger Stewart, President and Chief Executive Officer of UltraShape. "We are excited to begin the pivotal trial and move closer to the commercialization of UltraShape in the United States."
The UltraShape Contour Plus IDE 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.
In addition to Dr. Kenkel, five leading plastic and dermatological surgeons will serve as principal investigators: Steven R. Cohen M.D., F.A.C.S.; William P. Coleman III, M.D.; Sue Ellen Cox, M.D.; Jason N. Pozner M.D., F.A.C.S.; and Robert Weiss M.D. Other UltraShape Medical Advisory Board members who will play a role in the study include Steven Teitelbaum, M.D., F.A.C.S., and Felmont F. Eaves III, M.D.
The 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.
About the UltraShape(R) Contour Plus(TM)
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 50 countries and over 55,000 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.
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 http://www.ultrashape.com.
Paula Moggio/Vanessa Hughes
Gitam Porter Novelli
|SOURCE UltraShape Ltd.|
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