Navigation Links
UltraShape(R) Commences Pivotal Study for First Non-Invasive Fat Reduction and Body Contouring Device Using Non-Thermal Selective Focused Ultrasound
Date:6/12/2008

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.

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 http://www.ultrashape.com.

Contacts:

Paula Moggio/Vanessa Hughes

FischerHealth

+1-310-577-7870

pmoggio@fischerhealth.com

vhughes@fischerhealth.com

Jessica Fishman

Gitam Porter Novelli

+972-3-576-5798

jessica@gitam.co.il


'/>"/>
SOURCE UltraShape Ltd.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Mylan Commences Tender Offers and Consent Solicitations for Its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015 in Connection With Its Proposed Acquisition of Mercks Generic Pharmaceutical Business
2. Exelixis Commences Public Offering of Common Stock
3. Milestone Scientific Commences Declaratory Judgment Action With Respect to Its Single Tooth Anesthesia (STA(TM)) System and Compudent(TM) System
4. American Physicians Capital, Inc. Completes $15 Million Authorization and Commences $20 Million Authorization Under Stock Repurchase Program
5. Amarin Commences First Clinical Trial in Cardiovascular ProgramAmarin Commences First Clinical Trial in Cardiovascular Program
6. Cytopia Commences Phase II Cancer Drug Study
7. Reckitt Benckiser Commences Cash Tender Offer for All Outstanding Shares of Adams Respiratory Therapeutics
8. SXC Health Solutions Corp. Commences Exchange Offer For Shares Of National Medical Health Card Systems, Inc.
9. Takeda Commences Cash Tender Offer for all Outstanding Shares of Millennium
10. China Sky One Medical, Inc. Commences Trading on the American Stock Exchange
11. Neuromed Concludes a Special Protocol Assessment (SPA) with FDA for a Pivotal Phase 3 Study on NMED-1077
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... ... PawPaws brand pet supplements owned by Whole Health Supply is ... of felines. The formula is all-natural and is made from Chinese herbs that have ... Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root Extract ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at ... on several important health care topics including advance care planning, healthcare costs and ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... "With 30 ... their specific project," said Christina Austin - CEO of Pixel Film Studios. , ... and all within Final Cut Pro X . Simply select a ProHand generator ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. ... from injury. Recently, he has implemented orthobiologic procedures as a method for treating ... one of the first doctors to perform the treatment. Orthobiologics are substances that ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... A recent ... that most people are unfamiliar with. The article goes on to state that individuals ... also many of these less common operations such as calf and cheek reduction. The ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)...   Pulmatrix, Inc ., (NASDAQ: PULM ... announced today that it was added to the Russell ... comprehensive set of U.S. and global equity indexes on ... milestone for Pulmatrix," said Chief Executive Officer Robert ... progress in developing drugs for crucial unmet medical needs, ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... report to their offering. ... kidney failure, it replaces the function of kidneys by removing ... thus the treatment helps to keep the patient body,s electrolytes ... Increasing number of ESRD patients & substantial healthcare expenditure ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: ... 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay ... sepsis or septic shock. With this clearance, Roche is ... a fully integrated solution for sepsis risk assessment and ... with bacterial infection and PCT levels in blood can ...
Breaking Medicine Technology: