UltraShape(R) Commences Pivotal Study for First Non-Invasive Fat Reduction and Body Contouring Device Using Non-Thermal Selective Focused ...( YOQNEAM Israel and SAN RAMON Cali...),Health

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 Un
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