Israel, 15 November 2006 - In today’s era of body consciousness, interest in aesthetic medicine is growing daily and there is a clear need for a body contouring system that combines the simplicity and safety of non-surgical methods, with the effectiveness of surgical techniques. UltraShape’s guided, non-invasive, focused ultrasound selective (G-NIUS™) technology provides a new, intelligent combination of easily administered, non-surgical technologies that offer a safe and effective route to circumference reduction – and is available to clinicians worldwide today.

The Practical Patient-Friendly Alternative

The UltraShape procedure is the first and only approved non-invasive body contouring solution to disrupt fat safely and effectively in both men and women. The procedure requires no anesthesia and is free of the complications associated with surgery. UltraShape uses innovative focused ultrasound technology that gently disperses fat in a convenient, short “walk-in, walk-out” session carried out in an informal, non-surgical environment. The fat is then naturally disposed of by the body over a 3-4 week period. After treatment, patients can immediately resume their daily routines. Extensive clinical trials prove that after just one application patients can expect an average reduction of two centimeters in body circumference, without lumps, discomfort or scarring, and the majority of patients report a pain free experience.

Benefits for Clinicians

Designed by plastic surgeons with physicians in mind, the UltraShape procedure is easily administered by physicians or other healthcare professionals. Minimal training is required for users, with a short learning curve. Because the system can be administered in a certified physician’s office, operating room and anesthesia expenses are eliminated. UltraShape provides a user-friendly, time-saving and cost-effective treatment platform that safely delivers a measurable reduction in body circumference. Patients who previously avoided invasive treatments will welcome this new body contouring option.

“UltraShape's G-NIUS technology was developed by plastic surgeons and scientists based on proven proprietary therapeutic ultrasound technology,” said Sandra Ziv, Marketing Manager, UltraShape. She continued, “The safety and effectiveness of the UltraShape solution is backed by scientifically proven results from a series of worldwide multi-center clinical trials performed on hundreds of patients, and we are thrilled to be able to offer this treatment to patients around the world.”

UltraShape systems are distributed throughout 35 countries, with 150 systems installed and over 14,000 commercial treatments having been carried out on thousands of satisfied patients.

Revolutionary Technology

G-NIUS™ Technology is based on two proprietary technological innovations:

Focused Non-Invasive Ultrasound
The UltraShape technology is based on focused therapeutic ultrasound which selectively disrupts fat tissue. A predetermined amount of ultrasound energy is applied to the subcutaneous fat layer where acoustic waves converge in a confined focal volume causing mechanical disruption of fat. Since energy is delivered in pulses, there is no significant temperature elevation.

Most importantly, the mechanical effect allows for tissue selectivity - only adipose tissue within the targeted area is disrupted while surrounding tissues including blood vessels, nerves, and connective tissue remain unharmed.


Advanced Tracking and Guiding Software
The UltraShape treatment is guided by a real-time tracking and guidance system designed to guarantee homogenous body contouring results. The system includes a software algorithm that maps the three-dimensional treatment zone. Precision and safety are reinforced by an optical image guidance device which provides real-time feedback regarding acoustic contact, thus preventing treatment beyond the pre-marked zone and precluding repeat treatment.

The tracking system addresses the dynamic nature of the treated area, a major challenge in body contouring. As the patient breathes and moves the fat, being non-rigid, undergoes spatial deformities. To overcome these obstacles, the system records and synchronizes the body's position in real-time, enabling the patient to move freely or even get up during treatment. When the patient returns, the system accurately resumes treatment.

Fat Clearance After the Treatment

The most common question asked regarding the UltraShape treatment pertains to the fate of fat from the treated adipose tissue. Disruption of fat causes the release of triglycerides (TG) from the cells. A great portion of TG is most likely broken down into free fatty acids and glycerol. The free fatty acids, being relatively insoluble in water, bind to albumin and are slowly transported to the liver or other tissue that need these molecules as building blocks or energy. The glycerol is soluble in water and is transported to the liver or to other cells that could use this molecule. The TG or its derivatives are therefore processed by known metabolic pathways, and no unnatural or new metabolic pathways are required.

After completion of treatment, the patient can simply go back to his or her normal routine but will be advised to take regular exercise and avoid fatty foods to help the body rid itself of the fats. The clearance of the cell debris and the resulting healing process occurs through a physiological process over the first 3-4 weeks. Since the damage to the cells is not due to thermal effects, there is no risk of burn injury.

Clinical Evidence

The UltraShape treatment has received CE approval under the Medical Device Directive from the European Union. Initial clinical trials were performed in Israel to monitor safety and effectiveness of the treatment. Trials included histological evaluation of tissues. These histological specimens demonstrated disrupted adipose tissue and intact blood vessels, connective tissue, nerves, and skin.

A multi-center clinical trial with the device included five sites in the USA, UK, and Japan, in which 137 patients underwent a single treatment. On average a 2 cm reduction in circumference was observed post-treatment.

How Do I Find Out More?

UltraShape is actively seeking distributors worldwide.
For more information on how to offer UltraShape at your clinic, please visit www.ultrashape.com

About UltraShape

UltraShape Ltd, founded in 2000, develops, manufactures and markets innovative, non-invasive solutions for the aesthetic medical field. The UltraShape expert team of scientists is dedicated to the development of cutting-edge body-contouring technology in a bid to enhance patients’ self-image and sense of well-being.

The company was founded in Delaware by Ami Glicksman M.D., formerly a senior plastic surgeon at the Sheba Medical Centre Tel Aviv, and Yoram Eshel, Ph.D, MBA, a leading expert in medical physics with fifteen years’ experience in high power ultrasound technology. UltraShape operates through its fully owned subsidiaries in Israel.

The company adheres to the highest scientific and quality standards. UltraShape is ISO 13485: 2003 certified.

For More Information Please Contact: