SOURCE: ZELTIQ

ZELTIQ

September 08, 2010 11:15 ET

Say Goodbye to Unwanted Love Handles: CoolSculpting by ZELTIQ™ Receives FDA Clearance for a Patented, Non-Invasive Cooling Treatment for Fat Reduction

Revolutionary Procedure Safely Eliminates an Average of 20% Fat in Treated Area

PLEASANTON, CA--(Marketwire - September 8, 2010) -  Great news for men and women dealing with one of the most exercise and diet-resistant problem areas: "love handles." CoolSculpting™ is now cleared by the U.S. Food and Drug Administration (FDA) for the non-invasive reduction of fat. ZELTIQ™, a global medical device company, developed the procedure which delivers a non-invasive, safe, and clinically proven method for the selective reduction of "love handles" or flank.

"There is a strong demand for non-invasive procedures that can address the concerns of people who are not considered overweight, but despite diet and exercise, have pockets of fat that bother them," said Dr. Jeffrey S. Dover, a board certified dermatologist, associate clinical professor of dermatology at Yale University School of Medicine, and co-director of SkinCare Physicians. "While traditional liposuction and laser liposuction are invasive surgical procedures that are designed for fat reduction, CoolSculpting is an exciting new approach that is non-invasive and has shown significant, durable, and reliable results in clinical studies for removing fat without the potential risks and downtime of invasive procedures."

CoolSculpting fills a previously unmet need in the medical aesthetic marketplace with a safe procedure cleared by the FDA that gently cools unwanted fat cells in the body to induce a natural, controlled elimination of fat cells. This reduces bulges in the treated area of the body. On average, each CoolSculpting procedure results in a 20% reduction of fat in the treated area, and patients can start to see results as soon as three weeks following treatment, with the most dramatic results occurring over a period of two to four months in most patients.

Unlike most other methods of fat reduction, CoolSculpting involves no needles, surgery or downtime. During the procedure, a non-invasive applicator delivers precisely controlled cooling to the treatment area to specifically target underlying fat, leaving surface skin tissue unaffected. Procedures last about one to two hours. Patients can have additional procedures for more pronounced effects if they desire.

Developed at the Wellman Center for Photomedicine at Massachusetts General Hospital in Boston, the CoolSculpting breakthrough is based on extensive scientific research that demonstrates that fat cells are more susceptible to extreme cold and are selectively, painlessly, and permanently destroyed. This process is known as Cryolipolysis™ (cold lipolysis). Starting several weeks after the procedure, cooled fat cells begin a process called apoptosis (natural cell death) and begin to shrink and disappear. Comprehensive multi-center clinical studies submitted to the FDA validated that CoolSculpting kills fat cells in the area treated based on histological and ultrasound assessment.

The CoolSculpting procedure by ZELTIQ will be available through an elite network of CoolSculpting Centers across the U.S. starting immediately. Consumers are urged to ask for CoolSculpting by name, for there are no comparable non-invasive alternatives. Worldwide, more than 7,000 patients have already been treated.

The 'Skinny' on Fat Reduction
CoolSculpting by ZELTIQ is not intended as a weight-reduction program for overweight individuals. The best candidates for the CoolSculpting procedure are people near their ideal body weight who eat well and exercise regularly and have pockets of fat that have not responded to a healthy lifestyle. They are seeking long-lasting spot reduction for this specific area of fat, but they are not considering a surgical procedure with its inherent expense, downtime, and safety risks.

About ZELTIQ
Founded in 2005, ZELTIQ™ is a global medical device company that developed its patented, non-invasive, clinically proven procedure to selectively reduce fat. The initial Cryolipolysis™ research and patents were originated at the Wellman Center for Photomedicine at Massachusetts General Hospital in Boston, a teaching affiliate of Harvard Medical School, by Dr. Dieter Manstein and Dr. R. Rox Anderson. ZELTIQ has exclusive rights to this innovative, "cool" approach to permanently removing fat. CoolSculpting™ is cleared in the United States, Canada, the European Union, and other international markets for non-invasive fat layer reduction. Physicians and patients are encouraged to visit www.coolsculpting.com to receive additional information and announcements about ZELTIQ.

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