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Relief for "Thigh Shy" Consumers: CoolSculpting(R) Receives FDA Clearance for Non-Surgical Reduction of Thigh Fat

PLEASANTON, CA--(Marketwired - Apr 14, 2014) - ZELTIQ® Aesthetics, Inc. (NASDAQ: ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology, today announced that the CoolSculpting procedure has received U.S. Food and Drug Administration (FDA) clearance to treat the thighs with its entire suite of applicators. The CoolSculpting procedure is clinically proven to non-surgically reduce unwanted fat, and is already FDA cleared to treat the abdomen and flanks.

With its newest applicator, the CoolSculpting procedure is the first and only clinically proven non-surgical solution using cooling for fat reduction of the thighs. The newest applicator utilizes non-vacuum based cooling, easily and specifically treats the outer thighs and other non-pinchable fat bulges, and features a comfortable design that adjusts to fit each individual patient. In combination with an applicator launched last year and designed to treat longer fat bulges and hard-to-reach areas such as the inner thigh, the CoolSculpting procedure can now treat the complete thigh area.

"In my practice, I have seen a growing number of patients who, despite leading a healthy lifestyle through diet and exercise, cannot eliminate stubborn fat on certain parts of their bodies, and the thigh ranks high on the list of target spots they wish to treat," said Grant Stevens, MD, medical director of Marina Plastic Surgery in Marina del Rey, Calif. "Being able to perform this procedure on three of the most challenging parts of the body -- the abdomen, flank and now thighs -- presents additional opportunities for my patients who want to improve the contour of their bodies without surgery."

With this new indication, thighs join the abdomen and flank as parts of the body successfully treated by the CoolSculpting procedure. A recent market research study in the United States revealed that 7.2 million people expressed an interest in the CoolSculpting procedure as a solution for inner or outer thigh fat1. This is in addition to the 13.2 million and 7.4 million interested in undergoing the procedure for the abdomen and flank1, respectively. 

Through the use of different applicators, the CoolSculpting procedure can be customized to treat different body types and several areas of the body. In clinical studies, 86% percent of patients reported a visible reduction in outer thigh fat 16 weeks following treatment and were satisfied with results. Of note, 89% of patients would recommend the CoolSculpting procedure to a friend1.

The unique CoolSculpting procedure was developed by Harvard scientists and is based on the science of Cryolipolysis®, a process demonstrating that when fat cells are exposed to extreme cold, they die and are eliminated naturally from the body. Only the CoolSculpting procedure selectively targets (freezes) the fat cells which, once crystallized, die and are naturally eliminated from the body. Fat cells treated and eliminated by the procedure are gone for good, and patients can expect long-lasting results.

In the United States, the CoolSculpting procedure is cleared for non-invasive fat reduction in the abdomen, flank and thighs. In other international markets, it is cleared for general non-invasive fat reduction. The CoolSculpting procedure results in a noticeable and measurable reduction of fat in the treated areas, and the treated fat is gone for good. Most patients can start to see results as soon as three weeks following treatment, with the most dramatic results occurring over a period of one to three months. Every patient is unique, so patients are encouraged to talk to their physicians about a customized treatment plan as part of the initial consultation. Additional treatments in the same or multiple areas may enhance the desired aesthetic effect. 

The CoolSculpting procedure is available through an elite network of CoolSculpting Centers worldwide. Dermatologists, plastic surgeons and leading aesthetic specialists that offer CoolSculpting can be found at www.coolsculpting.com.

About the CoolSculpting® Procedure
The CoolSculpting procedure is a non-surgical, clinically proven procedure that selectively reduces fat bulges in problem areas using a patented cooling technology. Cleared by the FDA for noninvasive fat reduction in the abdomen, flank and thighs, it gently cools unwanted fat cells in the body to induce a natural, controlled elimination of fat cells without harming surrounding tissue, and the treated fat cells are gone for good. Over 1,000,000 CoolSculpting cycles and 2,200 systems have been shipped to more than 60 countries. The CoolSculpting procedure is available through an elite network of CoolSculpting Centers worldwide. Dermatologists, plastic surgeons and leading aesthetic specialists that offer CoolSculpting can be found at www.coolsculpting.com.

Be sure to follow CoolSculpting on Facebook, Twitter, Pinterest and YouTube.

About ZELTIQ® Aesthetics, Inc.
ZELTIQ Aesthetics, Inc. is a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform. ZELTIQ's first commercial product, the CoolSculpting system, is designed to selectively reduce stubborn fat that may not respond to diet or exercise. The CoolSculpting procedure is based on the scientific principle that fat cells are more sensitive to cold than the overlying skin and surrounding tissues. It utilizes patented technology of precisely controlled cooling to reduce the temperature of fat cells in the treated area, which is intended to cause fat cell elimination through a natural biological process known as apoptosis. ZELTIQ developed the CoolSculpting procedure to safely, noticeably, and measurably reduce the fat layer.

1 Data on file

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