Market Overview

ZELTIQ Announces FDA Clearance to Treat Thighs

ZELTIQ Aesthetics, Inc. (NASDAQ: ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology, today announced it has received U.S. Food and Drug Administration (FDA) clearance to treat the thigh area with its entire suite of applicators. The CoolSculpting procedure is a clinically proven, non-surgical procedure that reduces fat in the treated area for good, and is already FDA cleared to treat the abdomen and flanks.

The CoolSmooth™ applicator features non-vacuum based cooling that easily treats non-pinchable fat bulges, such as the outer thigh, and the comfortable design adjusts to fit each individual patient. In a recent CoolSmooth clinical study where patients received unilateral outer thigh treatments, 86% of patients noticed visible fat reduction after just one treatment and 86% of patients were satisfied with their results. Of note, 89% of patients said they would recommend CoolSculpting to a friend(1). Combining the CoolSmooth applicator with the CoolFit 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.

"We are extremely pleased to receive FDA clearance to treat the thigh, as we know how many individuals struggle with reducing fat in this difficult-to-treat part of the body -- in fact, a recent market research study revealed that in the United States, 7.2 million people expressed an interest in CoolSculpting as a solution for inner or outer thigh fat(2)," said Mark Foley, President and Chief Executive Officer of ZELTIQ. "This FDA clearance adds to the growing body of evidence demonstrating the safety, efficacy and long-lasting results of the CoolSculpting procedure across expanding indications, which we believe will help attract new physician customers. We are excited to be able to expand our offering to both new and existing physicians and, ultimately, the many individuals who may benefit from our unique technology. We started taking pre-orders for this device in the first quarter and saw stronger than expected customer demand. In anticipation of this clearance and increased demand, we have been ramping up our inventory and manufacturing efforts for both the new CoolSmooth applicator and the existing CoolSculpting system and are pleased to begin initial shipments of the CoolSmooth applicator today."

Grant Stevens, MD, medical director of Marina Plastic Surgery in Marina del Rey, California, said, "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. 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."

Suzanne L. Kilmer, MD, director of the Laser and Skin Surgery Center of Northern California in Sacramento, California, added, "As a long-time user of the CoolSculpting system, I have personally seen the reproducible, consistent results and high patient satisfaction it can deliver. With the CoolSmooth applicator, I can now confidently treat thighs and other non-pinchable fat bulges knowing that it can reliably deliver the same results and satisfaction associated with the CoolSculpting procedure."

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 revealed that 7.2 million people expressed an interest in CoolSculpting as a solution for outer thigh fat(2). This is in addition to the 13.2 million and 7.4 million interested in undergoing the CoolSculpting treatment for the abdomen and flank(3), respectively.

In the United States, the CoolSculpting procedure is cleared for non-invasive fat reduction in the abdomen, flank and thigh. In other international markets, it is cleared for general non-invasive fat reduction. The CoolSculpting treatment results in a noticeable 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 3 weeks following treatment, with the most dramatic results occurring over a period of 1-3 months. Every patient is unique, which is why ZELTIQ recommends a customized treatment plan as part of the initial consultation. Additional treatments in the same or multiple areas may enhance the desired aesthetic effect.

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 and flank, it gently cools unwanted fat cells in the body to induce a natural, controlled elimination of fat cell 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.

Posted-In: News FDA Press Releases

 

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