ZELTIQ® Receives FDA Clearance to Perform CoolSculpting® Procedure at Lower Temperatures for Shorter Treatment Times

by Riverchase Dermatology
January 18, 2016

zeltiq logo, coolsculpting, miamiNew Treatment Parameters Provide Significant Time Savings with Same Patient Outcomes – Company Will Launch New CoolSmooth PRO™ Applicator in Conjunction with This Clearance

ZELTIQ® Aesthetics, Inc. (ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced that it has received Food and Drug Administration (FDA) clearance to perform the CoolSculpting® procedure at lower temperatures, which will enable shorter treatment times. In conjunction with this clearance, ZELTIQ will be introducing a brand new applicator, CoolSmooth PRO™, which is a second generation surface applicator that features non-vacuum based cooling to treat non-pinchable fat bulges, such as the outer thigh area.

“This FDA clearance will enable healthcare professionals to perform the CoolSmooth procedure in nearly half the time with the same outcomes, which will significantly enhance the procedural efficiency and profitability for the practice while also improving the patient experience,” said Mark Foley, President and Chief Executive Officer of ZELTIQ. “Through an ongoing investment in R&D and technological innovation, we are pleased to continue to provide our CoolSculpting partners with differentiated solutions that enhance their treatment options. And, we look forward to applying this technological advancement to our other CoolSculpting applicators in the future.”

The FDA clearance is based on clinical study data demonstrating that optimized temperatures enable shorter treatment times with equivalent benefits, safety, efficacy and customer satisfaction, when compared to current CoolSculpting procedures.

The new treatment parameters will initially be offered with the CoolSmooth PRO applicator, which is uniquely designed to safely control treatments at colder temperatures. The CoolSmooth PRO applicator also includes an enhanced strapping system that provides increased conformity at the treatment site, while also improving ease of use and patient comfort.

The CoolSmooth PRO will be available in Q2 of this year and ZELTIQ plans to offer current CoolSmooth customers an exchange program to facilitate access to the new technology.

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. Nearly 1.5 million CoolSculpting treatments have been performed in over 70 countries around the world. The CoolSculpting procedure is available through an elite network of CoolSculpting Centers worldwide. Dermatologists, plastic surgeons and leading aesthetic specialists that offer the CoolSculpting procedure can be found at www.coolsculpting.com. Be sure to follow the CoolSculpting procedure 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.