Zeltiq Receives FDA Clearance To Perform Coolsculpting® Procedure At Lower Temperatures For Shorter Treatment Times

New Treatment Parameters Provide Significant Time Savings with Same Patient Outcomes

Company Will Launch New CoolSmooth PRO™ Applicator in Conjunction with This Clearance

PLEASANTON, Calif.--(BUSINESS WIRE)--ZELTIQ^® Aesthetics, Inc. (NASDAQ: 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.

“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.”

“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.

Forward-Looking Statements

The statements made in this press release regarding the expected performance and benefits of CoolSmooth PRO to patients and medical practices, and the timing of the introduction of CoolSmooth PRO, are forward-looking statements. The word "will" is used to identify these forward-looking statements. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond ZELTIQ's control, including, but are not limited to: physician and patient demand for the new CoolSculpting procedure using CoolSmooth PRO may be lower than ZELTIQ expects; technical difficulties may be experienced in the finalization of the introduction of CoolSmooth PRO may be encountered, which could delay or prevent the introduction of CoolSmooth PRO; as well as those other risks and uncertainties set forth in ZELTIQ's Quarterly Report on Form 10-Q for the third quarter ended September 30, 2014, filed with the SEC on October 28, 2014. These forward-looking statements speak only as of the date of this press release. ZELTIQ expressly disclaims any obligation to update information contained in these forward-looking statements whether as a result of new information, future events or otherwise.

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