Zeltiq(TM) Aesthetics Announces European CE Mark Approval for Non-Invasive Fat Layer Reduction Using Cryolipolysis(TM)

NICE, France -

- Impressive Clinical Results Presented at Major Scientific Meeting of Dermatologists and Plastic Surgeons from Five Continents

Zeltiq Aesthetics announced that it received European CE Mark approval for non-invasive reduction of unwanted fat tissue in targeted areas of the body. The Zeltiq System(TM) is the first and only technology based on the patented method of Cryolipolysis(TM) — the use of controlled cooling to safely target and eliminate fat cells. In this way, the Zeltiq Procedure non-invasively reduces fat bulges in properly selected patients without needles, incisions, anesthesia, or down time.

The CE Mark approval gives the company the ability to market the Zeltiq device to countries of the European Union and coincided with the company’s launch to select centers of excellence in major markets. The important milestone was announced at the 5 Continent Congress of Lasers and Aesthetic Medicine which was held here on September 10-12, 2009, and represented a key step in Zeltiq’s global commercialization strategy.

“Early clinical data on the Zeltiq approach using a prototype device to reduce the thickness of the fat layer with precisely controlled cooling is very promising, provided there is careful patient selection and direct physician involvement in treatment planning,” said Roy G. Geronemus, MD, Director of the Laser & Skin Surgery Center of New York, during the opening plenary session of the international Congress. “The Zeltiq Procedure represents one of the most innovative and unique technologies for cosmetic fat reduction, with significant potential to meet the huge patient demand for a safe, nonsurgical solution to improve localized fat bulges,” added the past president of the American Society of Laser Medicine & Surgery and the American Society for Dermatologic Surgery.

Cryolipolysis(TM), the science behind the Zeltiq Procedure, was discovered by dermatologists Dieter Manstein, MD, and R. Rox Anderson, MD, of the Wellman Center for Photomedicine at Massachusetts General Hospital, affiliated with Harvard Medical School in Boston, Mass.

Speaking on the podium, Dr. Manstein explained: “Our basic research demonstrated the natural biologic vulnerability of fat cells to controlled cold exposure.” He said that his Harvard-based research team “published clear evidence of selective fat layer reductions of up to 1 cm in a single exposure. These early findings led to the collaboration between our institution and Zeltiq Aesthetics.”

According to Dr. Henry HL Chan, who was the first physician to commercially introduce the procedure in his dermatology practice in Hong Kong, Zeltiq has quickly become one of the most requested procedures in his clinic due to its ability to gently reduce unwanted abdominal fat, love handles and back fat. Dr. Chan is the Honorary Clinical Associate Professor of The University of Hong Kong and The Chinese University of Hong Kong.

Addressing Congress attendees, Dr. Chan noted: “Our patients report 100% satisfaction and significant fat reduction in two to four months following a single Zeltiq Procedure. In fact, we have had satisfied patients come back for a second procedure to achieve more fat reduction. I attribute this to the fact that the Zeltiq Procedure is comfortable, there is no downtime, and patients can see and feel a noticeable contour change in stubborn fat bulges such that they remark how much better their clothes fit.” Dr. Chan also pointed out that his patients have experienced no complications.

Clinical Study Results

Zeltiq conducted the first human study to test the safety and efficacy of its device for fat layer reduction of love handles and back fat pads in men and women. The unique bilateral control study design showed unequivocal results at relatively low energy settings with an early clinical prototype device. Based on ultrasound assessment, an average fat layer reduction of 22.4% was demonstrated after only one procedure.

Continued technology advancements in the device, combined with use of higher rates of tissue cooling and repeat procedures were shown to improve results with no increase in adverse events or patient discomfort. Further, the initial procedure followed by a second procedure two to three months later appears to provide incremental fat reduction with apparent safety.

About Zeltiq Aesthetics

Zeltiq Aesthetics, founded in 2005, is a science-based medical device company dedicated to the development of non-invasive procedures for the reduction of unwanted fat tissue. The initial Cryolipolysis research and patents were originated at The Wellman Center by Dr. Dieter Manstein and Dr. R. Rox Anderson. Zeltiq has exclusive rights to this innovative new approach to removing fat.

The Zeltiq Procedure is cleared by Health Canada and the European Union for non-invasive fat layer reduction through cold-assisted lipolysis and is available for sale to physicians on a limited basis in the European Union, Canada, the USA, and other select international markets. The Zeltiq device is also cleared by the U.S. FDA for various applications related to skin cooling during dermatologic treatments, with a pending application for non-invasive fat layer reduction. For more information, visit www.zeltiq.com .

Source: Zeltiq Aesthetics

Nadine Tosk for Zeltiq Aesthetics, +1-847-920-9858, nadinepr at gmail.com