Zeltiq Aesthetics

FIRST HUMAN STUDY OF NON-INVASIVE CRYOLIPOLYSIS YIELDS PROMISING RESULTS IN PATIENTS WITH LOVE HANDLES AND BACK FAT

Wausau, Wisconsin – April 1, 2009. Findings from the first multi-center study of non-invasive cryolipolysis for subcutaneous fat layer reduction in humans were a “cool” topic at the 29th Annual Conference of the American Society for Laser Medicine and Surgery (ASLMS) in National Harbor, Maryland. Invented by world-renowned dermatologists from Harvard Medical School and the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston, Massachusetts, cryolipolysis is a breakthrough technology that is based on the natural biologic vulnerability of fat cells to the effects of cold via controlled energy extraction.

Two of the study’s lead investigators, Jeffrey Dover, MD, director of SkinCare Physicians in Chestnut Hill, MA, and Elizabeth Tanzi, MD, co-director of the Washington Institute of Dermatologic Laser Surgery in Washington, DC, presented data confirming that cryolipolysis treatment is safe and provides a significant benefit of fat volume reductions when performed in a routine clinical setting. The prospective clinical study also corroborated earlier animal research showing that precisely controlled cooling via a hand-held applicator attached to a sophisticated medical device causes a gradual reduction of targeted fat cells through a naturally induced cell death without harming surrounding tissues. According to Dr. Dover, this mechanism of action is fundamentally different from ultrasound or heat-based approaches that create acute injury and eliminate fat cells through traumatic cell death.

“This is the first controlled study to demonstrate that cryolipolysis for fat layer reduction of love handles and back fat pads in men and women is well-tolerated and produces a visible contour change in the majority of subjects,” said Dr. Dover, who is an associate clinical professor of dermatology at Yale University School of Medicine, New Haven, Connecticut. “Unlike traditional surgical procedures to remove fat, cryolipolysis is performed without needles, incisions, anesthesia or pain medication, plus there is no recovery time.”

During the procedure, a non-invasive applicator delivers precisely controlled cooling to target and eliminate fat cells in targeted body areas. As they are exposed to cooling, the fat cells begin a process of natural cell death and removal. The fat cells in the treated area are gradually eliminated through the body’s normal metabolism process. The result is a flattening of fat bulges that is visible in most patients over three to four months.

Cryolipolysis Clinical Study
Thirty-two male and female subjects age 18 and older with clearly visible fat on the flank (love handle) or back considered appropriate for treatment with cryolipolysis participated in a multi-center, prospective, non-randomized, IRB-approved study. Cooling was applied by a prototype device to the treatment area using pre-programmed treatment profiles that control the rate of heat extraction and treatment duration. A contralateral untreated area (i.e., the opposite love handle or portion of the back on the other side) served as the control. The efficacy of the procedure was evaluated by ultrasound measurement of fat layer reduction, comparison of pre- and post-treatment photographs, and physician assessment.

Based on interim results from these evaluations, researchers confirmed that cryolipolysis resulted in a visible contour change in a majority of the 32 subjects. Specifically, ultrasound measurements taken on a subset of 10 subjects demonstrated a fat layer reduction in 100 percent of subjects, with an average reduction of 22.4 percent at four months post-treatment. Dr. Dover added that subjects with modest fat bulges had the best cosmetic results from the procedure, and no device-related adverse events were reported by any of the subjects.

“Our study showed that selective cryolipolysis produces gradual reductions in subcutaneous fat after only one treatment while avoiding damage to the surrounding tissues,” concluded Dr. Dover. “This early research is extremely encouraging, and we look forward to evolving this technology such that we can optimize treatment parameters, patient selection and clinical outcomes in these and other areas of the body.”

The American Society for Laser Medicine and Surgery (ASLMS) is the world’s preeminent resource for laser research, safety, education, and clinical knowledge. Founded in 1980, ASLMS promotes excellence in patient care by advancing clinical application of lasers and related technologies. For more information and physician referrals, please log on to the Society’s website: www.aslms.org.

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