ZELTIQ Receives FDA Clearance to Treat Submental Fat With Coolsculpting Procedure

October 1, 2015

The FDA granted an expanded clearance for ZELTIQ(R) Aesthetics, Inc.’s Coolsculpting procedure, paving the way for the introduction of the new, CoolMini(TM) applicator, which is designed to treat smaller pockets of fat, including the submental, or chin fat area. The CoolSculpting(R) procedure has demonstrated in over 50 published clinical articles and 4,000 clinical trial patients to non-invasively and consistently reduce unwanted fat and the procedure has been successfully used in over two million treatments to date, according to the company.

The new CoolMini applicator is uniquely designed for small volume areas of fat. The applicator's size, shape and curvature is designed to comfortably fit these small, problem areas. Patients may see results as early as three weeks, with the most dramatic results generally observed one to three months following treatment.

The FDA clearance is based on data from a U.S. pivotal clinical trial involving 60 male and female patients, ranging in age from 22 to 65 years. In the trial, patients received one to two treatments in the area under the chin, each six weeks apart resulting in an average of 20 percent fat reduction, which is in line with results achieved with other CoolSculpting applicators. Additionally, no significant adverse events were observed and patients experienced little to no discomfort or downtime.

"When utilizing the CoolMini applicator, I can generally achieve optimal results in one or two treatments," said Brian Zelickson, MD, Director of Zel Skin & Laser Specialists in Edina, Minnesota. "Moreover, since the CoolSculpting procedure is entirely non-invasive, my patients can typically resume normal activities immediately after treatment."

The accumulation of fat under the chin can be a result of lifestyle, age or genetic factors and—unlike other common problem areas of the body—it cannot be hidden or disguised with clothing. Data from a 2014 study conducted by The American Society for Dermatologic Surgery (ASDS) showed that approximately 68 percent of people were concerned with chin and neck fat; this number increased eight percent from the previous year. Additionally, a recent study conducted in the United States revealed that 22.4 million people are interested in seeking non-invasive fat reduction solutions.

"The outcomes I have observed using the CoolMini applicator to treat the submental area have been extremely positive and this treatment has also demonstrated very high levels of patient satisfaction," said Suzanne Kilmer, MD, Founding Director of the Laser and Skin Surgery Center of Northern California in Sacramento. "The CoolSculpting procedure's predictable results, non-invasive technology, comfort, lack of downtime and affordable pricing make it a very attractive treatment option for patients looking to eliminate unwanted fat."

Over 500 CoolMini treatments have been performed to date as a result of pilot clinical work, clinical trials and our controlled European launch that commenced in June. The results, achieved in as little as one to two office visits, have been very encouraging with very high patient satisfaction and the same level of efficacy achieved with other CoolSculpting applicators.

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