Welcome relief for millions of men and women dealing with one of the most exercise and diet-resistant problem areas – “belly fat” – as CoolSculpting, developed by ZELTIQ® Aesthetics, Inc. (Nasdaq: ZLTQ), a medical technology company, is now cleared by the U.S. Food and Drug Administration (FDA) for the non-surgical reduction of fat for the abdomen area. This is the latest clearance for the company, which received FDA clearance for non-surgical reduction of fat for the flank area (or love handles) in September 2010.
Abdomen Before & After treated with CoolSculptng (Photo: Business Wire)
“Securing FDA clearance for fat reduction of the abdomen is a significant event for ZELTIQ,” said Mark Foley, Interim President and Chief Executive Officer. “This achievement underscores the company’s commitment to expanding current treatment opportunities,” Mr. Foley continued.
In the battle to look one’s best, CoolSculpting has been clinically shown to reduce fat in the treated area without surgery or the downtime. In a recent study of CoolSculpting physicians, 95 percent of patients who had just one CoolSculpting treatment were satisfied with the reduction of fat in the treated area, and because it is so effective patients have been very keen on returning for additional CoolSculpting treatments in other areas or for a more pronounced reduction in the same area. In a nationwide survey of adults, 59 percent reported the abdomen is the area of the body they are most interested in having treated with CoolSculpting. 1
A problem area for men and women alike, the midsection of the body is the most common area people want to change about themselves. According to a body image study in Fitness Magazine, 48 percent of men and 36 percent of women chose “abs” as being the body part they are most unhappy with – almost three times more than any other trouble zone. While men are more likely to gain weight around the waistline2, many women have to contend with accumulated belly fat, known as a “post pregnancy pooch,” after having babies. In both scenarios, exercise alone is often not sufficient to get the desired results.
“When diet and exercise just are not enough to lose stubborn fat in the abdominal area of the body, CoolSculpting is a great option for patients to achieve the shape they want without the discomfort, expense and down time of more invasive procedures,” said Dr. Jeffrey S. Dover, a board certified dermatologist, Associate Clinical Professor of Dermatology at Yale University School of Medicine, and Co-Director of SkinCare Physicians. “Even if people lead generally healthy lifestyles, there are always going to be contributing factors we have no control over such as age, gender, body shape, hormones and genetics. Having a little extra help can be a much needed answer for many people.”
Each CoolSculpting treatment typically results in an undeniable reduction of fat in the treated areas. Patients typically start to see results as soon as three weeks following treatment, with the most dramatic results occurring over a period of two to four months. As part of the clinical study submitted to the FDA, four out of five doctors correctly identified before and after photos in an independent, blinded photo evaluation.
Unlike most other methods of fat reduction that use heat, CoolSculpting cools fat cells to temperatures that trigger their natural death, shrinking the cells that are then eliminated naturally by the body over the following weeks and months. During the procedure, a non-surgical applicator delivers precisely controlled cooling to the treatment area to specifically target underlying fat, without damaging the skin. CoolSculpting does not involve needles, surgery, pain medication or downtime. Patients typically return to normal activities immediately following treatment, which lasts one to two hours.
Developed at the Wellman Center for Photomedicine at Massachusetts General Hospital in Boston, a teaching affiliate of Harvard Medical School, the CoolSculpting breakthrough is based on extensive scientific research that demonstrates that fat cells are particularly susceptible to cold and are selectively and permanently destroyed. This process is known as Cryolipolysis (cold lipolysis). Starting several weeks after the procedure, cooled fat cells begin a process called apoptosis (natural cell death) and begin to shrink and disappear. Comprehensive multi-center clinical studies submitted to the FDA validated that CoolSculpting kills fat cells in the area treated based on independent blind photo reviews and ultrasound assessments.
CoolSculpting is available through an elite network of CoolSculpting Centers across the U.S., and more than 300,000 treatments have been performed worldwide.
CoolSculpting is not intended as a weight-reduction program for overweight individuals. The best candidates for the CoolSculpting procedure are people near their ideal body weight who eat well and exercise regularly and have fat bulges that have not responded to a healthy lifestyle. They are seeking long-lasting removal of these exercise-resistant fat areas without the need for surgery which has associated cost, safety and recovery limitations.
CoolSculpting® is a non-surgical, clinically proven procedure designed to selectively reduce fat bulges in problem areas using a patented cooling technology. Physicians report a 95 percent satisfaction rate3. It is a procedure cleared by the FDA that gently cools unwanted fat cells in the body to induce a natural, controlled elimination of fat cells. It is designed to reduce fat bulges in treated areas of the body without harming surrounding tissue. CoolSculpting is available through an elite network of CoolSculpting Centers worldwide. Dermatologists, plastic surgeons and leading aesthetic specialists that offer CoolSculpting can be found at www.coolsculpting.com.
ZELTIQ® Aesthetics, Inc. (Nasdaq: ZLTQ) 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 bulges that may not respond to diet or exercise. CoolSculpting is based on the scientific principle that fat cells are more sensitive to cold than the overlying skin and surrounding tissues. CoolSculpting 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 CoolSculpting to safely, noticeably, and measurably reduce the fat layer within a treated fat bulge without requiring the patient to diet or exercise.
1Data on file.
2Mayo Clinic – www.mayoclinic.com/health/belly-fat/MC00054
3As reported by physicians; data on file.
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