User:CorporateM/Coolsculpting

CoolSculpting is a Cryolipolysis procedure that uses controlled cooling techniques to damage fat cells below the skin.

History
CoolSculpting was originally used as an FDA-approved method to cool and numb a patient's skin before performing dermatological procedures, but many doctors were using it off-label as a Cryolipolysis device. The technology for CoolSculpting as a body sculpting procedure was developed by scientists at the Wellman Center for Photomedicine at Massachusetts General Hospital.

CoolSculpting was cleared by the Food and Drug Administration for flanks (sides) in September 2010 and for stomach fat in 2012. It has also been cleared by Health Canada and the European Union. By late 2010 CoolSculpting had been introduced in Europe, Asia and Canada. It became popular in the United States around 2011. By January 2012, there had been 150,000 CoolSculpting treatments. In 2014, ZELTIQ introduced a new model called CoolSmooth that doesn't use a suction cup and was cleared by the FDA for use on thighs.

Treatment process
The CoolSculpting device is the size of a small fridge. It's moved on wheels and has an attached applicator. A gel sheet is placed on the treatment area and the cup-shaped applicator sucks in a fatty bulge. The fatty bulge is cooled between two panels for one to three hours.

Cryolipolysis
CoolSculpting is based on Cryolipolysis, the practice of using controlled cold exposure to cause shrinkage and eventual death in fat cells, which are then eliminated by the body over the following weeks or months. This is based on the idea that fat tissue is more vulnerable to cold than surrounding skin or organs. The procedure is intended for reducing a discrete fat bulge and not for general weight loss.

Research
Early experiments on pigs with a prototype CoolSculpting device found that ten-minute cold applications between 20 to -7 degrees celsius led to a 40% reduction of the subcutaneous fat layer over 3.5 months following treatment, without damaging the skin surface.

In a recent study, an ultrasound measurement found that a CoolSculpting treatment resulted in a 22.4 percent reduction in the fat layer. Out of the 32 patients that were evaluated, the best results were from those with "localized discrete fat bulges". According to cosmetic dermatologist Dr. Marc Avram, CoolSculpting is safe and noninvasive, but can cause numbness or pain in the treated area.

In 2009, a study of ten patients using ultrasound measurements, published in Cutaneous Medicine and Surgery, found that the ten patients evaluated lost an average of 20% of their fat layer four months after treatment. They experienced "mild side effects" such as bruising and numbness, which subsided in about one week.

According to an article in Lasers in Surgery Medicine, since the procedure was approved by the FDA in 2010, "several studies have demonstrated the safety and efficacy of cryolopolysis. In a ten-person study, subjects experienced an average 20.4 percent reduction in their fat layer in the treated area after three months and 25.5% after six months, using ultrasound measurements. A larger study using caliper measurements found an average 25% reduction.

ZELTIQ
The CoolSculpting procedure is marketed and licensed by ZELTIQ Aesthetics Inc., a public company based in Pleasanton, California. ZELTIQ's revenues come from selling CoolSculpting equipment and from a fee doctors pay for each treatment they perform. The Massachusetts General Hospital owns the CoolSculpting patents, and has an exclusive licensing agreement with ZELTIQ.

ZELTIQ was founded in 2005 as Juniper Medical, Inc. and was renamed to ZELTIQ Aesthetics in July 2007. It had four funding rounds by 2010, raising $50 million. In 2011 the company filed for an initial public offering. At the time of the IPO, the company was not yet profitable, but revenues had been increasing significantly. The IPO raised $91 million. According to Investors Business Daily there was a "shakeup" in 2012, with new management and changes in corporate structure that prompted business growth.