FDA approves Allergan's CoolTone device for toning up abdomen, buttocks and thighs

The U.S. Food and Drug Administration has approved Allergan Plc's CoolTone device for use in strengthening, toning and firming the abdominal area, buttocks and thighs, Allergan said Monday. CoolTone uses magnetic muscle stimulation to penetrate muscle layers, which then causes involuntary muscle contractions. The body responds to the contractions by strengthening muscle fibers, leading to increased muscle tone. The drugmaker said CoolTone has 50% more magnetic intensity than the leading competitor, but that claim has not been clinically established. Allergan also makes the CoolSculpting device, a non-surgical fat-elimination device that works by freezing and killing fat cells in targeted areas like the abdomen, flanks or under the chin. Shares of the drugmaker have fallen 3.4% so far this year, but were down as much as 12.5% in June before buzz of a possible company split helped bolster the stock price. Allergan has been dealing with some significant issues in the past year -- investors are worried about the future of Botox, the company's biggest earner, as it faces competition in the anti-wrinkle and injectable migraine treatment markets. Investors were also rattled by the failure of depression drug rapastinel -- once considered by many to be Allergan's next big blockbuster drug -- in clinical trials earlier this year. In May, Chief Executive Brent Saunders said he had heard investors' concerns "loud and clear," adding that "everything is on the table," including the possibility of splitting the company up.

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