Cynosure's Cellulaze Cellulite Laser Work Station Receives Korean Regulatory Approval

Date Announced: 30 Nov 2011

Company Continues to Expand Geographic Reach of Minimally Invasive Technology for the Long-Term Reduction of Cellulite.

WESTFORD, Mass. , Nov. 30, 2011 /PRNewswire/ -- Cynosure, Inc. (NASDAQ: CYNO - News), a leader in laser- and light-based treatments for minimally invasive and non-invasive aesthetic applications, today announced that it has received market approval from the Korea Food & Drug Administration (KFDA) for its Cellulaze™ Cellulite Laser Workstation. Sales through Cynosure Korea, the Company's wholly owned subsidiary in Seoul, Korea , are expected to begin in the first quarter of 2012.

Cellulaze is the world's first minimally invasive aesthetic device designed for the long-term reduction of cellulite. The product received CE Mark certification in February 2011 , and is currently being marketed in the European Union. Cellulaze also is cleared for marketing in Australia and Canada . Cynosure's 510(k) application for marketing clearance of Cellulaze in the United States is being reviewed by the U.S. Food and Drug Administration.

"Success in international markets remains key to our long-term growth strategy," said Michael Davin , Cynosure's president and chief executive officer. "The KFDA's approval of Cellulaze reflects both the increasing global adoption of this highly effective solution for long-term cellulite reduction, and our ongoing progress in bringing Cynosure's innovative technology to consumers worldwide."

Approximately 85% of women over the age of 20(1,2) have some form of cellulite – pockets of fat deposited just beneath the surface of the skin, around the hips, thighs, and buttocks, which produces an "orange-peel" or a "cottage cheese" appearance(3). In the United States alone, treatment of cellulite is a multibillion-dollar industry, according to market estimates.

Cellulaze uses a proprietary SideLight 3D™ side-firing technology to target the exact causes of cellulite beneath the skin: herniated pockets of fat, stiffened septae and thin skin. During the procedure, a tiny laser fiber is inserted under the skin, which gently heats the skin and disrupts or melts the fat. Next the laser releases the fibrous bands that create the dimpling effect from pulling down on the skin. This release creates a smoother look. Finally the laser's energy stimulates collagen production to increase skin's depth and elasticity for a more even, healthier appearance.

Patients usually see improvements within a few weeks, with the most significant results continuing to develop for a few months following the procedure. Cellulaze also complements other body shaping technologies, such as Cynosure's Smartlipo™ family of workstations. Together, these technologies synergistically deliver the benefits of cellulite reduction and skin tightening through tissue coagulation.

Source: Cynosure

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