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

WESTFORD, Mass., Nov. 30, 2011 /PRNewswire/ -- Cynosure, Inc. (NASDAQ: CYNO), 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.

About Cynosure, Inc.
Cynosure, Inc. develops and markets aesthetic treatment systems that are used by physicians and other practitioners to perform non-invasive and minimally invasive procedures to remove hair, treat vascular and pigmented lesions, rejuvenate the skin, liquefy and remove unwanted fat through laser lipolysis, reduce the appearance of cellulite and treat Onychomycosis. Cynosure’s products include a broad range of laser and other light-based energy sources, including Alexandrite, pulse dye, Q-switched, Nd:YAG and diode lasers, as well as intense pulsed light. Cynosure was founded in 1991. For corporate or product information, contact Cynosure at 800-886-2966, or visit www.cynosure.com.

Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Cynosure, Inc., as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the global economy and lending environment and their effects on the aesthetic laser industry, Cynosure’s history of operating losses, its reliance on sole source suppliers, the inability to accurately predict the timing or outcome of regulatory decisions, changes in consumer preferences, competition in the aesthetic laser industry, economic, market, technological and other factors discussed in Cynosure’s most recent Annual Report on Form 10-K, which is filed with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Cynosure’s views as of the date of this press release. Cynosure anticipates that subsequent events and developments will cause its views to change. However, while Cynosure may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Cynosure’s views as of any date subsequent to the date of this press release.

(1) Harvard Women‘s Health Watch Cellulite meltdown. Harv. Health Pub. Group 5, 7 (1998).
(2) Sainio, E.L., Rantanen, T. and Kanerva, L. Ingredients and safety of cellulite creams. Eur. J. Dermatol. 10, 596603 (2000).
(3) Drealos, Z.D. and Marenus, K.D. Cellulite: etiology and purported treatment. Dermatol. Surg. 23, 11771181 (1997).

SOURCE Cynosure, Inc.