Cynosure Receives FDA 510(k) Clearance for Cellulaze Cellulite Laser Workstation

WESTFORD, Mass., Jan. 30, 2012 /PRNewswire/ -- Cynosure, Inc. (NASDAQ: CYNO) today announced that the U.S. Food and Drug Administration has cleared the Company's Cellulaze™ Workstation for commercial distribution, giving millions of American women the first minimally invasive solution in their battle against cellulite.

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"Cellulaze is the world's first and only minimally invasive medical device designed to treat women who have struggled to eliminate cellulite through diet and exercise, or have tried the myriad of lotions and creams currently on the market," said Cynosure President and Chief Executive Officer Michael Davin. "Unlike those products, Cellulaze is the only aesthetic device that directly treats the physiological structure of cellulite, providing clinically proven, results." 

An estimated 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, the treatment of cellulite is a multibillion-dollar industry, according to market estimates.

Cellulaze reduces cellulite – in just one treatment – by restoring the normal structure of the skin and underlying connective tissue. Cellulaze diminishes the lumpy pockets of fat, releases the areas of skin depression typifying cellulite and increases the elasticity and thickness of the skin.

Nearly four years of clinical research puts Cellulaze in a class of its own: the only single-treatment aesthetic procedure clinically shown to reduce cellulite.  Clinical data has demonstrated that Cellulaze treatments can increase the thickness of the skin by 25% and increase the elasticity of the skin by 29% at one year.  No other anti-cellulite treatment has been proven to deliver these results.

"Based on the scientific data and the patient results we have observed over the past several years of evaluating the device, Cellulaze represents a new and highly effective standard of treatment for cellulite," said Barry E. DiBernardo, MD, a board certified plastic surgeon and Clinical Associate Professor, Department of Surgery, Division of Plastic Surgery, University of Medicine and Dentistry of New Jersey.  Dr. DiBernardo, one of five clinical investigators in a multi-center study of Cellulaze, has published one year results on a subset of the treated patients.[4]

"The study was designed with both traditional, subjective measurements of clinical improvement and new objective, quantitative measures as well.  All of the analysis led to the conclusion that patients treated with Cellulaze maintained results at least one year," said Dr. DiBernardo.

Cellulaze uses a proprietary SideLight 3D™ side-firing technology to target the 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 thickness 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.

Cellulaze is also currently being marketed in Canada, the European Union, Australia and South Korea.  Cynosure is pursuing regulatory approvals in additional international markets.  

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., including those related to the market potential of Cellulaze, 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 market's acceptance of Cellulaze, the global economy and lending environment and their effects on the aesthetic laser industry, Cynosure's 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 and economic, market, technological and other factors discussed in Cynosure's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, which are 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, 596– 603 (2000).

[3] Drealos, Z.D. and Marenus, K.D. Cellulite: etiology and purported treatment. Dermatol. Surg. 23, 1177–1181 (1997).

[4] DiBernardo, BE, "Treatment of Cellulite with One Year Follow-up using a 1440nm pulse laser" Aesthetic Surgery Journal, March 2011

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SOURCE Cynosure, Inc.