Cellulaze_510(k)_1_30_2012

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Contact: Investors Media Scott Solomon Behrman Communications Sharon Merrill Associates, Inc. 212.986.7000 617.542.5300 [email protected] Cynosure Receives FDA 510(k) Clearance for Cellulaze Cellulite Laser Workstation World’s First Minimally Invasive Aesthetic Device for Cellulite Reduction Westford, Mass., January 30, 2012Cynosure, 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. “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. 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, 1177 1181 (1997).

description

FDA approved for cellulite. Minimally-invasive cellulite reduction. Cottage-cheese BEGONE!

Transcript of Cellulaze_510(k)_1_30_2012

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Contact: Investors Media Scott Solomon Behrman Communications Sharon Merrill Associates, Inc. 212.986.7000 617.542.5300 [email protected]

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

World’s First Minimally Invasive Aesthetic Device for Cellulite Reduction

Westford, Mass., January 30, 2012– 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.

“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 201,2 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.

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).

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“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.

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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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.

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