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, 596–603
(2000).
(3) Drealos, Z.D. and Marenus, K.D. Cellulite: etiology and
purported treatment. Dermatol. Surg. 23, 1177–1181 (1997).
Timothy Baker
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Scott Solomon
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Executive VP, Treasurer and
CFO
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Vice President
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Cynosure, Inc.
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Sharon Merrill
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978.256.4200
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617.542.5300
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TBaker@cynosure.com
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CYNO@investorrelations.com
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SOURCE Cynosure, Inc.