WESTFORD, Mass., Feb. 2, 2011 /PRNewswire/ -- Building on the
success of its Smartlipo™ technology for laser lipolysis, Cynosure,
Inc. (Nasdaq: CYNO) today introduced the Cellulaze™ Cellulite Laser
Workstation, the world's first minimally invasive surgical device
designed to reduce cellulite by restoring the normal structure of
the skin and underlying connective tissue. Cellulaze has
recently received CE Mark certification and will be available in
the European Union in the second quarter of 2011. Cynosure (Booth
#2921) will exhibit Cellulaze at the American Academy of
Dermatology's 69th Annual Meeting Feb.
4-8 in New Orleans.
An estimated 85 percent of women over age 20 are affected by
cellulite(1), a degenerative and largely untreated condition in
which dimply herniations and depressions develop within the layers
of the skin.
"Cellulaze is supported by two years of clinical research that
has led to the development of a revolutionary approach that has
been shown to reduce cellulite for 12 months or longer, with a high
level of patient satisfaction," said Cynosure President and Chief
Executive Officer Michael Davin.
"Unlike the non-invasive treatment approaches that aim to
temporarily treat the appearance of cellulite, Cellulaze uses a
three-dimensional approach to directly target the subdermal
structure that forms the foundation of cellulite."
Cellulite is caused by several physiological changes as women
age including: 1) an increase in the number or size of fat cells
pushing up through the tissue beneath the skin; 2) thin connective
tissue under the skin that becomes stretched or distended as a
result of aging or weight gain; and 3) undulations caused by
hardening of tissue underneath the skin.
In the Cellulaze procedure, which is performed under a local
anesthetic, the physician inserts a small cannula -- a narrow tube
the size of the tip of a pen -- under the skin. Cynosure's
proprietary SideLight 3D™ side-firing technology directs
controlled, laser thermal energy to the treatment zones --
typically the buttocks and thighs. The laser is designed to
diminish the lumpy pockets of fat, release the areas of skin
depression and increase the elasticity and thickness of the skin.
Patients require just one treatment.
Patients in one U.S. study demonstrated an average increase in
skin thickness of 23 percent and 27 percent at one month and one
year, respectively, while skin elasticity increased an average of
32.5 percent at one month and 21 percent at one year.
"The cases we have performed with Cellulaze to date demonstrate
a benefit from the use of subcutaneous laser energy in terms of
tissue tightening through tissue coagulation as well as the
regeneration of collagen and connective tissue," said Dr.
Gerhard Sattler, M.D., Cosmetic
Surgeon and Director of the Rosenpark Klinik in Darmstadt,
Germany.
As with Cynosure's minimally invasive Smartlipo MPX and Triplex
workstations, Cellulaze incorporates the company's proprietary
ThermaGuide™ intelligent energy delivery system. ThermaGuide is
designed to provide the physician with the ability to accurately
determine the treatment doses that are likely to provide safer and
more effective tissue tightening through tissue coagulation. In
addition, the temperature-sensing ThermaGuide technology allows the
physician to maintain an even, controlled flow of laser energy.
With CE Mark certification, Cellulaze will be available for sale
to physicians in the European Union in the second quarter of 2011.
Cellulaze will be marketed and sold through Cynosure's European
direct sales force in France,
Germany, Spain, and the United Kingdom, and through international
distributors in other EU countries.
Cellulaze is not available in the
United States. The U.S. Food and Drug Administration (FDA)
has determined that clearance of Cellulaze in the United States requires a 510(k)
submission, which the company has filed in late 2010. The FDA has
approved an Investigational Device Exemption ("IDE") for Cellulaze,
and nearly 100 patients have been treated as part of a clinical IDE
study. Regulatory action on the 510(k) submission is
currently expected in the first half of 2011.
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 and temporarily
reduce the appearance of cellulite. Cynosure's products include a
broad range of laser and other light-based energy sources,
including Alexandrite, pulsed dye, 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 global economy and lending
environment and their effects on the aesthetic laser industry, 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 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) Rawlings, A.V. Cellulite and its treatment. Int. J.
Cosmet. Sci. 28, 175–190 (2006).
Contacts:
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Investors
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Media
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Tim Baker
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Brynn Vitale
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Chief Financial
Officer
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Waggener Edstrom
Worldwide
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Cynosure, Inc.
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(415) 547-7031
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(800) 886-2966
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cynosure@waggeneredstrom.com
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TBaker@cynosure.com
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Scott Solomon
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Vice President
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Sharon Merrill Associates,
Inc.
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(617) 542-5300
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CYNO@investorrelations.com
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SOURCE Cynosure, Inc.