Cynosure Receives FDA Clearance for Smartlipo(TM) System
November 09 2006 - 1:42PM
PR Newswire (US)
First and Only Laser-Assisted Lipolysis Device Available in U.S.
WESTFORD, Mass., Nov. 9 /PRNewswire-FirstCall/ -- Cynosure, Inc.
(NASDAQ:CYNO), a leading developer and manufacturer of a broad
array of light-based aesthetic treatment systems, today announced
it has received clearance from the U.S. Food and Drug
Administration for its Smartlipo(TM) system for laser assisted
lipolysis, or LaserBodySculpting(SM), a procedure that disrupts fat
cells and causes coagulation of the tissue leading to skin
tightening. The Smartlipo system provides aesthetic surgeons a new,
less- invasive method for reducing fat cells. Cynosure believes the
demand for liposuction and body sculpting procedures that remove or
reduce fat cells is increasing. For example, nearly 500,000
liposuction procedures were performed in the U.S. in 2005, making
it the number one surgical cosmetic procedure among both women and
men according to the American Society for Aesthetic Plastic Surgery
(ASAPS). "I believe that the Smartlipo system is particularly
useful for treating areas with localized fat deposits. In addition
to disrupting fat, it coagulates and tightens tissue," said Bruce
Katz, MD, Clinical Professor at Mt. Sinai School of Medicine and
Medical Director of JUVA Skin and Laser Center in New York City.
"We have seen excellent results with this new laser lipolysis
procedure." The LaserBodySculpting uses a small cannula, or tube,
containing a laser fiber that is inserted into the skin and passed
throughout the treatment area. The laser's energy is applied
directly to the fat cells, causing them to rupture and drain away.
Treatments with the Smartlipo system generally result in less
swelling and bleeding as compared to traditional liposuction
methods and can usually be performed in one 45-minute session. "The
Smartlipo laser lipolysis is a minimally invasive procedure that is
well suited for the treatment of small areas," said Karen Kim, MD,
a board- certified dermatologist at the Laser Skin and Surgery
Center of New York. "Our early clinical trials suggest that
patients experience rapid healing with little tissue trauma.
Post-operative results can be seen as soon as one week, with
continued improvement over several months." Cynosure Chairman and
Chief Executive Officer Michael R. Davin said, "We are pleased with
receiving the FDA clearance ahead of our projected timeline. We are
excited to have the exclusive North American distribution rights
for this product and expect to launch the Smartlipo system in 2007.
The addition of the Smartlipo system to Cynosure's award-winning
product suite furthers our ability to provide the aesthetic
treatment systems market with diverse tools to enhance our
customers' businesses and practices. We believe there will be
continued growth in the laser body sculpting and liposuction market
as innovative technologies, such as the Smartlipo system, is
introduced to meet this growing market." About Cynosure, Inc.
Cynosure, Inc. develops and markets aesthetic treatment systems
that are used by physicians and other practitioners to perform
non-invasive procedures to remove hair, treat vascular lesions,
rejuvenate skin through the treatment of shallow vascular and
pigmented lesions 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
http://www.cynosurelaser.com/. Any statements in this press release
about future expectations, plans and prospects for Cynosure, Inc.,
including statements about the growth in the laser body sculpting
and liposuction market, market acceptance and consumer demand for
LaserBodySculpting, Cynosure's ability to successfully market and
sell the Smartlipo system, and 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 our history of operating losses, our reliance on
sole source suppliers, competition in the aesthetic laser industry,
economic, market, technological and other factors discussed in
Cynosure's Annual Report on Form 10-K filed with the SEC. 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. DATASOURCE: Cynosure, Inc. CONTACT:
Scott Solomon, Vice President of Sharon Merrill Associates, Inc.
for Cynosure, Inc., +1-617-542-5300, or Web site:
http://www.cynosurelaser.com/
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