Cynosure Receives FDA Clearance for PicoSure™, the First Picosecond
Device to Remove Tattoos and Benign Pigmented Lesions
WESTFORD, Mass., Dec. 4, 2012 /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 FDA 510(k) clearance to market
the PicoSure™ laser workstation for the removal of tattoos and
benign pigmented lesions. The Company expects to sell PicoSure
initially through its U.S. direct sales force to aesthetic
dermatologists and plastic surgeons beginning in early 2013.
(Photo:
http://photos.prnewswire.com/prnh/20121204/NY23390)
"FDA clearance of PicoSure is a major milestone that caps nearly
a decade of research and development at Cynosure to commercialize
the world's first safe and effective picosecond aesthetic laser
specifically designed for the removal of tattoos and benign
pigmented lesions," said President and CEO Michael Davin. "PicoSure accomplishes this by
delivering short-pulse bursts of energy to the skin in
trillionths of a second. With data indicating that an
estimated 20 percent of the 45 million Americans with at least one
tattoo want to have it removed, the FDA clearance of PicoSure
creates a first-mover advantage for Cynosure to treat a large and
vastly underserved market."
Roy Geronemus, M.D., Director of
the Laser & Skin Surgery Center of New York, performed a study in which 22
subjects with multicolored and recalcitrant tattoos were treated
with PicoSure over a two-week period. The results
demonstrated greater than 80% overall tattoo clearance. On average,
94% clearance was achieved for blue and green ink.
"The picosecond laser's shorter pulse duration erases tattoo
pigment more efficiently, leading to a higher level of patient
satisfaction and improved results compared with current nanosecond
technology," Dr. Geronemus said. "Our study shows that picosecond
technology more effectively targets blue and green pigment, which
is typically difficult to remove. In addition, PicoSure more
rapidly lightens other colors, with improved recovery time due to
less collateral injury to the surrounding tissue."
Boston dermatologists
Kenneth A. Arndt, M.D. and
Jeffrey Dover, M.D., Directors of
SkinCare Physicians in Chestnut Hill,
Massachusetts, called PicoSure "the most dramatic
improvement in the treatment of tattoos and pigmented lesions in
more than two decades" and said they expected the product to
rapidly become the "first-in-class treatment" for these
indications.
A study led by Drs. Arndt and Dover focused on demonstrating
that treatment with a picosecond laser improved clearance of benign
pigmented lesions and tattoos with reduced side effects and fewer
treatments than other lasers. A total of 15 subjects with
tattoos and five subjects with benign pigmented lesions were
enrolled in the study. Follow-up was conducted at one month and
three months after the last treatment. The study found that
100% of the pigmented lesions were cleared by two treatments, and
that tattoo clearance of greater than 75% was achieved in 75% of
patients within three to four treatments.
"PicoSure delivers photothermal and significant photomechanical
effects to the tattoo or pigmented lesion while leaving the
surrounding tissue unheated," Dr. Arndt said. "The speed of the
picosecond laser makes this technology ideal for aesthetic
applications in which large photomechanical stresses are applied to
a particular target."
Davin concluded, "Our multi-year investment in PicoSure reflects
our commitment to innovate and develop industry-leading technology.
We continue to build a broad intellectual property portfolio
targeting a range of high-volume aesthetic applications."
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, remove multi-colored tattoos,
rejuvenate the skin, liquefy and remove unwanted fat through laser
lipolysis, reduce 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 statements about commercialization or
potential market acceptance of PicoSure, 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 levels of
demand for procedures performed with Cynosure products and for
Cynosure products themselves, Cynosure's ability to maintain its
profitability, competition in the aesthetic laser industry, general
business and economic conditions, effects of acquisitions that
Cynosure has made or may make, Cynosure's ability to develop and
commercialize new products, Cynosure's reliance on sole source
suppliers, the inability to accurately predict the timing or
outcome of regulatory decisions, and economic, market,
technological and other factors discussed in Cynosure's most recent
Quarterly Report on Form 10-Q, 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, although 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.
SOURCE Cynosure, Inc.