Thermage(R), Inc.
(Nasdaq: THRM) today announced that the Food & Drug Administration (FDA)
provided a first-time-ever 510 (k) clearance for the non-invasive treatment
of periorbital wrinkles and rhytids, including upper and lower eyelids.
Thermage’s proprietary ThermaCool(R) system, utilizing customized
ThermaTip(TM) treatment tips, is the only medical device in the
non-invasive skin tightening category with this clearance.
“Thermage is the first and only company to receive FDA clearance for
non-invasive eyelid treatments,” said Stephen J. Fanning, president and
chief executive officer at Thermage. “We believe that the clinical data
supporting this milestone further defines Thermage as the gold standard in
non-invasive skin tightening and contouring, differentiating our
technology, safety profile and efficacy from other companies in the
aesthetic market.”
Eyes by Thermage(TM) is one of several treatment procedures provided by
Thermage. The procedure was launched in March 2006 under the FDA general
clearance for the non-invasive treatment of wrinkles and rhytids. This
exclusive treatment reduces hooding, improves skin texture and tone, and
smoothes the eye area. To date, more than 20,000 procedures have been
completed worldwide and clinicians in 27 countries have been trained on
Eyes by Thermage with approved procedure guidelines. The specific FDA
clearance for eyelids is based on a multi-center clinical study conducted
in the United States and Canada.
“This is a landmark event in the non-invasive aesthetics industry as no
other device has a specific eyelid indication,” said Brian Biesman, M.D.
Consumers are seeking cosmetic improvements but due to demanding
lifestyles, downtime is often not an option. According to recent reports
from the American Society for Aesthetic Plastic Surgery, non-invasive
aesthetic procedures are a rapidly growing alternative to cosmetic surgery
with eyelid surgery as one of the top five procedures performed during
2006. Physicians can now be assured that by offering patients Eyes by
Thermage, the only FDA cleared non-invasive alternative to eyelid surgery,
they are providing an effective and desired treatment for the reduction of
wrinkles.
About Thermage, Inc.
Thermage’s innovative technology provides a unique non-invasive
procedure designed to tighten and contour skin, significantly expanding the
non-invasive aesthetic applications physicians can offer to the rapidly
growing “anti-aging” market. The company commercially launched its flagship
ThermaCool(R) system in 2002 when it received clearance from the U.S. Food
& Drug Administration. Today, the ThermaCool system is available in 80
countries; more than 400,000 patients have been treated with Thermage and
approximately 2,000 dermatologists, plastic surgeons and other cosmetic
physicians are using the Thermage(R) procedure worldwide.
This press release contains forward-looking statements within the
meaning of the U.S. Private Securities Litigation Reform Act of 1995.
Specifically, statements concerning our belief that we are the gold
standard of non-invasive skin tightening and contouring and our estimate of
the number of Eyes by Thermage(TM) procedures performed constitute such
forward-looking statements. Forward-looking statements are based on
management’s current, preliminary expectations and are subject to risks and
uncertainties, which may cause Thermage’s actual results to differ
materially from the statements contained herein. Actual results may be
affected by a number of factors, including the introduction of other
medical devices for the non-invasive treatment of eyelids. Further
information on potential risk factors that could affect Thermage’s business
are detailed in the Company’s Form 10-Q for the period ended March 31,
2007. Undue reliance should not be placed on forward-looking statements,
which speaks only as of the date they are made. Thermage undertakes no
obligation to update publicly any forward-looking statements to reflect new
information, events or circumstances after the date they were made, or to
reflect the occurrence of unanticipated events.
Thermage and ThermaCool are registered trademarks of Thermage, Inc.
ThermaTip and Eyes by Thermage are trademarks of Thermage, Inc.
Thermage, Inc.
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