ZELTIQ Announces FDA Clearance to Treat Thighs
April 14 2014 - 8:30AM
Marketwired
ZELTIQ Announces FDA Clearance to Treat Thighs
Newest Indication Adds Thighs to List of Problem Areas
Successfully Treated by CoolSculpting(R) Procedure
PLEASANTON, CA--(Marketwired - Apr 14, 2014) - ZELTIQ
Aesthetics, Inc. (NASDAQ: ZLTQ), a medical technology company
focused on developing and commercializing products utilizing its
proprietary controlled-cooling technology, today announced it has
received U.S. Food and Drug Administration (FDA) clearance to
treat the thigh area with its entire suite of applicators. The
CoolSculpting procedure is a clinically proven, non-surgical
procedure that reduces fat in the treated area for good, and is
already FDA cleared to treat the abdomen and flanks.
The CoolSmooth™ applicator features non-vacuum based cooling
that easily treats non-pinchable fat bulges, such as the outer
thigh, and the comfortable design adjusts to fit each individual
patient. In a recent CoolSmooth clinical study where patients
received unilateral outer thigh treatments, 86% of patients noticed
visible fat reduction after just one treatment and 86% of patients
were satisfied with their results. Of note, 89% of patients said
they would recommend CoolSculpting to a friend1. Combining the
CoolSmooth applicator with the CoolFit applicator, launched last
year and designed to treat longer fat bulges and hard-to-reach
areas such as the inner thigh, the CoolSculpting procedure can now
treat the complete thigh area.
"We are extremely pleased to receive FDA clearance to treat the
thigh, as we know how many individuals struggle with reducing fat
in this difficult-to-treat part of the body -- in fact, a recent
market research study revealed that in the United States, 7.2
million people expressed an interest in CoolSculpting as a solution
for inner or outer thigh fat2," said Mark Foley, President and
Chief Executive Officer of ZELTIQ. "This FDA clearance adds to the
growing body of evidence demonstrating the safety, efficacy and
long-lasting results of the CoolSculpting procedure across
expanding indications, which we believe will help attract new
physician customers. We are excited to be able to expand our
offering to both new and existing physicians and, ultimately, the
many individuals who may benefit from our unique technology.
We started taking pre-orders for this device in the first quarter
and saw stronger than expected customer demand. In
anticipation of this clearance and increased demand, we have been
ramping up our inventory and manufacturing efforts for both the new
CoolSmooth applicator and the existing CoolSculpting system and are
pleased to begin initial shipments of the CoolSmooth applicator
today."
Grant Stevens, MD, medical director of Marina Plastic Surgery in
Marina del Rey, California, said, "In my practice, I have seen a
growing number of patients who, despite leading a healthy lifestyle
through diet and exercise, cannot eliminate stubborn fat on certain
parts of their bodies, and the thigh ranks high on the list of
target spots they wish to treat. Being able to perform this
procedure on three of the most challenging parts of the
body -- the abdomen, flank and now thighs -- presents
additional opportunities for my patients who want to improve the
contour of their bodies without surgery."
Suzanne L. Kilmer, MD, director of the Laser and Skin Surgery
Center of Northern California in Sacramento, California, added, "As
a long-time user of the CoolSculpting system, I have personally
seen the reproducible, consistent results and high patient
satisfaction it can deliver. With the CoolSmooth applicator, I can
now confidently treat thighs and other non-pinchable fat bulges
knowing that it can reliably deliver the same results and
satisfaction associated with the CoolSculpting procedure."
With this new indication, thighs join the abdomen and flank as
parts of the body successfully treated by the CoolSculpting
procedure. A recent market research study revealed that 7.2 million
people expressed an interest in CoolSculpting as a solution for
outer thigh fat2. This is in addition to the 13.2 million and 7.4
million interested in undergoing the CoolSculpting treatment for
the abdomen and flank3, respectively.
In the United States, the CoolSculpting procedure is cleared for
non-invasive fat reduction in the abdomen, flank and thigh. In
other international markets, it is cleared for general non-invasive
fat reduction. The CoolSculpting treatment results in a noticeable
reduction of fat in the treated areas, and the treated fat is gone
for good. Most patients can start to see results as soon as 3 weeks
following treatment, with the most dramatic results occurring over
a period of 1-3 months. Every patient is unique, which is why
ZELTIQ recommends a customized treatment plan as part of the
initial consultation. Additional treatments in the same or multiple
areas may enhance the desired aesthetic effect.
About the CoolSculpting® Procedure The CoolSculpting procedure
is a non-surgical, clinically proven procedure that selectively
reduces fat bulges in problem areas using a patented cooling
technology. Cleared by the FDA for noninvasive fat reduction in the
abdomen and flank, it gently cools unwanted fat cells in the body
to induce a natural, controlled elimination of fat cell without
harming surrounding tissue, and the treated fat cells are gone for
good. Over 1,000,000 CoolSculpting cycles and 2,200 systems have
been shipped to more than 60 countries. The CoolSculpting procedure
is available through an elite network of CoolSculpting Centers
worldwide. Dermatologists, plastic surgeons and leading aesthetic
specialists that offer CoolSculpting can be found at
www.coolsculpting.com.
Be sure to follow CoolSculpting on Facebook, Twitter, Pinterest
and YouTube.
About ZELTIQ® Aesthetics, Inc. ZELTIQ Aesthetics, Inc. is a
medical technology company focused on developing and
commercializing products utilizing its proprietary
controlled-cooling technology platform. ZELTIQ's first commercial
product, the CoolSculpting system, is designed to selectively
reduce stubborn fat that may not respond to diet or exercise. The
CoolSculpting procedure is based on the scientific principle that
fat cells are more sensitive to cold than the overlying skin and
surrounding tissues. It utilizes patented technology of precisely
controlled cooling to reduce the temperature of fat cells in the
treated area, which is intended to cause fat cell elimination
through a natural biological process known as apoptosis. ZELTIQ
developed the CoolSculpting procedure to safely, noticeably, and
measurably reduce the fat layer.
1, 2, 3 Data on file
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