ZELTIQ® Receives FDA Clearance to Perform CoolSculpting® Procedure at Lower Temperatures for Shorter Treatment Times
January 29 2015 - 8:30AM
Business Wire
New Treatment Parameters Provide Significant
Time Savings with Same Patient Outcomes
Company Will Launch New CoolSmooth PRO™
Applicator in Conjunction with This Clearance
ZELTIQ® Aesthetics, Inc. (NASDAQ: ZLTQ), a medical
technology company focused on developing and commercializing
products utilizing its proprietary controlled-cooling technology
platform, today announced that it has received Food and Drug
Administration (FDA) clearance to perform the CoolSculpting®
procedure at lower temperatures, which will enable shorter
treatment times. In conjunction with this clearance, ZELTIQ will be
introducing a brand new applicator, CoolSmooth PRO™, which is a
second generation surface applicator that features non-vacuum based
cooling to treat non-pinchable fat bulges, such as the outer thigh
area.
“This FDA clearance will enable healthcare professionals to
perform the CoolSmooth procedure in nearly half the time with the
same outcomes, which will significantly enhance the procedural
efficiency and profitability for the practice while also improving
the patient experience,” said Mark Foley, President and Chief
Executive Officer of ZELTIQ. “Through an ongoing investment in
R&D and technological innovation, we are pleased to continue to
provide our CoolSculpting partners with differentiated solutions
that enhance their treatment options. And, we look forward to
applying this technological advancement to our other CoolSculpting
applicators in the future.”
The FDA clearance is based on clinical study data
demonstrating that optimized temperatures enable
shorter treatment times with equivalent benefits, safety,
efficacy and customer satisfaction, when compared to current
CoolSculpting procedures.
The new treatment parameters will initially be offered with the
CoolSmooth PRO applicator, which is uniquely designed to safely
control treatments at colder temperatures. The CoolSmooth PRO
applicator also includes an enhanced strapping system that provides
increased conformity at the treatment site, while also improving
ease of use and patient comfort.
The CoolSmooth PRO will be available in Q2 of this year and
ZELTIQ plans to offer current CoolSmooth customers an exchange
program to facilitate access to the new technology.
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, flank and thighs, it
gently cools unwanted fat cells in the body to induce a natural,
controlled elimination of fat cells without harming surrounding
tissue, and the treated fat cells are gone for good. Nearly 1.5
million CoolSculpting treatments have been performed in over 70
countries around the world. The CoolSculpting procedure is
available through an elite network of CoolSculpting Centers
worldwide. Dermatologists, plastic surgeons and leading aesthetic
specialists that offer the CoolSculpting procedure can be found at
www.coolsculpting.com. Be sure to follow the CoolSculpting
procedure 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.
Forward-Looking
Statements
The statements made in this press release regarding the expected
performance and benefits of CoolSmooth PRO to patients and medical
practices, and the timing of the introduction of CoolSmooth PRO,
are forward-looking statements. The word "will" is used to identify
these forward-looking statements. You should not place undue
reliance on these forward-looking statements because they involve
known and unknown risks, uncertainties and other factors that are,
in some cases, beyond ZELTIQ's control, including, but are not
limited to: physician and patient demand for the new CoolSculpting
procedure using CoolSmooth PRO may be lower than ZELTIQ expects;
technical difficulties may be experienced in the finalization of
the introduction of CoolSmooth PRO may be encountered, which could
delay or prevent the introduction of CoolSmooth PRO; as well as
those other risks and uncertainties set forth in ZELTIQ's Quarterly
Report on Form 10-Q for the third quarter ended September 30, 2014,
filed with the SEC on October 28, 2014. These forward-looking
statements speak only as of the date of this press release. ZELTIQ
expressly disclaims any obligation to update information contained
in these forward-looking statements whether as a result of new
information, future events or otherwise.
IC1869-A
GOLD PR for ZELTIQShari Gold, 714-251-0375sgold@goldpr.com
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