WAYLAND, Mass., July 18, 2016 /PRNewswire/ -- Syneron Medical
Ltd. (NASDAQ: ELOS), a leading global aesthetic device company,
announces the U.S. Food and Drug Administration (FDA) clearance of
its non-invasive fat destruction device, UltraShape Power™. The FDA
clearance is for non-invasive reduction of abdominal circumference
via fat cell destruction.
UltraShape Power uses focused, pulsed mechanical ultrasound
energy to target and destroy fat, offering measurable fat reduction
to the abdominal area. UltraShape Power's advanced USculpt
transducer delivers 20% more energy than its predecessor. A recent
clinical study with UltraShape Power's USculpt transducer documents
a 32% reduction in subcutaneous fat thickness, positioning
UltraShape Power as a powerful solution for non-invasive fat
reduction.
"UltraShape Power represents the latest advancement in
non-thermal focused ultrasound for fat destruction. The device's
unique deployment of higher acoustic energy via its new transducer
allows for the precise targeting of small and large pockets of fat
with minimal increase in tissue temperature, resulting in a
comfortable treatment experience. The outcomes observed using
UltraShape Power have been positive and our patient experience has
been very satisfactory," says Suzanne
Kilmer, MD, FAAD, Founding Director of the Laser & Skin
Surgery Center of Northern
California.
UltraShape Power's ultrasound energy is applied to the skin in a
proprietary pulse structure to ensure effective fat destruction
with no damage to surrounding tissue including blood vessels,
nerves and muscles, resulting in a safe and comfortable treatment
experience. UltraShape Power's lighter transducer for high
maneuverability enables the customized treatment of large and small
fat pockets. The device also incorporates a sophisticated treatment
and patient management software package combined with flexible
communication options.
"The new UltraShape Power system allows for fully customizable
treatments that meet the unique needs of each patient," says
Alix Charles, M.D., FAAD, clinical
trial investigator, from Dupage Medical Group, Hinsdale, IL. "The clinical studies show a
pain score of less than one out of a ten point scale, and my
patients have experienced similar comfort levels."
"We are pleased to announce that we have received FDA clearance
for UltraShape Power in the US. UltraShape Power's strong
market acceptance since its launch in the second quarter 2016
outside of the U.S. has been driven by its powerful non-invasive
fat reduction capability, patient comfort and an emphasis on ease
of use. We believe that this new generation of UltraShape will have
a significant impact on our ability to continue building our global
leadership position in the fast growing, non-invasive fat
destruction market," says Amit Meridor, CEO of Syneron Candela.
Discussing the third quarter 2016 market launch of the
UltraShape Power in the United
States, Jeff Nardoci,
President, North American Body Group says, "We look forward to
launching our new UltraShape Power campaign following the ramp up
of our installations. Initial testing outcomes indicate that the
campaign resonates well with consumers and carries through with our
professional audience as well. The UltraShape Power's increased
energy provides greater efficacy and high comfort, while the
device's advanced treatment modes allow us to treat a full abdomen
in close to 30 minutes. WiFi connectivity allows for remote
diagnostics and scheduling support. We believe the combination of
these features provides the professional market with a very strong
value proposition in the arena of non-invasive fat destruction," he
concludes.
About Syneron Candela:
Syneron Candela is a leading global aesthetic device company with a
comprehensive product portfolio and a global distribution
footprint. The Company's technology enables physicians to
provide advanced solutions for a broad range of medical-aesthetic
applications including body contouring, hair removal, wrinkle
reduction, tattoo removal, improving the skin's appearance through
the treatment of superficial benign vascular and pigmented lesions,
and the treatment of acne, leg veins and cellulite. The Company has
a wide portfolio of trusted, leading products including UltraShape,
VelaShape, CO2RE, CO2RE Intima, GentleLase, VBeam Perfecta,
PicoWay, Profound and elos Plus.
Founded in 2000, the corporate, R&D, and manufacturing
headquarters for Syneron Candela are located in Israel.
Syneron Candela also has R&D and manufacturing operations in
the U.S. The company markets, services and supports its
products in 86 countries. It has offices in North
America, France,
Germany, Italy, Portugal, Spain,
UK, Australia, China, Japan, and Hong
Kong and distributors worldwide.
SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. Such forward-looking
statements include the expectations, plans and prospects for the
Company, including potential clinical successes, market acceptance
of new products, and projected revenues, margins, earnings and
market shares. The statements made by the Company are based upon
management's current expectations and are subject to certain risks
and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
These risks and uncertainties include the risk factors and
other cautionary statements described in the Company's filings with
the SEC, including those described in the Company's most recent
Annual Report on Form 20-F, and in the filings that Syneron Medical
makes with the SEC, and other factors beyond the Company's control.
If one or more of these factors materialize, or if any underlying
assumptions prove incorrect, Syneron Medical Ltd.'s actual results,
performance or achievements may vary materially from those
expressed or implied by these forward-looking statements.
These forward-looking statements should not be relied upon as
representing Syneron Medical Ltd.'s views as of any date after the
date of this document. The Company does not intend to update these
statements and undertakes no duty to any person to provide any such
update under any circumstance.
For additional information, please
visit http://www.syneron-candela.com.
Media contacts:
Kim
Angelastro, Cohn & Wolfe
E: Kim.Angelastro@cohnwolfe.com
M: 912.441.8263
P: 212.798.9740
Investor Relations contact:
Zack Kubow, The Ruth Group
E: zkubow@theruthgroup.com
P: 646-536-7020
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SOURCE Syneron Medical Ltd.