IRVINE, California,
September 10, 2013 /PRNewswire/
--
In a clinical study of forty-two
patients, an average abdominal circumference reduction of 2.6 cm
was achieved following a single VelaShape III treatment
protocol
Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in
the aesthetic medical device marketplace, announced Food and Drug
Administration (FDA) clearance and CE mark approval for VelaShape®
III[1], the Company's new non-invasive body shaping
platform. This new platform is effective for temporary reduction in
circumference of the abdomen and is also used in a wide range of
other body shaping applications such as cellulite treatments.
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"In a VelaShape III clinical study[2] of forty-two
patients an average abdominal circumference reduction of 2.6 cm was
recorded post 10 weeks following a single treatment," said
Ruthie Amir, M.D., Global Vice
President of Clinical Affairs. "Within the same study, we uncovered
that 100 percent of the patients responded to the single treatment
protocol with an abdominal circumference reduction of at a least
1.5 cm, with results seen as early as two weeks."
Since its introduction in 2008, with more than 10,000 procedures
performed daily and over 40 published clinical studies, VelaShape
remains the most trusted brand for cellulite treatment and
non-invasive body shaping by physicians, beauty experts and
millions of patients worldwide. As the third generation,
VelaShape III builds on the success of the original VelaShape
technology, which pioneered the category in non-invasive body
shaping and cellulite reduction industry for physicians and
consumers.
Based on the proven energy combination technology of elōs® and
with the extensive scientific and clinical experience accumulated
from all the Vela[3] brands, the new VelaShape III
system also comes equipped with a multitude of new features
designed to significantly reduce the number of treatments while
reducing the percentage of non-responders. Some of these new
features include increased radio-frequency power of up to 150W,
sophisticated real time feedback mechanisms for consistent RF
delivery independent of tissue variations and a built-in, real time
tissue surface temperature sensor. The system also offers a
complete range of new tip configurations for various body
locations. All these advanced features have been packaged into a
sleek, state-of-the-art design with a highly optimized and
user-friendly interface.
The VelaShape III platform is set to be a body shaping
powerhouse. "In clinical trials we found that we can achieve a
quicker temperature end point in a matter of minutes with VelaShape
III as opposed to the prolonged time required by the previous
device," said Lori Brightman, M.D.,
board certified Dermatologist at the Laser & Skin Surgery
Center of New York and one of the
lead investigators for both the original and the new VelaShape III
system. "By reaching temperature endpoint quicker,
practitioners can use the valuable time to maintain the necessary
temperature to effectively complete the treatment in a much shorter
session."
Painless and fast-acting, VelaShape III is proven to be safe and
effective in significant waist circumference reduction - a common
problem area that can be resistant to exercise and dieting which
add to its other well established indications including treatment
of cellulite and thigh circumferential reduction.
According to a survey of over 1,000 American women commissioned
by Syneron Medical, seven in ten (70 percent) admit they are most
concerned about developing a tummy bulge now and in the future (66
percent).[4] The launch of the new Velashape III
platform meets the growing demand for affordable, practical and
comfortable non-invasive body shaping techniques.
Dr. Shimon Eckhouse, Chief
Executive Officer of Syneron, commented, "We designed a
sophisticated body shaping platform that delivers visible outcomes
in a single or small number of treatments, fits the doctor's
business needs and leads the body shaping category to the next
level. Together with our physician partners and engineers, our
customers now have a clinically proven solution that addresses what
consumers are telling us they want."
About Syneron
Syneron Medical Ltd. 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, 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
sells its products under two distinct brands, Syneron and Candela.
Founded in 2000, the corporate, R&D, and manufacturing
headquarters for Syneron Medical Ltd. are located in Israel. Syneron 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.
For additional information, please visit
http://www.syneron-candela.com.
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, anticipated
regulatory approvals and future product launches, 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
market conditions and other factors beyond the Company's control
and 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 the
other factors described in the filings that Syneron Medical makes
with the SEC. The Company does not intend to update these
statements and undertakes no duty to any person to provide any such
update under any circumstance.
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1. The VelaShape III system was internally named the Transcend
system.
2. Not part of the FDA submission for clearance of the
device
3. Vela brand includes VelaSmooth, VelaShape and VelaShape
II
4. Data on file from Women Survey by Kelton, October 2012
Contacts:
Zack Kubow
The Ruth Group
+1-646-536-7020
zkubow@theruthgroup.com
Hugo Goldman
Chief Financial Officer
Hugo.Goldman@syneron.com
Syneron Medical - Public Relations
pr@syneron.com