IRVINE, Calif., Nov. 8, 2016 /PRNewswire/ -- Syneron Medical
Ltd. (NASDAQ: ELOS), a leading global aesthetic device company,
announced today that it has achieved two major milestones to
further strengthen Profound's position in the marketplace.
Profound™ is a minimally invasive, fractional radiofrequency
(RF) microneedling device indicated for use in dermatologic and
general surgical procedures for electrocoagulation and hemostasis.
Specifically, the 25º Dermal handpiece and cartridge are used for
percutaneous treatment of facial wrinkles, and the 75º SubQ
handpiece and cartridge are used to improve the appearance of
cellulite in patients with Fitzpatrick skin types I-III as
supported by long-term clinical data (6 months).
FDA 510(K) CLEARANCE OF PROFOUND™ SUBQ TO
IMPROVE THE APPEARANCE OF CELLULITE
Syneron Candela has
received U.S. Food and Drug Administration (FDA) 510(k) clearance
for Profound™ when using the SubQ handpiece and cartridge to
improve the appearance of cellulite in patients with Fitzpatrick
skin types I-III, as supported by long term data (6 months).
A recent multi-center clinical study of Profound showed
improvement of cellulite severity (in dimples and/undulation
irregularities) in 94% of treated thighs assessed at a three month
follow up by blinded review. Sustained improvement was observed at
six month follow up in 93% of the treated thighs. When considering
improvement in each cellulite feature separately, 86% of the
treated thighs (of the 80 thighs with dimples at baseline) showed
improvement in dimples, and 76% of the thighs (all thighs had
undulation at baseline) showed improvement in undulation
irregularities. Per subject results were similar, where 88% of the
treated subjects showed improvement in the appearance of cellulite
in both thighs in dimples and/or undulation at 3 months follow up,
and 86% of the treated subjects showed improvement at 6 months
follow up.
"The FDA clearance of Profound for treatment of cellulite is a
major addition to the capabilities of this device and to our body
shaping offering. Cellulite is one of the most disturbing aesthetic
problems bothering women and one of the most difficult to treat.
Cellulite is also one of the most prevalent aesthetic conditions
bothering women at all ages, it is estimated that between 85-98% of
adult women suffer from cellulite1. This new FDA
clearance provides a new treatment opportunity for patients with
minimal discomfort and downtime" said Philippe A. Schaison, CEO of
Syneron Candela North America, "We are thrilled to be able to add
to our portfolio a long term solution to improve the appearance of
cellulite that is complementary to our existing products. In
addition, this builds on the recent enhancement of the intellectual
property position for Profound, which further strengthens our
position in the market."
"There has been an increased demand for treatments that can
impact the appearance of cellulite over the past few years as it's
a driver of insecurities in both men and women," said Macrene
Alexiades, MD, Ph.D, Associate Clinical Professor, Yale University School of Medicine, and Director
& President of Dermatology & Laser Surgery Center of
New York. "Profound is an optimal
treatment for patients with cellulite who are apprehensive about
invasive procedures, as well as for those who are looking to
improve the appearance of areas impacted by cellulite in a single
treatment. Some subjects showed improvement starting at one month
after treatment."
FDA clearance for Profound to improve the appearance of
cellulite using the SubQ cartridge and handpiece is based on
positive data from utilizing the device in an institutional review
board (IRB) reviewed multi-center study. The study measured success
by analyzing the dimples and/or undulation irregularities in the
thighs of 50 women with Fitzpatrick skin types I-III. Syneron
Candela plans to release the product in 2017.
1 Avram, Cellulite a review of its physiology and
treatment, J Cosmet Laser Ther 2005; 7: 1–5
NOTICE OF ALLOWANCE FOR USA PATENT
The United States Patent
and Trademark Office (USPTO) has issued a Notice of Allowance,
indicating that yet another patent will issue with claims covering
the technology used in the Company's Profound device. The new
allowed claims cover any device that uses an array of needles to
deliver energy into the dermal layer of skin to induce fractional
thermal damage. The allowed claims and eventual patent are owned by
Massachusetts General Hospital (MGH) and Syneron holds an exclusive
worldwide license to this intellectual property for use in
aesthetic applications. In addition to this intellectual property,
Syneron holds several additional U.S. and international patents
covering the Profound™ RF micro-needle fractional system.
Dr. Shimon Eckhouse, Chairman of
Syneron Medical, commented, "The allowance of these broad new
claims protecting our RF micro-needling technology is a significant
development that further strengthens our position in this fast
growing market and enhances our ability to enforce the Profound
intellectual property against current or future violators. We
believe this broad coverage has the potential of positioning
Syneron as the only company in the U.S. utilizing a micro-needle
array to deliver RF energy into the dermis. This technology has
been clinically proven to induce growth of new collagen, elastin
and hyaluronic acid significantly improving the appearance of skin.
These new broad claims and our unique Profound™ technology are a
result of many years of technology development and clinical
research at MGH and Syneron and are an excellent example of the
great potential of the close collaboration between leading
academia, industry and leading aesthetic doctors that brings this
new non-surgical technology to doctors and patients world-wide. We
look forward to continue educating practices and patients on the
unique capabilities of the Profound™ system and plan to expand the
technology into new aesthetic applications in the
future."
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,
women's intimate wellness treatments, 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, GentleLase, VBeam
Perfecta, PicoWay, CO2RE, CO2RE Intima, Profound and elōs Plus.
Founded in 2000, 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.
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SOURCE Syneron Medical Ltd.