Cynosure Announces Presentation of Favorable Results from Post-Marketing Studies of Smartlipo MPX
April 02 2009 - 8:30AM
PR Newswire (US)
Findings Demonstrate Statistically Significant Improvements in Skin
Tightening and Tissue Shrinkage; WESTFORD, Mass., April 2
/PRNewswire-FirstCall/ -- Cynosure, Inc. (NASDAQ: CYNO) today
announced the presentation of positive efficacy data from two
post-marketing studies that demonstrate the skin-tightening and
tissue-shrinking effects of the Company's Smartlipo MPX(TM) laser
lipolysis workstation. The studies are being presented at the 2009
American Society for Laser Medicine and Surgery (ASLMS) Annual
Conference, which is taking place April 1-5 at the Gaylord National
Resort & Convention Center near Washington, D.C. A randomized,
blinded study, conducted by Barry DiBernardo, M.D., Medical
Director of New Jersey Plastic Surgery & MedNet Technologies,
Inc., compared Smartlipo MPX workstation against liposuction for
their ability to improve skin elasticity and tighten tissue. A
total of 10 women received a single treatment with liposuction on
one side of the abdomen and the dual-wavelength Smartlipo MPX on
the other. Skin shrinkage was evaluated through photographic
imaging and measurement of temporary ink markings. Skin tightening
was evaluated with the use of an elasticity device. Measurements
were taken at baseline and at one and three months post-treatment.
At one and three months, skin treated with Smartlipo MPX had a
statistically significant higher skin shrinkage ratio than skin
treated with liposuction only, Dr. DiBernardo reported. Of the nine
patients who were fully evaluated, eight, or 89%, had an average of
54% greater shrinkage at three months on the Smartlipo MPX side
than the liposuction side. The study also showed a statistically
significant difference in skin tightening. At three months, the
average improvement in skin tightening was 62% with Smartlipo MPX
compared with a 5% improvement on the side treated with
liposuction. "This is the first head-to-head quantitative study
comparing the efficacy of the Smartlipo MPX workstation with that
of liposuction, and the first study to illustrate the effects of
subdermal applications of laser energy on skin laxity and tissue
tightening," Dr. DiBernardo said. "The ability of Smartlipo MPX to
lipolyze and remove unwanted areas of fat already has been clearly
established. The results of our study now demonstrate that laser
lipolysis can achieve greater skin tightening and skin shrinkage
than liposuction alone." Smartlipo MPX also was the focus of a
post-marketing study conducted by Bruce Katz, M.D., Clinical
Professor of Dermatology at The Mount Sinai School of Medicine and
Director of the Juva Skin & Laser Center in New York. A total
of 20 subjects with unwanted localized areas of fat and skin laxity
were treated with Smartlipo MPX. In a subset of five patients, skin
tightening through surface area reduction was measured with the use
of temporary tattoo markings, and biopsies were performed before
the procedure, as well as three days and one month post-treatment,
to determine the presence of new collagen markers. In addition to a
reduction in localized fat deposits, the study demonstrated new
collagen formation and an 18% decrease in skin surface area. "The
data clearly indicate that Smartlipo MPX not only has a significant
skin tightening effect, but also contributes to new collagen
formation that is vital to skin tonicity," Dr. Katz said. Cynosure
President and Chief Executive Officer Michael Davin said, "These
studies provide powerful scientific evidence that affirms the
dramatic results already being observed by physicians and patients.
We believe this research, and subsequent studies, will drive
further adoption of Smartlipo MPX and amplify the benefits of our
laser lipolysis technology as a complete solution for fat removal
with the potential added advantage of skin tightening and body
sculpting." Dr. DiBernardo's study, "Evaluation of Shrinkage and
Skin Tightening in Laser Lipolysis vs. Liposuction: A Randomized
Blinded Split Abdomen Study," will be presented as part of the
ASLMS Annual Conference's ePoster session. The poster is scheduled
to be available for electronic viewing in the Exhibit Hall from
9:00 a.m. to 7:00 p.m. Friday and from 9:00 a.m. to 6:30 p.m.
Saturday. Dr. Katz's abstract, "A Study of the Efficacy of a 1064nm
and 1320nm Sequentially Firing Nd: YAG Laser Device with an
Accelerometer Safety Mechanism for Lipolysis and Skin Tightening,"
is scheduled to be presented at 10:54 a.m. Sunday in the Maryland
ballroom. In addition to the two studies conducted by Drs.
DiBernardo and Katz, Cynosure's technology is featured in seven
scientific presentations at the ASLMS Annual Conference: --
"Efficacy of a New Fractional CO2 Laser in the Treatment of
Photodamage & Acne Scarring," Bruce E. Katz, M.D., Clinical
Professor, Mt. Sinai School of Medicine, Director, JUVA Skin &
Laser Center, Director, Cosmetic Surgery & Laser Clinic, Mt.
Sinai Medical Center, New York, New York -- "Laser Treatment of
Vascular Lesions," Pablo Boixeda, M.D., Hospital Ramon y Cajal,
Madrid, Spain -- "Smartlifting - Technological Innovation for
Facial Rejuvenation," Richard Gentile, Northeastern Ohio
University, Youngstown, Ohio -- "A Nd:YAG Laser with Sequential
Emission of 1320nm and 1440nm Wavelengths with CAP Technology is
Effective in Neck Rejuvenation," Adriana Ribe, Natalie Ribe,
Institut Natalie Ribe, Carceloa, Barcelona, Spain -- "Evaluation of
Laser Thermal Effects in Lipolysis Using a 1064/1320nm Nd:YAG
Laser," Barry E. DiBernardo, Jennifer Reyes, New Jersey Plastic
Surgery & MedNet Technologies, Inc., Montclair, New Jersey; Bo
Chen, Mirko Mirkov, Cynosure, Inc., Westford, Massachusetts --
"Clinical Evaluation of a Single-Wavelength Fractional Laser and a
Novel Multi-Wavelength Fractional Laser in the Treatment of
Photodamaged Skin," Laurel Naversen Geraghty, Brian Biesman, New
York University School of Medicine, New York, New York, Vanderbilt
University Medical Center, Nashville, Tennessee -- "A Comparison of
Three Separate Clinical Studies Evaluating the Safety and Efficacy
of Laser-Assisted Lipolysis Using 1064nm, 1320nm and a Combined
1064/1320nm MultiPlex Device," Katrina E. Woodhall, Raminder
Saluja, Jane Khoury, Mitchel P. Goldman, La Jolla Spa MD, La Jolla,
California About ASLMS The American Society for Laser Medicine and
Surgery is the world's largest scientific organization dedicated to
promoting research, education and high standards of clinical care
in the field of medical laser applications. It provides a forum for
the exchange of scientific information and participates in
communicating the latest developments in laser medicine and surgery
to clinicians, research investigators, government and regulatory
agencies, and the public. Founded in 1980, the Society has more
than 4,000 members. About Cynosure, Inc. Cynosure, Inc. develops
and markets aesthetic treatment systems that are used by physicians
and other practitioners to perform non-invasive and minimally
invasive procedures to remove hair, treat vascular and pigmented
lesions, rejuvenate the skin, liquefy and remove unwanted fat
through laser lipolysis and temporarily reduce the appearance of
cellulite. Cynosure's products include a broad range of laser and
other light-based energy sources, including Alexandrite, pulsed
dye, Nd:YAG and diode lasers, as well as intense pulsed light.
Cynosure was founded in 1991. For corporate or product information,
contact Cynosure at 800-886-2966, or visit
http://www.cynosure.com/. Forward-Looking Statements Any statements
in this press release about future expectations, plans and
prospects for Cynosure, Inc., including statements about the
Company's expectations, as well as other statements containing the
words "believes," "anticipates," "plans," "expects," "will" and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including Cynosure's history of operating losses, its
reliance on sole source suppliers, the inability to accurately
predict the timing or outcome of regulatory decisions, changes in
consumer preferences, competition in the aesthetic laser industry,
economic, market, technological and other factors discussed in
Cynosure's most recent Annual Report on Form 10-K and Quarterly
Report on Form 10-Q, which are filed with the Securities and
Exchange Commission. In addition, the forward-looking statements
included in this press release represent Cynosure's views as of the
date of this press release. Cynosure anticipates that subsequent
events and developments will cause its views to change. However,
while Cynosure may elect to update these forward-looking statements
at some point in the future, it specifically disclaims any
obligation to do so. These forward-looking statements should not be
relied upon as representing Cynosure's views as of any date
subsequent to the date of this press release. DATASOURCE: Cynosure,
Inc. CONTACT: Scott Solomon of Sharon Merrill Associates, Inc.,
+1-617-542-5300, Web Site: http://www.cynosure.com/
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