WESTFORD, Mass., March 30, 2011 /PRNewswire/ -- Cynosure,
Inc. (Nasdaq: CYNO), a leader in laser- and light-based treatments
for minimally invasive and non-invasive aesthetic applications,
today announced the presentation of two new studies involving its
Cellulaze™ workstation, the world's first minimally invasive
surgical device designed to reduce cellulite appearance by
restoring the normal structure of the skin and underlying
connective tissue. The two studies are being presented at the
31st Annual Scientific Conference of the American Society for Laser
Medicine and Surgery (ASLMS). "LASER 2011" will be held on
March 30 - April 3, 2011, at the
Gaylord Texan Resort and Convention Center in Grapevine, Texas.
The studies are being presented by Barry
DiBernardo, M.D., Medical Director of New Jersey Plastic
Surgery, and by Bruce Katz, M.D.,
Clinical Professor, Mt. Sinai School of Medicine, and Director of
the Juva Skin and Laser Center in New
York. Dr. DiBernardo's study was a report on the
treatment of cellulite with one-year follow-up using Cellulaze.
Dr. Katz's study was focused on the efficacy of a
bi-directional sidelight optical fiber and Cellulaze in the
treatment of cellulite, as measured by 3-D surface imaging.
Dr. DiBernardo's study concluded that a single treatment with
Cellulaze improves the appearance of cellulite in this preliminary
study of ten patients and that improvement persists for at least
one year with minimal adverse effects. Skin thickness – as
shown by ultrasound – and skin elasticity increased significantly
at one-, three-, six- and 12-month intervals as shown by objective
measurements. Physician and subject evaluations also
indicated improvement, high subject satisfaction and minimal
adverse effects.
"The results of our study one year post-procedure indicated that
there are considerable potential benefits from the use of
subcutaneous laser energy in addressing cellulite," said Dr.
DiBernardo. "We observed positive results from patients both
in terms of tissue tightening through tissue coagulation as well as
the regeneration of collagen and connective tissue."
Dr. Katz's study concluded that a sidelight three-dimensional
optical fiber and 1440 nm Nd:YAG laser (which is used in Cellulaze)
appear "to have long-lasting benefits in the treatment of
cellulite." The results of Katz's 15-person study were that
68% of subjects showed significant improvement in cellulite by
photographic evaluation and 65% with Vectra 3D surface imaging.
Patient and physician evaluations also revealed good to
excellent results in 76% and 69% of cases, respectively.
"The results of our study demonstrate that a minimally invasive
surgical approach to cellulite can be effective," Dr. Katz said.
"By all objective and subjective measurements, Cellulaze was able
to achieve significant improvements in two-thirds of the patients
we treated. While studies of the device are still ongoing, it
appears that Cellulaze is capable of delivering meaningful and
long-lasting results with a single treatment."
Michael Davin, president and
chief executive officer of Cynosure, said, "Cellulaze is the first
minimally invasive surgical approach to target cellulite beneath
the surface of the skin. Given the scope of the cellulite
market, with more than 85 percent of women over age 20 being
affected, patients and doctors are seeking a solution that
confronts the underlying components of cellulite rather than just
performing a superficial treatment. We are pleased to have
scientific evidence that supports the role we believe Cellulaze can
play in addressing the subdermal structure that forms the
foundation of cellulite."
Having received CE Mark certification earlier this year,
Cellulaze will be available for sale to physicians in the European
Union in the second quarter of 2011. Cellulaze is not
available in the United States.
The company filed a 510(k) notification with the U.S. Food
and Drug Administration (FDA) in late 2010, and regulatory action
on that submission is expected in the second quarter. The FDA
has approved an Investigational Device Exemption (IDE) for
Cellulaze, and over 100 patients have been treated as part of a
clinical IDE study.
In addition to the studies conducted by Drs. DiBernardo and
Katz, Cynosure's technology is featured in other scientific
presentations at the 2011 ASLMS Annual Conference:
- "Laser Assisted Facial Rhytidectomy and Facial Rejuvenation: A
Review of the First 500 Procedures," Richard Gentile, M.D., Northeastern Ohio College of Medicine, Youngstown, OH
- "Bilateral Axilla Hair Removal Comparing a Single Wavelength
Alexandrite Laser with Combined Multiplexed Alexandrite and Nd:YAG
Laser Treatment from a Single Laser Platform," Eric Bernstein, M.D., University of Pennsylvania, Ardmore, PA
Cynosure's presence at the conference is further supported by
the inclusion of its technology in three scientific posters.
- "Hair Removal with Alexandrite Laser on Skin Grafts after
Reconstructive Facial Surgery," Cesar
Arroyo, M.D., Madrid,
Spain
- "Port Wine Stains Previously Treated with an Intense Pulsed
Light System. Treatment with a Dual- Wavelength Laser System
(595, 1064nm) in 40 Patients," Jesus del
Pozo, M.D., University Rey Jaun Carlos, Madrid, Spain
- "Histopathology and Immunohistochemistry of Cuaneous Lupus
Erythematosus After Pulsed Dye Laser Treatment," Pablo Boixeda,
M.D., Ramon y Cajal Hospital, Madrid,
Spain
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 reduce the
appearance of cellulite. Cynosure’s products include a broad range
of laser and other light-based energy sources, including
Alexandrite, pulse 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
www.cynosure.com.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Cynosure, Inc., 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 the global economy and lending
environment and their effects on the aesthetic laser industry,
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, which is 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.
Contact:
Scott Solomon
Vice President
Sharon Merrill Associates, Inc.
Phone: (617) 542-5300
cyno@investorrelations.com
SOURCE Cynosure, Inc.