WESTFORD, Mass., Nov. 18, 2014 /PRNewswire/ -- Cynosure, Inc.
(NASDAQ: CYNO), today announced that it has signed an exclusive
agreement with El.En. S.p.A. to market and distribute in
North America the MonaLisa Touch™,
a carbon dioxide (CO2) laser for the treatment of
vaginal atrophy, a condition that affects primarily postmenopausal
women, breast cancer survivors and women who have undergone
hysterectomies.
Cynosure plans to introduce the MonaLisa Touch at the 2014
Pelvic Anatomy and Gynecologic Surgery Symposium (PAGS), which
takes place next month in Las
Vegas. The Company expects to begin selling the product in
the U.S. in the first quarter of 2015 through a specialty surgical
sales force.
"The MonaLisa Touch complements and expands our product
portfolio for non-core physicians in the area of gynecological
treatments and aesthetics," said Michael
Davin, Cynosure's Chairman and Chief Executive Officer.
"Affecting tens of millions of women worldwide, vaginal atrophy is
a medical condition with a large unmet treatment need. The
procedure, which can be administered in a doctor's office, requires
no anesthesia and has been performed on thousands of patients
worldwide. Patients report a significant improvement in their
condition."
The MonaLisa Touch delivers short CO2 ablative laser
pulses to the vaginal wall, decreasing vaginal atrophy symptoms
such as vaginal dryness, soreness and itching as well as painful
urination and intercourse. The device received marketing clearance
from the U.S. Food and Drug Administration in September 2014.
Results of a recently published study of postmenopausal women
who received three applications of the MonaLisa Touch laser over a
12-week period concluded that the device induced a significant
improvement of vaginal atrophy symptoms. Recent clinical work also
has been conducted to investigate the effects of the laser on
sexual function and overall satisfaction with sexual life in
postmenopausal women with vaginal atrophy.
Treatment with the MonaLisa Touch is designed to reverse the
deterioration of the vaginal walls associated with the loss of
estrogen due to aging, hormonal treatments for breast cancer, and
other conditions. The system is designed to stimulate and promote
the regeneration of collagen fibers and the restoration of
hydration and elasticity within the vaginal mucosa.
According to research, the prevalence of vaginal atrophy in
postmenopausal women is close to 50%1. There are an
estimated 33 million postmenopausal women in the U.S. The
incidence of vaginal atrophy by symptom can be higher in certain
subgroups of women, such as the more than 2.8 million women in the
U.S. with a history of breast cancer. In a cohort of breast cancer
survivors, vaginal dryness was present in 23.4% of the
premenopausal patients and in 61.5% of the postmenopausal
patients2.
El.En., based in Calenzano FI, Italy, manufactures lasers in Europe and light-based medical devices
worldwide. Under an existing exclusive distribution agreement
between the companies, Cynosure distributes El.En.'s SLTII, a
component used in Cynosure's Cellulaze™ and Smartlipo
Triplex™ systems.
About Cynosure, Inc.
Cynosure develops and markets
aesthetic treatment systems that enable plastic surgeons,
dermatologists and other medical practitioners to perform
non-invasive and minimally invasive procedures to remove hair,
treat vascular and benign pigmented lesions, remove multi-colored
tattoos, revitalize the skin, liquefy and remove unwanted fat
through laser lipolysis, reduce cellulite, clear nails infected by
toe fungus and ablate sweat glands. Cynosure's product
portfolio is composed of a broad range of energy sources including
Alexandrite, diode, Nd: YAG, picosecond, pulse dye, Q-switched
lasers, intense pulsed light and radiofrequency technology.
Cynosure sells its products globally under the Cynosure, Palomar,
ConBio and Ellman brand names through a direct sales force in
the United States, Canada, Mexico, France, Germany, Spain, the United
Kingdom, Australia,
China, Japan and Korea, and through international
distributors in approximately 120 other countries. For
corporate or product information, visit Cynosure's website at
www.cynosure.com.
Forward-Looking Statements
Any statements in this
press release about Cynosure's execution of the exclusive agreement
to market the MonaLisa Touch for gynecology indications, as well as
other statements containing the words "plans," "expects," 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 market acceptance of the MonaLisa
Touch, levels of demand for procedures performed with Cynosure
products and for Cynosure products themselves, competition in the
aesthetic laser industry, general business and economic conditions,
effects of acquisitions that Cynosure has made or may make,
Cynosure's ability to develop and commercialize new products,
Cynosure's reliance on sole source suppliers, the inability to
accurately predict the timing or outcome of regulatory decisions,
and economic, market, technological and other factors discussed in
Cynosure's most recent Annual Report on Form 10-K and subsequently
filed quarterly reports on Form 10-Q for the first, second, and
third quarters of 2014, 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,
although 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.
(1) Maire B. Mac Bride,
Deborah J. Rhodes, Lynne T. Shuster
Vulvovaginal Atrophy. Mayo Clin
Proc. 2010 January; 85(1): 87–94
(2) Crandall C, Petersen L, Ganz P, Greendale GA.
Association of breast cancer and its therapy with menopause-related
symptoms. Menopause 2004;11(5):519-530
Contact
Scott Solomon
Vice President
Sharon Merrill Associates
617-542-5300
cyno@investorrelations.com
SOURCE Cynosure, Inc.