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.
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
Sharon Merrill Associates
SOURCE Cynosure, Inc.