Cynosure, Inc. announced that it has received a medical device license issued by Health Canada to market MonaLisa Touch® for the treatment of symptoms related to Genitourinary Syndrome of Menopause (GSM), including vaginal dryness, vaginal burning, vaginal itching, pain, dysuria and dyspareunia. The condition affects approximately half of all postmenopausal women.
“Health Canada’s authorization of MonaLisa Touch is an important regulatory milestone for Cynosure as we continue to expand the geographic reach of this innovative and efficacious aesthetic medical technology to new markets,” said Cynosure CEO Michael Davin. “With its varied and sometimes debilitating symptoms, GSM can significantly affect quality of life. We are excited about the ability to offer the nearly 7 million mid-life and older women in Canada this potentially life-changing treatment, which we believe has the potential to rapidly become a first-line therapy for GSM.”
MonaLisa Touch is a fractional carbon dioxide (CO2) laser specifically designed to help restore vaginal health in postmenopausal women as well as breast cancer survivors. The procedure is performed in an office environment without the need for anesthesia and with virtually no pain or side effects. MonaLisa Touch, which has successfully treated thousands of patients around the world, received marketing clearance from the U.S. Food and Drug Administration in September 2014.
GSM is a comprehensive term that includes symptomatic vulvovaginal atrophy as well as lower urinary tract symptoms related to low estrogen levels1. Symptoms can be chronic and progressive and are unlikely to improve over time2,3.
In addition to the treatment of GSM symptoms, Health Canada also authorized the marketing of MonaLisa Touch for incision, excision, ablation, vaporization and coagulation of body soft tissues in gynecology and genitourinary surgery.
About Cynosure, Inc.
Cynosure develops and markets aesthetic treatment systems that enable plastic surgeons, dermatologists and other medical practitioners to remove unwanted hair, treat vascular and benign pigmented lesions, remove multi-colored tattoos, revitalize the skin, reduce fat through non-invasive and minimally invasive laser lipolysis, reduce cellulite, clear nails infected by toe fungus, ablate sweat glands and improve vaginal health. Cynosure also markets radiofrequency energy sourced medical devices for precision surgical applications such as facial plastic and general surgery, gynecology, ear, nose, and throat procedures, ophthalmology, oral and maxillofacial surgery, podiatry and proctology. 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 atwww.cynosure.com.
Any statements in this press release about Cynosure’s receipt of Health Canada authorization to market MonaLisa Touch, 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 market acceptance ofMonaLisa Touch in Canada, 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 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 Report on Form 10-Q for the quarter ended June 30, 2015, 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 Menopause: The Journal of The North American Menopause Society, Vol. 21, No. 10.
2 Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013;20: 888-902.
3 Winneker RC, Harris HA. Progress and prospects in treating postmenopausal vaginal atrophy. Clin Pharmacol Ther 2011;89:129-132.