Cynosure, Inc. 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 US 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 anaesthesia 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 US 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%. 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 patients.
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.