Cynosure announced that it has signed an exclusive agreement with El.En. 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 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 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.