Cynosure (CYNO) to Present Statistically Significant Data on MonaLisa Touch Laser data at 2014 PAGS

December 3, 2014 8:58 AM EST
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Cynosure (Nasdaq: CYNO) announced that clinical data will be presented at a national meeting of gynecologists and ObGyns that will show a statistically significant improvement in the vaginal health of women treated with the MonaLisa Touch fractional carbon dioxide (CO2) laser. Cynosure has an exclusive agreement to market the laser in North America for the treatment of gynecology indications including vaginal atrophy, a condition affecting primarily postmenopausal women, breast cancer survivors and women who have undergone hysterectomies.

At the 2014 Pelvic Anatomy and Gynecologic Surgery Symposium (PAGS) in Las Vegas, a symposium titled, "A New and Novel Therapy for Vulvovaginal Atrophy: Results of the First U.S. Trial" will describe preliminary findings from a trial evaluating the laser treatment on postmenopausal women and breast cancer survivors experiencing vaginal health issues. The data will be presented by Dr. Mickey Karram, Director of Fellowship Program on Female Pelvic Medicine & Reconstructive Surgery, The Christ Hospital, Cincinnati, OH and Dr. Eric Sokol, Associate Professor of Obstetrics and Gynecology at the Stanford University Medical Center.

The multicenter trial assessed the use of CO2 fractional laser therapy on 30 women with vaginal health issues due to menopause. All of the patients were treated with MonaLisa Touch, which delivers CO2 laser energy to the vaginal wall to promote vaginal mucosal revitalization and a return to premenopausal vaginal health. This minimally invasive, painless procedure was performed in an office setting and required no anesthesia. It was performed in three treatments, each taking less than five minutes, six weeks apart.

"All 30 patients experienced overwhelmingly positive and immediate results," said Dr. Karram. "The women showed highly statistically significant improvement in symptoms – including dryness, pain, itching, painful urination and painful intercourse – after the first treatment. They experienced no side effects or adverse reactions and showed an escalation of progress with each subsequent treatment."

Issues of vaginal health are commonly seen in postmenopausal women, breast cancer survivors and women who have had a hysterectomy. The MonaLisa Touch treatment is particularly well suited for patients who cannot, or elect not to, receive estrogen therapy. In the U.S., there are nearly 46 million women between the ages of 50 and 801, and more than 2.8 million breast cancer survivors.2

"I have been really impressed by the initial results of the MonaLisa Touch therapy for the treatment of vaginal atrophy in our study," said Dr. Sokol. "Physicians currently have a limited number of treatment options, and many patients cannot use standard therapies or find them unsatisfactory. So I think this will fill a very important medical need for a very common and debilitating problem, and it has the potential to become a preferred treatment approach for a lot of patients suffering from genitourinary syndrome of menopause."

The system is designed to stimulate and promote the regeneration of collagen fibers and the restoration of hydration and elasticity within the vaginal mucosa. The laser is able to release energy through a special pulse, and the laser energy heat penetrates to a depth that stimulates the synthesis of new collagen which results in the thickening of the vaginal skin, increasing moisture and better lubrication which restores the vagina to a state similar to before menopause.

"Since its European launch in 2008, the MonaLisa Touch treatment has been used on thousands of patients worldwide and studied under a variety of protocols with excellent results," said Michael Davin, Cynosure's Chairman and Chief Executive Officer. "We believe that the MonaLisa Touch is a game-changing procedure for women suffering from vaginal atrophy."

Cynosure plans to launch the MonaLisa Touch in the U.S. through a specialty surgical sales force in the first quarter of 2015.



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