Health Canada approves Viveve System to improve sexual function after childbirth

The Viveve System addresses this unmet need in women's sexual health

Viveve, Inc., a woman's health company and pioneer in non-surgical vaginal tissue restoration, announces Health Canada has issued a Medical Device License for the Viveve System to treat laxity of the vaginal introitus (opening) after vaginal childbirth, to improve sexual function. The Viveve procedure is the first of its kind and clinical results have shown an improvement in the feeling of vaginal tightness and sexual satisfaction for women.

"Canada is a very important market for Viveve and presents a significant opportunity.  The Health Canada approval is a key milestone in our commercialization strategy," said Patricia Scheller, CEO of Viveve. "We are looking forward to introducing the Viveve System to gynecologists and family practitioners at the upcoming Society of Obstetricians and Gynaecologists of Canada (SOGC) Annual Clinical Meeting. Canadian physicians will now be able to offer the first ever non-surgical treatment for vaginal laxity to their patients."

The Viveve System is a radiofrequency device that uses low levels of energy to restore collagen fibers overstretched and damaged during vaginal childbirth. The procedure is performed in the doctor's office by a trained physician, without the need for anesthesia, in approximately 30 minutes. There is no downtime and the patient can return to normal activities immediately following the procedure.

"Unfortunately, women's sexual health concerns have not been addressed in the medical community at the same rate or with the same intensity as men's," states Dr. Gail Knudson, MD and Clinical Associate Professor at UBC Department of Sexual Medicine. "I am happy Viveve is introducing this procedure for women in Canada. I am also hoping physicians will see this as a reminder of the importance of talking to women about their overall sexual health and particularly changes in sexual health that may occur as a result of having children."

In a Viveve-sponsored survey of over 400 women, nearly half of women who responded expressed concern with laxity. In 2009, a "First in Women" Non-Significant Risk (NSR) IRB-approved study using the Viveve System was conducted in the United States. All women in the study reported an improved feeling of vaginal tightness during intercourse at one, three and six months post treatment.  In addition, of the women who had experienced a decrease in sexual satisfaction at least one-year post vaginal delivery, all reported an improvement in sexual satisfaction at the one, three and six-month intervals. This study was published in September 2010 by the Journal of Sexual Medicine and can be found on the company website at www.viveve.com. A second study in Japan was recently completed with similarly positive results and the three month interim report can also be found on the Viveve website.

"When I heard about Viveve and had the opportunity to read the data, I was very interested in this procedure," said Dr. Le Mai Tu, MD, MSc, Professor of Urology, specializing in Urogynecology, University of Sherbrooke, Sherbrooke, Quebec. "In fact, many of my patients who have experienced vaginal deliveries have talked to me about the vaginal anatomical changes such as laxity and its impact on their sexual satisfaction. It's encouraging that there is finally a non-invasive technology which can improve this condition and I am looking forward to learning more about the technique and introducing the Viveve procedure to my patients."