What you need to know about the new direct marketing guidance note
Nadine Mather and Chloë Loubser
Viveve's non-surgical vaginal laxity treatment receives European CE mark
Viveve, Inc, a development stage women's health company, has announced that it has received the European CE (Conformite Europeenne) mark for the use of its Viveve System for the non-surgical treatment of laxity of the vaginal introitus (opening), after childbirth, to improve female sexual function.
"The CE mark is a key milestone in our commercialisation strategy," said Kerry Pope, president and CEO of Viveve. "We have heard from key opinion leaders in Europe and Canada about the Viveve procedure and the importance of its availability to their patients."
Substantial market opportunity
"I can say that worldwide, research and development to benefit women's sexual function have not been at the forefront of medical innovation," stated Dr. Michael Krychman, gynaecologist and executive director, The Southern California Centre for Sexual Health and Survivorship, Newport Beach CA. "With the CE mark, Viveve can bring their procedure to my European colleagues whose patients I believe will benefit from this procedure."
"We'll immediately begin building our distribution network within the European Union as well as other countries that rely on the CE mark process, such as Canada and Australia," Pope continued. "Our clinical advisors along with our own research tell us that the market opportunity for the Viveve procedure in developed countries is substantial and we're looking forward to establishing our presence in Europe."
Three components to the Viveve System
There are three components to the Viveve System: the RF generator that has been optimised for use in an office setting; the hand piece that is specifically designed for the application; and the single-use disposable tip. The procedure is performed in the doctor's office by a trained OB/GYN, without the need for anaesthesia, in approximately 30 minutes. In 2009, a "First in Women" Non-Significant Risk 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 1, 3 and 6 months post treatment. In addition, of the women who had experienced a decrease in sexual satisfaction at least 1-year post vaginal delivery, all reported an improvement in sexual satisfaction at 1, 3 and 6 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.
Source: Viveve, Inc.
