Viveve Obtains CE Mark for Gynecologic Treatment of Vaginal Laxity
PALO ALTO, Calif., Jan. 6, 2011 /PRNewswire/ -- Viveve, Inc. , a development stage women's health company, announced today 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 commercialization 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."
"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, Gynecologist and Executive Director, The Southern California Center 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."
There are three components to the Viveve System: the RF generator that has been optimized 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 anesthesi