Viveve Obtains CE Mark for Gynecologic Treatment of Vaginal Laxity
By Viveve Inc., PRNEWednesday, January 5, 2011
Company to begin distribution discussions at J.P. Morgan Conference
PALO ALTO, California, January 6, 2011 - 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.
(Logo: photos.prnewswire.com/prnh/20110106/SF25673LOGO)
"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 anesthesia, 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.
About Viveve(TM)
Viveve is a privately held women's sexual health company based in Palo
Alto, California. The Viveve System is a medical device used for the
non-surgical procedure of post-birth laxity of the vaginal introitus, a
medically recognized quality of life condition. It is currently not available
for sale in the U.S.
The company's Series A financing was led by GBS Venture Partners and 5AM
Ventures. For more information, visit www.viveve.com or contact
Sherree Lucas at +1-650-321-3332 ext 213.
Sherree Lucas of Viveve, Inc. +1-650-321-3332, ext. 213
Tags: california, January 6, Palo alto, Viveve Inc.