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Last updated on April 16, 2014 at 17:34 EDT

Viveve receives health Canada medical device license for Non-surgical treatment to improve women’s sexual satisfaction after childbirth

June 18, 2012

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

SUNNYVALE, California, June 18, 2012 /PRNewswire/ – 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.”

About Viveve, Inc.:

Viveve is a privately held women’s health company based in Sunnyvale,
California. The Viveve System is a medical device used for the
non-surgical treatment of post-partum laxity of the vaginal introitus,
a medically recognized quality of life condition. The Viveve System has
received CE Mark approval allowing the product to be marketed for its
intended use in Europe.  The Viveve System is currently not available
for sale in the U.S. for this indication.

The company’s Series A and Series B financing was led by GBS Venture
Partners and 5AM Ventures.

Viveve, Inc. is currently an associate member of the Society of
Obstetricians and Gynaecologists of Canada.

For more information, visit www.viveve.com.

SOURCE Viveve, Inc.


Source: PR Newswire