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Viveve: Clinical Results of First-in Woman Study Show Nonsurgical Viveve(TM) Procedure Provides Significant Treatment Effect in Patients With Post-Birth Vaginal Laxity


11/16/2009 11:24:54 AM

ORLANDO, Fla., Nov. 16 /PRNewswire/ -- (Booth 113), -- Seth Jordan Herbst, MD, Principal Investigator and OB/GYN at the Institute of Women's Health, West Palm Beach, Florida, will present positive results from the study "Safety and Effectiveness of Radiofrequency Treatment for Vaginal Laxity -Nonsurgical Vaginal Tightening" at the AAGL 38th Global Congress of Minimally Invasive Gynecology in Orlando, Fla., this week.

The Viveve procedure, being presented for the first time at AAGL this week, is a quick and simple nonsurgical procedure using radiofrequency energy. The purpose of the treatment is to increase the feeling of vaginal tightness, offering patients the potential for enhanced physical sensation and improved sexual satisfaction.

The 24-patient study(1) demonstrated statistically significant improvement in all of the study's endpoints, including increases in vaginal tightness and sexual satisfaction, based on one- to three month post-procedure data. The study results were based on subjective self-reported patient assessments used to measure outcomes. The key study findings included:

"A decrease in sexual satisfaction due to vaginal looseness is a common problem for many women following vaginal childbirth," said Herbst. "This study demonstrates the potential value of the Viveve procedure to address an unmet need for a large population of women."

"We are pleased these early results show great promise for the Viveve procedure," said Kerry Pope, chief executive of Viveve. "This is an important step in elevating the conversation about a woman's sexual satisfaction and its role in her overall sexual health."

The study results are from a single treatment of the Viveve procedure. The data shows that the procedure was well tolerated by women without need for topical anesthesia. No device-related adverse events were reported for the duration of the study. All of the women in the study were pre-menopausal, ranged from ages 27 to 44 and had at least one vaginal delivery.

About Viveve(TM)

Viveve is a privately held women's sexual health company based in Palo Alto, California, formerly known as TiVaMed. Viveve is a nonsurgical procedure for the medically recognized condition of post-birth laxity of the vaginal introitus. The Viveve system received a general 510(k) clearance from FDA in 2008. Further studies are planned prior to seeking regulatory clearance for the indication of post-birth laxity of the vaginal introitus.

The company's Series A financing was led by GBS Venture Partners and 5AM Ventures. For more information, visit the Viveve Web site at www.viveve.com or phone 650-321-3332.

About 5AM Ventures:

Founded in 2002, 5AM Ventures makes seed and early-stage investments in next-generation life science companies, taking a focused, hands-on approach to company building. The 5AM portfolio is diversified among innovative platforms, spinouts from established biotechnology and pharmaceutical companies, and companies developing near-term products. For more information about 5AM Ventures, please visit www.5amventures.com.

About GBS Ventures:

GBS Venture Partners (GBS) is a leading life science venture capital firm founded in 1996. GBS invests in young businesses developing and commercializing products which, when combined with the right management and finance, will make a significant difference to patients' lives and deliver financial returns for our investors. For more information about GBS, please visit www.gbsventures.com.au.

(1)Twenty-four women participated in the first-in-women clinical study of the Viveve procedure. Of those, 23 completed the 3-month follow-up; one relocated and was lost to follow-up.

CONTACT: Sherree Lucas of Viveve, +1-650-321-3332, Ext. 213,
slucas@viveve.com; or Angela Gillespie of WeissComm Group, +1-415-946-1091,
or +1-415-312-2504, agillespie@wcpglobal.com, for Viveve

Web site: http://www.viveve.com/
http://www.5amventures.com/
http://www.gbsventures.com.au/



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