Viveve Sponsors Study in Japan for New Procedure to Treat Vaginal Laxity
PALO ALTO, Calif., July 11, 2011 /PRNewswire/ — Viveve Inc. today announced the collection of 30 day post treatment data for 24 patients from its sponsored study in Japan. The study objective is to evaluate the safety and efficacy of its new procedure to reduce vaginal laxity post childbirth in Japanese women. Dr. Yuki Sekiguchi, Urologist and CEO of three Luna Clinics in Yokohama, is the lead investigator of the study.
“I am pleased to be the first doctor to perform the Viveve procedure in Japan,” stated Dr. Sekiguchi. “The quality of life for Japanese women, as with women all over the world, is impacted by the condition of vaginal laxity resulting from childbirth”.
The Viveve procedure is non-surgical and performed in a physician’s office in less than 30 minutes. No anesthesia is required and there is no downtime post treatment. A woman can return to her routine daily activities immediately following the procedure.
“The Viveve procedure is technically an easy procedure to perform and my patients tolerated it well,” reported Dr. Sekiguchi. “The 30 day data shows no adverse events and promising outcomes for improvement in tightening and sexual satisfaction.”
“We’re very pleased to see similar results in the Japan study at 30 days post treatment compared to the same follow-up time period in the First in Women study completed in the United States in 2009,” said Kerry Pope, President and CEO of Viveve. “We expect to see this trend continue through the end of the study, demonstrating the safety and efficacy of this procedure.”
The patients in the study were asked to score their vaginal laxity and sexual satisfaction pre-childbirth, pre-treatment, and post-treatment at one, three and six months. Prior to delivery, the average vaginal laxity score was 4.0 on a 7 point scale with 7 representing “Very Tight.” However, after delivery and prior to treatment, the average score had declined to 2.5. After receiving the Viveve treatment, the one month average score rose back up to 3.8. Based on these scores, the average vaginal laxity/looseness score returned to near pre-delivery status at one month. In a separate questionnaire, patients rated their level of sexual satisfaction prior to delivery, after delivery but before treatment, and after treatment. Patient scores indicate that levels of sexual satisfaction also rose back to a level nearly that of their pre-delivery state.
The Viveve procedure is performed by a physician with the Viveve System, a radiofrequency device that uses a treatment tip to deliver coolant to protect the surface tissue while energy is delivered into sub-mucosal tissue. The energy is converted to heat resulting in collagen reformation in the tissue within 30 days of procedure and continues for at least 90 days post treatment.
Patients in the First in Women U.S. study completed in 2009 reported an increased feeling of vaginal tightness and sexual satisfaction through the one year post treatment follow up period. This study was published in the September 2010 issue of Journal of Sexual Medicine.
In the Japan study, patient follow-up will continue through the end of the year. Final study results will be submitted for publication in 2012.
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.
SOURCE Viveve Inc.