- Three-arm study compares Viveve's Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and cryogen-only sham to inert sham treatment
- Topline results anticipated in third quarter 2020
Viveve Medical, Inc., a medical technology company focused on women's intimate health, announced today that it has completed enrollment in its three-arm, three-month feasibility study to compare Viveve's Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. The Investigational Testing Application (ITA) study, approved by the Canadian Ministry of Health, was initiated in January 2020.
"Completion of enrollment in our short-term feasibility study is an important milestone in our SUI clinical development program. We are pleased that enrollment was achieved expeditiously by our clinical trial sites. We look forward to the results of this study in the third quarter 2020," said Scott Durbin, Viveve's chief executive officer.
"SUI is a condition that affects an estimated 25-30 million women worldwide. We believe that our single-session procedure may offer women the potential for significant improvement in urine leakage and the ability to engage in their daily lives with greater comfort and control. We are hopeful that the results will enable the resubmission of our Investigational Device Exemption to the Food and Drug Administration to conduct a pivotal clinical trial for SUI in the United States."
About the International SUI Feasibility Study
The international three-arm SUI feasibility study is a prospective, randomized, single-blind clinical trial comparing the use of the Viveve CMRF treatment and a cryogen-only sham to an inert sham treatment in women with SUI. Three clinical trial sites in Canada have enrolled a total of approximately 36 subjects (12 per treatment arm) randomized on a 1:1:1 ratio to each of the three study arms. The primary efficacy endpoint is the mean change from baseline in the standardized 1-hour Pad Weight Test at three months post-treatment. The treatment protocol will assess additional objective endpoints, including the 24-hour Pad Weight Test and 3-day voiding diary at three months post-treatment. The study design also includes exploratory endpoints as well as safety follow-up throughout the study.
Viveve Medical, Inc. is a medical technology company focused on women's intimate health. Viveve is committed to advancing new solutions to improve women's overall well-being and quality of life. The internationally patented Viveve® System incorporates CMRF technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate neocollagenesis in a single in-office session.
In the United States the Viveve System is cleared by the FDA for use in general surgical procedures for electrocoagulation and hemostasis. International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications in more than 50 countries. Viveve is conducting VIVEVE II, a multicenter, randomized, double-blind, sham-controlled clinical trial to assess improvement of sexual function in women following vaginal childbirth. Completion of full 250 subject enrollment was announced in early March 2019. The topline 12-month data read-out of the VIVEVE II trial is expected in late April 2020. If successful, VIVEVE II results could support a marketing application for a new U.S. commercial indication.
For more information, visit www.viveve.com.