Viveve Completes Enrollment in Stress Urinary Incontinence Feasibility Study

Viveve Medical Inc., a medical technology company focused on women’s intimate health, 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.
 
“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 CEO. “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.”
 
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 one-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 three-day voiding diary at three months post-treatment. The study design also includes exploratory endpoints as well as safety follow-up throughout the study.
 
Last month, Viveve Medical received regulatory clearance from the Canadian Ministry of Health for the Company’s next-generation Viveve 2.0 Cryogen-cooled Monopolar Radiofrequency (CMRF) system and consumable treatment tips for improvement of sexual function in women following vaginal childbirth.
 
“We are very pleased to have received regulatory clearance of the Viveve 2.0 System from Health Canada, which we believe is another confirmation of the proven efficacy and safety profile of our innovative technology in the treatment of women’s intimate health conditions,” said Durbin. “This clearance in Canada brings additional momentum to our rapidly expanding Viveve 2.0 platform throughout the world.”