Viveve Initiates LIBERATE-International Trial for Improvement of Stress Urinary Incontinence

Viveve Medical (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, announced today the initiation of LIBERATE-International, a multicenter, randomized, double-blinded, sham-controlled trial to evaluate the safety and efficacy of its proprietary, cryogen-cooled monopolar radiofrequency (CMRF) technology for the improvement of stress urinary incontinence (SUI) in women.

As quoted in the press release:

“Initiation of LIBERATE-International represents a significant advance in our pursuit of regulatory clearances for the treatment of SUI, a condition that effects an estimated 25-30 million women worldwide. Our single-session procedure offers women the potential for significant improvement in urine leakage and quality of life. The results of LIBERATE-International, if successful, could support multiple international clearances for use of our CMRF technology in the treatment of SUI around the world, including Health Canada and CE Mark clearances, among others,” stated Scott Durbin, chief executive officer and director of Viveve.

In conjunction with initiation of the LIBERATE-International trial, Viveve also announced regulatory clearance in Argentina, for use of the Viveve® System, for the improvement of urinary incontinence.

“It is our belief that these clearances demonstrate continued regulatory confidence in the safety of our procedures and CMRF technology.  As we continue our commitment towards rapid label expansion, we remain on track to complete the submission of our Investigational Device Exemption to the U.S. Food and Drug Administration (FDA) for LIBERATE-U.S., our second SUI registration trial, in the third quarter,” continued Mr. Durbin.

Click here to read the full press release.