Viveve Submits Investigational Device Exemption to FDA to Conduct LIBERATE-U.S. Trial for Improvement of Stress Urinary Incontinence

Viveve Medical (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, today announced submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) for authorization to begin LIBERATE-U.S., a multicenter, randomized, double-blinded, sham-controlled trial to evaluate the safety and efficacy of the Company’s proprietary, cryogen-cooled monopolar radiofrequency (CMRF) technology for the improvement of stress urinary incontinence (SUI) in women.

As quoted in the press release:

“The IDE submission for approval to conduct the LIBERATE-U.S. trial is an important milestone towards our objective to obtain regulatory clearances for CMRF for the treatment of SUI, a condition that we estimate affects approximately 25-30 million women worldwide,” stated Scott Durbin, chief executive officer and director of Viveve.  “This trial is also another reflection of our commitment to conducting sound scientific research and rigorous clinical trials that support the highest levels of evidence-based medicine to deliver safe and effective treatment of women’s intimate health conditions using our proprietary CMRF technology.  Pending authorization to proceed with the LIBERATE-U.S. trial, Viveve will have two ongoing multicenter SUI registration studies underway including our LIBERATE-International trial initiated in Canada in August 2018.”

Click here to read the full press release.