Viveve Announces Initiation of Pivotal U.S. PURSUIT Trial in Stress Urinary Incontinence

Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, announced today that it has initiated its multicenter, randomized, double-blinded, sham-controlled trial entitled Prospective U.S. Radiofrequency SUI Trial (PURSUIT). The protocol of the PURSUIT Trial reflects changes to the study design that were approved by the U.S. Food and Drug Administration (FDA) in December 2020, including an increase in size to 390 subjects across 30 U.S. investigational sites and better-defined inclusion/exclusion criteria related to a diagnosis of moderate stress urinary incontinence (SUI) for participants. The study changes are designed to provide a clearer assessment of the trial's primary endpoint. If positive, results could support a marketing application for a new SUI indication for Viveve's cryogen-cooled monopolar radiofrequency (CMRF) technology in the U.S.