Viveve Submits Investigational Device Exemption to FDA to Conduct LIBERATE-U.S. Trial for Improvement of Stress Urinary Incontinence
Viveve Medical, Inc. (VIVE)
Last viveve medical, inc. earnings: 11/7 04:02 pm
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Source: GlobeNewswire
ENGLEWOOD, Colo., Sept. 11, 2018 (GLOBE NEWSWIRE) -- Viveve Medical, Inc. (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. “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
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