Viveve Submits VIVEVE II Clinical Study 30-Day Patient Safety Data to FDA
Viveve Medical, Inc. (VIVE)
Last viveve medical, inc. earnings: 11/7 04:02 pm
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Source: GlobeNewswire
No serious adverse events reported in the submission Final study results could support a marketing application for expanded U.S. indication for the improvement of sexual function in women ENGLEWOOD, Colo., July 03, 2018 (GLOBE NEWSWIRE) -- Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, today announced that it has submitted 30-day patient safety data to the U.S. Food and Drug Administration (FDA) for 38 subjects completing the 1-month assessment in the company’s multicenter randomized Viveve Treatment of the Vaginal Introitus to EValuate Safety and Efficacy (VIVEVE II) clinical study. “Submission of this safety data addresses the FDA’s request to review the 30-day safety data from at least 25 patients in the VIVEVE II study and represents a major step forward in the progression of the VIVEVE II trial,” said Scott Durbin, chief executive officer of Viveve. “As planned, enrollment will continue up to
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