Viveve Medical Files IDE to FDA to Begin Study on Vaginal Laxity Treatment System (NASDAQ:VIVE)


Viveve Medical (NASDAQ:VIVE) said pre-market Tuesday it filed an investigational device exemption to the Food and Drug Administration, seeking approval to start a clinical study of its Viveve System as a treatment for sexual dysfunction in women caused by vaginal laxity. The proposed study will include about 250 patients from up to 25 sites in the U.S. and Canada and will use the Female Sexual Function Index as the primary efficacy endpoint. The trial is slated to begin patient enrollment in Q1, contingent upon FDA review and approval of the IDE.

The stock increased 1.54% or $0.11 during the last trading session, hitting $7.25. About 56,211 shares traded hands or 13.23% up from the average. Viveve Medical Inc (NASDAQ:VIVE) has risen 4.17% since February 24, 2016 and is uptrending. It has underperformed by 7.76% the S&P500.

Viveve Medical, Inc., formerly PLC Systems, Inc., designs, develops, makes and markets medical devices for the non-invasive treatment of vaginal laxity. The company has a market cap of $77.67 million. The Company’s Viveve Treatment is a non-invasive solution for vaginal laxity that is performed in approximately 30 minutes, in a physician’s office. It currently has negative earnings. The Viveve System uses monopolar radiofrequency energy to generate low temperature heat.

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