Viveve Medical, Inc. (NASDAQ:VIVE) declined Thursday after the company regained NASDAQ compliance.
The Englewood, Calif.-based company is a medical technology company focused on women's intimate health.
Thursday’s news release, which included the compliance angle, noted that in the United States, the Viveve System is cleared by the U.S. Food and Drug Administration (FDA) for use in general surgical procedures for electrocoagulation and hemostasis.
International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications in more than 50 countries.
Viveve is conducting VIVEVE II, a multicenter, randomized, double-blind, sham-controlled clinical trial to assess improvement of sexual function in women following vaginal childbirth. Completion of full 250 subject enrollment was announced in early March 2019. The top-line 12-month data readout of the VIVEVE II trial is expected in April 2020. If successful, VIVEVE II results could support a marketing application for a new U.S. commercial indication.
Viveve continues to advance its clinical development program in stress urinary incontinence (SUI) and plans to initiate a short-term feasibility study in the first quarter 2020 following the recently announced approval of the submitted Investigational Testing Application by the Canadian Ministry of Health.
Following the positive yet inconclusive results of the LIBERATE-International trial, the planned feasibility study will be a single-blind, three-arm, three-month study to compare Viveve's CMRF treatment to cryogen-only treatment and to inert sham treatment in order to capture short-term safety and effectiveness data on use of the Viveve System for the improvement of SUI in women.
Viveve shares sank 14.8 cents, or 11.74%, to $1.11 to begin Thursday
