World News: 21:03 GMT Thursday 6th December 2018. [Viveve Medical, Inc. via Globe Newswire via SPi World News]
ENGLEWOOD, Colo., Dec. 06, 2018 (GLOBE NEWSWIRE) -- Viveve Medical, Inc. (NASDAQ: VIVE) (“Viveve”), a medical technology company focused on women's intimate health, today announced positive 12-month data from an investigator-initiated, single-arm, 12-month feasibility study using its cryogen-cooled, monopolar radiofrequency (CMRF) technology platform for the treatment of mild-to-moderate stress urinary incontinence (SUI) in women. The study was conducted by Bruce Allan, PhD, MD, FRCS(C), founder and medical director of the Allan Centre in Calgary, Alberta.
“These positive results build upon the demonstrated effectiveness and durability of our single-session CMRF treatment for women experiencing SUI symptoms, as previously reported in the six-month interim data from this feasibility study, as well as the 12-month data in the separate SUI pilot study,” said Scott Durbin, chief executive officer and director of Viveve. “We look forward to reporting the full data from this feasibility study at our upcoming SUI physician key opinion leader symposium and are continuing to advance our two SUI clinical registration trials, LIBERATE-International, currently underway, and the planned LIBERATE-U.S. study, pending U.S. Food and Drug Administration approval of an Investigational Device Exemption.”
The live webcast of this event can be accessed through Viveve’s investor relations website at . A webcast replay of the presentation will be posted on the Viveve website approximately two hours after the event and will be available for 90 days.
International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications in over 50 countries. In the second quarter of 2018, Viveve initiated VIVEVE II, a multicenter, randomized, double-blind, sham-controlled clinical trial to assess improvement of sexual function in women following vaginal childbirth after receiving approval of an Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA) in March of 2018. If successful, this trial could support a marketing application for a new U.S. commercial indication. Currently, in the United States, the Viveve System is cleared by the FDA for use in general surgical procedures for electrocoagulation and hemostasis.
Viveve has initiated LIBERATE-International, one of two planned independent, multicenter, randomized registration trials for the improvement of SUI in women and plans to re-submit an IDE to the FDA for LIBERATE-U.S., after conducting certain safety testing in the third quarter of 2019. The results of these two trials, if successful, could support marketing applications in the U.S. and additional countries around the world for this new commercial indication.
For more information visit Viveve's website at .
Amato and Partners, LLC Investor Relations Counsel
Globe Newswire: 21:03 GMT Thursday 6th December 2018
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