Viveve Submits Investigational Device Exemption (IDE) for VIVEVE II
SUNNYVALE, CA -- (Marketwired) -- 09/27/16 -- Viveve Medical, Inc. ("Viveve") (NASDAQ: VIVE), a medical technology company focused on women's health, today announced submission of an Investigational Device Exemption (IDE) to the Food and Drug Administration (FDA), under a de novo 510K, for authorization to begin the VIveve Treatment of the Vaginal Introitus to EVauate Efficacy (VIVEVE II) study involving use of the Viveve System for the treatment of vaginal tissue to improve sexual function in women. The clinical trial will use the Female Sexual Function Index (FSFI) as the primary efficacy endpoint.
The proposed VIVEVE II clinical study is a randomized, double-blinded, and sham-controlled trial that is proposed to include approximately 250 patients from up to 25 study sites in the United States and Canada. Subjects will be randomized in a 1:1 ratio for active and sham treatment. The trial is anticipated to begin enrollment in Q1 of 2017, contingent upon FDA review and approval of the IDE.
"We are proud to continue our commitment to high-quality, scientific clinical research, as demonstrated by the success of our randomized, blinded and sham controlled VIVEVE I clinical study, as well as two earlier single-arm studies conducted in the U.S. and Japan," said Patricia Scheller, chief executive officer of Viveve. "We believe that VIVEVE II will be a ground-breaking study that, if successful, will clinically demonstrate that the Viveve Treatment provides significant benefits to patients suffering from sexual dysfunction caused by vaginal laxity."
Viveve Medical, Inc. is a women's health company passionately committed to advancing new solutions to improve women's overall well-being and quality of life. The company's lead product, the internationally patented Viveve System, is a non-surgical, non-ablative medical device that remodels collagen and restores tissue with only one treatment session. The Viveve System treats the condition of vaginal laxity that can result in decreased physical sensation and sexual satisfaction. Physician surveys indicate that vaginal laxity is the number one post-delivery physical change for women, being more prevalent than weight gain, urinary incontinence or stretch marks. The Viveve Treatment uses patented, reverse-thermal gradient radiofrequency technology to tighten vaginal tissue in one 30-minute out-patient treatment in a physician's office. The Viveve System has received regulatory approval in many countries throughout the world and is available through physician import license in Japan. It is currently not available for sale in the U.S. For more information, please visit Viveve's website at www.viveve.com.
Safe Harbor Statement
All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. While management has based any forward-looking statements included in this press release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control, which could cause actual results to materially differ from such statements. Such risks, uncertainties and other factors include, but are not limited to, the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing, competition, general economic conditions and other factors that are detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
Viveve® is a registered trademark of Viveve, Inc.
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Source: Viveve Medical, Inc.
Released September 27, 2016