Viveve Announces Expanded Indication for Viveve System in South Korea
Viveve System now approved for vaginal laxity treatment in addition to general surgical use for electrocoagulation and hemostasis
SUNNYVALE, CA -- (Marketwired) -- 05/09/17 -- Viveve Medical, Inc. ("Viveve") (NASDAQ: VIVE), a medical technology company focused on women's health, today announced that the company has received regulatory approval for an expanded indication for the Viveve® System from the Ministry of Food and Drug Safety in South Korea. Previously, the Viveve System was indicated for use in general surgical procedures for electrocoagulation and hemostasis. Under the terms of the expanded indication, the Viveve System will now also be indicated for the treatment of vaginal laxity in South Korea.
"We are very pleased that the South Korean approved indication for the Viveve System has been expanded to include treatment of vaginal laxity. As one of the largest global markets for aesthetic procedures in women's health, South Korea plays an important role in influencing medical and health trends throughout Asia," said Patricia Scheller, chief executive officer of Viveve. "We look forward to working with our exclusive distribution partner, JOYMG, to further build market awareness and use of the safe and effective Viveve treatment to improve vaginal laxity," she continued.
Viveve Medical, Inc. is a women's health and wellness company passionately committed to advancing new solutions to improve women's overall well-being and quality of life. The internationally patented Viveve System, that delivers the GENEVEVE™ treatment, incorporates clinically-proven cryogen-cooled, monopolar radiofrequency (CMRF) energy-based technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate robust neocollagenesis in one 30-minute in-office session.
In the United States, the Viveve System is cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis. Consistent with approvals in many countries internationally, Viveve is currently in the process of submitting an IDE to the FDA to conduct a pivotal study on use of the device in the United States for improvement in sexual function. For more information 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.
Geneveve is a trademark of Viveve, Inc.
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Source: Viveve Medical, Inc.
Released May 9, 2017