Viveve Announces Regulatory Approval for Viveve(R) System in South Korea
Viveve System -- Painless Out-Patient Procedure to Treat Vaginal Laxity -- Now Approved for Marketing in 26 Countries Around the World
SUNNYVALE, CA -- (Marketwired) -- 08/04/16 -- 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 the sale of the Viveve System from the Ministry of Food and Drug Safety in South Korea. Previously, Viveve announced an exclusive distribution partnership for marketing the Viveve System with JOYMG, Co., Ltd ("JOYMG"), a leading distributor of medical devices in South Korea.
"The receipt of market approval in South Korea represents another important milestone in our commercialization of the Viveve System in Asia and our quest to make this clinically proven treatment available to the millions of women around the world who are living with vaginal laxity," said Patricia Scheller, chief executive officer of Viveve, adding "South Korea represents a major global market for women's health treatments, and we expect to rapidly build our commercial presence there through our partnership with JOYMG."
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 restore 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.
Investor relations contact:
Amato and Partners, LLC
90 Park Avenue, 17th Floor
New York, NY 10016
Berry & Company Public Relations
Source: Viveve Medical, Inc.
Released August 4, 2016