VIVEVE Announces Regulatory Approvals in Colombia and Costa Rica
Approvals expand Commercialization Opportunities for GENEVEVE(TM) Treatment to Improve Sexual Function
SUNNYVALE, CA -- (Marketwired) -- 01/05/17 -- Viveve Medical Inc. ("Viveve") (NASDAQ: VIVE), a medical technology company focused on women's health, today announced the company has received regulatory approvals from the Ministries of Health in Colombia and Costa Rica. In each country the Viveve® System is indicated for treatment of the vaginal introitus to improve sexual function after vaginal childbirth.
"Regulatory approval of the Viveve System in these countries is a significant milestone for Viveve," said Patricia Scheller, chief executive officer of Viveve. "Elective procedures that improve women's sexual health and quality of life have been readily adopted throughout the region, and we believe the Viveve System will be embraced by women and practitioners alike. With the support of our distinguished regional distributors, trained medical providers will be able to offer this clinically-proven safe and effective procedure. Women experiencing the very common condition of vaginal laxity will have access to a comfortable, single-session GENEVEVE treatment that can have a profound and lasting impact on their sexual satisfaction and function."
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 GENEVEVE™ treatment, incorporates clinically-proven, cryogen-cooled, monopolar radiofrequency (CMRF) 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 GENEVEVE treatment is cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis. Consistent with approvals in many countries internationally, Viveve is currently seeking regulatory clearance 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 January 5, 2017