Viveve Announces Additional Regulatory Approvals in Middle East
Expands Commercialization Opportunities for GENEVEVE(TM) Treatment to Improve Vaginal Laxity
ENGLEWOOD, CO -- (Marketwired) -- 09/12/17 -- Viveve Medical, Inc. ("Viveve") (NASDAQ: VIVE), a medical technology company focused on women's health, today announced that the company has received regulatory approvals for the Viveve® System in Bahrain, Kuwait, and Qatar. The Viveve System, that delivers the Geneveve Treatment, is cleared for marketing as a treatment of the vaginal introitus to improve vaginal laxity.
"Regulatory approvals in these countries strengthens our ongoing commercial efforts in this important region of the world," said Patricia Scheller, chief executive officer of Viveve. She continued, "We support Medica, our distribution partner in the Middle East, and the trained medical providers they serve to provide the best option for treating a condition that can profoundly impact a woman's quality of life."
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.
International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications from over 50 countries. Consistent with these approvals, Viveve has submitted an IDE to the FDA to conduct a pivotal study on use of the device for improvement in sexual function. Currently, in the United States, the Viveve System is cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis.
InControl Products by Viveve are FDA cleared medical devices that treat stress, urge, and mixed incontinence conditions and products to improve pelvic floor strength. Viveve exclusively distributes InControl Medical's products to healthcare providers in the United States. 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 September 12, 2017