Viveve Announces Regulatory Approval for Viveve System in Taiwan
Expands Commercial Availability in Key Asia Pacific Market
ENGLEWOOD, CO -- (Marketwired) -- 10/10/17 -- Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women's health and wellness, today announced that it has received regulatory approval to market the Viveve® System from the Taiwanese Food and Drug Administration (TFDA) for use in general surgical procedures for electrocoagulation and hemostasis.
"Regulatory approval for the Viveve System in Taiwan, one of the largest markets in Asia for advanced medical technologies, is a significant milestone in our strategic commercialization efforts to offer this 30-minute single-session treatment to clinicians and women in the Asia Pacific region," said Patricia Scheller, chief executive officer of Viveve. "We fully support our distribution partner for this market, Dynamic Medical Technologies, Inc., and their commitment to provide physicians and medical professionals with high-quality, clinically-proven products supported by exceptional marketing and training services."
Regulatory approvals and clearances for the Viveve System for treatment of vaginal laxity and/or improvement in sexual function indications have been received from more than 50 countries. In the United States, the Viveve System is currently cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis. Viveve is in the process of submitting an investigational device exemption (IDE) to the U.S Food and Drug Administration (FDA) to conduct a pivotal study on use of the device for improvement in sexual function in women.
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. This treatment is indicated for vaginal laxity or improvement of sexual function in 54 countries around the world.
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 October 10, 2017