Viveve(R) Announces Regulatory Approval for Viveve(R) System in Australia and Distribution Partnership with Device Consulting in Australia and New Zealand
Painless, Non-Surgical Treatment for Vaginal Laxity -- Now Approved for Marketing in 28 Countries Around the World
SUNNYVALE, CA -- (Marketwired) -- 09/08/16 -- 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 Therapeutic Goods Administration (TGA) in Australia. The Company also announced a new distribution partnership for the Viveve System in Australia and New Zealand with Device Consulting, a distinguished supplier of medical products headquartered in Victoria, Australia.
"Our regulatory approval in Australia and our distribution partnership with Device Consulting represent important milestones in our rapidly expanding efforts to build a global commercial infrastructure for the Viveve System," said Patricia Scheller, chief executive officer of Viveve. "Our research shows that vaginal laxity is a significant risk and concern for women following pregnancy. We believe that the clinically demonstrated safety and efficacy profile of this painless procedure will position the Viveve Treatment as the best alternative for a condition that can profoundly impact a woman's sexual satisfaction and quality of life. We look forward to bringing the advantages of the Viveve System to women in this region who are living with the challenges of vaginal laxity."
Device Consulting specializes in the distribution of innovative technologies to address both established and emerging healthcare needs. Device Consulting will support the regional distribution of the Viveve System to medical practices throughout Australia and New Zealand through its extensive distribution channels.
"The Viveve System is precisely aligned with our mission to bring high-quality and clinically proven technologies to physicians and their patients. Our goal is to more efficiently communicate the advantages of the Viveve procedure to clinicians and all women who may benefit from the treatment," said Milivoj Boltuzic, chief executive officer and general manager of Device Consulting.
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. Viveve'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 tighten 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.
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Source: Viveve Medical, Inc.
Released September 8, 2016