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VIVEVE I Clinical Study Results Published in Journal of Sexual Medicine
07 / 02 / 2017
Benchmark study documents safety and efficacy of GENEVEVE(TM) treatment to improve vaginal laxity and sexual function.
SUNNYVALE, CA -- (Marketwired) -- 02/07/17 -- Viveve Medical, Inc. ("Viveve") (NASDAQ: VIVE), a medical technology company focused on women's health, today announced publication of the results of the VIVEVE I clinical study in the Journal of Sexual Medicine (JSM). The article, under the Female Sexual Function category in the February 2017 issue, is authored by Dr. Michael Krychman, et al. and entitled, "Effect of Single-Treatment, Surface-Cooled Radiofrequency Therapy on Vaginal Laxity and Female Sexual Function: The VIVEVE I Randomized Controlled Trial."
"Publication of the VIVEVE I results, we believe, is a benchmark for the use of energy-based treatments for women's sexual health conditions," said Patricia Scheller, chief executive officer of Viveve. "Large, randomized, sham-controlled studies have not historically been conducted to demonstrate the safety and efficacy of energy-based procedures in gynecological applications, including vaginal laxity, a significant medical condition affecting millions of women worldwide that may lead to a reduction in sexual function. Viveve is the only company in the energy-based device arena to undertake, successfully complete and have published the results from a female sexual function study of this magnitude," she continued.
The primary endpoint of the VIVEVE I study was a comparison of the proportion of women reporting no vaginal laxity in the treatment group versus the sham group at 6 months post-treatment.
• Subjects receiving the active treatment were 3 times more likely to report no vaginal laxity at six months versus the sham group (p-value = 0.006).
• Statistically significant and sustained improvement in sexual function (baseline FSFI total score ≤26.5) after a single treatment, with an adjusted mean difference in the active group vs sham group of 3.2 at 6 months (p-value = 0.009). "Placebo effect" in sham group did not rise above dysfunctional (FSFI ≤26.5) and diminished at 6 months.
• Statistically significant improvement in sexual function was achieved in 93% of subjects in the active group vs the sham group in two individual key domains of FSFI (p-value = 0.007).
"The VIVEVE I study and publication of the full data from the trial in JSM is a monumental advancement in the practice of clinical sexual medicine on a global level. As a global company, Viveve continues its commitment to providing sound clinical data supporting innovative technology and treatments that have demonstrated benefits to women's health and wellness," said Michael Krychman, M.D., executive director of the Southern California Center for Sexual Health and Survivorship Medicine and the primary author of the publication. "The prevalence of vaginal laxity, its impact on a woman's sexual function, and the efficacy of Viveve's cryogen-cooled monopolar radiofrequency (CMRF) single-session treatment is scientifically legitimized and further validates the significant benefits to clinicians and patients."
An Investigational Device Exemption (IDE) was submitted in September of 2016 to the Food and Drug Administration (FDA) for authorization to begin the VIveve Treatment of the Vaginal Introitus to EVauate Efficacy (VIVEVE II) study. The study will begin in the U.S. when the FDA completes its review and if approval is received.
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 GENEVEVETM 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.
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Geneveve is a trademark of Viveve, Inc.
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Source: Viveve Medical, Inc.