VIVEVE I Trial Sub-Analysis Published in Journal of Women's Health
Data show Geneveve treatment results in statistically significant improvements in sexual function domains in women with vaginal laxity
ENGLEWOOD, CO -- (Marketwired) -- 12/05/17 -- Viveve Medical Inc. (NASDAQ: VIVE), a medical technology company focused on women's health and wellness, today announced the Journal of Women's Health (JWH) published a sub-analysis of the Female Sexual Functions Index (FSFI) domains from the VIVEVE I trial (VIveve Treatment of the Vaginal Introitus to EValuate Efficacy). The article, authored by Dr. Michael Krychman, et al, will appear in an upcoming 2018 print issue and is currently available in an online version.
"The publication by the JWH of our FSFI domain sub-analysis data from the VIVEVE I clinical trial is an important scientific milestone for the Viveve System's cryogen-cooled monopolar radiofrequency (CMRF) technology for women's sexual health conditions," said Patricia Scheller, chief executive officer of Viveve. "The findings, that a single, non-ablative CMRF treatment significantly improves overall sexual function in women, with statistically significant and/or clinically important improvement in four of the six FSFI domains of Desire, Arousal, Lubrication, and Orgasm, reinforces our continued commitment to reporting sound clinical data supporting treatments that have demonstrated benefits to women's sexual health and wellness."
Results of the full VIVEVE I clinical trial, published in February 2017, provided the first comparative effectiveness data between a standard clinical treatment and a sham treatment to support the safe and effective use of CMRF therapy for the treatment of vaginal laxity for improved sexual function. These new data represent a sub-analysis of the VIVEVE I trial evaluating the impact of CMRF therapy of the vaginal introitus in women with sexual dysfunction (baseline FSFI score ≤26.5) on each of the FSFI domains that contribute to female sexual function.
- At six months, women with sexual dysfunction randomized to active treatment (n=73) had greater improvement in all FSFI domains of sexual function versus sham subjects (n=35).
- Change from baseline analyses showed statistically significant improvements in the active treatment group for Sexual Arousal (p=0.004), Lubrication (p=0.04) and Orgasm (p=0.007).
- Clinically important and statistically significant improvements in Sexual Desire (Odds Ratio[OR]=3.01), Arousal (OR=2.73) and Orgasm (OR=2.58) were additionally shown in women with sexual dysfunction who received active treatment versus sham.
Michael Krychman, M.D., executive director of the Southern California Center for Sexual Health and Survivorship Medicine and primary author of the publication, commented, "The VIVEVE I domains sub-analysis findings of sexual function improvement provide further evidence supporting the clinical utility of CMRF treatment for millions of women worldwide experiencing the condition of vaginal laxity. I believe these scientific data validate the GENEVEVE treatment as a non-surgical, 30-minute, in-office procedure that can improve vaginal introital laxity and sexual function. It advances the practice of clinical sexual medicine with the potential to benefit both clinicians and the patients they serve."
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 55 countries. Consistent with these approvals, Viveve is seeking an IDE from 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.
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Geneveve is a trademark of Viveve, Inc.
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Released December 5, 2017