VIVEVE I Trial Sub-Analysis Published in Journal of Women's Health

ENGLEWOOD, CO--(Marketwired - December 05, 2017) - 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."