VIVEVE I Clinical Study Results Accepted for Publication in Journal of Sexual Medicine
Publication of full data from landmark study reflects paradigm shift in development of energy-based treatment options for vaginal laxity
SUNNYVALE, CA -- (Marketwired) -- 12/01/16 -- Viveve Medical Inc. ("Viveve") (NASDAQ: VIVE), a medical technology company focused on women's health, today announced the Journal of Sexual Medicine (JSM) has accepted for publication the results of the VIVEVE I clinical study for the treatment of vaginal laxity. The article, authored by Dr. Michael Krychman, et al, will appear in an upcoming 2017 issue of JSM, the authoritative peer-reviewed journal of the International Society of Sexual Medicine (ISSM).
"With the publication of the VIVEVE I results, we believe that a new paradigm has been established for the use of energy-based treatments for women's sexual health conditions. Large, randomized, sham-controlled studies have not historically been conducted to demonstrate the safety and efficacy of energy-based procedures in gynecological applications, demonstrating, I believe, a profound lack of regard for the treatment of these significant medical conditions. Viveve will be the first, and, to date, the only company to clinically demonstrate the efficacy and safety of its treatment," said Patricia Scheller, chief executive officer of Viveve. She continued, "The published results will reaffirm our commitment to providing sound clinical data supporting treatments that have demonstrated benefits to women's sexual health and wellness."
In April 2016 Viveve Medical announced topline results from the VIVEVE I clinical trial. The primary endpoint of the study was a comparison of the proportion of women reporting no vaginal laxity in the Viveve treatment group versus the proportion of women reporting no vaginal laxity in the sham group at six months post-treatment.
- At six months, the proportion of subjects reporting no vaginal laxity in the active group was 41.7% versus the sham group of 19.2% with a Chi-Squared p-value of 0.005.
- Subjects receiving the active treatment were three times more likely to report no vaginal laxity at six months versus the sham group with a p-value of 0.006 (based on logistic regression).
- Mean change from baseline for the active group was 1.9 versus the sham group of 1.1 on the seven point VSQ scale with a p-value of 0.007.
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 prevalence of vaginal laxity, its impact on a woman's sexual function, and the efficacy of the cryogen-cooled monopolar radiofrequency (CMRF) treatment is scientifically legitimized by the results of the VIVEVE I study and publication of the full data from the trial in JSM. Data from VIVEVE I, a scientifically designed multi-center, randomized, sham-controlled trial, further validates the technology as a non-surgical, single treatment, 30-minute procedure that can improve vaginal introital laxity and sexual function while advancing the practice of clinical sexual medicine with significant benefits for clinicians and patients."
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 GENEVEVE™ 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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Source: Viveve Medical, Inc.
Released December 1, 2016