Viveve (NSDQ:VIVE) today announced results from a sub-analysis of its Viveve 1 trial exploring the use of the Viveve system for treating vaginal introitus in women with sexual dysfunction, touting improvements on the Female Sexual Functions Index.
The Englewood, Colo.-based company’s Viveve System is designed as a non-surgical treatment for post-partum laxity of the vaginal introitus.
Sub-analysis results were published today in the Journal of Women’s Health, the company said.
“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 technology for women’s sexual health conditions. 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,” Viveve CEO Patricia Scheller said in a press release.
Results from the sub-analysis indicated that at six months, women with sexual dysfunction showed greater improvements across FSFI domains of sexual function than patients in the sham cohort. Statistically significant improvements were noted in the active treatment group across domains of sexual arousal, lubrication and orgasm, according to the results.
Clinically significant improvements across the domains of sexual desire, arousal and orgasm were also shown in women with sexual dysfunction who were in the Viveve treatment group, the company reports.
“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,” co-primary author Dr. Michael Krychman of the Southern California Center for Sexual Health and Survivorship Medicine said in a prepared statement.
In October, Viveve said it won approval from Mexico’s regulatory authority, COFEPRIS, to market its Viveve system in Mexico with indications for treating vaginal introitus, after vaginal childbirth and to improve sexual function.
Join us Oct. 8-10 for the 7th annual DeviceTalks Boston, back in the city where it all began.
DeviceTalks offers three days of world-class education, networking, and a technology exhibition featuring the leading companies in the industry.
Early Registration is now open.