Establishing a benchmark for energy-based device companies, Viveve undertook and successfully completed a multicenter, blinded, randomized, sham controlled study of an elective vaginal procedure to assess the effect the treatment had on women suffering from the changes their bodies undergo after vaginal childbirth.
The Viveve I study demonstrated:
There were NO serious adverse events in patients treated with the active treatment
Improvement of arousal and/or orgasm was statistically significant as self-reported by 9 out of 10 patients (Data on file and publication pending)
Further, two previous pilot clinical trials conducted by Viveve in the U.S. and Japan, showed sustained tightening at 12 months. (Data on file)