Viveve Could Hit Reset Button After Failing to Meet Endpoints in Trial

Viveve Medical has hit a snag after it failed to meet the endpoints in a clinical trial for technology to improve the sexual function in women following vaginal childbirth. The Englewood, CO-based company said as a result of the results and impact from the COVID-19 pandemic that it was evaluating strategic alternatives, as well as actively assessing its current organization and cost structure. Viveve is developing a Cryogen-cooled Monopolar Radiofrequency (CMRF) technology that can treat vaginal laxity. The technology delivers RF energy deeply into soft tissues – which results in neocollagenesis, or a straightening or tightening of the skin. In a Securities and Exchange Commission filing, the company said the VIVEVE II study did not meet its primary endpoint of demonstrating a statistically significant improvement in the mean change from baseline in total Female Sexual Function Index (FSFI) score at 12 months. The study included 220 subjects that completed 12-month follow-up. Subjects were randomized in a 1:1 ratio for the active (N=114) and the sham (N=106) treatments at 17 clinical sites in the U.S. The adjusted mean change for the active group was 9.8 and the adjusted mean change for the sham group was 9.0, a difference of 0.8 (p=0.3942). There were no serious device-related adverse events reported. The treatment groups were well balanced, and the number of subjects lost to follow-up was as expected. "We are extremely disappointed that the VIV...
Source: MDDI - Category: Medical Devices Tags: Business Source Type: news