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 VIVEVE II trial did not achieve its primary endpoint. Although there was substantial improvement in the total FSFI score from baseline to the final 12-month follow-up in the active group, indicating a significant treatment effect, there was not sufficient separation from the sham group to achieve statistical significance," said Scott Durbin, CEO of Viveve, said in a release. "We intend to thoroughly analyze the complete data set, including all secondary and exploratory endpoints to better understand this outcome.
In August of 2018, Viveve won a nod from FDA to continue enrollment in the trial. The company had also submitted an IDE application to FDA to get authorization for a device to treat stress urinary incontinence (SUI).