The company added that it is currently evaluating strategic alternatives and assessing its organization and cost structure following the missed endpoint amid the current COVID-19 pandemic.
The Viveve II clinical trial is a multicenter, randomized, double-blinded, sham-controlled study for evaluating its CMRF technology in improving the sexual function of women following vaginal childbirth. The study included 220 subjects randomized at a 1:1 ratio that successfully completed a 12-month follow-up across 17 clinical sites in the U.S.
It 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 adjusted mean change for the active group was 9.8 and the adjusted mean change for the sham group was 9.0. There were no serious device-related adverse events reported, according to a news release.
“We are extremely disappointed that the VIVEVE II trial did not achieve its primary endpoint,” Viveve CEO Scott Durbin said in the release. “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.
“We intend to thoroughly analyze the complete data set, including all secondary and exploratory endpoints to better understand this outcome.”