The study did not meet its primary endpoint of achieving a statistically significant higher proportion of patients experiencing more than a 50% reduction in urine leakage compared to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment in the active treatment versus the sham control group.
About 415 subjects participated in the trial. 49.8% of patients reported over a 50% reduction in leakage in the active group and 56.7% in the sham group.
The study also did not meet several secondary endpoints. There were no serious device-related adverse events reported.
Due to the company's business prospects following the SUI trial, it has significantly reduced its workforce and intends to explore strategic options.
Further, as previously disclosed, the company's securities are subject to delisting from the Nasdaq Stock Market.
As a result of the company's business prospects following the SUI trial, the company cannot present a plan to regain compliance with Nasdaq's continued listing standards at the hearing scheduled on Jan. 19.
Accordingly, Nasdaq will delist the company by filing Form 25.
Price Action: VIVE shares are down 68.04% at $0.2820 during the premarket session on the last check Tuesday.
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