Viveve Medical Seeks Strategic Alternatives After Failed Stress Urinary Incontinence Trial

Author: Vandana Singh | January 17, 2023 09:05am

• Viveve Medical Inc (NASDAQ:VIVE) announced topline results from the U.S. Pivotal PURSUIT clinical trial evaluating Viveve treatment for stress urinary incontinence (SUI) in women.
• 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.
• Photo Via Company

Posted In: VIVE