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Viveve Medical Seeks Strategic Alternatives After Failed Stress Urinary Incontinence Trial

  • 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

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