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Viveve Medical Seeks Strategic Alternatives After Failed Stress Urinary Incontinence Trial

Viveve Medical Seeks Strategic Alternatives After Failed Stress Urinary Incontinence Trial

压力性尿失禁试验失败后,Viveve Medical寻求战略替代方案
Benzinga Real-time News ·  2023/01/17 08:08
  • 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
  • Viveve 医疗公司 纳斯达克股票代码:VIVE)公布了评估Viveve治疗女性压力性尿失禁(SUI)的美国Pivotal PURSURI临床试验的主要结果。
  • 该研究没有达到其主要终点,即在主动治疗组中,与假对照组相比,在治疗后12个月进行标准化1小时Pad Weight测试时,尿液泄漏减少50%以上的患者比例在统计学上显著增加。
  • 大约有415名受试者参加了该试验。49.8%的患者报告说,活跃组的渗漏量减少了50%以上,虚假组的渗漏量减少了56.7%。
  • 该研究也没有达到几个次要终点。没有报告与设备相关的严重不良事件。
  • 由于SUI试验后公司的业务前景,该公司已大幅裁员,并打算探索战略选择。
  • 此外,正如先前披露的那样,该公司的证券必须从纳斯达克股票市场退市。
  • 由于SUI审判后公司的业务前景,该公司无法在定于1月19日举行的听证会上提出重新遵守纳斯达克持续上市标准的计划。
  • 因此,纳斯达克将通过提交25号表格将该公司除名。
  • 价格走势: 在周二的最后一次盘前交易中,VIVE股价下跌了68.04%,至0.2820美元。
  • 照片来自公司
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