Viveve Medical Seeks Strategic Alternatives After Failed Stress Urinary Incontinence Trial
Viveve Medical Seeks Strategic Alternatives After Failed Stress Urinary Incontinence Trial
VIVEVE 醫療在壓力性尿失禁試驗失敗後尋求策略性替代方案
- 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
- 維威醫療股份有限公司 (NASDAQ: VIVE) 公佈美國關鍵追求臨床試驗的頂層結果，評估 VIVVE 治療女性壓力性尿失禁 (SUI) 的治療方法。
- 與主動治療後 12 個月的標準化 1 小時墊體重測試相比，該研究未達到其主動治療後 12 個月進行的標準化 1 小時墊重量測試的基線，尿洩減少了 50％ 以上的患者的主要終點。
- 約 415 名受試者參加了該試驗。49.8％ 的患者表示，活躍組的洩漏量減少了 50％ 以上，而假組的洩漏量減少了 56.7％。
- 研究也未符合數個次要端點。沒有報告與設備相關的嚴重不良事件。
- 由於該公司在 SUI 試驗之後的業務前景，因此它大大減少了員工，並打算探索策略性選項。
- 此外，正如之前披露的那樣，該公司的證券將從納斯達克股票市場除牌。
- 由於該公司在 SUI 審判後的業務前景，該公司無法在 1 月 19 日舉行的聽證會上提出重新遵守納斯達克持續上市標準的計劃。
- 因此，納斯達克將通過提交表格 25 撤銷公司的上市。
- 價格行動： 在上次檢查週二的盤前時段期間，VIVE 的股票下跌了 68.04%，報 0.2820 美元。
- 通過公司照片
譯文內容由第三人軟體翻譯。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。