share_log

Viveve Medical To Seek Strategic Alternatives And Will Be Delisted From Nasdaq; Company Announced Treatment For Female Stress Urinary Incontinence Did Not Meet Primary Endpoint

Viveve Medical To Seek Strategic Alternatives And Will Be Delisted From Nasdaq; Company Announced Treatment For Female Stress Urinary Incontinence Did Not Meet Primary Endpoint

Viveve Medical 尋求策略性替代方案,並將從納斯達克除牌;公司宣布女性壓力性尿失禁的治療未達到主要終點
Benzinga Real-time News ·  2023/01/17 19:31

Viveve Medical, Inc. (NASDAQ:VIVE) today announced topline result from the U.S. Pivotal PURSUIT clinical trial. PURSUIT was a multicenter, randomized, double-blinded, sham-controlled U.S. study to evaluate the safety and efficacy of the Viveve treatment for SUI in women. The results were obtained by the company on Friday evening, January 13, 2023. The PURSUIT study did not meet its primary endpoint of achieving a statistically significant higher proportion of patients who experienced greater 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 group versus the sham control group. The analysis was conducted on the intent-to-treat population of 415 subjects. Subjects were randomized in a 2:1 ratio for the active (N=279) and the sham (N=136) treatments at approximately 30 clinical sites in the U.S. The proportion of patients with over a 50% reduction in leakage in the active group was 49.8%, and the proportion of patients with over a 50% reduction in leakage in the sham group was 56.7% (p-value = 0.2035). The study also did not meet several secondary endpoints. There were no serious device-related adverse events reported. "We are extremely disappointed that the PURSUIT trial did not achieve its primary efficacy endpoint. Based on the reported results, we do not see a path forward, nor do we intend to pursue FDA registration of our Viveve System and its dual-energy treatment for SUI in women," said Scott Durbin, Viveve's chief executive officer. "We want to thank our investigators, clinical sites, and patients for their dedicated efforts and participation in the U.S. PURSUIT trial. Additionally, I want to personally acknowledge the extraordinary efforts of the entire Viveve organization over the last three years, including our clinical advisors and consultants, for their contributions to Viveve's SUI development program," concluded Mr. Durbin. Due to the company's business prospects following the SUI trial, the company has significantly reduced its workforce and intends to explore strategic options, including a sale of the company's business or assets, and/or a wind-down of the company's operations. Further, as previously disclosed, the company's securities are subject to delisting from the Nasdaq Stock Market unless the company presents a plan to regain compliance with Nasdaq's continued listing standards before the Nasdaq hearings panel. The company has a hearing before the panel on January 19, 2023. As a result of the company's business prospects following the SUI trial, the company is unable to present a plan to regain compliance with Nasdaq's continued listing standards at the hearing. Accordingly, Nasdaq will delist the company by filing a Form 25. Following the effectiveness of the delisting, the company intends to file a Form 15 with the Securities and Exchange Commission to suspend its reporting obligations under the Securities Exchange Act of 1934, as amended.

維維夫醫療股份有限公司 (NASDAQ: VIVE) 今天宣佈美國關鍵追求臨床試驗的頂線結果。追求是一項多中心、隨機、雙盲、深層對照的美國研究,旨在評估女性 VIVEVE 療法的安全性和有效性。該公司於 2023 年 1 月 13 日(星期五)晚上獲得結果。與假對照組在治療後 12 個月進行的標準化 1 小時墊體重測試的基線相比,該研究未達到其在統計學上顯著較高比例的尿洩量減少了 50% 以上的患者的主要終點。該分析是針對 415 受試者的意圖治療人口進行的。受試者在美國約 30 個臨床部位的活性(N = 279)和假(N = 136)治療的比例以 2:1 的比例進行隨機分配,活性組洩漏減少 50% 以上的患者比例為 49.8%,而假組洩漏減少 50% 以上的患者比例為 56.7%(p 值 = 0.2035)。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。「我們感到非常失望,因為 ASSEMENCY 試驗沒有達到其主要功效終點。根據報告的結果,我們看不到前進的道路,我們也不打算對我們的 Vivea系統及其女性 SUI 雙能量治療進行 FDA 註冊。」Vivve 首席執行官 Scott Durbin 表示。「我們要感謝我們的調查人員,臨床站點和患者的努力和參與美國追求試驗。此外,我要親自感謝整個 Vivve 組織在過去三年中所做的非凡努力,包括我們的臨床顧問和顧問,以表揚他們對 Vivve SUI 開發計劃的貢獻。」由於該公司在 SUI 試驗之後的業務前景,該公司已大大減少其勞動力,並打算探索策略性選項,包括出售公司的業務或資產,和/或公司運營的風險。此外,正如先前披露的那樣,除非該公司提出重新遵守納斯達克聆訊委員會之前重新遵守納斯達克持續上市標準的計劃,否則該公司的證券將從納斯達克證券市場除牌。該公司於 2023 年 1 月 19 日在事務委員會席前進行聆訊。由於該公司在 SUI 試驗後的業務前景,該公司無法在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 來撤銷該公司的上市。繼除牌程序的有效性後,該公司擬向美國證券交易委員會提交表格 15,暫停其經修訂的《1934 年證券交易法》下的申報義務。

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。
    搶先評論