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A rendering of the UroActive implant in a female patient. [Image courtesy of UroMems]
女性患者体内UroActive植入物的渲染图。[图片来源:UroMems]
UroMems
尿路感染
announced that the entire treatment cohort in the first-of-its-kind study in female patients successfully reached its primary endpoints.
宣布在首项针对女性患者的研究中,整个治疗队列成功达到了主要终点。
Grenoble, France-based UroMems — which has its U.S. headquarters in Minneapolis — develops an implantable system called UroActive. Powered by a MyoElectroMechanical system (MEMS), UroActive goes into the urethral duct in men and bladder neck in women. It’s controlled by a patient’s activity without the need for manual adjustments.
法国格勒诺布尔的UroMems公司(其美国总部位于明尼阿波利斯)开发了一种名为UroActive的可植入系统。该系统由肌电机械系统(MEMS)驱动,男性植入尿道,女性植入膀胱颈。它通过患者的活动自动控制,无需手动调节。
This provides patients ease of use and better quality of life compared to other options..
这为患者提供了比其他选择更方便的使用和更好的生活质量。
The company previously had
公司之前有
positive early feasibility data in a study of six men
研究中的六名男性初步可行性数据积极
, then reported the first-ever
,然后报告了有史以来第一次
female implant last year
去年女性植入物
. In June 2024, the company
。2024年6月,该公司
raised $47 million
筹集了4700万美元
to support clinical trials for its smart automated artificial urinary sphincter (AUS).
支持其智能自动人工尿道括约肌(AUS)的临床试验。
More about the UroMems study
更多关于UroMems研究的信息
Participants in the France-based study successfully reached the six-month primary endpoints. The company said it marks a new era for women suffering from stress urinary incontinence (SUI). According to UroMems, it signals a transition for surgeons treating SUI in France and across Europe and the U.S.
法国研究的参与者成功达到了六个月的主要终点。公司表示,这标志着患有压力性尿失禁(SUI)的女性迎来了一个新时代。据UroMems称,这标志着治疗SUI的外科医生在法国、欧洲和美国的转变。
as well..
以及..
UroMems’ latest assessment took place through a prospective multicenter clinical study. All six women have been implanted for at least seven months and the first patient is closing in on two years post-implant. Devices operated as expected over the respective implant time periods with no need for revision or explant..
UroMems的最新评估是通过一项前瞻性的多中心临床研究进行的。所有六名女性植入设备至少已达七个月,首位患者即将接近植入后两年。在各自的植入时间段内,设备均按预期运行,无需修正或移除。
The company also reported “phenomenal” follow-up on secondary outcome measures. Those include leak rate values and patient quality of life questionnaires.
该公司还报告了“惊人”的次要结局指标的后续结果。这些指标包括渗漏率值和患者生活质量问卷。
“With women suffering from higher rates of SUI and currently no effective solutions available to them, we are ecstatic to be the first to demonstrate the feasibility of our breakthrough technology now in a total of 12 women and men,” said
“由于女性遭受更高比例的应力性尿失禁,并且目前没有有效的解决方案,我们非常激动能够首次在总共12名女性和男性身上展示我们突破性技术的可行性,”
Hamid Lamraoui
哈米德·拉姆拉维
, UroMems CEO and co-founder. “All of the female patients participating in our study have returned to living life fully after years of struggling with SUI. We sincerely thank them for participating in our study along with their physicians and our team for bringing this one step closer to providing a new and effective option to the millions of people suffering from SUI in the U.S.
,UroMems首席执行官兼联合创始人。“参与我们研究的所有女性患者在与压力性尿失禁(SUI)斗争多年后,都重新回归了正常生活。我们衷心感谢她们以及她们的医生和我们的团队,帮助我们朝着为美国数百万SUI患者提供一种全新且有效的治疗选择迈近了一步。
and .
和。
Europe
欧洲
.”
”