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BlueWind Medical, Ltd

蓝风医疗有限公司

., a leader in implantable Tibial NeuroModulation (iTNM) and developer of the Revi

，植入式胫骨神经调节（iTNM）的领导者和Revi的开发人员

®

®

System, a patient-centric solution for urgency urinary incontinence (UUI), announced today the publication of two-year results from the pivotal OASIS study in the

该系统是一种以患者为中心的紧急尿失禁（UUI）解决方案，今天宣布公布了美国关键的OASIS研究的两年结果

March 2025 issue of the

2025年3月发布

Journal of Urology

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.

The OASIS study is a prospective, multicenter, single-arm, open-label clinical study of 151 adult women (mean age 58.8 years) with UUI (urgency urinary incontinence; overactive bladder-wet syndrome [OAB-wet]). The trial evaluated the efficacy and safety of Revi in treating UUI symptoms in patients with OAB-wet.

OASIS研究是一项前瞻性，多中心，单臂，开放标签的临床研究，对151名成年女性（平均年龄58.8岁）患有UUI（尿急性尿失禁；膀胱过度活动综合征[OAB-wet]）。该试验评估了Revi治疗OAB湿性患者UUI症状的有效性和安全性。

Primary efficacy and safety endpoints were assessed at six and 12 months, with 97 participants consenting to and completing the 24-month assessment..

主要疗效和安全性终点在6个月和12个月进行评估，97名参与者同意并完成24个月的评估。。

Key findings at two years demonstrate Revi’s durable efficacy, highly favorable safety profile, and high patient satisfaction, supporting its use for treating UUI. Notably, a sustained therapy response was observed utilizing a more flexible provider and patient-driven schedule in year two (≥ two 30-minute sessions/week) compared to the first year (30-minute daily sessions).

两年的主要发现证明了Revi的持久疗效，非常有利的安全性和患者满意度高，支持其用于治疗UUI。值得注意的是，与第一年（每天30分钟）相比，第二年（每周≥两次30分钟）使用更灵活的提供者和患者驱动的时间表观察到持续的治疗反应。

Patients averaged at least one treatment session on eight of 10 days, tailored to individual symptom needs..

患者平均在10天中的8天内至少进行一次治疗，以适应个人症状需求。。

The OASIS study’s two-year analysis demonstrated that Revi provided sustained therapy response with:

Durable reduction in UUI episodes, with 79% of participants experiencing a ≥50% reduction in UUI episodes and 56% achieving a ≥75% reduction in UUI

UUI发作持续减少，79%的参与者UUI发作减少≥50%，56%的参与者UUI发作减少≥75%

High satisfaction rates, with 97% of the participants satisfied and 97% reporting feeling “better” to “very much better”

满意度高，97%的参与者感到满意，97%的参与者表示感觉“更好”到“非常好”

Freedom from leaks with 28% of patients dry on a three-day voiding diary

Substantial reduction in large volume urgency-related leaks, one of the most debilitating aspects of UUI, from 0.9/day to 0.1/day

An excellent safety profile, with no (0%) device- or procedure-related serious adverse events, no device migrations, and no device revision procedures

良好的安全性，没有（0%）与设备或程序相关的严重不良事件，没有设备迁移，也没有设备修订程序

“What sets Revi apart is its patient centricity. The system allows patients to tailor treatment intervals to their symptoms and providers to individualize treatment plans to each patient,” said John Heesakkers, M.D., Chairman of the Department of Urology of the Maastricht University Medical Center in the Netherlands.

荷兰马斯特里赫特大学医学中心泌尿外科主任约翰·希萨克斯医学博士说：“Revi的与众不同之处在于它以患者为中心。该系统允许患者根据自己的症状和提供者调整治疗间隔，为每位患者制定个性化的治疗计划。”。

“It is encouraging to see that the OASIS study long-term data continues to validate the Revi System as a durable and effective treatment for UUI.”.

“令人鼓舞的是，OASIS研究的长期数据继续验证Revi系统是一种持久有效的UUI治疗方法。”。

With

与

recent concerns

最近的担忧

about the potential link between anticholinergic agents and dementia risk, there is an increased need for flexible, non-pharmacologic treatment options. Revi is the first iTNM device for the treatment of UUI labeled for use without prior failure of more conservative therapies. Revi, with its unique label, offers an effective treatment option, supported by the .

关于抗胆碱能药物与痴呆风险之间的潜在联系，人们越来越需要灵活的非药物治疗选择。Revi是第一个用于治疗UUI的iTNM设备，该设备被标记为在没有更保守疗法失败的情况下使用。Revi以其独特的标签提供了一种有效的治疗选择，并得到了支持。

newly updated 2024 Guideline

on the Diagnosis and Treatment of Idiopathic Overactive Bladder from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, which advocates for early consideration of minimally invasive therapy and emphasizes shared decision-making in OAB and UUI management..

美国泌尿外科协会和尿动力学、女性盆腔医学和泌尿生殖道重建学会关于特发性膀胱过度活动症的诊断和治疗，该协会提倡早期考虑微创治疗，并强调OAB和UUI管理的共同决策。。

“The two-year study results affirm the Revi System’s significant impact in improving OAB and UUI symptoms and underscore its innovation and effectiveness as a minimally invasive neuromodulation option,” said Roger Dmochowski, M.D., Chief Medical Advisor, BlueWind Medical. “Our commitment remains steadfast to enhancing treatment options and elevating the quality of life for people grappling with UUI.”.

BlueWind Medical首席医学顾问Roger Dmochowski医学博士说：“两年的研究结果证实了Revi系统在改善OAB和UUI症状方面的重大影响，并强调了其作为微创神经调节选择的创新性和有效性。”。“我们仍然坚定地致力于加强治疗选择，提高UUI患者的生活质量。”。

For more information on BlueWind Medical and the Revi System, please visit

有关BlueWind Medical和Revi系统的更多信息，请访问

bluewindmedical.com

bluewindmedical.com

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.

About BlueWind Medical Ltd.

关于蓝风医疗有限公司。

BlueWind Medical is transforming the field of neuromodulation therapy through the development of innovative, patient-centric medical technology for the treatment of disease. BlueWind is committed to enhancing the quality of life and overall well-being of patients with an initial focus on those living with urge urinary incontinence (UUI).

BlueWind Medical通过开发以患者为中心的创新医疗技术来治疗疾病，正在改变神经调节治疗领域。BlueWind致力于提高患者的生活质量和整体幸福感，最初的重点是那些患有急迫性尿失禁（UUI）的患者。

BlueWind’s Revi.

BlueWind的修订版。

®

®

System is the first and only implantable tibial neuromodulation device activated by a battery-operated external wearable to receive FDA clearance for patients with UUI. Revi is the only neuromodulation therapy on the market that allows physicians to use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System rather than mandating “step-therapy.”.

该系统是第一个也是唯一一个由电池供电的外部可穿戴设备激活的植入式胫骨神经调节装置，可为UUI患者获得FDA许可。Revi是市场上唯一一种神经调节疗法，允许医生在使用Revi系统之前自行决定患者是否应该失败或不能耐受更保守的治疗，而不是强制要求“分步治疗”。

For additional information about BlueWind Medical, please visit

有关BlueWind Medical的更多信息，请访问

bluewindmedical.com

bluewindmedical.com

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.