PARK CITY, Utah, April 23, 2024 /PRNewswire/ -- BlueWind Medical, Ltd., a pioneer in implantable Tibial NeuroModulation (iTNM) and the developer of ReviTM, a patient-centric solution for urge urinary incontinence (UUI), today announced that the peer-reviewed results from the OASIS pivotal trial were published in the Journal of Neurourology and Urodynamics (NAU).

犹他州帕克城，2024年4月23日/PRNewswire/--植入式胫骨神经调节（iTNM）的先驱BlueWind Medical，Ltd.和以患者为中心的急迫性尿失禁（UUI）解决方案ReviTM的开发人员今天宣布，OASIS pivotal试验的同行评审结果发表在《神经泌尿学和尿动力学杂志》（NAU）上。

OASIS, a prospective, multicenter, single-arm, open-label clinical study of 151 women, was designed to demonstrate the safety and efficacy of Revi in reducing symptoms of overactive bladder (OAB)..

OASIS是一项针对151名女性的前瞻性，多中心，单臂，开放标签临床研究，旨在证明Revi在减轻膀胱过度活动症（OAB）症状方面的安全性和有效性。。

The trial results demonstrate a statistically significant improvement with a 78.4% clinical success rate as defined by at least a 50% reduction in UUI at 12 months in the intention to treat (ITT) analysis (p<.0001). In the completers analysis, at the 12-month follow-up, 82.0 % of participants achieved at least a 50% reduction in UUI episodes, 66.9% achieved at least a 75% reduction, and 50% were dry for at least 3 consecutive days.

试验结果显示，在意向治疗（ITT）分析中，UUI在12个月时至少减少50%，临床成功率为78.4%，具有统计学意义（p<0.0001）。在完成者分析中，在12个月的随访中，82.0%的参与者UUI发作至少减少了50%，66.9%的参与者至少减少了75%，50%的参与者至少连续3天干燥。

Notably, there were no procedure- or device-related serious adverse events and no surgical reintervention/revisions as a consequence of implant migration, lead breakage, or battery replacement..

值得注意的是，没有与手术或设备相关的严重不良事件，也没有因植入物迁移，导线断裂或电池更换而进行手术再次干预/修订。。

'OAB is a chronic and debilitating condition that significantly impairs quality of life with significant financial costs for many people. One in six adults in Europe and the U.S. have OAB,' said John Heesakkers, M.D., Chairman of the Department of Urology of the Maastricht UMC, the Netherlands, and the International Continence Society General Secretary.

“OAB是一种慢性衰弱性疾病，严重影响生活质量，给许多人带来巨大的经济成本。荷兰马斯特里赫特UMC泌尿外科主任、国际节制协会秘书长约翰·希萨克斯（JohnHeesakkers）医学博士说，欧洲和美国有六分之一的成年人患有OAB。

'The data published in NAU underscore the effectiveness of Revi as a valuable therapy for individuals living with UUI who oftentimes go untreated.'.

“NAU发布的数据强调了Revi作为UUI患者的一种有价值的治疗方法的有效性，而UUI患者往往未经治疗。”。

Additional 12-month data highlights include:

其他12个月数据亮点包括：

93.5% of participants with available PGI‐I data reported their symptoms were better, much better, or very much better

93.5%有PGI-I数据的参与者报告他们的症状更好、更好或更好

84.6% of participants had a mean improvement greater than the 10-point minimum clinically important difference in Health-Related Quality of Life

84.6%的参与者在与健康相关的生活质量方面的平均改善程度大于10分的最小临床重要差异

88.0% of participants demonstrated a significant improvement in either UUI or large volume (severe) incontinence episodes

88.0%的参与者表现出UUI或大容量（严重）尿失禁发作的显着改善

These strong efficacy results, a compelling safety profile combined with high patient satisfaction and clinically significant improvements in quality of life, clearly demonstrate the value of the Revi System in reducing OAB symptoms. In addition, the unique patient-centric nature of the therapy, which allows for individually tailored treatment, resulted in an increasing improvement in UUI over time..

这些强大的疗效结果，令人信服的安全性，以及高患者满意度和临床上显着的生活质量改善，清楚地证明了Revi系统在减少OAB症状方面的价值。此外，该疗法独特的以患者为中心的性质，可以进行个性化治疗，随着时间的推移，UUI的改善程度越来越高。。

'The publication of the OASIS pivotal data within the Journal of Neurourology and Urodynamics marks a significant milestone for Revi, showcasing our commitment to advancing treatment options for people living with UUI,' said Dan Lemaitre, chief executive officer of BlueWind Medical. 'Moreover, BlueWind is dedicated to supporting the patients who are impacted by urge incontinence and the health care providers who care for them.'.

BlueWind Medical首席执行官丹·勒梅特尔（DanLemaitre）说：“OASIS关键数据在《神经泌尿学和尿动力学杂志》（Journal of Neurourology and Urodynamics）上的发布标志着Revi的一个重要里程碑，表明了我们致力于推进UUI患者的治疗选择。”此外，BlueWind致力于支持受急迫性尿失禁影响的患者以及照顾他们的医疗保健提供者。”。

OAB is a chronic condition that requires consistent and long-term therapy to manage symptoms. Drug therapy is often used to manage OAB and UUI, however, concerns have emerged regarding the long-term use of anticholinergics, the most common medications used. Anticholinergics, in addition to poor tolerability due to side effects, have in recent years come under the spotlight due to significant associations between their use and increased risk of cognitive impairment and dementia.1 Increasingly, providers are discontinuing anticholinergic prescribing, however, the alternative medications for OAB, the b3-adrenergic receptor agonists, are not available to many patients due to cost and insurance plans with limited access.2 Thus, Revi presents a safe and effective long-term solution for those suffering with UUI..

OAB是一种慢性病，需要持续和长期的治疗来控制症状。药物治疗通常用于管理OAB和UUI，然而，人们对长期使用抗胆碱能药物（最常用的药物）产生了担忧。抗胆碱能药物除了由于副作用导致的耐受性差外，近年来由于其使用与认知障碍和痴呆风险增加之间的显着关联而备受关注。1越来越多的提供者正在停止抗胆碱能药物处方，然而，由于成本和保险计划有限，许多患者无法获得用于OAB（b3肾上腺素能受体激动剂）的替代药物。因此，Revi为UUI患者提供了一种安全有效的长期解决方案。。

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 wellbeing 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 System is the first and only implantable tibial neuromodulation device activated by a battery-operated external wearable to receive FDA marketing authorization 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.'.

BlueWind的Revi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，可获得FDA针对UUI患者的营销授权。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 https://bluewindmedical.com/

有关BlueWind Medical的更多信息，请访问https://bluewindmedical.com/

1. Clinical Consensus Statement: Association of Anticholinergic Medication Use and Cognition in Women With Overactive Bladder. Female Pelvic Med Reconstr Surg. 2021;27(2):69-71. doi:10.1097/SPV.0000000000001008

临床共识声明：膀胱过度活动症患者抗胆碱能药物使用与认知的关系。女性骨盆医学重建外科2021；27（2）：69-71。doi:10.1097/SPV.0000000000001008

2. Dmochowski RR, Newman DK, Rovner ES, Zillioux J, Malik RD, Ackerman AL. Patient and Clinician Challenges with Anticholinergic Step Therapy in the Treatment of Overactive Bladder: A Narrative Review. Adv Ther. 2023;40(11):4741-4757. doi:10.1007/s12325-023-02625-8

2.Dmochowski RR，Newman DK，Rovner ES，Zillioux J，Malik RD，Ackerman AL。抗胆碱能阶梯疗法治疗膀胱过度活动症的患者和临床医生挑战：叙述性综述。高级Ther。2023年；40（11）：4741-4757。内政部：10.1007/s12325-023-02625-8

SOURCE BlueWind Medical

来源蓝风医疗