New Guideline Now Includes Implantable Tibial NeuroModulation (iTNM)

新指南现在包括植入式胫骨神经调节（iTNM）

Transitions Away from Step Therapy Requirement

从逐步治疗要求过渡

PARK CITY, Utah, April 29, 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), announced today that the Revi System, a minimally invasive therapy, is now included in the American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) clinical practice guideline on the diagnosis and treatment of idiopathic overactive bladder (OAB).

犹他州帕克城，2024年4月29日/新闻通讯社/--植入式胫骨神经调节（iTNM）的先驱和ReviTM（一种以患者为中心的急迫性尿失禁（UUI）解决方案）的开发者BlueWind Medical，Ltd今天宣布，Revi系统是一种微创疗法，现已纳入美国泌尿外科协会（AUA）和尿动力学，女性盆腔医学和泌尿生殖重建学会（SUFU）关于特发性膀胱过度活动症（OAB）诊断和治疗的临床实践指南。

The revised guidelines are a major affirmation of the importance of Revi as a therapy for patients with UUI. First, the guidelines were updated to include iTNM as an acceptable minimally invasive therapy.  In addition, the revised guidelines shift away from traditional step therapy approaches, allowing physicians and patients to bypass behavioral and pharmacotherapy before considering minimally invasive therapies, including Revi..

修订后的指南主要肯定了Revi作为UUI患者治疗的重要性。首先，指南进行了更新，将iTNM纳入可接受的微创治疗。此外，修订后的指南改变了传统的分步治疗方法，允许医生和患者在考虑包括Revi在内的微创治疗之前绕过行为和药物治疗。。

Revi is the only minimally invasive implant with an indication that matches the new guidelines and does not require that patients fail or not tolerate more conservative therapies first. Revi, which was granted De Novo marketing request by the US Food and Drug Administration (FDA) in August 2023, is an innovative device implanted near the ankle during a single outpatient procedure performed under local anesthesia, with or without sedation, and without the reintervention due to lead fracture, migration and battery depletion seen with other UUI therapies.

Revi是唯一一种适应症符合新指南的微创植入物，不要求患者首先失败或不耐受更保守的治疗。Revi于2023年8月获得美国食品和药物管理局（FDA）的从头上市请求，是一种创新设备，在局部麻醉下进行的单次门诊手术中植入脚踝附近，有或没有镇静，并且没有由于其他UUI疗法所见的铅断裂，迁移和电池耗尽而再次介入。

For activation, a lightweight wireless wearable is placed around the ankle at the patient's convenience once to twice daily to provide stimulation to the posterior tibial nerve to provide relief..

为了激活，在患者方便的情况下，将轻便的无线可穿戴设备放置在脚踝周围，每天一到两次，以刺激胫后神经以缓解疼痛。。

'The understanding and treatment of voiding dysfunction and OAB is truly in an evolutionary phase,' said Roger Dmochowski, MD, MMHC, and BlueWind Medical Chief Medical Officer. 'These recent guideline modifications reflect a modern understanding of how to attain improvements in practice, patient access, and hoped-for advancements in patient outcomes and patient acceptance of therapy.'.

“对排尿功能障碍和OAB的理解和治疗确实处于进化阶段，”医学博士、MMHC和BlueWind Medical首席医疗官Roger Dmochowski说这些最近的指南修改反映了对如何在实践，患者获取方面取得改进的现代理解，并希望在患者结果和患者接受治疗方面取得进展。”。

'We are delighted to witness the transformation of the new OAB treatment guideline by the AUA/SUFU. This guideline represents a significant turning point in physicians' approach to OAB management,' commented Dan Lemaitre, Chief Executive Officer of BlueWind Medical. 'Consistent with the guideline, Revi's unique indication eliminates the need for patients to try and fail step therapy, instead empowering clinicians and patients to make shared treatment decisions.

“我们很高兴看到AUA/SUFU对新OAB治疗指南的转变。BlueWind Medical首席执行官丹·莱梅特尔（DanLemaitre）评论说，这一指南代表了医生OAB管理方法的一个重要转折点与指南一致，Revi的独特适应症消除了患者尝试和失败步骤治疗的需要，而是赋予临床医生和患者共同做出治疗决策的权力。

As partners in the care of people living with UUI, we reaffirm our commitment to advancing patient-centric solutions.'.

作为护理UUI患者的合作伙伴，我们重申致力于推进以患者为中心的解决方案。”。

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, 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 prescriptions, and alternative medications for OAB such as β3-adrenergic receptor agonists are cost-prohibitive for many patients due to price and limited access through insurance.2 Revi presents a safe and effective long-term solution for people 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。抗胆碱能药物除了耐受性差外，近年来也受到关注，因为它们的使用与认知障碍和痴呆风险增加之间存在显着关联。越来越多的提供者正在停止抗胆碱能药物处方，而OAB的替代药物如β3-肾上腺素能受体激动剂由于价格昂贵且通过保险获得的机会有限，因此对许多患者来说成本高昂。2 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。女性盆腔医学重建外科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