Key initial results from AURA-2 study highlight good safety and scalability of Amber-UI therapy A strong efficacy signal was seen in the form of complete resolution of incontinence episodes six months post implant in 80% (4 of 5) evaluable women with mixed urinary incontinencePreliminary data from the study were presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) annual meeting (February 2024) London, UK, 27 February 2024 – Amber Therapeutics (‘Amber’ or the ‘Company’), an innovative medical technology company developing next-generation, intelligent bioelectrical therapies to transform clinical outcomes in patients with functional disorders of the peripheral nervous system, announces the presentation of the first data from its AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study evaluating Amber-UI.

AURA-2研究的主要初步结果突出了琥珀色UI疗法的良好安全性和可扩展性。在80%（5/4）可评估的混合性尿失禁女性中，植入后6个月尿失禁发作完全消退，这是一个强有力的疗效信号。该研究的初步数据已在尿动力学学会上发表，女性盆腔医学与泌尿生殖道重建（SUFU）年会（2024年2月），英国伦敦，2024年2月27日-琥珀疗法（“琥珀”或“公司”），一家创新的医疗技术公司，开发下一代智能生物电疗法，以改变周围神经系统功能紊乱患者的临床结果，宣布首次在评估琥珀色UI的人体研究中展示其AURA-2（增强尿反射活动）的第一个数据。

Amber-UI is the first fully implantable closed-loop bioelectrical therapy in clinical development for urinary incontinence (UI), which is made possible by being able to access and target the pudendal nerve – the nerve that directly controls continence – through a novel, minimally invasive surgical procedure.

琥珀色尿失禁（Amber UI）是临床开发中针对尿失禁（UI）的第一种完全植入式闭环生物电疗法，它可以通过一种新颖的微创外科手术进入并靶向阴部神经（直接控制尿失禁的神经）。

Leveraging Amber’s expertise in closed-loop neuromodulation concepts, the Amber-UI multi-modal therapy can both directly regulate the urge to void the bladder (urge incontinence or overactive bladder) and augment resistance to urine leakage caused by activities such as coughing or lifting (stress incontinence), allowing for restoration of normal bladder function.

利用Amber在闭环神经调节概念方面的专业知识，Amber UI多模式疗法既可以直接调节排空膀胱的冲动（急迫性尿失禁或膀胱过度活动），又可以增强对咳嗽或举重（压力性尿失禁）等活动引起的尿漏的抵抗力，从而恢复正常的膀胱功能。

The AURA-2 trial (clinicaltrials.gov identifier: NCT05241379) recruited 13 women with either severe refractory urge UI or mixed UI and was conducted at the University Hospital Antwerp (Belgium) by Stefan De Wachter, Professor of Urology, a leading expert.

AURA-2试验（clinicaltrials.gov标识符：NCT05241379）招募了13名患有严重难治性急迫性UI或混合性UI的女性，由领先专家泌尿学教授Stefan De Wachter在安特卫普大学医院（比利时）进行。