- 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 incontinence
- Preliminary 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.
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.
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.
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 in pelvic floor disorders and a co-founder of Amber.
The study fulfilled its primary aim of demonstrating safety and feasibility of Amber’s new surgical procedure, validating a scalable approach to accurately implant two electrode leads on the pudendal nerve. The therapy showed strong evidence of initial efficacy, especially in women with mixed urinary incontinence of whom four out of five study completers (at six months follow up) achieved complete resolution of their incontinence episodes (dry). Clinically significant improvements in symptom-related quality-of-life were observed in both mixed and refractory urge UI patients.
Using state-of-the-art serial intra-operative and awake electrophysiological and urodynamic data, the AURA-2 study is generating promising clinical proof of principle evidence for the advanced capabilities of the Amber-UI therapy. Acute stimulation showed clear effects on both barrier muscle functions (sphincter and pelvic floor contraction and EMG measurements) and on suppression of detrusor overactivity leading to increased mean cystometric (bladder) capacity. In patients with mixed UI, this was manifest as reductions in both stress and urge incontinence events.
The study also demonstrated the utility of patient-controlled adaptive algorithms using Amber-UI’s integrated sensors. Relevant physiological biomarkers of pelvic neuromuscular activity could be detected real-time, in vivo, and classified to execute a control policy for fully adaptive (closed-loop) stimulation in the next planned trial.
Stefan De Wachter, Professor of Urology at Antwerp University, co-Founder of Amber Therapeutics and lead investigator for the AURA-2 study, commented: “I am very excited to see these excellent preliminary results with Amber-UI in a very difficult to manage patient group with mixed urinary incontinence, and for whom no single therapy exists. With these data, Amber’s pioneering technology is demonstrating its promise to be a safe and scalable solution for patients that personalises therapy to their needs and helps them regain control of their bladder and their lives. We look forward to completing the follow-up period with the remaining patients and presenting final data that we hope will further reinforce Amber-UI’s potential to have a meaningful impact for patients dealing with this common and debilitating condition.”
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About Amber Therapeutics
Amber Therapeutics is developing a closed-loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcomes of a very large untreated patient population. Amber’s approach leverages the intelligent capability of its next-generation neuromodulation platform, the Picostim DyNeuMo, to create ‘synthetic reflex arcs’ that can sense, interpret, adapt and respond to a patient’s individual signals thereby restoring normal physiological function. This principle can be used in broader functional disorders of the nervous system that the Company’s academic partnerships are exploring.
Amber Therapeutics was founded by a multidisciplinary team of clinicians, translational neuroengineers, medtech industry professionals and experienced entrepreneurs focused on developing transformational therapy innovation for major unmet medical conditions. The Company was spun out from the University of Oxford in 2021 and is backed by Oxford Science Enterprises, 8VC, and Innovate UK through a Biomedical Catalyst grant.
About Urinary Incontinence and the Current Neuromodulation Market
Urinary incontinence (UI) is a debilitating medical condition that affects many millions of women and men globally. Common consequences that sufferers can experience include falls and fractures, hospitalisations, and can bring about a sense of loss of control and shame, leading to isolation and depression. Many patients do not actively seek treatment, with symptoms of UI found in 40 million individuals in the US but only 16 million currently managed on any form of therapy.
It is estimated that 6.8 million patients in the US are eligible for the existing sacral neuromodulation therapy, a patient population which is still highly underpenetrated (c.50,000 implants a year) and only treats urge incontinence. Mixed urinary incontinence is more than three times more common than urge but until now there is no single therapy available on the market or in development.
Contacts
Amber Therapeutics
Aidan Crawley, CEO
press@amber-tx.com
MEDiSTRAVA Consulting
Sandi Greenwood, Mark Swallow
+44 203 928 6900
ambertherapeutics@medistrava.com
