THERAPY INNOVATION POWERED BY CLOSED-LOOP INTELLIGENCE
Developing the next-generation of bioelectrical therapies that can sense and adapt as well as stimulate, with the potential to radically improve clinical outcomes in patients with functional disorders of the peripheral nervous system
ABOUT US
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
Our first therapy – Amber-UI – is in clinical development with the aim of becoming the first fully implantable closed-loop bioelectrical therapy for both urge and mixed urinary incontinence (UI).
The Company was spun out from the University of Oxford in 2021 with funding from Oxford Science Enterprises, 8VC and a UKRI Biomedical Catalyst grant.
Winner of Innovate UK’s Biomedical Catalyst Award 2020
TECHNOLOGY
Our core technology leverages closed-loop intelligence to create synthetic reflex arcs that sense, interpret, adapt and respond precisely to each individual patient – restoring normal physiological function.
Our goal is to upgrade from the existing neuromodulation landscape, which is largely stimulation only and where there has been little therapy innovation over the past 20 years. In so doing, we aim for a revolutionary rather than evolutionary approach to significantly improve outcomes for patients.
AMBER - URINARY INCONTINENCE
Amber-UI is the first fully implantable closed-loop bioelectrical therapy in clinical development for urge and mixed urinary incontinence.
Through our ability to access the pudendal nerve – the nerve that directly controls continence – Amber-UI 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.
This makes Amber-UI the first single therapy for mixed incontinence, where sufferers have symptoms of both urge and stress UI. This is not possible with the existing neuromodulation approaches (such as sacral or tibial nerve stimulation) that can only influence the bladder indirectly.
First-in-human clinical studies
The clinical potential (safety and pilot efficacy) of Amber-UI is being explored in the AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study in 15 women (clinicaltrials.gov identifier: NCT05241379).
The study is expected to conclude towards the end of 2023.
Clinical Need and Market Opportunity
Urinary incontinence is a debilitating medical condition that affects many millions of women and men globally. It can cause 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.
NEWS
Amber Therapeutics announces positive preliminary results from its first-in-human investigation of Amber-UI, its new adaptive implanted pudendal neuromodulation system for urinary incontinence
Amber Tx acquires Bioinduction Limited and its Picostim DyNeuMo platform, on which Amber’s closed-loop neuromodulation therapy for mixed urinary incontinence is being developed
Amber Therapeutics announces successful first-in-human implants of Amber-UI: an intelligent, closed-loop bioelectrical therapy for urge and mixed urinary incontinence