- Acquisition of Bioinduction transforms Amber into an integrated developer and manufacturer of intelligent, closed-loop neuromodulation therapies.
- Amber-UI therapy for mixed incontinence is currently progressing through a first-in-human study (AURA-2) with early indications confirming the safety and feasibility of the surgical procedure and adaptive therapy.
- The deal provides a clear path to a pivotal trial in the US for Amber-UI and the ability to fully commercialise any therapy concept the Company develops.
- The integrated enterprise benefits from ISO 13485 certified quality management systems and manufacturing facilities, and leverages experience from thousands of human implants to date.
London and Bristol, UK. 5 September 2023 - Amber Therapeutics (‘Amber’ or the ‘Company’) announces it has acquired Bioinduction Limited (‘Bioinduction’) and its Picostim DyNeuMo neuromodulation therapy platform. Amber is using the platform to explore a closed-loop therapy for mixed urinary incontinence (Amber-UI). The acquisition supports the Company’s strategy to develop intelligent, transformative neuromodulation therapies for patients with functional disorders of the nervous system. Financial details are not disclosed.
Amber now occupies a unique position in the UK as a vertically integrated designer, developer and manufacturer of Class III Active implantable systems. In addition, the acquisition brings a highly skilled team with real-world experience developing and manufacturing neuromodulation devices for urinary incontinence, with more than 4,000 devices implanted to date through Finetech Medical, a subsidiary of Bioinduction. The integrated structure supports the Company’s accelerated effort to bring the Amber-UI therapy into a pivotal trial in the US, and eventually to end-market commercialisation globally.
The next-generation Picostim DyNeuMo platform is the implantable system used for delivering the Amber-UI therapy. The hardware is supported by a state-of-the-art, integrated data science toolkit for rapidly prototyping adaptive therapy algorithms. Amber-UI is currently progressing through a first-in-human study (AURA-2) with early indications confirming the safety and feasibility of the surgical procedure and adaptive therapy. The study is expected to conclude in early 2024.
The Picostim DyNeuMo system was originally developed as a cranial implant for delivering deep brain stimulation to treat patients with Parkinson’s disease. The system was further enhanced for closed-loop, adaptive therapies in partnership with a consortium of academic collaborators led by those at the University of Oxford and is currently in multiple first-in-human therapy trials.
Aidan Crawley, CEO of Amber, commented: “We are very excited to announce the acquisition of Bioinduction and its Picostim-DyNeuMo platform. Our teams worked together developing the platform from concept to first-in-human trials in under two years. This deal formally brings together an experienced group of professionals with decades of design, clinical and manufacturing experience, who can now focus on taking our first therapy to market.”
Tim Denison, Amber’s Chief Engineer, added: “The hardware, know-how and manufacturing experience that we gain with the acquisition of Bioinduction offers us the chance to accelerate the development and commercialisation of Amber-UI. The ability to rapidly prototype therapy innovations with our integrated research platform enables us to build a pipeline of novel neuromodulation therapies. In partnership with our academic ecosystem, we aim to develop cost-effective therapies for functional disorders of the nervous system, based on neuroscience, to address significant unmet needs.”
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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 / Frazer Hall / Mark Swallow
+44 203 928 6900
ambertherapeutics@medistrava.com
