Amber Therapeutics, a UK-based medical technology company co-founded by Professor Timothy Denison, has secured investment of £80 million ($100 million) from leading healthcare and technology investors in the US and UK for its breakthrough adaptive neuromodulation therapy to treat mixed urinary incontinence.
The financing is one of the largest Series A rounds ever in Europe for a medical technology company and was led by New Enterprise Associates as part of a syndicate of new investors F-Prime Capital, Lightstone Ventures, and Intuitive Ventures, alongside existing investors Oxford Science Enterprises and 8VC.
Dr Christina Guindy, Royal Academy of Engineering Associate Director, Research Programmes and Awards, said: “My congratulations to Professor Denison and all his associates—to have achieved investment on this scale is hugely impressive. It is also an endorsement of the important and impactful engineering research being conducted by the Academy’s Chairs in Emerging Technologies and an illustration of what can be achieved when visionary engineers like Tim are given long-term funding to bring their groundbreaking and influential ideas to fruition.”
Amber-UI is the first fully implantable adaptive neuromodulation therapy in clinical development for women with mixed urinary incontinence, targeting the pudendal nerve through a novel, minimally invasive surgical procedure. Urinary incontinence is a debilitating medical condition that affects millions of women globally. Many of these women experience symptoms of both urge incontinence (urgent and uncontrollable bladder leaks) and stress incontinence (bladder leaks during physical activity or exertion).
Planning for pilot studies in Europe and a pivotal trial of Amber-UI in the US is already underway following initial discussions with regulators and supported by highly promising preliminary results from a first-in-human study (AURA-2), announced in February 2024, confirming the safety and feasibility of both the surgical procedure and adaptive therapy as well as a strong efficacy signal. Results from the fully enrolled study are expected in the second half of 2024.
Notes for editors
- Urinary Incontinence and the Neuromodulation Market Urinary incontinence (UI) is a debilitating medical condition that affects many millions of women 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 do not actively seek treatment, with symptoms of UI found in 40 million women in the US but only 16 million currently managed on any form of therapy.
Existing therapies focus on either urge incontinence (e.g. sacral or tibial neuromodulation) or stress incontinence (e.g. bulking agents, slings, mesh supports). There is no singular therapy option available for mixed urinary incontinence (both urge and stress), which is a sizeable population more than double that of the urge segment that neuromodulation currently addresses. - Amber Therapeutics is developing Amber-UI, a breakthrough adaptive neuromodulation therapy to treat women suffering with mixed urinary incontinence with the hope of transforming the clinical outcome and quality of life of a large untreated population. Amber-UI runs on the Company’s fully implantable Picostim system that targets the pudendal nerve to both stimulate and sense physiological responses. The therapy is configurable to the individual’s need and can respond dynamically to different events, adapting as needed between modes of operation. Amber’s technology platform is highly versatile and can be used to explore other novel therapy applications in both the pelvis and the broader nervous system, demonstrated by the work being carried out by the Company’s academic partnerships.
- The Academy’s Chairs in Emerging Technologies programme is funded by the UK Department for Science, Innovation and Technology and aims to identify global research visionaries and provide them with long-term support to lead on developing emerging technology areas with high potential to deliver economic and social benefit to the UK. Each £2,500,000 award covers employment and research costs, enabling each researcher to focus on advancing their technology to application in a strategic manner over a period of up to 10 years. More about all awardees.