Amber Therapeutics Closes $100 Million Series A Financing to Advance Breakthrough Amber-UI Neuromodulation Therapy for Mixed Urinary Incontinence towards US FDA Approval

US approval would make Amber-UI the first fully implantable adaptive neuromodulation therapy for women with mixed urinary incontinence (MUI)By targeting the pudendal nerve, Amber-UI has the unique potential to treat the millions of women who suffer from both urge and stress incontinence with a singular adaptive therapyThe financing – one of the largest Series A rounds ever in Europe for a medical technology company – was led by New Enterprise Associates (NEA) as part of a syndicate of new investors F-Prime Capital, Lightstone Ventures and Intuitive Ventures, alongside existing investors Oxford Science Enterprises and 8VC London, UK. 10th June 2024 – Amber Therapeutics, a UK-based medical technology company developing a breakthrough adaptive neuromodulation therapy to treat mixed urinary incontinence (MUI), announces the successful closing of its Series A financing raising a total of $100 million (£80 million) from leading healthcare and technology investors in the US and UK. 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 (NEA) as part of a syndicate of new investors F-Prime Capital, Lightstone Ventures, and Intuitive Ventures, alongside existing investors Oxford Science Enterprises (OSE) and 8VC. “Securing this significant financing round from such a blue-chip group of US and UK investors is a huge validation of our therapy value proposition and the quality of the team we have built,” said Aidan Crawley, CEO of Amber Therapeutics. “Amber can now execute the critical next phase of our strategy to take Amber-UI to US regulatory approval and fulfil our mission of making this breakthrough therapy available to the millions of women suffering from mixed urinary incontinence.” Amber-UI is the first fully implantable adaptive neuromodulation therapy in clinical development for women with MUI, targeting the pudendal nerve through a novel, minimally invasive surgical procedure. The proceeds of the financing will be used to fund the development of Amber-UI through pilot and pivotal studies towards regulatory approval in the US. Urinary incontinence (UI) 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). However, there is no singular therapy available to treat patients with these MUI symptoms. “We believe Amber Therapeutics has the potential to become the first ever approved therapy for a significantly under-addressed patient population,” said Tiffany Le, Principal at NEA. “This technology is the culmination of decades of research, and we are proud to support such an innovative therapy that could provide an effective treatment for an often overlooked and under-discussed condition that affects so many women worldwide.” Ali Behbahani, M.D., Partner and Co-Head of Healthcare at NEA, added, “At NEA, we aim to back transformative companies. We are excited by Amber’s potential to change the standard of care, make a meaningful difference in patients’ lives, and advance the field of neuromodulation.” Amber-UI runs on Amber’s Picostim System, an adaptive neuromodulation system able to both stimulate and sense physiological responses that is configurable to the individual’s needs and can respond dynamically to different events. Amber-UI has the potential to be the first singular neuromodulation therapy for MUI that both directly regulates the urge to void the bladder and augment resistance to urine leakage caused by activities such as coughing or lifting, allowing for restoration of normal bladder function. 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. “This significant new round of capital is a huge testament both to Amber’s clinical and technological innovation and the team behind it,” said Heather Roxborough, Head of Health Tech at Oxford Science Enterprises. “We’re proud to have been part of Amber’s journey from the very beginning, having worked closely with the founders to help create the company and transform it into the UK’s only fully integrated developer and manufacturer of Class III active implantable devices.” In conjunction with the closing of the Series A financing, Tiffany Le, Principal at NEA, Caroline Gaynor, Partner at Lightstone Ventures and Kevin Chu, Principal at F-Prime have joined Amber’s Board of Directors, which also includes Liliane Chamas, Principal at OSE. – ENDS – About 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. About Amber Therapeutics 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. Amber Therapeutics is backed by leading US and UK healthcare and technology investors New Enterprise Associates (NEA), F-Prime Capital, Lightstone Ventures, Intuitive Ventures, Oxford Science Enterprises and 8VC. www.amber-tx.com ContactsAmber TherapeuticsAidan Crawley, [email protected] MEDiSTRAVASandi Greenwood / Frazer Hall / Mark [email protected]