Amber Therapeutics closes £80m Series A to further urinary incontinence therapy
US FDA Approval is in sights for the breakthrough Amber-UI Neuromodulation Therapy for mixed urinary incontinence.
Amber Therapeutics, a UK-based medical technology company focused on urinary incontinence in women has announced (10 June 2024) the close of its Series A financing raising a total of $100 million (£80 million) from leading healthcare and technology investors in the US and UK.
Urinary incontinence is a debilitating medical condition affecting millions of women globally. Yet existing treatments focus on either urge incontinence or stress incontinence - and there’s no single therapy if you have both (which many women do). Amber Therapeutic’s ‘Amber-UI’ is a breakthrough adaptive neuromodulation therapy to treat mixed urinary incontinence (MUI) for the first time.
A significant funding round
This Series A round is one of the largest 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.”
Working towards FDA approval
Amber-UI is first fully implantable adaptive neuromodulation therapy in clinical development for women with MUI. It targets the pudendal nerve through a novel, minimally invasive procedure.
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.
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.
“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.”
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.