Amber Therapeutics, a UK-based medical technology company, has successfully closed a $100 million Series A financing round. The investment will advance their Amber-UI neuromodulation therapy towards US FDA approval. The financing round, one of the largest ever in Europe for a medical technology company, was led by New Enterprise Associates (NEA) with participation from F-Prime Capital, Lightstone Ventures, Intuitive Ventures, and existing investors Oxford Science Enterprises (OSE) and 8VC.

Image: Amber Therapeutics

Amber-UI is set to become the first fully implantable adaptive neuromodulation therapy for women suffering from mixed urinary incontinence (MUI). MUI affects millions of women globally, combining symptoms of urge incontinence (urgent and uncontrollable bladder leaks) and stress incontinence (bladder leaks during physical activity or exertion). Unlike existing treatments that address either urge or stress incontinence separately, Amber-UI targets the pudendal nerve to provide a single adaptive therapy for both conditions.

“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 fulfill our mission of making this breakthrough therapy available to the millions of women suffering from mixed urinary incontinence.”

Tiffany Le, Principal at NEA, stated: “We believe Amber Therapeutics has the potential to become the first ever approved therapy for a significantly under-addressed patient population. 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.”

The funds from the Series A financing will now be used to support pilot and pivotal studies of Amber-UI in the US, with planning for pilot studies in Europe already underway. Initial discussions with regulators have been promising, bolstered by preliminary results from a first-in-human study (AURA-2) announced in February 2024. This study confirmed the safety and feasibility of both the surgical procedure and adaptive therapy, showing a strong efficacy signal. Full results from this 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.”

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