After posting preliminary results from the first-in-human trial of its closed-loop neuromodulation implant for urinary incontinence, Amber Therapeutics has pulled a $100 million funding round to accelerate its development.
The U.K.-based startup aims to be the first to offer a fully implantable therapy capable of addressing both stress and urge urinary incontinence, which includes the leaks that occur spontaneously during physical activity as well as the onset of sudden, uncontrollable impulses to go to the bathroom also known as overactive bladder.
In February, Amber announced early clinical findings from its minimally invasive, bioelectrical device targeting the pelvic pudendal nerve—where stimulation can help boost sphincter and pelvic floor muscle function as well as suppress the contractions of the bladder wall to increase overall capacity.
The study enrolled 13 women in Belgium to demonstrate the feasibility of the company’s surgical procedure; four out of the five participants that completed the trial reported complete resolution of their mixed incontinence episodes. Full results are expected by the end of this year.
The company, founded in 2021 as a spinout from the University of Oxford, described its series A round as one of the largest ever for a European medtech. It was led by New Enterprise Associates and joined by F-Prime Capital, Lightstone Ventures, Intuitive Ventures, Oxford Science Enterprises and 8VC.
“Securing this significant financing round from such a blue-chip group of U.S. and U.K. investors is a huge validation of our therapy value proposition and the quality of the team we have built,” Amber CEO Aidan Crawley said in a statement.
“Amber can now execute the critical next phase of our strategy to take Amber-UI to U.S. regulatory approval and fulfill our mission of making this breakthrough therapy available to the millions of women suffering from mixed urinary incontinence,” Crawley said, with the company planning to launch new pilot studies in Europe and a pivotal trial in the U.S.
Amber’s adaptive approach both stimulates the nerve and observes the body’s response to regulate bladder function, using a system originally developed as a cranial implant for people with Parkinson’s disease.
Current therapies focus on treating either urge or stress incontinence alone—through sacral or tibial neuromodulation, for example, or with the use of bulking agents and other surgical implants. The company estimates that while as many as 40 million women in the U.S. may have incontinence symptoms, only 16 million are currently receiving any type of therapy.
“We believe Amber Therapeutics has the potential to become the first ever approved therapy for a significantly under-addressed patient population,” said New Enterprise Associates principal Tiffany Le, who joined the company’s board of directors. “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.”