Amber Therapeutics completed its $100 million Series A raise to support its implantable therapy for mixed urinary incontinence through a registrational trial in 2026.
The proceeds should give Amber a runway of at least three years, CEO Aidan Crawley told Endpoints News in an interview. Within this timeframe, the company plans to start US pivotal development for its adaptive neuromodulation therapy for mixed incontinence, dubbed Amber-UI.
“We’ll be doing another feasibility study in Europe next year, which will give us the data and safety profile to get FDA approval to do our pivotal trial in the US, which we will be targeting for 2026,” Crawley said. The company is currently discussing pivotal trial design with the FDA and has settled on the primary outcome measure of reduction in incontinence episodes, he added.
The Series A raise was led by New Enterprise Associates with support from new investors F-Prime Capital, Lightstone Ventures and Intuitive Ventures. Existing investors Oxford Science Enterprises and 8VC also contributed to the fundraise.
Current treatments for urinary incontinence are split into those for urge incontinence and stress incontinence, but there is no single option that addresses both. Amber-UI is an implantable device that targets the pudendal nerve to regulate both, Crawley said.
It was designed using Amber’s Picostim technology — an adaptive neuromodulation system that can both sense and stimulate physiological responses. “The idea of having a system that is adaptive to your incontinence and able to address any aspect of it is obviously a much cleaner solution than having to look down multiple different streams to treat it,” Crawley said.
Urinary incontinence symptoms affect around 40 million women in the US according to Amber, but only 16 million are currently being treated.