In one of the biggest Series A funding rounds for a medtech company in Europe, UK-based Amber Therapeutics has raised $100m (£80m) to advance its implantable neuromodulation therapy for women with mixed urinary incontinence (MUI).

The round was led by New Enterprise Associates (NEA), with participation from F-Prime Capital, Lightstone Ventures, and Intuitive Ventures, alongside existing investors Oxford Science Enterprises (OSE) and 8VC.

Amber’s lead asset is Amber-UI, a fully implantable device targeting the treatment of MUI in women. The device runs on the Picostim System, an adaptive neuromodulation system that can be configured for patients on an individual basis.

Amber acquired the technology when it acquired Bioinduction late last year, with the latter company having developed the stimulation implant originally for deep brain use.

Amber is targeting a condition that accounts for around 20%-30% of chronic urinary incontinence cases. MUI is a combination of stress and urge incontinence.  Patients living with the condition have involuntary urinary leakage due to urgency, as well as force exertion. The company states its system regulates the urge to void the bladder and protects against urine leakage from pressure such as coughing or lifting.

Amber stated it has commenced planning for pilot studies in Europe and a pivotal trial in the US. The system has already demonstrated positive preliminary data from a first-in-human study, according to the British company. The study, conducted at Belgium’s University Hospital Antwerp, enrolled 13 women with severe refractory urge urinary incontinence or mixed urinary incontinence. It met its primary aim of demonstrating the safety and feasibility of the procedure. Results from the fully enrolled study are slated to come in the second half of 2024.

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Amber’s CEO Aidan Crawley said: “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.”

The urinary incontinence device market is growing fast, though many devices currently focus on the stress sub-type. UroMems, for example, has reported positive results from its UroActive implant that automatically changes the sphincter opening by pressure adjustments based on the patient’s activity.

Using neuromodulation to treat urinary incontinence is not new, with Medtronic being the first company to gain US Food and Drug Administration (FDA) approval for the indication back in 1997. Aviation Medical, meanwhile, claims to have the only FDA-approved closed-loop and non-invasive neuromodulation system for bladder control in the US. Its Vivally system received an FDA regulatory approval in April 2023. The company released confirmatory positive data in patients with urinary urgency and urinary incontinence caused by overactive bladder syndrome in late 2023.