Amber Therapeutics

Amber Therapeutics' lead product is Amber-UI, a fully implantable, closed-loop bioelectrical therapy targeting the treatment of mixed urinary incontinence (MUI) in women. The Amber-UI therapy can access and target the pudendal nerve, which directly controls continence, through a minimally invasive surgical procedure. Leveraging closed-loop neuromodulation concepts, Amber-UI can directly regulate the urge to void the bladder (urge incontinence) and augment resistance to urine leakage caused by activities like coughing or lifting (stress incontinence), thereby restoring normal bladder function.

In late 2022, Amber Therapeutics initiated the AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study to evaluate Amber-UI's safety and pilot efficacy in 15 women. As of January 2023, three participants had been safely implanted with the Amber-UI system, with the adaptive algorithm activated and running continuously in a home setting. Early indications confirmed the feasibility of the surgical procedure and therapy. The study is expected to conclude by the end of 2023, with learnings used to optimize the Amber-UI therapy for a pivotal trial.

In September 2023, Amber Therapeutics acquired Bioinduction Limited and its Picostim DyNeuMo neuromodulation platform, which is used to deliver the Amber-UI therapy. This acquisition transformed Amber into a vertically integrated designer, developer, and manufacturer of Class III Active implantable systems, supporting the company's accelerated effort to bring Amber-UI into a pivotal trial in the US and eventual global commercialization.

In June 2024, Amber Therapeutics closed a USD 100 million Series A financing round led by New Enterprise Associates, with participation from F-Prime Capital, Lightstone Ventures, Intuitive Ventures, and existing investors Oxford Science Enterprises and 8VC. The funds will support the development of Amber-UI through pilot studies in Europe and a pivotal trial in the US, aiming for regulatory approval.

Amber Therapeutics was spun out from the University of Oxford in 2021 and is backed by Oxford Science Enterprises, 8VC, and a UKRI Biomedical Catalyst grant.