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First-in-human implants for Amber Therapeutics’ bioelectrical therapy

Amber-UI presents a significant opportunity to treat urge and mixed urinary incontinence.

Amber Therapeutics – an Oxford University spin-off developing next-generation bioelectrical therapies – has announced that the first participants have been implanted with Amber-UI, the company’s proprietary therapy for urge and mixed urinary incontinence (UI).

Amber-UI is the first fully implantable closed-loop bioelectrical therapy in clinical development for UI. It is made possible by being able to access the pudendal nerve, which directly controls continence, through a minimally invasive surgical procedure.

Amber’s multi-modal therapy can both directly regulate the urge to void the bladder and augment resistance to urine leakage caused by activities such as coughing or lifting. This process allows for the restoration of normal bladder function.

In order to further explore the clinical potential of Amber-UI, the company initiated its AURA-2 (Augmenting Urinary Reflex Activity) first-in-human trial last year. AURA-2 is designed to evaluate the pilot efficacy and safety of Amber-UI in 15 women.

The study is being conducted at the University Hospital Antwerp by Stefan De Wachter, professor of urology, a leading expert in pelvic floor disorders and a co-founder of Amber.

So far, three participants have been safely implanted with the Amber-UI system, with the adaptive algorithm running continuously in an at-home setting. The remaining participants will be enrolled during the first half of 2023. Early indications have confirmed the feasibility of the surgical procedure.

Aidan Crawley, chief executive officer of Amber, explained: “Reaching this first-in-human milestone in under two years demonstrates our ability to rapidly prototype new bioelectrical therapy concepts. But what is most exciting is the potential for our UI therapy to have a radical impact on clinical outcomes not only in patients with urge UI but also for the first time in many more patients with mixed UI for whom no single therapy is currently available.”

De Wachter, added: “Most of the current available implanted therapies for incontinence are static (tapes, slings) or can only influence the bladder indirectly, such as sacral or tibial nerve stimulation. With Amber-UI, we stimulate the pudendal nerve, the natural pathway of continence control, and can reinforce the existing physiologic reflexes when it is needed.”

Tim Denison, chief scientific officer at Amber, concluded: “Modern bioelectronic systems have the unique capability to measure physiological signals and adjust stimulation in real-time. In partnership with clinicians, we can create novel adaptive reflex-like algorithms for exploring new therapies.”

The study is expected to conclude towards the end of this year, with learnings used to optimise the Amber-UI therapy in preparation for a pivotal trial.