The first fully implantable closed-loop bioelectric treatment implant for UI is currently in clinical development and is called Amber-UI. It is made possible by a minimally invasive surgical technique that allows access to the pudendal nerve, which directly regulates continence. A substantial possibility exists with Amber-UI to address urge and mixed incontinence. In order to treat urge and mixed urine incontinence, Amber Therapeutics, an Oxford University spin-off firm that is researching next-generation bioelectrical therapeutics, has implanted Amber-UI in the first participants (UI).
The multi-modal therapy Amber uses can both directly control the urge to urinate and increase resistance to pee leaks brought on by actions like coughing or lifting. This procedure enables the return of regular bladder function.
The business started its AURA-2 (Augmenting Urinary Reflex Activity) first-in-human trial last year in order to further investigate the clinical potential of Amber-UI. The purpose of AURA-2 is to assess the safety and efficacy of Amber-UI in 15 female pilot patients.
Stefan De Wachter, a professor of urology, a recognized authority on abnormalities of the pelvic floor, and a co-founder of Amber, is directing the trial at the University Hospital Antwerp.
The Amber-UI system has so far been implanted safely in three volunteers, and the adaptive algorithm is currently operating constantly in a home environment. During the first half of 2023, the remaining participants will be added. Early results have shown the surgical procedure’s viability.
“Reaching this first-in-human milestone in under two years highlights our capacity to quickly develop new bioelectrical therapeutic approaches,” said Aidan Crawley, chief executive officer of Amber. The most intriguing aspect of our UI therapy, however, is its potential to significantly alter clinical outcomes in a large number of patients with mixed UI for whom no single medication is now available, as well as in patients with urge UI.
“Most of the current implanted therapies for incontinence are static (tapes, slings) or can only indirectly affect the bladder, such as sacral or tibial nerve stimulation,” continued De Wachter. Utilizing Amber-UI, we encourage the
pudendal nerve, which serves as the body’s natural conduit for controlling urination and can supplement physiologic reflexes when necessary.
“Modern bioelectronic systems offer the unique power to analyze physiological signals and alter stimulation in real-time,” Tim Denison, chief scientific officer at Amber, said in his conclusion. We can develop fresh adaptive reflex-like algorithms in collaboration with physicians to investigate novel therapeutics.
As the study draws to a close by the end of this year, lessons learned will be applied to improve the Amber-UI therapy in anticipation of a critical trial.
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First-in-human bioelectric treatment implant from Amber Therapeutics
