Amber Therapeutics acquires neurostim implant at the heart of its urinary incontinence therapy

2023-09-05

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Amber Therapeutics acquires neurostim implant at the heart of its urinary incontinence therapy

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来源: FierceBiotech

Financial terms of the deal weren’t disclosed, but the acquisition will give Amber Therapeutics full control of the development and manufacturing of its therapeutic systems and will support the company’s goals of launching a U.S. pivotal trial and building a broader portfolio of neurostim tech.

Two years after spinning out of the University of Oxford, Amber Therapeutics is now the proud owner of the technology that serves as the basis for its neuromodulation system.

The startup has acquired Bioinduction, a fellow U.K.-based company and the maker of the Picostim DyNeuMo platform, Amber announced Tuesday.

Bioinduction’s implant was initially designed as a deep-brain stimulation device to help treat people with Parkinson’s disease. It has since been integrated into closed-loop neuromodulation systems like Amber’s that can automatically adapt to each patient’s needs as neurostimulation therapy is delivered.

Financial terms of the deal weren’t disclosed, but Amber noted that the acquisition will give it full control of the development and manufacturing of its therapeutic systems. The newly bulked-up structure will support the company’s work to bring the first of those systems—dubbed Amber-UI—into a pivotal clinical trial in the U.S. while also allowing it to build out a broader portfolio of neurostim technologies.

“The hardware, know-how and manufacturing experience that we gain with the acquisition of Bioinduction offers us the chance to accelerate the development and commercialization of Amber-UI,” Tim Denison, Ph.D., Amber’s chief engineer, said in the announcement.

“The ability to rapidly prototype therapy innovations with our integrated research platform enables us to build a pipeline of novel neuromodulation therapies,” Denison continued. “In partnership with our academic ecosystem, we aim to develop cost-effective therapies for functional disorders of the nervous system, based on neuroscience, to address significant unmet needs.”

Amber-UI is pitched as the first therapeutic aimed at treating mixed urinary incontinence, where patients experience symptoms of both stress and urge incontinence.

The Picostim DyNeuMo implant is placed near the pelvic area pudendal nerve in a minimally invasive procedure. Once there, by stimulating the nerve—and with the adaptive algorithm taking in feedback as the implant works and automatically adjusting its output—Amber’s system can both regulate the repeated impulse to empty the bladder that’s caused by urge incontinence and help the body resist symptoms of stress incontinence, where coughing, heavy lifting and other activities can lead to urinary leakage.

The company began testing Amber-UI in a first-in-human study in Belgium at the end of 2022. The researchers aim to study the safety and efficacy of the implanted system in a total of 15 women with mixed incontinence.

The study is on track to wrap up early next year, but early results are already pointing toward success in both the implantation process and the therapy itself, Amber said in Tuesday’s announcement. If those positive outcomes hold steady throughout the entire trial, the results will then be used to prepare Amber-UI for a pivotal U.S. trial.

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