Iota Biosciences: Bladder implant

Main article: Urination

2024: Product Announcement

In mid-October 2024, Iota Biosciences, a subsidiary of Astellas Pharma, received approval to use an experimental bladder implant. Regulators approved a study to assess the safety and effectiveness of the device under study, which, according to the developers, provides electrical stimulation of the bladder wall, causes its contraction and thereby facilitates urination in persons with hypoactive bladder.

The first phase of the study will include just three participants, with at least one male and one female among those participants. After the safety assessment of the first stage, the regulatory authorities will approve the expansion of the study cohort to 10 participants.

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Iota Biosciences

Iota Biosciences CEO Michel Maharbiz notes that current treatment options for underactive bladder are limited, often forcing patients to rely on intermittent catheterization, which is burdensome to the patient and carries a certain risk of complications.

Our team worked hard to create an alternative treatment option and was able to get permission for the study after just four years, "noted Michelle Maharbiz. - These outstanding achievements show how committed we are to our patients and innovation. We are pleased that we can accelerate clinical development and make this device available to all patients in need.

In 2020, Astellas acquired Iota to study and develop bioelectronic technologies for the treatment of a number of diseases.

We look forward to the results of this study with the potential to make a dramatic difference for hypoactive bladder patients, "noted Adam Pearson, Astellas Chief Strategic Officer.[1]

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