Japanese pharmaceutical company Astellas Pharma Inc (TSE: 4503) announced on Thursday that its US subsidiary iota Biosciences Inc has received approval from the US Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) for an Early Feasibility Study (EFS).

The EFS is intended to assess the safety and feasibility of an investigational implantable device designed to deliver electrical stimulation directly to the bladder wall, inducing contractions that facilitate bladder emptying in individuals affected by underactive bladder (UAB).

The FDA has offered a staged approval of the EFS for this novel device. The first stage includes enrolment of three subjects (at least one male and one female). Following successful safety results from Stage 1, the study will be expanded to a total of 10 subjects.

Michel Maharbiz, Ph.D., iota Biosciences' CEO, said: "Current treatment options for underactive bladder are limited, often forcing patients to rely on clean intermittent catheterisation, which can be burdensome and carry risk of complications. Our team has diligently worked on a potential alternative treatment option, achieving concept to IDE approval in less than four years, a remarkable feat that highlights our commitment to patients and innovation. We are excited to advance clinical development and bring this potential new solution closer to those in need."