iota Biosciences, Inc., a wholly-owned subsidiary of Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, „Astellas“) announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) for an Early Feasibility Study (EFS). The EFS will evaluate 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 impacted by underactive bladder (UAB).
The FDA granted a staged approval of the EFS for this novel device. The first stage will include enrollment of three participants (at least one male and one female). Following successful safety outcomes from Stage 1, the FDA approved expanding the study to a total of 10 participants.
UAB is characterized by a combination of lower urinary tract symptoms related to detrusor underactivity. Symptoms of UAB may include slow urinary stream, difficulty initiating urination, difficulty maintaining the urinary stream and the sensation of incomplete bladder emptying.1 UAB impacts millions worldwide, affecting up to 28 percent of men over 50 with lower urinary tract symptoms and 45 percent of older women. This figure rises to 48 percent in men aged 70 and older.
