Iota Biosciences' Implantable Bladder Device Receives FDA IDE Approval for Clinical Trial
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Iota Biosciences (search), an Astellas subsidiary, received FDA IDE approval for its implantable device to treat underactive bladder (search) (UAB).
The early feasibility study will assess the device's safety and ability to stimulate bladder contractions for emptying in UAB patients.
The trial will begin with three participants and expand to ten after successful safety outcomes in the initial phase.
Astellas Pharma's subsidiary, iota Biosciences (search), has secured FDA approval for its Investigational Device Exemption (IDE) to initiate a clinical trial of its innovative implantable device designed for treating underactive bladder (search) (UAB). This early feasibility study (EFS) aims to evaluate the safety and efficacy of the device in stimulating bladder contractions to facilitate emptying in individuals suffering from UAB.
The FDA has granted a staged approval for the EFS. The initial phase will involve three participants, including at least one male and one female. Upon successful completion of this first stage and demonstration of favorable safety outcomes, the study will expand to include a total of ten participants.
Addressing Underactive Bladder
Underactive bladder (search) is characterized by a combination of lower urinary tract symptoms resulting from detrusor (search) underactivity. Patients often experience a slow urinary stream, difficulty initiating or maintaining urination, and a sensation of incomplete bladder emptying. The condition affects a significant portion of the population, with prevalence rates reaching up to 28% of men over 50 with lower urinary tract symptoms and 45% of older women. In men aged 70 and older, this figure increases to 48%.
Aims to Reduce Reliance on Catheterization
Michel Maharbiz, Ph.D., CEO of iota Biosciences (search), emphasized the limitations of current treatment options, noting that patients often rely on clean intermittent catheterization, which can be burdensome and carry a risk of complications. "Our team has diligently worked on a potential alternative treatment option, achieving concept to IDE approval in less than four years," Maharbiz stated, highlighting the company's commitment to innovation and patient care. "We are excited to advance clinical development and bring this potential new solution closer to those in need."
The implantable device delivers electrical stimulation directly to the bladder wall, inducing contractions that facilitate bladder emptying. This approach aims to provide a more convenient and less invasive alternative to traditional methods.
Astellas' Strategic Investment in Bioelectronic Medicine
Astellas acquired iota Biosciences (search) in 2020 to further explore and develop bioelectronic technologies for various target conditions. Adam Pearson, Chief Strategy Officer (CStO) of Astellas, commented on the initiation of the early feasibility study, stating, "It reflects our shared commitment to expand treatment options beyond traditional pharmaceuticals through innovative science and health technologies. We look forward to the progress of this research and its potential to make a difference for patients impacted by underactive bladder (search)."
This collaboration underscores a strategic focus on bioelectronic medicine, potentially offering solutions for conditions beyond bladder disorders, including autoimmune diseases and cancer.