iota Biosciences Wins FDA IDA Approval to Study Implantable Bladder Device

The U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption Early Feasibility Study for iota Biosciences Inc.’s implantable device for underactive bladder treatment.

The study will evaluate the safety and feasibility of iota Biosciences’ investigational implantable device that delivers electrical stimulation directly to the bladder wall, inducing contractions that facilitate bladder emptying in patients suffering from underactive bladder (UAB).

The FDA granted a staged approval of the study for this 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 10 participants.

“The initiation of the early feasibility study reflects our shared commitment to expand treatment options beyond traditional pharmaceuticals through innovative science and health technologies,” Astellas Pharma Chief Strategy Officer Adam Pearson said. “We look forward to the progress of this research, and its potential to make a difference for patients impacted by underactive bladder.”

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% of men over 50 with lower urinary tract symptoms and 45% of older women. This figure rises to 48% in men aged 70 and older.²

“Current treatment options for underactive bladder are limited, often forcing patients to rely on clean intermittent catheterization, which can be burdensome and carry risk of complications,” iota Biosciences CEO Michel Maharbiz, Ph.D., stated. “Our team has 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.”

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries worldwide. The company acquired iota Biosciences in 2020 to explore and advance bioelectronic technologies for target conditions. Astellas Pharma promotes the Focus Area Approach, which identifies opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on biology and modality. The firm is also looking beyond its foundational focus to create Rx+ healthcare solutions that combine its expertise and knowledge with cutting-edge technology in different fields of external partners.

Established in 2017, iota Biosciences is a wholly-owned subsidiary of Astellas Pharma focused on building a foundation for the future of bioelectronic medicine. iota develops diagnostic and therapeutic bioelectronic devices designed to transform the way doctors manage and treat disease. Its proprietary wireless technologies communicate with, and power, custom implantable medical devices. These advanced technologies can potentially enable sensing and neural stimulation in parts of the body inaccessible to currently available implantable devices, or to be used in combination with, or as an alternative to, drug therapies. iota Biosciences is exploring its application in numerous indications, including bladder disorders, autoimmune diseases, and cancer, tailoring its devices to suit the different needs of each condition.

References
¹ Christopher R. Chapple, Nadir I. Osman, Lori Birder, Gommert A. van Koeveringe, Matthias Oelke, Victor W. Nitti, Marcus J. Drake, Osamu Yamaguchi, Paul Abrams, Philip P. Smith. The Underactive Bladder: A New Clinical Concept? European Urology. 2015 Sep;68(3):351-3.
² Nadir I. Osman, Christopher R. Chapple, Paul Abrams, Roger Dmochowski, Francois Haab, Victor Nitti, Heinz Koelbl, Philip van Kerrebroeck, Alan J. Wein. Detrusor Underactivity and the Underactive Bladder: A New Clinical Entity? A Review of Current Terminology, Definitions, Epidemiology, Aetiology, and Diagnosis. European Urology. 2014 Feb;65(2):389-98.