FDA Grants iota Biosciences IDE Approval for First-In-Human Early Feasibility Study with Implantable Bladder Device

ALAMEDA, Calif., Oct. 10, 2024 /PRNewswire/ -- 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.²

Michel Maharbiz, Ph.D., CEO of iota Biosciences
"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. 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."

Adam Pearson, Chief Strategy Officer (CStO) of Astellas
"The initiation of the early feasibility study 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."

Astellas acquired iota Biosciences in 2020 to explore and advance bioelectronic technologies for target conditions.

About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+^® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.

About iota Biosciences
Established in 2017, iota is a wholly-owned subsidiary of Astellas Pharma focused on building a foundation for the future of bioelectronic medicine. iota's mission is to create and develop state-of-the-art diagnostic and therapeutic bioelectronic devices that are safe and effective. We are working to transform the way doctors manage and treat disease, to make a life-changing difference for patients. Our proprietary wireless technologies uniquely communicate with, and power, custom implantable medical devices. These advanced technologies have the potential to 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. We are exploring their application in numerous indications, including bladder disorders, autoimmune diseases and cancer, tailoring our devices to suit the different needs of each condition. For more information regarding iota, please visit https://iota.bio/.

Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical and medical device markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical and medical device products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

References
¹Christopher 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.
²Nadir 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.

SOURCE Astellas Pharma Inc.