FDA Grants iota Biosciences IDE Approval for First-In-Human Early Feasibility Study with Implantable Bladder Device
iota Biosciences, a subsidiary of Astellas Pharma, has received FDA approval for an Investigational Device Exemption (IDE) to conduct an Early Feasibility Study (EFS) on a novel implantable bladder device. The device aims to treat underactive bladder (UAB) by delivering electrical stimulation to induce bladder contractions. The FDA granted a staged approval, initially allowing enrollment of three participants, with potential expansion to 10 participants upon successful safety outcomes.
UAB affects up to 28% of men over 50 and 45% of older women with lower urinary tract symptoms. The condition impacts millions worldwide, with current treatment options. This innovative approach could provide an alternative to clean intermittent catheterization, which can be burdensome and risky. The study marks a significant step in Astellas' commitment to expanding treatment options beyond traditional pharmaceuticals through bioelectronic technologies.
iota Biosciences, una filiale di Astellas Pharma, ha ricevuto l'approvazione della FDA per un'Esenzione per Dispositivo in Sperimentazione (IDE) per condurre uno Studio di Fattibilità Iniziale (EFS) su un innovativo dispositivo per la vescica impiantabile. Il dispositivo ha come obiettivo il trattamento della vescica iporeattiva (UAB), fornendo stimolazioni elettriche per indurre contrazioni della vescica. La FDA ha concesso un'approvazione graduale, inizialmente consentendo l'arruolamento di tre partecipanti, con una potenziale espansione a 10 partecipanti al verificarsi di esiti di sicurezza favorevoli.
La UAB colpisce fino al 28% degli uomini oltre i 50 anni e il 45% delle donne più anziane con sintomi delle basse vie urinarie. La condizione impatta milioni di persone in tutto il mondo, con attuali opzioni di trattamento limitate. Questo approccio innovativo potrebbe offrire un'alternativa alla cateterizzazione intermittente pulita, che può essere gravosa e rischiosa. Lo studio segna un passo significativo nell'impegno di Astellas di ampliare le opzioni di trattamento oltre i farmaci tradizionali attraverso tecnologie bioelettroniche.
iota Biosciences, una subsidiaria de Astellas Pharma, ha recibido la aprobación de la FDA para una Exención de Dispositivo en Investigación (IDE) para llevar a cabo un Estudio de Viabilidad Temprana (EFS) sobre un nuevo dispositivo implantable para la vejiga. El dispositivo tiene como objetivo tratar la vejiga hipoactiva (UAB) mediante la entrega de estimulación eléctrica para inducir contracciones de la vejiga. La FDA otorgó una aprobación escalonada, inicialmente permitiendo la inscripción de tres participantes, con una posible expansión a 10 participantes tras resultados de seguridad positivos.
La UAB afecta hasta el 28% de los hombres mayores de 50 años y el 45% de las mujeres mayores con síntomas del tracto urinario inferior. Esta condición impacta a millones en todo el mundo, con opciones de tratamiento actuales limitadas. Este enfoque innovador podría proporcionar una alternativa a la cateterización intermitente limpia, que puede ser onerosa y arriesgada. El estudio marca un paso significativo en el compromiso de Astellas de ampliar las opciones de tratamiento más allá de los productos farmacéuticos tradicionales mediante tecnologías bioelectrónicas.
iota Biosciences는 Astellas Pharma의 자회사로서 조기 타당성 연구(EFS)를 수행할 수 있도록 FDA 승인을 받았습니다. 이 연구는 새로운 이식 가능한 방광 장치에 대해 실시됩니다. 이 장치는 전기 자극을 통해 방광 수축을 유도하여 저활동성 방광 (UAB)을 치료하는 것을 목표로 합니다. FDA는 단계별 승인을 부여했으며, 처음에는 세 명의 참여자를 모집할 수 있으며, 안전성 결과가 성공적으로 나올 경우 10명으로 확대할 수 있습니다.
UAB는 50세 이상의 남성의 최대 28%와 하부 요로 증상이 있는 노인 여성의 45%에게 영향을 미칩니다. 이 질환은 전 세계 수백만 명에게 영향을 미치며, 현재의 치료 옵션은 제한적입니다. 이 혁신적인 접근법은 번거롭고 위험할 수 있는 클린 간헐적 카테터 시술에 대한 대안을 제공할 수 있습니다. 이 연구는 Astellas가 생체 전자 기술을 통해 전통적인 제약을 넘어 치료 옵션을 확장하기 위한 의지를 나타내는 중요한 발걸음입니다.
iota Biosciences, une filiale de Astellas Pharma, a reçu l'approbation de la FDA pour une Exemption de Dispositif d'Investigation (IDE) afin de mener une Étude de Faisabilité Précoce (EFS) sur un dispositif de vessie implantable novateur. Le dispositif vise à traiter la vessie hypoactive (UAB) en délivrant une stimulation électrique pour induire des contractions de la vessie. La FDA a accordé une approbation par étapes, permettant initialement l'inscription de trois participants, avec une possible expansion à 10 participants en cas de résultats de sécurité positifs.
L'UAB touche jusqu'à 28 % des hommes de plus de 50 ans et 45 % des femmes âgées présentant des symptômes des voies urinaires inférieures. Cette condition impacte des millions de personnes dans le monde, avec des options de traitement actuellement limitées. Cette approche innovante pourrait offrir une alternative à la catheterisation intermittente propre, qui peut s'avérer pénible et risquée. L'étude représente un pas significatif dans l'engagement d'Astellas à élargir les options de traitement au-delà des médicaments traditionnels grâce à des technologies bioélectroniques.
iota Biosciences, eine Tochtergesellschaft von Astellas Pharma, hat die FDA-Zulassung für eine Investigational Device Exemption (IDE) erhalten, um eine Frühfeasibilitätsstudie (EFS) zu einem neuartigen implantierbaren Blasengerät durchzuführen. Das Gerät zielt darauf ab, eine unteraktive Blase (UAB) zu behandeln, indem es elektrische Stimulation zur Induktion von Blasenkontraktionen liefert. Die FDA erteilte eine gestufte Zulassung, die zunächst die Einschreibung von drei Teilnehmern erlaubt, mit einer potenziellen Erweiterung auf 10 Teilnehmer bei erfolgreichem Sicherheitsausgang.
UAB betrifft bis zu 28 % der Männer über 50 Jahre und 45 % der älteren Frauen mit Symptomen der unteren Harnwege. Der Zustand betrifft weltweit Millionen, während die aktuellen Behandlungsmöglichkeiten begrenzt sind. Dieser innovative Ansatz könnte eine Alternative zur sauberen intermittierenden Katheterisierung bieten, die belastend und riskant sein kann. Die Studie stellt einen bedeutenden Schritt im Engagement von Astellas dar, die Behandlungsmöglichkeiten über traditionelle Pharmazeutika durch bioelektronische Technologien hinaus zu erweitern.
- FDA approval for Investigational Device Exemption (IDE) to conduct Early Feasibility Study
- Potential to address a large market with underactive bladder affecting millions worldwide
- Innovative approach offering an alternative to current treatment options
- Rapid development from concept to IDE approval in less than four years
- Early stage of development with initial study size of 3 participants
- Expansion to 10 participants dependent on successful safety outcomes from initial stage
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.
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SOURCE Astellas Pharma Inc.
FAQ
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