Cosmo to Unveil First-of-its-Kind Clinical Study on the Use of GI Genius(TM) with Apple Vision Pro at Rush University Medical Center
Cosmo Pharmaceuticals (OTC:CMOPF) has announced a groundbreaking clinical study integrating their GI Genius™ AI endoscopy module with Apple Vision Pro, set to begin in July 2025 at Rush University Medical Center. The first-of-its-kind usability study will evaluate a new software application that enables physicians to view AI-generated insights during live colonoscopy procedures through Apple Vision Pro.
The GI Genius™ system has demonstrated the ability to increase adenoma detection rates by 14.4%. The study results will support Cosmo's upcoming FDA submission. The technology is commercially distributed globally through Cosmo's partnership with Medtronic, their exclusive distributor since 2019.
Cosmo Pharmaceuticals (OTC:CMOPF) ha annunciato uno studio clinico innovativo che integra il loro modulo di endoscopia AI GI Genius™ con Apple Vision Pro, previsto per iniziare a luglio 2025 presso il Rush University Medical Center. Questo studio di usabilità, unico nel suo genere, valuterà una nuova applicazione software che permette ai medici di visualizzare le informazioni generate dall'AI durante procedure di colonscopia in tempo reale tramite Apple Vision Pro.
Il sistema GI Genius™ ha dimostrato di aumentare i tassi di rilevamento degli adenomi del 14,4%. I risultati dello studio supporteranno la prossima richiesta di approvazione FDA di Cosmo. La tecnologia è distribuita commercialmente a livello globale grazie alla partnership di Cosmo con Medtronic, distributore esclusivo dal 2019.
Cosmo Pharmaceuticals (OTC:CMOPF) ha anunciado un estudio clínico innovador que integra su módulo de endoscopía con IA GI Genius™ con Apple Vision Pro, que comenzará en julio de 2025 en el Rush University Medical Center. Este estudio de usabilidad, pionero en su tipo, evaluará una nueva aplicación de software que permite a los médicos ver las perspectivas generadas por IA durante procedimientos de colonoscopia en vivo a través de Apple Vision Pro.
El sistema GI Genius™ ha demostrado su capacidad para incrementar las tasas de detección de adenomas en un 14.4%. Los resultados del estudio respaldarán la próxima presentación ante la FDA de Cosmo. La tecnología se distribuye comercialmente a nivel mundial mediante la asociación de Cosmo con Medtronic, su distribuidor exclusivo desde 2019.
Cosmo Pharmaceuticals (OTC:CMOPF)는 GI Genius™ AI 내시경 모듈과 Apple Vision Pro를 통합한 획기적인 임상 연구를 발표했으며, 2025년 7월 Rush University Medical Center에서 시작될 예정입니다. 이 최초의 사용성 연구는 의사들이 Apple Vision Pro를 통해 실시간 대장내시경 중 AI가 생성한 인사이트를 볼 수 있도록 하는 새로운 소프트웨어 애플리케이션을 평가할 것입니다.
GI Genius™ 시스템은 선종 검출률을 14.4% 증가시키는 능력을 입증했습니다. 연구 결과는 Cosmo의 FDA 제출을 지원할 것입니다. 이 기술은 2019년부터 독점 유통사인 Medtronic과의 파트너십을 통해 전 세계적으로 상업적으로 배포되고 있습니다.
Cosmo Pharmaceuticals (OTC:CMOPF) a annoncé une étude clinique révolutionnaire intégrant leur module d'endoscopie IA GI Genius™ avec Apple Vision Pro, qui débutera en juillet 2025 au Rush University Medical Center. Cette étude d'utilisabilité inédite évaluera une nouvelle application logicielle permettant aux médecins de visualiser les informations générées par l'IA lors de procédures de coloscopie en direct via Apple Vision Pro.
Le système GI Genius™ a démontré sa capacité à augmenter les taux de détection des adénomes de 14,4 %. Les résultats de l'étude soutiendront la prochaine soumission de Cosmo à la FDA. La technologie est distribuée commercialement dans le monde entier grâce au partenariat de Cosmo avec Medtronic, leur distributeur exclusif depuis 2019.
Cosmo Pharmaceuticals (OTC:CMOPF) hat eine bahnbrechende klinische Studie angekündigt, die ihr GI Genius™ KI-Endoskopiemodul mit Apple Vision Pro integriert und im Juli 2025 am Rush University Medical Center starten wird. Die erste Studie dieser Art zur Benutzerfreundlichkeit wird eine neue Softwareanwendung bewerten, die Ärzten ermöglicht, KI-generierte Erkenntnisse während Live-Koloskopien über Apple Vision Pro einzusehen.
Das GI Genius™ System hat gezeigt, dass es die Adenom-Erkennungsrate um 14,4 % erhöhen kann. Die Studienergebnisse werden Cosmos bevorstehende FDA-Einreichung unterstützen. Die Technologie wird weltweit kommerziell über Cosmos Partnerschaft mit Medtronic, ihrem exklusiven Vertriebspartner seit 2019, vertrieben.
- First-mover advantage in combining AI endoscopy with spatial computing technology
- GI Genius system demonstrates 14.4% increase in adenoma detection rate
- Strategic partnership with Medtronic for global distribution
- Innovation potentially setting new standards in procedural medicine
- Study results will support upcoming FDA submission
- None.
Dublin, Ireland--(Newsfile Corp. - June 24, 2025) - Cosmo Pharmaceuticals N.V. (“Cosmo”) today announced that in July 2025, it will initiate their first usability study of a medical device software application connecting the Medtronic GI Genius™ intelligent endoscopy module, an AI-powered platform for gastrointestinal endoscopy, with Apple Vision Pro. The study, to be conducted at Rush University Medical Center in Chicago under the leadership of Irving Waxman, MD, James R. Lowenstine Professor and Chief, Division of Digestive Diseases & Nutrition, and will evaluate the real-time use of this innovative technology during live colonoscopy procedures.
The software application – designed by Cosmo for use with Apple Vision Pro – will enable physicians to visualize AI-generated insights from the GI Genius™ module directly through Apple Vision Pro, enabling physicians to view important information without looking away from the operative screen. This innovative, spatial experience is being investigated for the first time in GI endoscopy and is believed to set the foundation for a new standard in procedural medicine. The GI Genius™ system uses artificial intelligence to increase the adenoma detection rate (ADR) of colorectal polyps by as much as
This innovation was made possible through extensive development work with spatial computing technology, utilizing Apple Vision Pro’s software architecture, input, and high-resolution display system. Cosmo’s teams engineered the software application to operate natively on Apple Vision Pro, unlocking a fusion of clinical AI experiences and spatial computing visualization never before seen in endoscopy.
The upcoming usability study – the first of its kind and conducted on patients undergoing routine colonoscopy – will serve as a key component of Cosmo’s planned FDA submission, expected shortly after the study concludes.
“We are thrilled to be the first in the world to evaluate this technology in the endoscopy suite,” said Prof. Irving Waxman. “What Cosmo has built by connecting the GI Genius™ module with Apple Vision Pro is extraordinary. It has the potential to revolutionize how we practice – by giving us AI-powered insights exactly when and where we need them. This is not just an incremental improvement – it’s a complete reimagining of procedural medicine, and I’m proud that Rush is leading the way.”
“This is a historic moment for Cosmo and for the field of endoscopy,” added Giovanni Di Napoli, CEO of Cosmo. “By integrating the GI Genius™ module with Apple Vision Pro, we will be delivering an entirely new experience – intelligent, and intuitive. Developing this application for Apple Vision Pro has been an extraordinary journey, and the result will be a fusion of clinical AI experiences and spatial computing. This is what the future of medicine looks like: real-time AI, embedded naturally into the physician’s workflow by blending digital content with the physical world. We’re proud to be at the forefront of this transformation – and excited about what’s possible when world-class technology and medical innovation come together.”
The GI Genius™ module is commercialized globally through Cosmo’s strategic partnership with Medtronic, which has served as the exclusive distributor since 2019.
About Cosmo
Cosmo Pharmaceuticals N.V. is committed to revolutionizing healthcare and transforming people’s lives by researching and developing innovative products that tackle unfulfilled healthcare demands. As a pharmaceutical company, Cosmo is active in the areas of Healthtech/AI, dermatology, gastroenterology and contract manufacturing & development. For the commercialization and distribution of its products, Cosmo collaborates with leading partners worldwide, including Medtronic and Sun Pharma. Founded in 1997, Cosmo is headquartered in Dublin (Ireland) and has offices also in San Diego (USA), and Lainate/Rome/Catania (Italy). The Company has approximately 330 employees at the end of 2024, all dedicated to making a significant impact in the field of healthcare. For more information, please visit www.cosmopharma.com.
About Rush
Rush is a nonprofit health system that includes Rush University Medical Center, Rush University, Rush Copley Medical Center and Rush Oak Park Hospital, as well as an extensive provider network and numerous outpatient care facilities. Rush University Medical Center is ranked among the top hospitals in the nation by U.S. News & World Report and consistently is named among the top academic medical centers for excellence in patient care by Vizient Inc. and a Top Teaching Hospital by The Leapfrog Group. Rush University comprises three colleges: Rush Medical College, the College of Nursing and the College of Health Sciences.
Financial calendar
| Investor Day, Zurich | July 1, 2025 |
| 2025 Half-Year Results and Report | July 23, 2025 |
For further information, please contact:
Cosmo Pharmaceuticals Investor Relations, investor.relations@cosmopharma.com
Disclaimer
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.
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FAQ
When will Cosmo begin the GI Genius Apple Vision Pro clinical study?
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How much does the GI Genius system improve adenoma detection rate?
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