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

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 14.4%.

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.

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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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