Cosmo announces regulatory approval of GI Genius™ in Canada

Cosmo Pharmaceuticals N.V. / Key word(s): Regulatory Approval

17-Nov-2021 / 06:00 GMT/BST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.

Ad hoc announcement pursuant to Art. 53 LR

Dublin, Ireland - November 17, 2021: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) ('Cosmo') today announced that GI Genius(TM) has received regulatory approval in Canada.

GI Genius(TM) is an AI-enhanced endoscopy aid device for the detection of colorectal lesions during colonoscopy. The GI Genius(TM) intelligent endoscopy module offers a transformative solution, powered by Artificial Intelligence, to address the challenges of detecting colorectal cancer early.

GI Genius(TM) was developed by Cosmo and is marketed worldwide by Medtronic, the global leader in medical technology. GI Genius(TM) is already approved in the US, EU, Israel, UAE and Australia.

GI Genius(TM) works in real-time as an aid to the gastroenterologist during a colonoscopy for the purpose of highlighting regions with visual characteristics consistent with different types of mucosal abnormalities, such as colorectal polyps of all shapes, sizes, and morphology. It is designed to be integrated with all existing gastrointestinal endoscopes.

Alessandro Della Chà, CEO of Cosmo, commented: 'It is very good to see GI Genius(TM) rapidly becoming a real global franchise'.

About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has a partnership with Medtronic for the global distribution of GI Genius(TM) its artificial intelligence device that uses artificial intelligence to help detect potential signs of colon cancer. Cosmo has licensed Aemcolo(R) to Red Hill Biopharma Ltd. for the US and has licensed Relafalk(R) to Dr. Falk Gmbh for the EU and other countries. For additional information on Cosmo and its products please visit the Company's website: www.cosmopharma.com

Contact
Niall Donnelly, CFO 
Cosmo Pharmaceuticals N.V.            
Tel: +353 1 817 03 70
ndonnelly@cosmopharma.com