28.02.2020 – COSMO Pharmaceuticals N.V.

Cosmo announces Australian regulatory approval of GI GENIUS™

Cosmo announces Australian regulatory approval of GI GENIUS™

Dublin, Ireland – February 28, 2020 - Cosmo Pharmaceuticals N.V. (SIX: COPN) (“Cosmo”) today announced that GI Genius™ has received regulatory approval in Australia.

GI Genius™ is the first system using artificial intelligence to detect colorectal polyps and is already available in Europe.

Cosmo recently announced very positive results of the first investigator initiated prospective clinical study of its GI Genius™ artificial intelligence endoscopy device. In this trial the system increased adenoma detection rate by an absolute value of 16% from 40.9% in the control arm to 56.9% in the GI Genius™ group.

The trial required for the registration of GI Genius™ in the U.S. has commenced and is expected to last approximately 4-6 months.

Alessandro Della Chà (CEO of Cosmo) commented: “This is another positive development in relation to the commercialization of GI Geniusworldwide.”

For more information regarding the GI Genius™ investigator initiated trial please visit: https://www.cosmopharma.com/news-and-media/press-releases-and-company-news/2020/200220

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused in treating selected Gastrointestinal Disorders and Endoscopy. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, Colonic Infections and detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of GI Genius™ it’s artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo™ to Red Hill Biopharma and is the licensee of ByFavo™(remimazolam) for the U.S. for procedural sedation, which it has sub-licensed to Acacia. For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com


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Niall Donnelly, Chief Financial Officer & Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 1 817 03 70


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