Dublin - Cosmo Pharmaceuticals N.V. (SIX: COPN) ('Cosmo') today announced that GI Genius has received regulatory approval in Israel.

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 GI Genius registration in the U.S. which commenced earlier this year and which was substantially halted due to Covid-19 is now resuming. It is expected to last approximately 4-6 months.

Alessandro Della Cha (CEO of Cosmo) commented: 'We are very happy with the continued expansion of the GI Genius 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 recently entered into a partnership with Medtronic for the global distribution of GI Genius its 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.

Contact:

Niall Donnelly

Tel: +353 1 817 03 70

Email: ndonnelly@cosmopharma.com

Disclaimer

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