EQS-Adhoc

Cosmo announces FDA approval of GI Genius(TM) intelligent endoscopy module, its revolutionary Artificial Intelligence device for lesion detection during colonoscopy

EQS Group-Ad-hoc: Cosmo Pharmaceuticals N.V. / Key word(s): Miscellaneous Cosmo announces FDA approval of GI Genius(TM) intelligent endoscopy module, its revolutionary Artificial Intelligence device for lesion detection during colonoscopy 12-Apr-2021 / 06:00 GMT/BST Release of an ad hoc announcement pursuant to Art. 53 KR The issuer is solely responsible for the content of this announcement. Dublin, Ireland - 12 April 2021: Cosmo Pharmaceuticals NV (SIX: COPN) today announced the FDA approval of GI Genius(TM) intelligent endoscopy system, its revolutionary device for lesion detection during colonoscopy.

The GI Genius module FDA approval marks a pivotal milestone for Cosmo after more than 10 years of research and investments focused to generate disruptive innovations in the field of colon's disease and optimization of the colonoscopy procedure. The development of GI Genius intelligent endoscopy module has been possible thanks to the leadership position of Cosmo, its unique proprietary library of high-definition loss-less videos of colonoscopies and its proprietary software and algorithms. The device is the first of its kind to obtain the FDA approval through the De Novo application. The device operates in real time to assist the endoscopist in the detection of lesions, is very simple to use and is compatible with all endoscopes. Cosmo is the sole manufacturer. Medtronic is the exclusive world-wide distributor.

According to Prof. Michael Wallace, Fred C. Andersen Professor of Medicine at Mayo Clinic and Editor in Chief of Gastrointestinal Endoscopy: 'While colon cancer is the second deadliest cancer worldwide, it is the most preventable cancer yet full prevention remains unfulfilled. 1 in 20 US adult will be diagnosed with this disease in their lifetime but, encouragingly, 90% of patients can beat it if it is diagnosed early enough. Colonoscopy is the gold standard and most common screening method, but it's not perfect, as performance varies based on many factors including physician skill level. The GI Genius intelligent endoscopy module will help improve the accuracy of colonoscopy and reduce the number of undetected precancerous lesions, as has been shown in a recent randomized study (Repici et al.), where detection rates improved very significantly with GI Genius technology versus standard colonoscopy, regardless of skill level or endoscope used'.