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

Dublin (ots/PRNewswire) - 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."

Mauro Ajani, Chairman of Cosmo, commented: "This landmark approval is tremendous
news for Cosmo. The first ever approval of an artificial intelligence device for
lesion detection in colonoscopies further strengthens Cosmo's commitment to
fight colorectal cancer. This approval is a major milestone after many years of
strategic investments into the colon diseases and positions Cosmo at the
forefront of cutting-edge innovation. Through the strong partnership with
Medtronic over the last two years, Cosmo has expanded its position in the
medical device market within its core GI expertise, has gained global access and
will ultimately reach more patients. We are extremely pleased and very