DUBLIN, April 12, 2021 /PRNewswire/ -- Cosmo
Pharmaceuticals NV (SIX: COPN) today announced the FDA approval of
GI Genius™ 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 optimistic about the impact the GI Genius
intelligent endoscopy module will have on the US patient population
undergoing colonoscopy."
Alessandro Della Chà, CEO of Cosmo, said: "This approval
is gratifying in many ways as it is aligned with our mission of
serving markets with unmet needs. Through our global distribution
partnership with Medtronic we are excited to pursue an opportunity
which is worth at least $ 1.1bn,
looking only at the opportunity for artificial intelligence in the
colonoscopy market. Leveraging on the strength of Medtronic's large
US commercial footprint, we look forward to successfully and
rapidly developing this market."
The GI Genius™ intelligent endoscopy system is a registered
trademark of Medtronic plc.
The FDA announcement of the approval can be found at the
following link:
https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-device-uses-artificial-intelligence-help-detect-potential-signs-colon.
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 Ltd. for the US and has licensed
Relafalk® 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.
Calendar
Annual General Meeting, Amsterdam - May 28,
2021
Half-Year 2021 Report - July 30, 2021
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Contact:
Niall
Donnelly, CFO & Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel.: +353 1 817 03 70
ndonnelly@cosmopharma.com