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

Rhea-AI Summary

Cosmo Pharmaceuticals has received FDA approval for its GI Genius™ intelligent endoscopy system, a groundbreaking device designed for detecting lesions during colonoscopy. This marks a significant achievement after over a decade of research, as it is the first device of its kind to achieve approval via the De Novo application. The system operates in real-time, improving detection rates of precancerous lesions and is compatible with all endoscopes. Cosmo has partnered with Medtronic for worldwide distribution, aiming at a market potential worth at least $1.1 billion.

Positive

• FDA approval marks a major milestone after 10 years of research.
• GI Genius is the first AI device approved for lesion detection during colonoscopy.
• Partnership with Medtronic enhances global distribution and market reach.
• Market potential estimated at over $1.1 billion in the U.S. AI colonoscopy segment.

Negative

• None.

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

Disclaimer

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.

This communication is not an offer of securities of any issuer. Securities may not be offered or sold in the United States absent registration or an exemption from the registration requirement of the US Securities Act of 1933.

This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. The offer will be made solely by means of, and on the basis of, a securities prospectus to be published. An investment decision regarding the securities to be publicly offered should only be made on the basis of the securities prospectus.

This press release is made to and directed only at (i) persons outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. Any person who is not a relevant person should not act or rely on this press release or any of its contents.

This press release does not constitute an "offer of securities to the public" within the meaning of Directive 2003/71/EC of the European Union (the "Prospectus Directive") of the securities referred to in it (the "Securities") in any member state of the European Economic Area (the "EEA"). Any offers of the Securities to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities.

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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

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SOURCE Cosmo Pharmaceuticals N.V.

FAQ

What is the GI Genius intelligent endoscopy system?

The GI Genius is an FDA-approved device that uses artificial intelligence to assist in detecting lesions during colonoscopy procedures.

What does FDA approval mean for Cosmo Pharmaceuticals?

FDA approval allows Cosmo Pharmaceuticals to market the GI Genius system, significantly enhancing its position in the medical device market.

What is the market potential of the GI Genius system?

The market potential for the GI Genius system is estimated to be at least $1.1 billion in the U.S. alone.

How does the GI Genius improve colonoscopy procedures?

The GI Genius system improves detection rates of precancerous lesions, regardless of physician skill level, enhancing the accuracy of colonoscopy.

Who is distributing the GI Genius system?

Medtronic is the exclusive worldwide distributor of the GI Genius intelligent endoscopy system.