New Data Show ENDOCUFF VISION(TM) Improves Overall Performance in Colonoscopy and Increases Adenoma Detection Rate

LONDON, May 18, 2015 /PRNewswire/ --

Norgine B.V.'s partner Arc Medical Design Ltd. today announced that the device ENDOCUFF™ can significantly improve overall colonoscopy performance by

• Making the colonoscopy quicker Caecal intubation time (CIT) - 22.36%,p<0.005
• Increasing Adenoma Detection Rate (ADR) - 13.8%,p<0.05
• Increasing Mean number of adenomas per procedure (MAP) - 83%,p<0.05.

This prospective observational study was presented at Digestive Disease Week 2015.^[i]

     (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a )

ENDOCUFF™ is a simple device attached at the end of the colonoscope that opens up the field of view by retracting folds during withdrawal.

The study was divided in three consecutive periods: pre-cuff (no device used), during-cuff (device used) and post-cuff (no device used). Key quality colonoscopy indicators used were Adenoma Detection Rate, Mean number of adenomas per procedure and Caecal intubation time with a total number of procedures performed was 399.

Peter Martin, COO at Norgine said: "Improving quality of endoscopy is important because effective colon cancer screening lowers colon cancer rates and mortality. ENDOCUFF™ can transform patient's care because it clearly improves diagnosis  of lesions but also delivers better quality colonoscopy."

Tas Javed, MD at Arc Medical said: "ENDOCUFF™ is already available for use in the US and in Europe and we are confident that extensive use of the device when performing colonoscopy will help save lives and has the potential to ultimately reduce healthcare bills."

Colorectal cancer is the second most common cause of cancer-related mortality in the world,^[ii] with 412,00 new diagnoses every year in Europe.^[iii],[iv]

Other data presented at DDW included:

• ENDOCUFF™ assisted colonoscopy increased the detection of polyps: a prospective study of crossover colonoscopies using a colorectal anatomic model. Sa1607. 09:30 - 16:00. Saturday 16 May 2015. DDW 2015.
• Improved polyp detection among high risk patients with ENDOCUFF™. Sa1613. 09:30-16:00. Saturday 16 May 2015. DDW 2015.
• Adenoma detection with ENDOCUFF™ colonoscopy vs. conventional colonoscopy: a multicenter randomised controlled trial. Presentation 434, 17 May 2015. 14:30 -14:45. DDW 2015.

Full press release on http://www.norgine.com

i. ENDOCUFF VISION: impact on colonoscopist performance during screening. Abstract SA1423. Digestive Disease Week 2015.

ii. Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J et al.  Cancer incidence and mortality patterns in Europe:  Estimates for 40 countries in 2012. Eur J Cancer 2013;49:1374-1403

iii. Colorectal Cancer Statistics, World Cancer Research Fund International, http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/colorectal-cancer-statistics [Accessed 4 March 2015]

iv. Zavoral M et al. Colorectal cancer screening in Europe. World J Gastroenterol 2009;15(47):5907-5915

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