GI View Ltd. Receives FDA 510(k) Clearance for the Aer-O-Scope™ Colonoscope System for Colorectal Cancer Screening

RAMAT GAN, Israel, December 3, 2014 /PRNewswire/ --

GI View Ltd., developer of advanced GI screening systems, announced today that it has received FDA 510(k) clearance for its flagship product, the Aer-O-Scope™ Colonoscope System, an advanced, comprehensive and easy-to-use system for colorectal cancer screening.  Market introduction is expected in the U.S. in early 2016.

     (Logo: http://photos.prnewswire.com/prnh/20141203/719978 )

"Aer-O-Scope™ provides reliable and safe colorectal cancer screening. It also has the potential to increase the adenoma detection rate and concurrently help to prevent cancer," said Erwin Santo MD, Head, Department of Gastroenterology and Liver Diseases, Tel Aviv Sourasky Medical Center and principal investigator of the most recent Aer-O-Scope™ clinical trial.

Colorectal cancer is the second biggest cause of cancer death in most countries in the western world. This type of cancer can almost always be prevented by early detection and removal of polyps, which if left untouched, can develop into colorectal cancer over a 5-10 year period. More than 500,000 people worldwide die from colorectal cancer annually.

Dr. Tal Simchony, CEO of GI-View Ltd. said, "Aer-O-Scope™ is the only colorectal screening product that is single use, self-propelled and has 360° omni-directional visualization. This enables the physician to observe all the mucosa of the colon, including behind folds, which is critical for a complete colonic assessment. If a polyp is there, Aer-O-Scope™ will allow the physician the best possible chance of finding it."  

In addition to the 360° omni-directional visualization, Aer-O-Scope™ also has several other unique advantages. Its soft multi-lumen tube is designed to significantly reduce pressure on the colon wall, which in turn, increases patient safety. Safety and ease of use are further maximized by the system's self-propelled intubation, created using balloons and low pressure CO₂ gas. As the system is joystick controlled it is also extremely simple to operate and requires minimal training. And finally, but of extreme importance, because the colonoscope is single use and disposable, there is no risk of disease transmission from it.

Like other colonoscopes, Aer-O-Scope™ also provides insufflation, irrigation and suction.

About GI View Ltd. 

Headquartered in Ramat Gan, Israel, GI-View Ltd. is dedicated to fundamentally advancing the efficiency, accuracy and comfort of colorectal cancer screening. The company's flagship product is the Aer-O-Scope™ Colonoscope System, the only colonoscope with a 360° omni-directional view for colon cancer screening. GI-View has been granted ISO certification for quality systems. Aer-O-Scope™ Colonoscope System has a CE mark and is FDA cleared for market. The company has 24 granted patents and dozens more pending. Investors include: Israel HealthCare Ventures Ltd., Ziegler Meditech Equity Partners and Kemper Insurance.  For more information and to view the product video, please visit: http://www.giview.com

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SOURCE GI View Ltd.