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NeoGuide Announces FDA Clearance of its Breakthrough Computer-Assisted Colonoscopy System
(Los Gatos CA) - February 9, 2006 -- NeoGuide Systems, Inc., a developer of
technology to prevent and treat colorectal cancer, today announced that it received FDA
510(k) clearance to market its NeoGuide Endoscopy System. The system is designed to
enhance physician control of the colonoscope and to eliminate looping, the principle reason
why conventional colonoscopy procedures are painful, time consuming, and difficult.
“FDA clearance of our platform product – the first computer-assisted colonoscope –
represents a significant milestone for both NeoGuide and this area of medicine,” said Amir
Belson, M.D., co-founder and president of NeoGuide. “It is the result of years of research and
development by an extremely dedicated team. We look forward to working with
gastroenterologists to greatly improve their ability to screen, treat and diagnose colorectal
cancer.”
Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States,
yet it is highly preventable. Colonoscopy is considered the gold standard for CRC screening
as it is the only screening method that allows the physician to inspect the entire colon and
remove adenomatous polyps, the non-cancerous growths that have the potential to develop
into colorectal cancer. Studies have shown that the vast majority of CRC cases can be
prevented by screening colonoscopy and the removal of polyps.
In conventional colonoscopy, a flexible endoscope is inserted into the colon, which is
essentially a flexible and highly tortuous tube. Advancing the colonoscope displaces the colon
and stretches the surrounding tissue, a phenomenon known as looping. Unlike conventional
scopes, the NeoGuide colonoscope is built out of multiple segments that can be actively
controlled. As the physician inserts the NeoGuide scope, the system automatically creates a
three dimensional map of the colon and then directs these segments to follow the path taken
by the tip.
According to Dr. Bergein F. Overholt, President of Gastrointestinal Associates, P.C. in
Knoxville, Tennessee, “Looping is one of the most difficult challenges for physicians
performing colonoscopy. It makes the procedure difficult to teach and to perform, can cause
patient discomfort, and adds time to the procedure. By addressing this challenge, NeoGuide’s
Endoscopy System could make a significant difference in patient care and in the practice of
gastroenterologists.”
In September 2005, NeoGuide successfully completed its initial clinical study with the system
at Klinikum der Stadt Ludwigshafen in Ludwigshafen, Germany. Results of the study will be
presented at the 2006 Digestive Disease Week (DDW) meeting in May. The company has
also conducted extensive studies demonstrating the safety of the system and the potential to
reduce looping in various bench top models.
About NeoGuide Systems
NeoGuide Systems was founded in 2000 with the mission to transform the way endoscopic
procedures are conducted. The company is developing technology designed to revolutionize
the way physicians visualize and deliver therapies within the body. Representing a significant
departure in the way colonoscopies are performed, the NeoGuide Endoscopy System offers
physicians more control through advanced features. NeoGuide is privately held and backed by
Versant Ventures, Utah Ventures, 3i, Kaiser Permanente Ventures, Arboretum Ventures, DC
Capital, SBV and The Angel's Forum/Halo Fund. For more information, please visit the
company's website at www.neoguidesystems.com.
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