LOS GATOS, Calif., Feb. 9 /PRNewswire/ -- 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 http://www.neoguidesystems.com.
Vice President of Marketing
NeoGuide Systems, Inc.
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NeoGuide Systems, Inc.