Diagnostics & Imaging Week

NeoGuide Systems (Los Gatos, California), a developer of technology to prevent and treat colorectal cancer, reported receiving 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 principal reason why conventional colonoscopy procedures are painful, time consuming, and difficult.

"The company was founded in 2000, and it's taken awhile for us to get to this point, so it's a big milestone for us," Robert Eno, vice president of marketing for NeoGuide, told Diagnostics & Imaging Week.

Amir Belson, MD, co-founder and president of NeoGuide, said in a statement: "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."

Eno said the company is "very careful" in describing the product, since the 510(k) indicates "substantial equivalence" to existing products.

However, he explained that looping is fundamental to traditional colonoscopy. "It's inherent in the way the current devices work in that you're able to steer the tip but the shaft of the [device] is uncontrolled," Eno said.

He said that it's a difficult procedure because a physician is essentially inserting a "flexible tube inside another flexible tube, since the colon is "free-floating in the abdomen."

Eno said, "The only way that they can advance the scope is actually stretching the colon until there is counter-force against the wall and [it] stretches the surrounding tissue," adding that this is what leads to the pain in the procedure and the difficulty for the physician.

The NeoGuide Endoscopy System is designed to provide control for the physician over the shaft of the device that is inserted into the colon, in the expectation that it will reduce pain and potentially reduce the amount of sedation needed.

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 3-D map of the colon and then directs these segments to follow the path taken by the tip.

The company will be gathering additional data on the device during 2006 and developing iterations of the device in preparation for an early 2007 launch. NeoGuide, a venture-backed company with about 34 employees, will manufacture the device and will be building up its sales force in the meantime.

Colorectal cancer (CRC) is the second-leading cause of cancer deaths in the U.S., yet it is highly preventable. Colon-oscopy 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.

Dr. Bergein Overholt, president of Gastrointestinal Associates (Knoxville, Tennessee), said, "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 also has conducted extensive studies demonstrating the safety of the system and the potential to reduce looping in various bench top models.

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.

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