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First Human Use Study of Third Eye Retroscope(TM) Underway - Suggests That New Device May Improve Detection of Colon Cancer.

SUNNYVALE, Calif., Oct. 10 /PRNewswire/ -- Today Avantis Medical Systems, Inc. announced commencement of the first clinical study of the Third Eye Retroscope(TM), a new device for colorectal cancer screening and surveillance.

Used during colonoscopy, the Third Eye Retroscope is an auxiliary imaging device that provides an additional view to reveal polyps, cancers and other lesions that might be hidden from the lens of the traditional forward-viewing colonoscope.

Developed by Avantis Medical Systems, Inc. of Sunnyvale, Calif., this innovative device is passed through the instrument channel of a standard colonoscope until it extends beyond its tip. As it emerges, the device automatically turns around 180 degrees to aim "backward" toward the tip of the colonoscope. Then, as the colonoscope is withdrawn from the colon, the Third Eye comes along with it, providing a continuous retrograde view to complement the forward view of the colonoscope.

Colonoscopy is widely regarded as the "gold standard" for detection of abnormalities in the colon. However, previous research has revealed that 12-24% of polyps and a significant number of cancers can be missed during colonoscopy, especially if they lie behind folds in the colon wall (1,2,3). This new device is designed to solve that problem by allowing the physician to view the opposite side of those folds during the procedure.

An earlier laboratory bench study(4) found that use of the device resulted in a dramatic improvement in the ability of endoscopists to detect simulated polyps in anatomical models.

Of the polyps located on the proximal aspect of haustral folds in the models -- i.e., the opposite side when viewed from below -- the endoscopists detected only 12% with a standard colonoscope. However, they found 81% of the polyps when using a prototype of the Third Eye Retroscope in conjunction with an identical colonoscope. That study attracted a great deal of interest when it was presented at a plenary session of Digestive Disease Week (DDW) 2006.

Now George Triadafilopoulos, M.D. has used the device in humans for the first time, and is very impressed with the results.

Dr. Triadafilopoulos is Clinical Professor of Medicine at Stanford University School of Medicine and Editor-in-Chief of the leading journal, Gastrointestinal Endoscopy. Working at El Camino Hospital in Mountain View, California, where he has his private practice, Dr. Triadafilopoulos used the device during routine screening colonoscopy.

According to Dr. Triadafilopoulos, "Despite its remarkably small size, the image provided by the Third Eye Retroscope device is adequate to allow visualization of areas that are difficult or impossible to view with a standard colonoscope, including the proximal aspects of haustral folds and the inner curves of flexures. In fact, today I saw areas that I've never been able to see before during colonoscopy."

Fred Seddiqui, President and CEO of Avantis, states, "This was a terrific beginning for our first clinical study. We are optimistic that the results will demonstrate that a small, disposable ancillary device can dramatically improve the ability of endoscopists to detect colorectal cancer in its earliest stages."

Mr. Seddiqui points out that the next step will be to perform a larger study to evaluate the device's efficacy. He says, "That will involve a direct comparison of detection rates with the Third Eye device vs. detection rates with the colonoscope alone.

Dr. Triadafilopoulos feels that a major advantage of the Third Eye Retroscope is that it fits through the working channel of virtually any adult colonoscope, so "... facilities won't face major outlay for capital equipment to replace the existing infrastructure. Also, because the device complements, rather than replaces, standard colonoscopy technique, it involves minimal training for endoscopists and avoids disruption of existing referral patterns."

The Third Eye Retroscope has not yet been submitted for domestic (FDA) or international regulatory clearance and thus is not available for sale.

About Avantis

Avantis Medical Systems, Inc. is a medical device company founded to develop and manufacture catheter-based endoscopic devices. Based in Sunnyvale, Calif., the Company's initial focus is on devices for use in detecting and treating cancers of the gastrointestinal (GI) tract.

The Avantis team has many decades of experience in the medical device industry, and focuses on developing solutions for problems, hazards and inconveniences associated with traditional technologies. The Company is developing an extensive portfolio of patents covering innovative devices based on the convergent technologies of micro-chips and reinforced catheters.
 (1) Pickhardt PJ, Nugent PA, Mysliwiec PA, Choi JR, Schindler WR.
 Location of adenomas missed by optical colonoscopy. Annals of Internal
 Medicine 2004;141:352-360.

 (2) Pabby A, Schoen RE, Weissfeld JL, Burt R, Kikendall JW, Lance P,
 Shike M, Lanza E, Schatzkin A. Analysis of colorectal cancer occurrence
 during surveillance colonoscopy in the dietary Polyp Prevention Trial.
 Gastrointestinal Endoscopy 2005;61:385-391.

 (3) Rex DK, Cutler CS, Lemmel GT, Rahmani EY, Clark DW, Helper DJ, Lehman
 GA, Mark DG. Colonoscopic miss rates of adenomas determined by back-to-
 back colonoscopies. Gastroenterology 1997;112:24-28.

 (4) Triadafilopoulos G, Watts D, Higgins J, Van Dam J. A novel
 retrograde-viewing auxiliary imaging device ("Third Eye Retroscope(TM)")
 improves the detection of simulated polyps in anatomical models of the
 colon. Gastrointestinal Endoscopy 2006;63:AB103.

 CONTACTS:
 Jennifer Havlek
 Avantis Medical Systems, Inc.
 408-733-1901, ext. 200
 jhavlek@avantismedical.com



CONTACT: Jennifer Havlek, Avantis Medical Systems, Inc., +1-408-733-1901, ext. 200, or jhavlek@avantismedical.com

Web site: http://www.avantismedical.com/
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