Gastrointestinal (GI) malignancies are the most common cause of cancer in the world. Of the10.8 million people in the world each year who develop cancer, approximately 3.3 million have GImalignancies. Aside from prevention, effective, low cost, and comfortable early diagnosis technologiesare urgently needed to improve this situation. Traditional endoscopic or radioactive imaging methodspresent significant discomfort to the patients, is costly, or lack sensitivity. Current capsule endoscopy(CE) imaging technique represents great technological breakthrough. However, it still has drawbackssuch as ineffective forward looking FOV and poor image quality, and requests long diagnosis viewingtime. Altrum Technologies, Inc. in collaboration with Mayo Clinic proposes in this SBIR project to developa novel optical imaging capsule and video data visualization/analysis hardware/software system calledGISentinelTM for the next generation CE technology. Built on our patent pending 360 degree imagingoptics, with unique image unwrapping and robust panoramic registration techniques, GISentinel will havethe following clinic impact and significance: 3/4 A leapfrog technology for GI imaging: Used as a swallowable pill, GISentinel capsule offers instant 360o images mechanically free for GI tract tissue wall, thus causing no discomfort to patients - no more sedation or pain from the tube insertion of traditional endoscopes. 3/4 No missing GI disorder areas: GISentinel capsule offers a complete 360o surrounding of the GI tract, no area will be missed. 3/4 Accurate and rapid diagnosis: Through more effective image registration, GISentinel SW is expected to help GI doctors/nurses to rapidly (down to 0.5 hours) and accurately diagnose abnormalities. 3/4 A low cost capsule system for better mass acceptance and effective disease prevention: Due to its simple structural and optical design, GISentinel capsule can be manufactured at a cost of around $55 if over a quantity of 1000. 3/4 Expandable and scalable technology: The proprietary omni-directional technology developed for GISentinel can be easily applied to existing diagnosis instruments (endoscopes, colonscope, gastroscope, etc) to provide similar benefits to the patients The Millennium Research Group predicated the capsule endoscopy market is to generate morethan $500 million in 2008 in the United States alone - up from just $40 million in 2004. According toGiven Imaging Ltd., close to 1 million patients worldwide have gone through capsule endoscopyprocedures using their PillCam capsules. Capsule endoscopy is a rapidly-growing multi-billion dollarmarket. The commercialization potential of the proposed GISentinel system and technology is significant.

Public Health Relevance

The GISentinelTM system and technology developed under this SBIR project will provide great benefit to GI patients by providing a low cost and non-invasive method for early GI tract disease diagnosis and prevention. GISentinel provides an innovative panoramic imaging and mosaic technique leading to much shorter diagnosis time with more accurate results. With the extended capability over current pill cameras, GISentinel is expected to have a reasonably large market share of this multi-billion dollar industry. In addition, GISentinel technology will also benefit non-medical fields such as commercial perimeter surveillance, and water and gas pipe inspection.

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-SBIB-Q (90))
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Sachs, Jody
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Xyken, LLC
United States
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