Gastrointestinal (GI) malignancies are the most common cause of cancer in the world. Of the 10.8 million people in the world each year who develop cancer, approximately 3.3 million have GI malignancies. Aside from prevention, effective, low cost, and comfortable early diagnosis technologies are urgently needed to improve this situation. Traditional endoscopic or radioactive imaging methods present significant discomfort to the patients, is costly, or lack sensitivity. Current capsule endoscopy (CE) imaging technique represents great technological breakthrough. However, it still has drawbacks such as ineffective forward looking FOV and poor image quality, and requests long diagnosis viewing time. Altrum Technologies, Inc. in collaboration with Mayo Clinic proposes in this SBIR project to develop a novel optical imaging capsule and video data visualization/analysis hardware/software system called GISentinelTM for the next generation CE technology. Built on our patent pending 360 degree imaging optics, with unique image unwrapping and robust panoramic registration techniques, GISentinel will have the 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 more than $500 million in 2008 in the United States alone - up from just $40 million in 2004. According to Given Imaging Ltd., close to 1 million patients worldwide have gone through capsule endoscopy procedures using their PillCam capsules. Capsule endoscopy is a rapidly-growing multi-billion dollar market. 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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
6R43RR031309-02
Application #
8198844
Study Section
Special Emphasis Panel (ZRG1-SBIB-Q (90))
Program Officer
Sachs, Jody
Project Start
2010-08-01
Project End
2012-07-31
Budget Start
2010-11-01
Budget End
2011-07-31
Support Year
2
Fiscal Year
2010
Total Cost
$155,022
Indirect Cost
Name
Xyken, LLC
Department
Type
DUNS #
962171851
City
Vienna
State
VA
Country
United States
Zip Code
22182