SBIR/STTR Award attributes
AbstractAn estimatedmillion colonoscopies are performed annually in the US at a cost of about $Bhowever current colonoscopes with forward vision fail to detectof precancerous polypsOverof the missed polyps are located on or behind numerous folds in the colon where they are hidden from the sight of a forward view colonoscopeIn this research proposalwe propose to complete our development of an imaging system that provides unprecedented forward as well asdegree reverse views in a single imageIn our STTR Phase I studywe successfully developed our second prototype and re confirmed the substantial superiority of our Dual View technique over standard colonoscopyThe technology was invented by the cofounders of the companya gastroenterologist and an optical scientist at the University of Arizona and has been licensed by OmniscientDevice development was guided by feedback from endoscopists and industry executivesIn this proposal we will further miniaturize the deviceimprove resolution and build an imaging system that can be integrated with any commercial endoscopy platformOur market research indicated an overwhelming need for an `add onandaposthat can be used in conjunction with existing endoscopesrather than a totally new endoscopeIn collaboration with the University of ArizonaOmniscient will develop an imaging system where a capsule with a diameter of aboutmm can be attached to the tip of any existing colonoscope to provide endoscopists with unprecedented forward anddegree backwards views in a single display monitorThis reusable endoscopic accessory will avoid the need and expense of replacing an endoscopy platformallow our product to be highly cost effective and permit the endoscopist to continue to use their preferred endoscopeWe have assembled a multi disciplinary team and formed collaborations with industry partners in lens fabricationcamera manufacturing and medical device marketing to facilitate the successful development and market launch of our productWe will continue to use end use and market feedback to finetune the development of this imaging system while following regulatory standardsOmniscient has contacted the US Food and Drug Administration and will complete in vivo colonoscopy studies in pigsas well as reprocessability tests needed for regulatory approvalIn the latter stages of this researchthe company will begin organizing multi center human studies that should lead to product launch following regulatory approvalOur extraordinary technology will transform the way colonoscopy is performedIt will greatly enhance polyp detectionprevent more cancers and reduce the national expenditure for colonoscopy Project Narrative Colonoscopy is the preferred screening procedure to prevent colon cancerbut is far from perfect as current endoscopes fail to see behind folds and around cornersleading to missed lesions and unexpected cancersWe will complete the development of an affordablereusableDual View device that can be used with any existing endoscopes to provide forward and backwards views in the same imageWe will evaluate it in the pig colon and assess its reusability to meet FDA requirements for regulatory approval
