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Dual View Endoscopy for Colonoscopy

Award Number: R42CA203212
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2016
PERIOD OF PERFORMANCE END DATE: 09/30/2021

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Dual View Endoscopy for Colonoscopy - Abstract( ( An estimated 16 million colonoscopies are performed annually in the US at a cost of about $24B, however current colonoscopes with forward vision fail to detect 25-40% of precancerous polyps. Over 70% of the missed polyps are located on or behind numerous folds in the colon where they are hidden from the sight of a forward-view colonoscope. In this research proposal, we propose to complete our development of an imaging system that provides unprecedented forward as well as 360-degree reverse views in a single image. In our STTR Phase I study, we successfully developed our second prototype and re-confirmed the substantial superiority of our Dual View technique over standard colonoscopy. The technology was invented by the co- founders of the company, a gastroenterologist and an optical scientist at the University of Arizona and has been licensed by Omniscient. Device development was guided by feedback from endoscopists and industry executives. In this proposal we will further miniaturize the device, improve resolution and build an imaging system that can be integrated with any commercial endoscopy platform. Our market research indicated an overwhelming need for an `add-on' that can be used in conjunction with existing endoscopes, rather than a totally new endoscope. In collaboration with the University of Arizona, Omniscient will develop an imaging system where a capsule with a diameter of about 4 mm can be attached to the tip of any existing colonoscope to provide endoscopists with unprecedented forward and 360-degree backwards views in a single display monitor. This reusable endoscopic accessory will avoid the need and expense of replacing an endoscopy platform, allow our product to be highly cost-effective and permit the endoscopist to continue to use their preferred endoscope. We have assembled a multi-disciplinary team and formed collaborations with industry partners in lens fabrication, camera manufacturing and medical device marketing to facilitate the successful development and market launch of our product. We will continue to use end-use and market feedback to fine- tune the development of this imaging system while following regulatory standards. Omniscient has contacted the US Food and Drug Administration and will complete in-vivo colonoscopy studies in pigs, as well as reprocessability tests needed for regulatory approval. In the latter stages of this research, the company will begin organizing multi-center human studies that should lead to product launch following regulatory approval. Our extraordinary technology will transform the way colonoscopy is performed. It will greatly enhance polyp detection, prevent more cancers and reduce the national expenditure for colonoscopy.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	OMNISCIENT IMAGING, INC.	1661 N SWAN RD STE 300	TUCSON	AZ	85712	PIMA	USA	Cancer Detection and Diagnosis Research	000	4	2/17/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	OMNISCIENT IMAGING, INC.	6463 E VIA AMABLE	TUCSON	AZ	85750	PIMA	USA	Cancer Detection and Diagnosis Research	001	4	7/10/2021	NON-COMPETING CONTINUATION	$0
2021	2018	OMNISCIENT IMAGING, INC.	1661 N SWAN RD STE 300	TUCSON	AZ	85712	PIMA	USA	Cancer Detection and Diagnosis Research	000	2	3/31/2021	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $1,116,980 )
2019	2019	OMNISCIENT IMAGING, INC.	6463 E VIA AMABLE	TUCSON	AZ	85750	PIMA	USA	Cancer Detection and Diagnosis Research	003	4	8/2/2019	NON-COMPETING CONTINUATION	$1,116,980
2019	2018	OMNISCIENT IMAGING, INC.	6463 E VIA AMABLE	TUCSON	AZ	85750	PIMA	USA	Cancer Detection and Diagnosis Research	002	3	7/10/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$710,255
2019	2018	OMNISCIENT LLC	6463 E VIA AMABLE	TUCSON	AZ	85750	PIMA	USA	Cancer Detection and Diagnosis Research	000	2	4/3/2019	COMPETING CONTINUATION	$0
2019	2018	OMNISCIENT IMAGING, INC.	6463 E VIA AMABLE	TUCSON	AZ	85750	PIMA	USA	Cancer Detection and Diagnosis Research	001	2	7/9/2019	COMPETING CONTINUATION	-$710,255
														Subtotal = $1,116,980

Issue Date FY: 2018 ( Subtotal = $872,389 )
2018	2018	OMNISCIENT LLC	6463 E VIA AMABLE	TUCSON	AZ	85750	PIMA	USA	Cancer Detection and Diagnosis Research	000	2	9/20/2018	COMPETING CONTINUATION	$872,389
														Subtotal = $872,389

Grand Total All Awards = $1,989,369

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Dual View Endoscopy for Colonoscopy

Award Number: R42CA203212

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/01/2016

PERIOD OF PERFORMANCE END DATE: 09/30/2021

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