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Computer-based Screening for Diabetic Retinopathy

Award Number: SB1EY018280
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2008
PERIOD OF PERFORMANCE END DATE: 08/31/2020

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Computer-based Screening for Diabetic Retinopathy - Summary VisionQuest Biomedical LLC (VisionQuest) has developed a diabetic retinopathy (DR) screening system (EyeStar™) enabled by automated screening software (DR-RACS) that was developed under the EY018280 Phase II SBIR project. Our product provides immediate feedback to the physician on the state of diabetic eye disease without burdening an eye care specialist to review those cases without retinal disease. Diabetes affects over 29 million Americans, and DR is one of its main complications. If not detected early, DR leads to vision loss and blindness. With the number of diabetics projected to grow to over 50 million by 2025, worldwide DR has become a serious healthcare concern. DR- RACS will improve DR screening rates by providing a solution that is low-cost and integrated at the point of care, and that will result in increased revenues for insurance companies and healthcare providers. The main objective of this grant application is to complete the final steps needed to commercialize VisionQuest’s EyeStar™ DR screening system. For commercialization, VisionQuest requires FDA clearance of the enabling component, the DR-RACS software. This objective will be achieved through two specific aims. In Aim 1 we will make VisionQuest and the DR-RACS product compliant with the quality system regulations (QSR) in preparation for regulatory submissions. In Aim 2 we will prepare DR-RACS for FDA 510(k) submission. To achieve this goal, we will prepare a 510(k) pre-submission, carry out a multi-center clinical study, and submit a De Novo/510(k) application to the FDA. At the completion of this project, we will have the first FDA-cleared automated DR screening software. We will then be positioned to commercialize our automatic retinal screening system, EyeStar™, to serve the needs of the healthcare industry in the US and worldwide.


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: 2021 ( Subtotal = $0 )
2021	2018	VISIONQUEST BIOMEDICAL LLC	4801 LANG AVE NE STE 110	ALBUQUERQUE	NM	87109	BERNALILLO	USA	Vision Research	000	8	3/31/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $499,002 )
2018	2018	VISIONQUEST BIOMEDICAL LLC	4801 LANG AVE NE STE 110	ALBUQUERQUE	NM	87109	BERNALILLO	USA	Vision Research	000	8	8/27/2018	NON-COMPETING CONTINUATION	$499,002
														Subtotal = $499,002

Issue Date FY: 2017 ( Subtotal = $498,650 )
2017	2017	VISIONQUEST BIOMEDICAL LLC	4801 LANG AVE NE STE 110	ALBUQUERQUE	NM	87109	BERNALILLO	USA	Vision Research	000	7	8/24/2017	NON-COMPETING CONTINUATION	$498,650
														Subtotal = $498,650

Issue Date FY: 2016 ( Subtotal = $499,791 )
2016	2016	VISIONQUEST BIOMEDICAL LLC	2501 YALE BOULEVARD SOUTHEAST	ALBUQUERQUE	NM	87106	BERNALILLO	USA	Vision Research	000	6	9/15/2016	COMPETING CONTINUATION	$499,791
														Subtotal = $499,791

Grand Total All Awards = $1,497,443

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Computer-based Screening for Diabetic Retinopathy

Award Number: SB1EY018280

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/01/2008

PERIOD OF PERFORMANCE END DATE: 08/31/2020

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