VisionQuest Biomedical Inc — Department of Health and Human Services SBIR Phase I: NEI

Description

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 EY 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 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 million by 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 we will make VisionQuest and the DR RACS product compliant with the quality system regulations QSR in preparation for regulatory submissions In Aim we will prepare DR RACS for FDA k submission To achieve this goal we will prepare a k pre submission carry out a multi center clinical study and submit a De Novo 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 Narrative Diabetic retinopathy DR is a complication of diabetes a disease that affects over million Americans and is the leading cause of blindness in working age population The main objective of this project is to complete the final steps needed to commercialize VisionQuestandapos s EyeStar DR screening system This project is relevant to public health because it addresses the need of providing better and more widespread eye care to diabetics thus improving their health outcomes and preventing blindness