VASOPTIC MEDICAL, INC. — Department of Health and Human Services SBIR Phase II: NIA

Description

ABSTRACT The availability of improved diagnostic tools in the primary care environment capable of diagnosing diseases in their earliest stages could significantly improve disease managementPrimary beneficiaries would be the elderlywho are at increased risk for a number of progressively debilitating diseasesbut who may face practical cost and convenience hurdles in routinely presenting to specialists for examinationRetinal imaging is increasingly being recognized as a means to monitor not just ophthalmic healthbut also as a surrogate indicator of neurological and cardiovascular healthAnd thereforethere is increasing support for its integration into primary care practice via telehealth approachesHowevercurrent retinal imaging products that meet the costsizeand use case requirements of the primary care environment have significant limitations in their abilities such as their inadequacy to measure blood flow or other dynamic changes in physiologyTo address this shortcoming of current technology and make a clinical impactVasoptic has proposed to develop and commercialize a low costportablenoninvasive retinal imaging instrumentthe XyCAMthat can complement fundus photographs with retinal blood flow information obtained at high spatio temporal resolution without the introduction of any dyesDuring Phase I studieswe designed and developed a custom image sensing chip with high signal to noise ratioas needed for the low light retinal imaging applicationand developed a handheld prototype with a robust software suite for image acquisition and analysisUpon confirming safety against light toxicitywe characterized performance of the XyCAM prototype by conducting proof of concept experiments in animal models and proof of feasibility studies in human subjectsOur investigation has indicated that the XyCAM prototype can image retinal blood flow with a high spatiotemporal resolution and with high reproducibilityBased on this success and our learningswe propose a Phase II effort which will includeadevelopment and validation of robust mechanisms to automatically and objectively assess the vascular status in the retinaandbdemonstration of preliminary feasibility that the XyCAM can discriminate between normal and diseased retinas through point of care assessment of retinal blood flow and associated morphological and physiological metricsOur Phase II application focuses on two disease conditions that affect the elderly and severely impact their quality of lifeAlzheimer s diseasewhich is also the sixth leading cause of death in the United States and diabetic retinopathywhich causes as many asindividuals to experience serious visual impairment every yearWhile the former could also benefit from research carried out in primary care environments leading to the development of retinal blood flow as a robust biomarker for diagnosticsthe latter could benefit from increased patient compliance and early diagnostics as is possible through telehealth methodsIf we are successfulthis study will enable aksubmission to the US FDA seeking approval to market the validated XyCAM as a general purpose retinal imager and provide us the necessary early feasibility data that justifies multi center clinical trials to investigate the sensitivity and specificity for various disease diagnostics