VisionQuest Biomedical Inc — Department of Health and Human Services SBIR Phase II: M

Description

DESCRIPTION provided by applicant In the US there are annual incidences of heart attack out of which are first time heart attacks Risk factors for cardiovascular disease CVD are thought to be well defined but they do not identify all at risk individuals Therefore there is a need to detect other factors that provide more near term risk assessment for CVD The early manifestations of risk factors found in the retina can detect a threat of an impending cardiovascular event and monitoring these precursors provides an early insight into risk of CVD For this reason we have developed the andquot Comprehensive Assessment of Retinal Vasculatureandquot CARV a fully automated screening device for the detection of retinal abnormalities and assessment of associated CVD risk In Phase I the research team at Vision Quest Biomedical demonstrated the feasibility of the CARV second reader system to provide objective measurements and detect potential vascular abnormalities to assist a retinal reader resulting in increased disease detection at a reduced reading time In Phase II the second reader system will evolve into a fully automatic first reader system that quantifies the risk of CVD based on retinal abnormalities We will accomplish this through two specific aims In the first aim we will add additional methods for detecting retinal abnormalities and lesions We will then develop a classifier to automatically assign a CVD risk of low moderate or severe to each case CARV processes In the second aim we will combine these software tools to produce a near real time system to automatically detect signs of hypertensive retinopathy and assign a CVD risk grade based on the results At the end of Phase II we will demonstrate a validated CARV first reader and second reader system CARV second reader will likely be given a Class I device by the FDA and we expect clearance within a year The intended use will be that of an aid to readers in a telemedicine environment With CARV second reader serving as a predicate device the CARV first reader system can be submitted as a k device to the FDA following the successful completion of a clinical trial PUBLIC HEALTH RELEVANCE Signs of cardiovascular disease CVD manifest in the retina including changes to the vasculature and lesions These abnormalities can provide additional insight into CVD risk especially for those patients who may not have more traditional risk factors Manual grading these abnormalities as they appear in retinal images can result in inaccurate and variable results In Phase I of andquot Comprehensive Assessment of Retinal Vasculatureandquot CARV we demonstrated that our system was capable of assisting retinal graders improving disease detection and reducing time needed to do so In Phase II we will develop an automatic system that can detect retinal abnormalities associated with hypertensive retinopathy and provide a CVD risk grade based on those findings It is our intention that successful implementation of this product will identify patients who were previously unaware of their risk for a cardiovascular event