RetiVue WF - A Handheld, High-Resolution, Widefield Retinal Imager

Project Summary Retinopathy of prematurity (ROP) is a treatable eye disease potentially affecting the vision of over 28,000 premature babies born in the US each year. More than 50,000 babies worldwide suffer blindness each year due to this disease. Screening remains inadequate due to the low number of ophthalmologists trained for this and a lack of affordable ROP screening equipment for neonatal intensive care units (NICUs). AI driven tele- medicine based diagnosis and management of ROP could alleviate the burden of manual physician exam and ensure all infants receive timely screening. However, images from current technology lack sufficient diagnostic quality and these devices are not easy enough to use to replace expert physicians. To overcome this hurdle RetiVue L.L.C. has developed the RetiVue WF, the most affordable and easy to use baby camera that provides the highest resolution, highest image quality, and widest field of view of any porta- ble device. Our camera can screen the entire eye for ROP in one image making worldwide premature baby teleROP screening a reality. Beyond that we can identify the 1 in 70 healthy newborns who have undetected eye disease, including tumors, that can cause them to go blind. With our technology we can finally replace the inadequate penlight exam to assess newborn baby’s eye health. Our initial Phase II efforts have resulted in a revolutionary, first commercial version of our device, now being provided to customers and distributors worldwide. However, while seeing further out and having higher image quality than any competing device, this early iteration still requires multiple images to capture the entire retina (3 instead of 10), and requires direct contact with the eye to obtain the widest field of view. A number of tech- nical obstacles limited our ability to achieve our goal of capturing the entire eye in a one image. Our proposed Phase IIB workplan will solve these remaining limitations to achieve a single position, non-con- tact, automatic capture, single image of the entire baby’s retina. These limitations will be overcome by 1) cus- tom design of a novel 200° widefield non-contact lens appropriately sized for screening the retina edge to edge on all babies 2) refining our patented multi-beam optical design to increase the number of projector spot beams from 8 to 48, while narrowing the spot beam size to improve image quality 3) increasing our the camera speed to capture the multiple retinal images formed by each of these 48 spot beams 4) designing a new lid speculum to better align the camera with eye and hold eye in place for easy non-contact imaging 5) create a program- mable camera aperture and improve dehaze algorithms to improve image quality by limiting out of focus haze 6) validating in clinical trials that our device has improved sensitivity and specificity for detecting ROP with re- spect to both other baby cameras and direct physician exam. We believe this highly disruptive device once completed will overcome the remaining economic and technological barriers to establish successful ROP and universal newborn tele-screening programs worldwide.Project Narrative Each year 28,000 premature babies born in the US are at-risk for developing Retinopathy of Prematurity (ROP), an eye disease which will cause more than 500 babies to go blind. Photographic screening of the eye, with early treatment if ROP is seen, can prevent most vision loss, but this technology is not available at most hospitals because baby cameras are too hard to use, don’t take good pictures, and cost too much. At RetiVue LLC, we are designing the RetiVue WF, a baby camera that is $50,000 less than competing cameras, the only baby camera that can screen the entire eye in a single image, the only baby camera that doesn’t have to con- tact the eye to take a picture, and the only baby camera that takes these pictures by itself, automatically; all of which means any hospital can afford it and anyone can use it to help stop babies from continuing to go blind.