RETIVUE LLC — Department of Health and Human Services SBIR Phase II: N

Description

DESCRIPTION provided by applicant Retinopathy of prematurity ROP is a treatable eye disease which affects the vision of neonatal infants with a birth weight of andlt g or gestational age of andlt weeks There are infants born each year in the US at risk for developing ROP Globally the World Health Organization has declared ROP a leading cause of vision impairment in children with more than babies suffering blindness each year due to this disease Inad equate screening of these infants results from the low numbers of pediatric trained ophthalmologists and ROP diagnostic equipment in neonatal intensive care units NICUs Remote digital fundus imaging RDFI TM has per the American Academy of Pediatrics high potential for telemedicine based diagnosis and management of ROP This can alleviate the burden of repeat on site examina tions and ensure all infants receive timely screening However current technology unfortunately lacks the di agnostic sensitivity to replace manual physician exam To overcome this hurdle RetiVue L L C has developed an early prototype of the RetiVue WF an affordable hand held imager that can image the entire peripheral retina without the need to reposition the hand piece as now required with current devices Our imager will provide the highest resolution highest image quality and widest peripheral field of view of any portable device allowing it to finally replace the need for direct physician exam Our technology will also enable for the first time portable wide field retinal imaging on older children and adult patients Phase II efforts will be focused on redesigning our interchangeable imaging module to decrease fogging enhance sterilization and improve field of view refining our patented multi beam optical design to allow im proved imaging with decreased lens haze developing alignment and autofocus assist capabilities to im prove ease of use and validating in clinical trials that our device has improved sensitivity and specificity for detecting ROP with respect to both existing devices and manual physician exam Work completed during this Phase II application will lay the technical foundation on which we can commercial ize the worldandapos s first simple to manufacture affordable highly portable and easy to use ROP screening device We hope that this highly disruptive device can help overcome the primary economic and technological access barriers to establishing successful ROP tele screening programs within NICUs in developed and developing countries alike PUBLIC HEALTH RELEVANCE Retinopathy of Prematurity ROP is a potentially blinding eye disease that affects preterm babies with very low birth weight Each year in the US babies are at risk for developing ROP with more than babies becoming blind from this disease Proper screening and early treatment of ROP is cost effective and can great ly reduce vision loss due to ROP but it is not readily available at many hospitals At RetiVue LLC we are de signing the RetiVue WF an affordable portable camera that can accurately detect ROP We believe the Re tiVue WF will for the first time enable widespread telemedicine screening programs for this disease throughout the US and abroad and thereby greatly reduce the risk and cost of unnecessary blindness in these infants